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Adapting to a total endovascular approach for complex aortic aneurysm repair: Outcomes after fenestrated and branched endovascular aortic repair
Adapting to a total endovascular approach for complex aortic aneurysm repair: Outcomes after fenestrated and branched endovascular aortic repair Jacob Budtz-Lilly, MD, Anders Wanhainen, MD, PhD, Jacob Eriksson, MD, and Kevin Mani, MD, PhD, Uppsala, Sweden
ABSTRACT Objective: This study reports the feasibility of adopting a total endovascular approach for the treatment of complex abdominal aortic aneurysms (AAAs) at a European aortic center and compares the short- and midterm results against those from large and multicenter studies. Methods: All patients treated endovascular aortic repair (EVAR) for juxta/pararenal AAAs or thoracoabdominal aortic aneurysms (TAAAs), both elective and acute, as well as reoperations, from 2010 to 2015 were included. Treatment was fenestrated (FEVAR) or branched (BEVAR), and outcomes were analyzed for technical success and mortality at 30 and 90 days and by Kaplan-Meier curve estimates at 3 years. Outcomes on target vessels were reported as freedom from branch instability in the follow-up period. Reinterventions, endoleaks and perioperative and postoperative morbidities were analyzed. Results: A total of 71 patients were treated for juxta/pararenal AAA (n ¼ 40) or TAAA (n ¼ 31): 14 type II, 4 type III, and 13 type IV. There were 47 FEVAR (including 2 physician-modified fenestrated grafts) and 24 BEVAR procedures performed. Four TAAAs were ruptured. No open repairs were performed for these pathologies in this period. Mortality was 2.8% (n ¼ 2) at 30 days and 9.9% at 90 days (n ¼ 7). One late rupture occurred in a patient whose treatment was a technical failure. Survival at 3 years was 77.9% 6 5.6% overall, 90.9% 6 5.2% for juxta/pararenal AAAs, and 60.7% 6 10.3% for TAAAs. Graft deployment was successful in 69 of 71 patients. Revascularization was successful in 205 of 208 target vessels (98.6%): 51 of 51 superior mesenteric arteries, 27 of 27 celiac arteries, and 127 of 130 renal arteries. There were 131 fenestrated bridging stent grafts and 74 branched bridging stent grafts. Technical success was 68 of 71 (95.7%). There were nine cases of branch instability (5 BEVARs, 4 FEVARs) in five patients (7.0%). Seven vessels (5 renal arteries and 2 superior mesenteric arteries) underwent reintervention: 5 for stenoses, 1 for occlusion, and 1 for stent migration. Freedom from branch instability at 3 years was 92.7% 6 2.5% overall, 88.6% 6 6.4% for BEVAR, and 94.6% for FEVAR. Conclusions: The short- and midterm results obtained here indicate that the benefits of a total endovascular treatment for complex aortic aneurysms, as demonstrated by large and multicenter studies, can be adapted and replicated at other centers with a dedicated aortic service. This may help guide future considerations of how to refer or treat this complex patient group. (J Vasc Surg 2017;-:1-8.)
The extension of endovascular aortic stent graft treatment above the renal arteries is not uncommon, typically for extension of aneurysmal disease but also to obtain adequate sealing or for failure of previous endovascular stent graft treatment.1-4 The use of fenestrated endovascular abdominal aortic aneurysm (AAA) repair (FEVAR) and branched EVAR (BEVAR) has grown, and outcomes analyses from large centers have been favorable.5-7 Measurements of success, however, are somewhat hindered by the differing patient groups, pathologies,
From the Section of Vascular Surgery, Department of Surgical Sciences, Uppsala University. Author conflict of interest: none. Correspondence: Jacob Budtz-Lilly, MD, Department of Surgical Sciences, Section of Vascular Surgery, Uppsala University, Uppsala 75023, Sweden (e-mail: [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 2017 by the Society for Vascular Surgery. Published by Elsevier Inc. http://dx.doi.org/10.1016/j.jvs.2017.03.422
and even outcomes of focus. Outcomes for branch vessel patency and instability, for example, are of particular concern but are also difficult to interpret because of the heterogeneity of technique and graft construction.8,9 Some authors have called for a unique nomenclature for target vessel follow-up.10-12 Comparisons against open surgical repair are also difficult. Only recently have data been published on the patency of visceral arteries after open thoracoabdominal aortic aneurysm (TAAA) repair.13 In 2008, Greenberg et al14 reported similar rates of mortality and spinal ischemia for patients with TAAAs treated with EVAR or open surgical repair. The results were confounded, however, by indications of how to treatdpatients deemed clinically appropriate for open surgery were treated as such.14 As the application of FEVAR and BEVAR grows, documenting the “real-world” results of these procedures becomes increasingly important as they expand away from the pioneering larger centers of expertise. The vascular surgical aortic center at Uppsala University has previously treated complex aneurysmal disease with both open and hybrid surgery, but a total endovascular 1
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approach was adopted beginning in 2010. The objective of the present analysis was to assess the midterm outcomes of these procedures and thereby validate and guide other centers in considerations of this endeavor.
