From the Society for Vascular Surgery
Juxtarenal endovascular therapy with fenestrated and branched stent grafts after previous infrarenal repair Magnus Sveinsson, MD,a,b Thorarinn Kristmundsson, MD, PhD,b Nuno Dias, MD, PhD,b,c Bjorn Sonesson, MD, PhD,b,c Kevin Mani, MD, PhD,d Anders Wanhainen, MD, PhD,d and Timothy Resch, MD, PhD,b,c Helsingborg, Malmö, Lund, and Uppsala, Sweden
ABSTRACT Background: The treatment strategy for proximal aortic disease or type I endoleak after previous infrarenal repair has traditionally been open surgery. As endovascular treatment options with fenestrated and branched stent grafts increasingly rival open surgery for juxtarenal and pararenal aortic aneurysms, secondary proximal repair may similarly be performed endovascularly. Fenestrated stent grafts are individually tailored to each patient, whereas a more readily available “off-the-shelf” branched stent graft is often suitable in more urgent settings. Methods: All patients who had been reoperated on with a proximal fenestrated or branched cuff after previous infrarenal endovascular or open repair from two tertiary referral centers between 2002 and 2015 were included in the analysis. Patients were retrospectively enrolled in a digital database. Data were collected from chart review and digital imaging. Results: There were 43 patients, 37 (86%) male and six (14%) female, who were treated. The indications for proximal endovascular repair were type I endoleak (58%), proximal aneurysm formation (30%), and stent graft migration (12%). Median follow-up time was 33 months (range, 3-120 months); 34 patients (79%) received a fenestrated cuff, and branched stent grafts were used in 8 (19%) cases. The majority of grafts had three (47%) or four (49%) fenestrations or branches. Technical success was accomplished in 93% of cases. In two cases, the celiac trunk occluded; in one case, the hepatic artery was overstented, and a renal artery could not be cannulated in one case. Median hospital stay was 5 days (range, 2-57 days). The 30-day mortality was 0%, and 1-year mortality was 5%. One patient died of an aneurysm-related cause during the study period. Conclusions: An endovascular approach with fenestrated or branched stent grafts for treatment of proximal endoleak, proximal aneurysm formation, or pseudoaneurysms after previous infrarenal repair seems to be a valid alternative to open surgery. (J Vasc Surg 2019;-:1-7.) Keywords: FEVAR; Fenestrated; Branched; Cuff
Although infrarenal aortic repair with open and endovascular techniques is durable, redo aortic surgery is required in up to 10% of patients because of graft failure or extension of the aneurysmal disease.1 The treatment strategy of choice for failure after previous open and endovascular infrarenal repair has traditionally been open surgical explantation and aortic reconstruction
From the Department of Vascular Surgery, Helsingborg Regional Hospital, Helsingborga; the Vascular Center, Skåne University Hospital Malmö, Malmöb; the Department of Clinical Sciences, Lund University, Lundc; and the Department of Surgical Sciences, Uppsala University, Uppsala.d Author conflict of interest: N.D., B.S., K.M., A.W., and T.R. are consultants for Cook Medical. Presented as a poster at the 2017 Vascular Annular Meeting of the Society for Vascular Surgery, San Diego, Calif, May 31-June 3, 2017. Correspondence: Magnus Sveinsson, MD, Skåne University Hospital Malmö, Ruth Lundskogs gata 10/1, 205 02 Malmö, Sweden (e-mail: magnus.
