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to evaluate the outcomes of EVAR performed with a new generation of bifurcated endografts and limbs.
prospectively collected data from fifty consecutive patients with abdominal aortic aneurysms (AAA) treated at our institution with a Low Profile Zenith® bifurcated body/Zenith® Spiral-Z legs combo were analysed. AngioCT scans and Ultrasound exams were performed prior to discharge. Ultrasound examination was repeated 6 months after the procedure to assess endograft patency and to depict endoleaks
Median age was 70.6 years [50–88] and median ASA score was 3 [2–4]. Median aortic diameter was 56 mm [49–81]. Of the 100 external iliac access vessels, 14 had a diameter of 6 mm or lower. All endografts were successfully implanted. Post-operative Ultrasound examination and angioCT scan depicted both 1 type Ia, and 10 and 19 type 2 endoleaks respectively. An asymptomatic thrombosis of the left external iliac artery distal to the endograft limb was also depicted. 30-day mortality rate was 0%. Two patients died respectively three and four months after EVAR. Both deaths were not aneurysm related. All patients underwent an ultrasound exam 6–12 months after EVAR. All endografts main bodies and limbs were patent. Five endoleaks were depicted, all were type II endoleaks (the early type Ia endoleak had sealed spontaneously; it was confirmed by an angioCT scan). One patient presented a significant stenosis of the left iliac limb at the level of a narrow and calcified aortic bifurcation. It was successfully treated by bilateral iliac angioplasty and kissing balloon stenting.
EVAR performed with the Zenith LP main body in combination with Spiral-Z Iliac Legs is safe and effective. No limb occlusions were diagnosed at the 6 month follow up even in challenging iliac anatomies usually considered as contra indications for EVAR. Our first results are most satisfying and calling to be completed by a longer follow up.
This study is the first to evaluate EVAR performed with the combination of a low profile endograft main body and limbs constructed with a continuous spiral stent, both designed to accommodate patients with challenging iliac anatomies.
Since the first endovascular repair of an infrarenal abdominal aortic aneurysm (EVAR) published by Parodi et al.,
endografts have undergone continuous improvement. A decade ago, the various EVAR components required 18 to 24 Fr delivery systems, and 21 to 28 Fr for TEVAR - limiting treatment to patients with large vascular access vessels (at least 7 mm diameter) or requiring use of vascular conduits. According to the 2000 EUROSTAR report,
most conversions were required because of poor vascular access. To overcome these issues, manufacturers have developed lower profile delivery systems. Sheath sizes as low as 14–16 Fr allow treatment of patients with challenging access. It is also expected that these patients with challenging access and narrow, calcified tortuous iliac arteries will have higher rates of iliac complications such as limb occlusions, limb stenosis, and limb kinking. To address these issues a new generation of iliac limbs is also now available. Their design is intended to conform better to kinked and narrow iliac arteries. Cook Medical almost simultaneously released on the European market a new low profile endograft (Zenith LP) and a new iliac limb (Zenith Spiral-Z). Although not specifically indicated to be used together (the Spiral-Z iliac limb is indicated for uses with the Zenith Flex AAA), these Spiral-Z limb connects to the Zenith LP main body with 2 mm of oversizing. Moreover, the maximum sheath size for the Zenith LP and the Spiral-Z leg are both 16 Fr. As such this combination of devices provides a low profile system for patients with difficult access. Based on independent results with the Zenith LP bifurcated graft and the Zenith Spiral-Z legs, we hypothesized the combination would provide an optimal combination for EVAR. To test this hypothesis, our center started use of this combination of devices at the beginning of 2012. This paper presents the outcomes of the first fifty consecutive patients with a minimum 6-month follow-up.
Material and Methods
Study design and patient selection
Our study analysed the first fifty consecutive patients with abdominal aortic aneurysms or aortoiliac aneurysms treated at our institution with a Low Profile Zenith® (Cook medical, Bloomington, Ind, USA) bifurcated body in combination with Zenith® Spiral-Z legs (Cook medical) (Fig. 1).