ARTICLE HIGHLIGHTS d
d
METHODS Data collected prospectively for 71 consecutive patients who underwent FEVAR or BEVAR at the Uppsala University Hospital from January 2010 to December 2015 were analyzed. The vascular surgical center in Uppsala is a tertiary referral center with particular focus on aortic research and surgical repair. The tertiary referral catchment area for complex aortic disease encompasses 1.8 million inhabitants in mid-Sweden. The geographic area covered includes six counties in mid-Sweden, each of which has a dedicated vascular unit covering standard aortic pathology. All patients and procedures were discussed at a multidisciplinary meeting, which included vascular surgeons, cardiothoracic surgeons, radiologists, and angiologists. Indications for treatment, aneurysm pathology, and relevant patient demographic information were included. All patients underwent preoperative highresolution computed tomography (CT) imaging with 1-mm sections. The type of TAAA was determined according to the Crawford-Safi classification, notably according to the aortic pathology and not the extent of aortic endovascular coverage.15 All procedures were performed with Cook Medical endografts (Bloomington, Ind), including the physicianmodified grafts. Bridging stent grafts were balloonexpandable Advanta V12 (Atrium Medical Corp, Hudson, NH) or self-expandable Fluency (Bard, Tempe, Ariz) or Gore Viabahn (W. L. Gore and Associates, Flagstaff, Ariz) stent grafts, as well as extensions with nitinol selfexpandable Protégé Everflex stents (Covidien, Plymouth, Minn) in case of kinking. Data regarding radiation are reported as duration of fluoroscopy (minutes) and accumulated skin dose (Gy). Outcomes. Outcomes included technical success, defined as placement of both the main-body graft and successful stenting of target vessels in an intent-to-treat manner, further defined by the absence of an endoleak type I or III or graft obstruction, absence of the need to convert to open surgical repair, and survival >24 hours.16 Data on mortality are reported at 30 and 90 days and as Kaplan-Meier curve estimates at 3 years. Morbidity is reported with data on perioperative adverse events, including spinal ischemia (transient and permanent), permanent stroke, myocardial infarct, renal insufficiency requiring dialysis (transient and permanent), abdominal compartment syndrome requiring surgical decompression, and lower extremity compartment syndrome requiring fasciotomy. Finally, outcomes on target vessels are reported as branch instability, which include
2017
d
Type of Research: Retrospective analysis of prospectively collected single center data Take Home Message: Complex endovascular aneurysm repair in 71 patients was performed with a mortality of 2.8% at 30 days and 9.9% at 90 days, with relatively low reintervention rates, and a 77.9% 3-year survival. Recommendation: The authors suggest that branched and fenestrated endografts are a preferred choice of treatment of complex aneurysms in centers with appropriate expertise.
occlusion, stenosis, and stent migration or fracture, as previously suggested by the Cleveland group.10 The protocol for the prevention of ischemic spinal ischemia included cerebral spinal fluid drainage in all BEVAR procedures, all FEVAR procedures with four fenestrations, all procedures in which the anticipated aorta coverage was >20 cm, and in any patient who had previously undergone surgery of the descending or abdominal aorta. Procedures were also staged whenever possible. The postoperative protocol consisted of clinical followup with mandatory CT and duplex ultrasound imaging at 1 month and then yearly, provided there were no findings of concern, which then increased the frequency of imaging.17 Some patients were evaluated clinically at their center of referral, but all imaging was sent to the primary operators for individual evaluation. Data regarding the living status of patients was obtained from the electronic journal, which is cross-matched with the population registry, using a unique personal identification number for each patient. Data on target vessels were based on ultrasound and CT imaging, not on clinical status. The study complied with the Declaration of Helsinki. The regional Ethical Review Board approved the study, and informed patient consent was not required.