[email protected]). The editors and reviewers of this article have no relevant financial relationships to disclose per the JVS policy that requires reviewers to decline review of any manuscript for which they may have a conflict of interest. 0741-5214 Copyright Ó 2019 by the Society for Vascular Surgery. Published by Elsevier Inc. https://doi.org/10.1016/j.jvs.2019.01.078
with straight or bifurcated Dacron grafts. Failure of aneurysm repair is multifactorial, including progression of aneurysm disease proximally or distally, stent graft migration, and type IA endoleak.2 With regard to primary endovascular repair, poor selection of patients and treatment outside of instructions for use (IFU) are also contributing factors.2,3 Open conversion involves considerable operative trauma for patients and often includes suprarenal clamping and lengthy postoperative care. In-hospital mortality after open explantation because of failed endovascular aneurysm repair (EVAR) has been reported to be as high as 17% to 22%.1,4,5 As endovascular treatment options with fenestrated and branched stent grafts increasingly rival open surgery for juxtarenal and pararenal aortic aneurysms, secondary proximal repair may similarly be performed endovascularly. Fenestrated endografts were introduced in the late 1990s.6 The fenestrations allow the stent graft to be placed across the visceral segment of the aorta while preserving flow to the visceral arteries. Thus, the aortic repair is extended proximally to a healthy aortic segment where a stent graft can seal securely.7,8 In primary endovascular reconstruction of juxtarenal abdominal aortic 1
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aneurysms (AAAs), the fenestrated graft is usually accompanied by a bifurcated infrarenal multimodular stent graft for complete aneurysm exclusion. In secondary repair, a fenestrated “cuff” is often sufficient as a complementary component to the previous repair when the failure is in the proximal sealing zone. In the elective setting, fenestrated stent grafts are individually tailored to each patient. In urgent cases, in which immediate repair is warranted, customized designs are not available. In these situations, an “off-the-shelf” branched stent graft is often the only option. The Cook t-Branch (Cook Medical, Bloomington, Ind) has a standard design to accommodate target vessels in aneurysms involving the visceral aortic segment. Data indicate that the t-Branch endograft is applicable to 65% to 80% of these aneurysms.9,10 Clinical series on endovascular aortic repair for complex aneurysms after previous infrarenal repair are scarce in the literature, but reports indicate that it is a safe means of treatment.11-15 The reports consist largely of nonurgent treatment and are heterogeneous in selection of patients. The aim of this study was to evaluate operative outcome from secondary proximal endovascular repair after previous infrarenal reconstruction for AAAs.
METHODS All patients who were reoperated on between the years 2002 and 2015 with a proximal fenestrated or branched cuff after previous infrarenal endovascular or open aortic repair were included in the analysis. Data were collected from two tertiary referral centers in Sweden, Skåne University Hospital in Malmö and Uppsala University Hospital. Patients were retrospectively enrolled in a digital database, and charts and images were reviewed. Comorbidities and technical success were defined according to Society for Vascular Surgery/International Society for Cardiovascular Surgery reporting standards.16 In both centers, all procedures were performed with a Siemens Artis zee fixed imaging system (Siemens Medical Solutions, Erlangen, Germany) in a dedicated hybrid operating room. During the study period, protocols for intraoperative imaging and contrast material use remained virtually unchanged. However, a successive change to the use of lower dose fluoroscopy was implemented as imaging software was updated over time, particularly as fusion techniques progressed.17 For the purpose of this study, patients who underwent fenestrated EVAR for thoracoabdominal aneurysms were excluded from the analysis. All fenestrated grafts for elective patients were custommade and individually tailored to fit a particular patient and manufactured by Cook Medical Inc. Preoperative workup for all patients included a physical examination, blood tests, and high-resolution computed tomography angiography (CTA). Stent grafts were planned and
2019
ARTICLE HIGHLIGHTS d
d
d
Type of Research: Multicenter retrospective cohort study Key Findings: Endovascular treatment after 43 previous infrarenal aortic repairs using fenestrated or branched cuff resulted in 0% 30-day mortality. At 1 year, mortality was 5% and target vessel patency was 95.2%. Take Home Message: Endovascular treatment with fenestrated or branched stent grafts for type IA endoleak, proximal aneurysm formation, or pseudoaneurysms after previous infrarenal repair is a safe and effective choice.
designed using a three-dimensional workstation equipped with centerline measuring software (Aquarius iNtuition Viewer [TeraRecon, San Mateo, Calif] or 3mensio [Pie Medical Imaging BV, Maastricht, The Netherlands]). Follow-up consisted of clinical evaluation at 1 month as well as CTA at 1 month and 1 year, followed by CTA and plain radiography yearly. Death was verified through the Swedish National Population Registry. Aneurysmrelated death was defined as death occurring within 30 days of the procedure or late death associated with stent graft complications. During follow-up, changes in aneurysm diameter, structural changes in the stent graft, type IA endoleak, and target vessel patency were registered. Aneurysm diameter changes were considered significant when $5 mm. This study was approved by the Regional Ethics Committee at Lund University (2014/732) and at Uppsala University (2017/027). Informed consent was obtained from all patients participating in this study. Statistics. Statistical analysis was performed with SPSS version 24.0 software (IBM Corp, Armonk, NY). Categorical variables are indicated by frequency and percentage. Continuous results are shown by means and standard deviations or median and range. Kaplan-Meier analysis was performed for assessment of survival and reinterventions.