All data are reported according to the reporting standards for AAA endovascular repair.
Surgical data analysed the approach technique (upon surgeon's preference, open approach or percutaneous femoral puncture in combination with the Proglide® or Prostar® closure systems, (Abbott, Menlo Park, Calif, USA), the side of introduction of the bifurcated body, and the need for an additional procedure.
Post-operative data (performed before discharge) compiled the Doppler analysis of the iliac and femoral axis, and the CT scan analysis (contrast enhanced if the GFR was>40 ml/min).
All patients underwent a preoperative angioCT scan, except one whose renal function contraindicated iodinated contrast medium injection, and who therefore underwent an MR angiography. Preoperative sizing was done on a center line reconstruction of the preoperative CT scan using Aquarius software (TeraRecon, Focter City, CA, USA). The following anatomical data were analysed: diameter and length of the proximal neck, maximum aneurysm diameter, diameter and calcification of the aorto-iliac bifurcation, and diameter and calcification of the common and external iliac arteries. External and common iliac arteries were considered calcified when a calcified stenosis of at least 30% and a minimum 1 cm length was depicted.
All procedures were performed under general anaesthesia in an operating theatre using a motorized image intensifier (GE-OEC 9900, GE Medical Systems, Milwaukee, Wis, USA) in half-dose and pulse mode. We performed twenty-eight conventional open bilateral surgical approaches, and twenty-two bilateral percutaneous approaches with the Proglide® or Prostar® closing systems (Abbott). The EVAR procedures were performed following the instructions for use from the manufacturer (with the exception of a sheath exchange for the ipsilateral limb deployment).
Zenith® LP main body(cook medical)
According to the manufacturer, the Zenith Low Profile AAA Endovascular Graft bifurcated aortic main body (ZALB) is constructed of woven polyester fabric sewn to self-expanding nitinol stents with braided polyester and monofilament polypropylene suture. The body is fully stented. The bare suprarenal stent at the proximal end of the graft contains barbs for additional fixation of the device. The inner diameter of its integrated delivery sheath is 16Fr.
Zenith® Spiral-Z Iliac Legs (Cook medical)
The Zenith Spiral-Z AAA Iliac Legs (ZSLE) are constructed of full-thickness woven polyester fabric sewn to two self-expanding stainless steel Cook-Z® stents and a continuous nitinol spiral stent with braided polyester and monofilament polypropylene suture. The graft is also fully stented. The inner diameter of its delivery system is either 14Fr (16 mm and lower distal iliac leg diameter) or 16 Fr depending on the graft diameter.
Both clinical and technical successes were analysed. Technical success was defined as prosthesis implantation without surgical conversion, patient death nor type I or III endoleaks at 24 h. Clinical success was defined as absence of morbidity and mortality during the perioperative and postoperative period up to 30 days after surgery.
Major and minor adverse events were recorded, as well as all causes of death. Major adverse events were defined as myocardial infarction, post-operative decompensated renal failure, and acute respiratory failure requiring either assisted mechanical ventilation for more than 72 h, or reintubation. Decompensated renal failure was defined as a clearance decline of over 10% or over 20 mL.min-1 compared to preoperative clearance. Minor adverse events were presence of a pseudoaneurysm, of a femoral stenosis or a lymphocele, dissection of iliofemoral arteries or cutaneous infection.
In addition to the aforementioned postoperative exams, a new ultrasound examination of the aorta and the iliofemoral axis was performed six months after the endograft implantation.
Our retrospective study of prospectively collected data analysed the outcomes of fifty patients (forty-nine men), with a median age of 70.6 years [50–88] and a median ASA score of 3 [2–4], treated between January and June 2012. During the study period, 67 additional patients with an AAA were treated at our institution: 44 by open surgery, 2 with an aorto uni iliac endograft, and 21 with a fenestrated device.