STATISTICS Continuous data are presented as mean values 6 standard deviation or median values with the range or interquartile range (IQR) and were compared using the Student t-test or Mann-Whitney U test. Categoric variables are reported as absolute numbers (%) and were compared using the c2 test. Data on survival and branch vessel instability were analyzed using Kaplan-Meier curves and compared using the log-rank test. All data analysis was performed using SPSS 23.0 software (IBM Corp, Armonk, NY).
RESULTS The analysis included 71 consecutive patients (49 men and 22 women). No patients were excluded for anatomic
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Table I. Patient demographics Juxta/pararenal AAA (n ¼ 40)
Variablea Age, years
TAAA (n ¼ 31)
Table II. Aneurysm characteristics and treatment modality P value
70 (44-82)
<.01
34 (85.0)
15 (48.4)
<.01
6 (15.0)
16 (51.6)
73 (52-83)
b
Variable
Juxta/pararenal TAAA AAA (n ¼ 40) (n ¼ 31)
Procedure
Sex Men Women 2
BMI, kg/m
25.2 (23.3-29.7) 25.7 (22.8-27.7)
c
b
.66
Smoking, No. Never
3
6
Previous
9
12
Active Previous aorta surgery Hypertension Diabetes mellitus Ischemic heart disease
28 7 (17.5) 33 (82.5) 4 (10.0) 16 (40.0)
26 (83.9)
38
9
Fenestrations, No.
94
27
Scallops, No.
24
2
Balloon-expandable stents, No.
95
26
0
1
2
22
Self-expanding stents, No. BEVAR, No.
13 14 (45.2)
FEVAR, No.
c
.01
c
.88
c
0 (0)
.07
7 (22.6)
.12c
Fenestrations, No.
2
8
Branches, No.
6
68
Balloon-expandable stents, No.
4
20
Self-expanding stents, No.
4
56
6.7 6 0.6
6.2 6 1.3
Aneurysm diameter, mean 6 SD, cm Rupture, No.
c
0
4
5 (12.5)
4 (12.9)
.92
Previous dissection, No.
1
5
12 (30.0)
3 (9.7)
.04c
EVAR leak, No.
3
0
Peripheral arterial disease
2 (5.0)
3 (9.7)
.45c
Previous aortic treatment, No. Open AAA surgery
2
4
Previous stroke or TIA
3 (7.5)
3 (9.7)
.74c
EVAR
3
1
Renal insufficiency
6 (15.0)
7 (22.6)
.41c
TEVAR
1
3
COPD
9 (22.5)
13 (41.9)
.08c
Open ascending aortic/arch repair
0
6
Heart failure Atrial fibrillation
AAA, Abdominal aortic aneurysm; BMI, body mass index; COPD, chronic obstructive pulmonary disease; TAAA, thoracoabdominal aortic aneurysm; TIA, transient ischemic attack. a Continuous data are shown as the median (interquartile range [IQR]) and categoric data as number (%) or as indicated. b Mann-Whitney U test. c 2 c Test.