RESULTS During the study period, a total of 470 patients underwent primary fenestrated or branched endografting in both centers. Fewer than 10 patients underwent open conversion, mainly because of graft infection. In this series, 43 patients were treated, 37 (86%) male and 6 (14%) female. Median age was 72 years (range, 56-84 years). Baseline characteristics are shown in Table I. The indications for proximal endovascular repair were type I endoleak (58%), proximal aneurysm or pseudoaneurysm formation (30%), and stent graft migration (12%). The formation of pseudoaneurysm was exclusively
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Table I. Demographics
Male
Table II. Operative results No.
%
37
86.0
Mean 331
151
104
36
Age, years, mean
73
Fluoroscopy time, minutes
AAA diameter, mm, mean
66
Contrast material load, g
34.5
Smoking
34
79.1
Fenestrations or branches
3.4
Hypertension
31
72.1
Stented target vessels
2.8
7
16.3
Days in hospital
8.9
Coronary heart disease
15
34.9
SD, Standard deviation.
Congestive heart failure
5
11.6
COPD
11
25.6
CRI (GFR <60 mL/min/1.73 m2)
5
11.6
CVI
1
2.3
Diabetes
AAA, Abdominal aortic aneurysm; COPD, chronic obstructive pulmonary disease; CRI, chronic renal insufficiency; CVI, cerebrovascular insult (stroke); GFR, glomerular filtration rate.
seen after previous open repair. Mean aneurysm diameter at intervention was 66 mm (range, 27-108 mm). EVAR was the most common form of previous repair in 32 (75%) cases, and open repair was performed in 11 (25%) cases. Of 18 patients for whom images were available for adequate evaluation of the primary intervention, 12 (66%) were outside IFU for the initial stent graft regarding neck anatomy. There were 34 patients (79%) who received a fenestrated cuff, and branched stent grafts were used in 8 (19%) cases. In one case, a hybrid stent graft with a branch for the celiac trunk and fenestrations for the superior mesenteric artery and renal arteries was used; 28 patients (65%) were treated with only a fenestrated or branched cuff, 8 (19%) were relined with an infrarenal bifurcated system in addition to the cuff, and 7 (16%) received a cuff with or without a bifurcated system in addition to some form of synchronous arterial repair. The total number of target vessels was 146, of which 119 (82%) were stented. Target vessels treated with scallops were generally left unstented. In two instances, fenestrations aligned perfectly to the target vessel ostium without endoleak and were left unstented. All branches were stented. The mean number of scallops, fenestrations, or branches was 3.4. Four patients were treated urgently, and in three of these cases, a branched device was used. In the remaining case, a fenestrated graft fitted for the patient was ready for use in an elective setting as the patient presented in urgent need for repair because of rupture. Procedural outcomes are outlined in Table II. Technical success was accomplished in 93% of cases. In one case, the celiac trunk occluded because of a misaligned fenestration. This did not result in any type I endoleak. In one case, the hepatic artery was overstented because of dissection, and a renal artery could not be cannulated in one case. During the first 30 postoperative days, 16.3% of patients suffered from a minor complication and 20.9% had a
6 SD
Procedure time, minutes
19.6
10.0
major complication, as shown in Table III. Spinal ischemia occurred in two patients. In one, the ischemia resolved without the patient’s permanent dysfunction after replacement of the spinal canal drainage; the second case resulted in permanent paraplegia. Two patients suffered a minor stroke, and a significant renal insufficiency was observed in four cases, with one patient needing dialysis transiently. Median hospital stay was 5 days (mean, 9 days; range, 2-57 days), and mean intensive care unit stay was 1 day (range, 1-8 days); 69.8% of patients did not need intensive care and were managed in a dedicated postoperative care unit after the procedure in accordance with local routines. Table IV contains follow-up data. Median follow-up time was 33 months (range, 3-120 months). Mean time between the primary repair and the secondary proximal extension with the fenestrated or branched device was 59 months (range, 5-180 months). Type I endoleak was detected during the first 12 months of follow-up in three cases (7%). Target vessel patency was 97.3% after 1 month and 95.2% after 1 year. Reintervention was performed in 12 patients during the study period (Fig 1), including all cases of detected type I endoleak. Of those, a left renal artery was successfully restented in one case, and one patient needed proximal extension with chimneys to the superior mesenteric artery and both renals. In the last case with type IA endoleak, the patient had received a large self-expanding nitinol stent proximally in a failed attempt to treat a type I endoleak before the fenestrated cuff extension. Anticipating the challenging access to the renals, the patient was taken to the angiography suite preoperatively, and both renals were catheterized with ease. During subsequent placement of the fenestrated cuff, however, stenting of the left renal artery was not successful despite successful catheterization. This was due to “shuttering” from the struts of the proximal nitinol stent. This was the only case with persistent intraoperative type I endoleak. The 30-day mortality was 0%, and 1-year mortality was 4.3% (Fig 2). One patient died of an aneurysm-related cause during the study period as a result of sepsis after stent graft infection.