Among the fifty patients treated, forty-six had an aortic or aortoiliac aneurysm (including two false aneurysms), and four isolated common iliac aneurysms. Median aortic diameter was 56 mm [49–81] for the aortic or aortoiliac aneurysms, and median iliac diameter was 39 mm [32–48] for the isolated iliac aneurysms. Median proximal neck diameter was 23.3 mm [17–29 mm] and median proximal neck length was 27.7 mm [12–38].
The median common iliac arteries diameter in patients with isolated aortic aneurysms was 12.4 mm [8–48 mm] on the right side and 13.7 mm [7–43 mm] on the left side. Twenty common iliac arteries were calcified (40%). External iliac arteries had a median diameter of 9.2 mm [5–17 mm]; 25 were calcified (50%). Of the 100 external iliac access vessels, 14 had a diameter of 6 mm or lower.
Five different operators performed the fifty procedures. One patient was treated emergently upon detection of a tender 75 mm diameter AAA. Implantation under full anticoagulation established using sodium heparin (50 units/kg) of the main body and both iliac limbs was successfully performed in all cases. The main body was introduced through the right common femoral artery in 36 cases. No iliac conduits were required.
Five additional procedures were planned and performed: 3 embolizations of the origin of the internal iliac artery trunk and 2 angioplasty-stenting (one kissing bilateral common iliac angioplasty-stenting in a patient with an 18 mm calcified aortic bifurcation, and one angioplasty/stenting of a limb in a kinked iliac artery).
A left inferior polar renal artery (2.5 mm diameter) was deliberately covered to achieve a proximal seal (it was not associated with post-operative renal impairment). No unexpected coverage of a renal artery or an intern iliac artery occurred. Median contrast media volume and operation time were 72 ml (30–160 ml) and 83 min (44–130 min) respectively.
The only peroperative complication depicted was a percutaneous closure system failure (incomplete haemostasis requiring open femoral artery repair), which occurred twice on 46 percutaneous approaches (4.3%). These failures were not associated with small calibre access vessels (9 mm diameter in both cases) or calcifications.
Median hospital stay was 8.1 days [5–26]. All patients had post-operative antiplatelet therapy. Before discharge, 47 of the 50 patients underwent ultrasound examination of the aorta and the ilio–femoral axis. A postoperative angioCT scan was performed in 46 patients. The remaining 4 patients had a CT scan with no contrast medium injection because of an altered renal function. No patients required dialysis following EVAR.
Ultrasound examination depicted 11 endoleaks: 1 type I, 10 type II and no types III or IV. The type I endoleak was proximal, considered of very limited volume; no additional treatment was scheduled at his stage.
The ultrasound controls of femoral access sites identified: 5 hematomas, 2 pseudoaneurysms, 5 dissections, 2 stenosis, 1 lymphocele and 1 thrombosis of the left external iliac artery (distal to the endograft limb). All were asymptomatic and none required a secondary intervention (manual compression was performed to occlude the 2 pseudoaneurysms). The external iliac thrombosis was asymptomatic and required no further treatment; it was probably due to the small calibre of this vessel (6 mm diameter).
AngioCTscan analysis depicted 20 endoleaks: one proximal type I, 19 type II, and no type III or IV.
Six-month follow up
The survival rate at six months was 96%. Two patients died respectively three and four months after EVAR (cardiac failure and pneumonia). Both deaths were not aneurysm related.
All patients underwent an aorto-iliac control ultrasound exam 6–12 months after EVAR. All endografts main bodies and limbs were patent. Five endoleaks were depicted, all were type II endoleaks (the early type Ia endoleak had sealed spontaneously; it was confirmed by an angioCT scan). One additional femoral pseudoaneurysm was diagnosed (currently undergoing ultrasound surveillance).
During follow-up, one patient presented six months after discharge with disabling claudication of the lower limbs. Ultrasonography showed a patent endograft and an excluded aneurysm; however, there was a significant stenosis of the left iliac limb. A new analysis of the preoperative images found a narrow (18 mm) and calcified aortic bifurcation. A complementary procedure (bilateral iliac angioplasty and kissing balloon stenting of the iliac limbs with balloon expandable 10 mm stents) was thus performed 7 months after the initial surgery. Postoperative Doppler control showed good morphologic and haemodynamic results and the initial symptoms had resolved at discharge.