or technical reasons. There were 40 patients treated for juxta/pararenal AAAs and 31 treated for TAAAs: 14 type II, 4 type III, and 13 type IV. The median age was 71.9 years (range, 44-83 years). The median follow-up on patient living status was 25.0 months (IQR, 14-39 months), and the median follow-up for target vessel imaging was 17.0 months (IQR, 5-32 months). Two patients refused follow-up imaging. No patients underwent open surgical repair for these pathologies during this period. Further patient demographic information is provided in Table I. There were 47 FEVARs (including 2 physician-modified fenestrated grafts) and 24 BEVARs performed. There were no ruptures while awaiting treatment. The median operative time was 432 minutes (IQR, 325-557 minutes) for FEVAR procedures and 476.5 minutes (IQR, 408.3601.5 minutes) for BEVAR procedures. The median fluoroscopy time was 95 minutes (IQR, 60-129.5 minutes) for FEVAR and 110 minutes (IQR, 90.5-141 minutes) for BEVAR. The median accumulated skin dose was 4.3 Gy (IQR, 2.4-6.5 Gy) for FEVAR procedures and 5.0 Gy (2.3-8.1 Gy) for BEVAR procedures. Finally, the median hospital length of stay was 8.0 days (IQR, 5-15 days).
AAA, Abdominal aortic aneurysm; BEVAR, branched endovascular aortic repair; EVAR, endovascular aortic repair; FEVAR, fenestrated endovascular aortic repair; SD, standard deviation; TAAA, thoracoabdominal aortic aneurysm; TEVAR, thoracic endovascular aortic repair.
Of the 71 patients, 21 (29.6%) had undergone previous aortic treatment. There were four ruptured TAAAs. Mean aneurysm diameter was 6.1 6 0.8 cm. Aneurysmal and procedural details are summarized in Table II. Most of the FEVAR procedures used balloon-expandable stents, and self-expanding stents were primarily used for bridging in the BEVAR procedures. Table III details information on supplementary and staged procedures. Notably, all previous thoracic endovascular aortic repairs (TEVAR) and left subclavian artery (LSA) revascularizations were performed in patients with TAAAs. Graft deployment was successful in 69 patients. A persistent intraoperative type IIIb endoleak in one FEVAR procedure led to conversion to an aortouniiliac stent graft with supplementary femoral-femoral crossover bypass revascularization. The other failure was in an acute patient in which a physician-modified fenestrated graft was placed. Intraoperative endograft migration led to coverage of both renal arteries and subsequent Viabahn open revascularization technique to the right renal artery. Revascularization was successful in 205 of 208 target visceral vessels (98.6%): 51 of 51 superior mesenteric
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Table III. Supplementary and staged procedures Variable
Juxta/pararenal TAAA AAA (n ¼ 40), No. (n ¼ 31), No.
Total
Staged TEVAR
0
5
LSA revascularization
0
7
5 7
Conduit
4
7
11
Target vessel PTA
2
0
2
AAA, Abdominal aortic aneurysm; LSA, left subclavian artery; PTA, percutaneous transluminal angioplasty; TAAA, thoracoabdominal aortic aneurysm; TEVAR, thoracic endovascular aortic repair.
arteries, 27 of 27 celiac arteries, and 127 of 130 renal arteries (left and right in one patient). Thus, the technical success rate was 68 of 71 patients (95.7%). Two failed renal vessel catheterizations were in the abovementioned acute procedure with endograft migration. The other failed vessel catheterization was a severely stenosed left renal artery in a FEVAR procedure performed for a juxtarenal/pararenal AAA; revascularization was later performed with open surgery. There were two patients (2.8%) with permanent spinal cord ischemia (both treated with BEVAR for TAAAs, and neither surviving at 1 year), one permanent stroke (1.4%, treated with FEVAR), and two myocardial infarctions (2.8%, both treated with FEVAR). There were three cases of abdominal compartment syndrome, two for bleeding and one for mesenteric ischemia, resulting in an open left hemicolectomy. All three were procedurerelated and in patients treated electively for their aneurysm. There were two cases of lower extremity compartment syndrome requiring bilateral fasciotomies (both FEVARs, one for a juxta/pararenal AAA and one for a TAAA). Eight patients required temporary dialysis, two permanent (both BEVARs for TAAA). Mortality was 2.8% (n ¼ 2) at 30 days. One patient died of multiorgan failure (juxta/pararenal AAA/FEVAR), and the second (TAAA BEVAR) died out-of-hospital of sudden death and unknown causes. The 90-day mortality was 9.9% (n ¼ 7). In addition to the two deaths #30 days, the remaining deaths were procedurally related, in-hospital, and a result of multiorgan failure, including permanent spinal ischemia (n ¼ 2), mesenteric ischemia and sepsis (n ¼ 1), and heparin-induced thrombocytopenia (n ¼ 1). Five of these seven deaths were in patients with TAAAs (4 BEVAR, 1 FEVAR) and two were in patients with juxta/pararenal AAAs (both FEVAR). During the entire study period there were 15 deaths, comprising 10 TAAAs (7 BEVARs and 3 FEVARs) and five juxta/pararenal AAAs (all FEVARs). Causes of deaths were multiorgan failure in 6, an unknown cause in 5, bladder cancer in 1, hemorrhagic stroke in 1, and worsening dementia and respiratory failure in 1. Finally, one patient, whose aneurysm was unsuccessfully excluded during the primary operation (see below), returned 25 months after the failed procedure with a rupture
Fig 1. Kaplan-Meier survival estimates for juxta/pararenal abdominal aortic aneurysm (AAA) and thoracoabdominal aortic aneurysm (TAAA) patients.