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Table III. Complications within 30 days Complication
No.
Spinal ischemia
2
Acute myocardial infarction
1
Respiratory failure
2
Minor stroke
2
Renal insufficiency
4
Pneumonia
2
Groin hematoma
2
Groin infection
1
Urinary tract infection
1
Table IV. Follow-up results No. Type I endoleak Target vessel patency
%
3
7
138/146
94.5
Reintervention
12
27.9
30-day mortality
0
0
1-year mortality
2
4.7
Follow-up time, months, mean
Fig 1. Time to first reintervention in months.
33
DISCUSSION Reoperation after previous infrarenal aortic repair presents a challenge. In this study, we have shown that an endovascular approach with fenestrated or branched endografts for progressive proximal disease is a safe and feasible treatment strategy. It comes, however, with its due share of risks, such as failure to successfully cannulate a renal or visceral artery perioperatively or stenosis of a stented target vessel with elevated risk of occlusion during follow-up. Compared with primary fenestrated repair, the outcome from this series implies longer operating times with a lower technical success rate for a secondary fenestrated cuff. These results are comparable to other similar studies.2 However, the true procedure time of placing the fenestrated cuff was in many cases masked by the fact that other concomitant vascular repair was performed in the same setting. In an earlier series, we reported outcomes of primary repair with fenestrated endografts for juxtarenal AAAs with a frequency of type I endoleak of 1.0% and a reintervention rate of 12% in the first 12 months.18 The same parameters in this series show poorer results, indicating a higher frequency of complications when fenestrated stent grafts are used as a complementary repair to earlier infrarenal repair. The proximal sealing zone remains an important obstacle for endovascular abdominal aortic repair. Outcome in the setting of hostile necks is clearly jeopardized compared with EVAR performed within IFU.19,20 The leading causes for a secondary fenestrated cuff after
Fig 2. Survival of patients in months.
EVAR in this series were type I endoleak and stent graft migration. In >60% of cases, the neck anatomy was outside IFU for the device used in the primary repair, which highlights the need for good preoperative planning. Aneurysmal disease is a progressive one, and this will continue to be source of concern in preoperative evaluation of AAAs, regardless of open or endovascular strategy. The seal zone requirement has evolved over time as this series extends for a significant number of years. We aim for a minimum of 25 mm of new proximal seal. Currently, repair is usually made with a four-vessel design to achieve a 4- to 5-cm new proximal landing zone. In the early series, only two- or three-vessel extensions were more frequent because of perceived technical challenges.18 Fig 3 illustrates a failed EVAR due to graft
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Fig 3. A, Infrarenal bifurcated stent graft with distal migration, leaving almost no proximal seal. B, Insertion of a fenestrated cuff with a scallop for the celiac trunk and three fenestrations for the superior mesenteric artery and renals. C, Final angiography with a fully deployed cuff and stented target vessels.