Early experience with the Spiral-Z iliac limb in association with the LP body has shown very favourable outcomes, even in patients with challenging iliac anatomies. No procedure required a retroperitoneal approach or a conduit to enable vascular access. While the smallest iliac diameter in our series was 5 mm, fourteen vascular accesses were classified as difficult because of a vessel diameter of 6 mm or less. These 14 accesses entailed neither major perioperative complication nor necessity for conversion. Although we noted dissection and stenosis on these small calibre vessels, these complications have also been reported for superior calibre vessels in the literature.
reported access difficulties for 13% of all endovascular procedures in the EUROSTAR Registry. More specifically, 28.6% of the 49 conversion cases were a result of failure to introduce or injury from introduction of the bifurcated main body, historically the largest profile component of the system. However, the EVAR delivery systems used were of a larger diameter (20Fr and above) than those used in our study (16Fr inner diameter).
showed that one of the risk factors for contraindication to endovascular procedures was small vascular access and particularly external iliac arteries under 7 mm in diameter, thus unable to bear 18 Fr sheaths. According to them, only 70% of males and 44% of females were eligible for an endovascular procedure; of the excluded patients, 47% (both genders) were ineligible because of an unfavourable iliac anatomy. 16 Fr Low Profile EVAR was not available in 2000, their evaluation would probably be different nowadays.
Had we limited ourselves, in our study, to extern iliac axis greater than 7 mm, eleven patients (>20%) out of fifty wouldn't have been candidates for an EVAR procedure. Eight of them would have been eligible for an aorto-uniiliac endograft requiring a cross over femoral bypass.
Treating patients with small calibre vascular access could cause, on the long term, more limb occlusions and thrombosis, according to Carroccio et al.
They reported a 0% incidence of graft limb occlusion through 3 years in patients treated with adjunctive stent placement at the time of the procedure as compared to a 7.1% (13/184) rate of limb occlusion in patients without adjunctive stent placement. In our study, angioplasty was required in 2 patients during the index procedure and in one patient during follow-up to maintain all limbs patent.
Often extension of the limbs into the external iliacs is required to insure a good seal. However landing the endograft distally in the smaller diameter external iliac increases the thrombosis risk.
In our study, there were no limb occlusions when the Spiral Z limbs were implanted in the external iliacs (3 cases).
Several manufacturers have developed Low Profile EVAR systems. Medtronic's Endurant (Medtronic, Santa Rosa, Calif, USA) endograft is loaded an 18–20 Fr delivery system (outer diameter). The various series evaluating this endograft
report a satisfying technical success rate even in difficult anatomies. They all report difficulties or complications due to small calibre accesses, such as iliac artery dissections, conversion for iliac artery rupture, or launching failure. Rouwet and al described two claudication-inducing iliac artery dissections, one limb thrombosis before discharge, one limb occlusion at 30 days and three after a year.
in their 45-cases series, described 5 iliac limb stenosis that required iliac stenting. Follow-up showed, at one month, a limb thrombosis successfully treated by thrombectomy and angioplasty-stenting - a successful procedure with 12-month permeability. Our 50-case series found no limb occlusions at 6-month follow up, but documented one stenosis requiring angioplasty-stenting, and one post-operative external iliac thrombosis beyond the limb. This limb remained patent at six months.
Our series is the first to describe results of the Zenith LP main body in combination with Spiral-Z Iliac Legs. No major complications were depicted. Specifically there was a 0% rate of limb occlusions noted at the 6 month follow up. One external iliac artery occlusion was diagnosed below a patent iliac limb and one limb stenosis required a secondary procedure. Our first results are most satisfying in this cohort of patients some of whom had challenging anatomy and calling to be completed by a longer follow up.
Conflict of Interest
Stéphan Haulon is consultant for Cook Medical and GE Healthcare.
Transfemoral intraluminal graft implantation for abdominal aortic aneurysms.