and died after refusal of treatment. There were otherwise no late aneurysm ruptures after successful treatment. Kaplan-Meier estimates showed the combined survival at 3 years was 77.9% 6 5.6%. The 3-year estimate was 90.9% 6 5.2% for juxta/pararenal AAAs and 60.7% 6 10.3% for TAAAs (log-rank P ¼ .01; Fig 1). In the follow-up period, there were nine cases of branch instability (5 BEVARs and 4 FEVARs) in six patients. There were three cases of target vessel occlusion (3 right renal arteries), all in patients who underwent BEVAR procedures (2 TAAAs, 1 juxta/pararenal AAA). Only one of these patients, who preoperatively had one functional kidney, underwent reintervention with thrombolysis and stent relining. The other two renal occlusions were observed at follow-up imaging at 2 months and 2 years, respectively, and appeared to have no clinical significance and were thus not treated. Of the nine unstable branches, one vessel (left renal artery) in a patient treated with BEVAR for a juxta/pararenal AAA was identified with a stenosis at 30 days. At 1 year, there were seven unstable branches (5 renal arteries and 2 superior mesenteric arteries [4 FEVARs and 3 BEVARs]). Two of these were the abovementioned renal artery occlusions. One stent migration (FEVAR) occurred at 1 year within the left renal artery that required supplementary self-expanding stent placement. The remaining cases were stenoses and underwent percutaneous transluminal angioplasty or percutaneous transluminal angioplasty with supplementary stent placement. Seven target vessels underwent reintervention in five of 71 patients (7.0%). Five of the seven (71.4%) reinterventions were performed on renal arteries. The 3-year Kaplan-Meier estimate for freedom from branch instability was 92.7% 6 2.5% overall, 88.6% 6 6.4% for branched bridging stent grafts, and 94.6% 6 2.4% for fenestrated bridging stent grafts (logrank P ¼ .28; Fig 2).
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Fig 2. Kaplan-Meier estimates of freedom from branch instability for branched and fenestrated bridging stent grafts among those surviving 90 days and available for follow-up imaging.
Of the 62 patients who underwent follow-up imaging, there were 12 type II endoleaks at 30 days (8 FEVARs, 4 BEVARs), none with significant aneurysm diameter changes and thus no reintervention. One of these showed aneurysm growth at 1 year and underwent three coil-embolizations of lumbar arteries. One type Ib endoleak at 22 months was treated with distal graft extension of a previously placed BEVAR. There were no type III endoleaks. Regarding the ruptured TAAAs, one FEVAR (physicianmodified) and three BEVARs were performed acutely, with no technical failures. None of the patients required laparotomy for abdominal compartment syndrome or bleeding. One patient required further stent grafting of the right iliac artery because of a small rupture from the large introducing sheath. One patient presented with symptoms suggestive of spinal cord ischemia, but this resolved after postoperative cerebral spinal fluid drainage and blood pressure elevation. One patient (FEVAR) died at 3 months, and the remaining three were alive at 2 years with stable branch vessels. One of these patients, however, requires permanent dialysis.