migration, with placement of a fenestrated cuff and a final result. The alternative to endovascular repair with a fenestrated or branched graft is open surgery, explantation of the failing graft, and replacement with a Dacron graft. In treating complex aneurysms, this includes suprarenal clamping and often reimplantation of renal arteries to the graft. Studies have shown up to 19% perioperative mortality when ruptures are included.1 In the case of stent graft infection, one can argue that surgical conversion is the best option. Recent data suggest, however, that endovascular repair has a place as well. If an endoleak is present concomitantly, endovascular repair combined with laparotomy and abscess drainage can be used. In a series by Moulakakis et al,21 this “semiconservative approach” has outcomes that are acceptable and perhaps even comparable to open explantation. There are some definite challenges to secondary fenestrated repair after previous EVAR as is evident from the outcomes in this series. Problems with advancing a stent graft through previous graft limbs can cause difficulties in orientation of the fenestrated cuff. The use of brachial-femoral wires counteracts this rotational issue in many cases, and it is important to secure adequate iliac access aggressively as well. Catheterizing through transrenal stents can sometimes be challenging, particularly if there are struts crossing the target vessel orifice. The ability to push a strut aside to place a sheath and a stent depends on the type of suprarenal stent and also on what portion of that stent actually crosses the orifice. Laser-cut stents, such as on the Zenith Alpha (Cook Medical), are very strong, and it is sometimes impossible to deform a strut to make room. If the apex of a suprarenal stent is positioned across the orifice, it can also be difficult to pass a sheath through, even though a wire passes easily. Subsequent stents sometimes have to be
reinforced to ensure patency. Meticulous preoperative planning is therefore mandatory to foresee difficulties and to take pre-emptive action. On occasion, preoperative angiography can be performed to test whether the target vessels are accessible, and during such procedures, balloon angioplasty can be performed to facilitate access during later graft implantation.22 Although a fenestrated cuff is often sufficient as secondary repair, there is a trend toward total relining of the primary infrarenal repair with a distal bifurcated endograft system when possible to ensure adequate seal below the fenestrated cuff. A limiting factor in this setting is when the primary repair is composed of a graft with a short main body. This is mainly a concern after previous open repair but also with certain specific infrarenal endograft designs. Depending on the length of the main body of the existing graft, the fenestrated repair had to be tailored to accommodate this. The choice of repair was up to the operating surgeon. On some occasions, a bifurcated body with an inverted contralateral iliac limb23 was used to increase the overlap between the fenestrated and distal bifurcated components. If the existing main body was >4 cm long, the fenestrated cuff landed in the main body of the existing graft. In our current analysis, just under two-thirds of patients received a fenestrated cuff only. In cases in which relining with infrarenal components was applied, stent grafts were extended to existing graft legs or the common iliac artery. Only in cases in which the common iliac artery was not considered a suitable landing zone were iliac legs distended to the external iliac artery with embolization of the internal iliac artery or placement of an iliac branch device. In proximal and distal sealing zones, grafts were oversized by 15% to 20%. Over the years, significant advances have been implemented in fenestrated repair that have improved the
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for the renal arteries are advanced over these preloaded wires and thus go directly to the fenestrations without the need to identify and to catheterize the renal fenestrations as with a standard fenestrated device. A second wire is then used through the same sheath to catheterize the renal artery while the stent graft is still partially constrained. After the preloaded wire is removed, the sheath can be advanced into position in the renal artery. A recent study demonstrated the safety and applicability of this technique.24 This study has a number of limitations. Six patients were lost during follow-up because they were residing in other regions or countries, staying at the treating clinic only during the immediate operative and postoperative period. In a number of cases, additional procedures were performed during surgery, which renders data on procedure time unreliable with regard to the actual time spent on the fenestrated cuff. The same applies to fluoroscopy time during surgery. An additional limitation to this study is its relatively small cohort size of 43 patients. To our knowledge, it is, however, the largest one to date strictly involving secondary repair with a fenestrated or branched cuff in the juxtarenal segment only.
CONCLUSIONS Endovascular treatment with fenestrated or branched stent grafts for proximal endoleak, proximal aneurysm formation, or pseudoaneurysms after previous infrarenal repair is a safe and effective choice and a valid alternative to open surgery. Procedures can be technically challenging, and rigorous planning is required.
AUTHOR CONTRIBUTIONS Fig 4. The large number of superimposed stent markers can hamper correct deployment of the cuff.
technical aspects of these procedures. The increased experience in planning and implanting fenestrated grafts with three or four fenestrations to improve longterm durability in the primary setting has increased the applicability of this technique for secondary repair as well. Ancillary equipment, such as sheaths, catheters, and wires, has become better adapted for the specific use in fenestrated endografting as well. A development of the fenestrated graft delivery system itself as well as improved intraoperative imaging has also been significant improvement for these revision procedures. A problem that often occurs during implantation of a fenestrated device after previous EVAR is the multitude of markers that impedes visualization of the fenestrations during the procedure (Fig 4). By developing a preloaded fenestrated stent graft, this problem is minimized. The preloaded Cook Zenith Fenestrated AAA Endovascular Graft system is equipped with preloaded guidewires through the renal fenestrations. The sheaths
Conception and design: MS, TK, ND, BS, KM, AW, TR Analysis and interpretation: MS, TK, ND, BS, KM, AW, TR Data collection: MS, TK, ND, BS, KM, AW, TR Writing the article: MS, TK, ND, BS, KM, AW, TR Critical revision of the article: MS, TK, ND, BS, KM, AW, TR Final approval of the article: MS, TK, ND, BS, KM, AW, TR Statistical analysis: MS, TK, TR Obtained funding: Not applicable Overall responsibility: MS
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Submitted Sep 22, 2018; accepted Jan 17, 2019.