DISCUSSION Treatment of aneurysmal disease proximal to the renal arteries is a challenge because these patients often have significant comorbidities as well as anatomic obstacles that limit therapeutic options. Open surgical repair has been the conventional therapy for TAAAs and juxta/pararenal AAAs until the development of FEVAR and BEVAR treatment for more complex aortic aneurysms.5,6 A persistent and important concern has been the elevated risk of perioperative mortality and spinal cord ischemia, hitherto found to be similar between open surgery and endovascular treatment.14 However, gradual technologic development and increased expertise have
led to documented positive outcomes as well as expanded patient selection.7,18 An important question, then, is whether other aortic centers, outside the largest centers of expertise, can replicate these results. For open repair, the excellent results reported from single very high-volume open thoracoabdominal repair centers were not achieved in a broader setting.19 Although the volumes at Uppsala University Hospital are not comparable to the very high-volume centers, such as Cleveland or Houston, this is the second largest complex aortic center in Sweden, indicating that these annual repairs numbers are on the level of what can be expected at dedicated aortic units outside major high-volume centers.20 In addition, as a tertiary referral center affiliated with a major university, younger trainees are almost always involved in the operation and care of these patients. There were two senior attending physicians (A.W. and K.M.) responsible for the transition to total endovascular treatment, and often both were present for all of the procedures. The favorable midterm results presented here (Table IV) indicate that a total endovascular approach to juxta/pararenal AAAs and TAAAs is achievable at other aortic centers. The 30-day mortality of 2.8% fares well compared with previous reports ranging from 1% to 8% for endovascular or open surgical repair, as summarized in Table V.4,7,11,13,21,22 The midterm mortality rates displayed in Fig 1 are satisfactory and, notwithstanding treatment modality, importantly reflect the increased mortality of TAAAs. Greenberg et al14 pointed this out in their analysis; that is, the overwhelming predictive factor of risk in the treatment of TAAAs was the anatomic extent of the disease. Moreover, the natural history of TAAAs is lamentable, a consequence of aneurysmaland nonaneurysmal-related mortality, an implication of the severe concurrent comorbidities present in these patients.22,23 The technical success rate of 95.7% also accords well with previous reports, ranging from 82% to 100%, particularly when it is recalled that cases of rupture and physician-modified grafts were included.17,24-26 Only one of the technical failures was a result of failed target-vessel catheterization. The concern, however, in endovascular treatment of complex aneurysms is the patency and stability, or freedom from instability, of the target vessels over time. An interesting observation is that the cases of branch instability in the above patient group were well balanced between those treated with BEVAR and FEVAR. The three occlusions, however, were observed in right renal arteries in patients treated with BEVAR. Furthermore, most of the reinterventions were performed on renal arteries. That the renal arteries are typically the most vulnerable to instability has been well documented.8,10 Whether BEVAR or FEVAR
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Table IV. Summary of outcomes after fenestrated endovascular aortic repair (FEVAR) and branched endovascular aortic repair (BEVAR) treatment for 71 patients
Patients, No.
Technical success, %
30-day mortality, %
3-year survival,a mean 6 SD, %
3-year freedom from branch instability, mean 6 SD, %
Elective TAAA
27
96
3.7
56.7 6 11.7
92.1 6 4.6a
Elective J/PAAA
40
95
2.5
90.9 6 5.2
92.2 6 2.4a
Ruptured TAAA
4
100
0
75.0 6 21.7
100
Variable
J/PAAA, Juxta/pararenal abdominal aortic aneurysm; SD, standard deviation; TAAA, thoracoabdominal aortic aneurysm. a Kaplan-Meier curve estimate.
Table V. Summary of results on recent reports for both open and endovascular repair of complex aortic aneurysms Study, year of publication Verhoeven et al,11 2010 21
Martin-Gonzalez et al,
2015
Youssef et al,13 20151
Survival
Target vessel results
100 FEVAR, JRAAA
87%
5 years, 58%
5 years, 93%a
235 BEVAR
95%
2 years, 73%
2 years, 86%b
214 FEVAR, TAAA and JRAAA
99%
2 years, 82%
2 years, 95%
.
2 years, 71%
5 years, 95%c
354 FEVAR and BEVAR, type II and III TAAA
94%
3 years, 57%
3 years, 54%d
54 FEVAR
91%
5 years, 60%
5 years, 93%e
62 open TAAA
Eagleton et al,4 2016 22
Kristmundsson et al, 7
Technical success
Procedures and patients included
2014
Mastracci et al, 2015
610 FEVAR, type IV TAAA and JRAAA
Present study
47 FEVAR, 24 BEVAR (40 JRAAA, 31 TAAA)
97%
8 years, 20%
N/A
95.7%
3 years, 77.9%
3 years, 92.7%b
BEVAR, Branched endovascular aortic repair; FEVAR, fenestrated endovascular aortic repair; JRAAA, juxtarenal abdominal aortic aneurysm; N/A, not available; TAAA, thoracoabdominal aortic aneurysm. a Cumulative visceral branch patency. b Freedom from branch instability. c Primary patency. d Freedom from unplanned secondary intervention. e Primary-assisted patency.
performs better in this regard is not entirely resolved, primarily as a result of differing treatment indications, anatomic and stent configurations, as well as patient selection. The most recent multicenter analysis, however, found that occlusions of the renal arteries were greater after BEVAR than after FEVAR.21 As evident in Table II, most of the bridging stent grafts in the current series were balloon-expandable stent grafts in FEVAR and self-expandable stent grafts in BEVAR procedures. If the branch or fenestration ended in a kinked artery, the bridge was extended with a self-expanding nitinol stent. Permanent spinal ischemia occurred in two patients. Both had been treated with BEVAR, and both died #12 months. The spinal ischemia prevention program has evolved during this period, and the protocol in place at our institution is described above. Experience and the establishment of protocols are critical in the prevention of spinal ischemia, and this appears to be well supported by the low numbers of cases in this patient cohort.27 Whether revascularization of the LSA plays a role in the prevention of spinal ischemia is difficult to ascertain. Revascularization was performed if coverage of the LSA was anticipated, and this was true also for those patients in whom the LSA was covered during a previous TEVAR.
Specifying optimal surgical treatments is difficult because of the heterogeneity of these patients and their disease; however, the following generalized observations can be made: A fenestrated solution for branch vessel revascularization was preferred for patients with juxta/pararenal aneurysms, where there was often limited room for deployment of a branch in a nonaneurysmal distal descending aorta. A branched solution was favored in TAAAs with disease in the distal descending and paravisceral aorta to increase stent graft overlap and reduce the risk of a type III endoleak. In all elective patients, access procedures (eg, iliofemoral bypass for stent graft insertion) and supra-aortic deviations (eg, carotid-subclavian bypass) for acquisition of a safe proximal landing zone were performed as staged procedures, separate from the main F/BEVAR procedure. In patients with thoracoabdominal aneurysms requiring extensive aortic coverage including a TEVAR in addition to a F/BEVAR, the thoracic endografting was performed as a staged procedure separate from the F/BEVAR procedure. Generally, 2 to 4 weeks was allowed for recovery between each stage of the procedure. No ruptures occurred during these staging episodes.
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Although careful planning and staging are optimal to perform these procedures, it is encouraging to note the technical success and outcomes of the four ruptured TAAAs in this cohort. Further refinement of branched or fenestrated grafts may enable increased patient treatment considerations.28-30 Although data were collected prospectively, the analysis by nature is retrospective and thus exposed to selection biases. The period of analysis was from the implementation of endovascular treatment for complex aortic disease, and there are undoubtedly aspects of a learning curve that may have affected the results reported here. This may, however, strengthen or validate the essence of this analysis in sharing the experience of adapting to complex treatments. In addition, various minor technical developments occurred during the study period, for example, the use of two-dimensionalthree-dimensional fusion, which may have affected outcomes. No formal analysis was performed to evaluate changes or improvements over time. Although no patients were refused treatment because of anatomic constraints, no information was available on the number of patients refused treatment for reasons of comorbidities. Furthermore, there are no precise data on anatomic measurements or criteria for selection of a specific procedure, which could be explored in an analysis of branch instability. Also of note is that there was a natural lag between the follow-up of the patient’s living status and the status of the graft patency. None of the patients who died #90 days, for example, underwent specific imaging for these purposes. Of the two patients who refused follow-up imaging, one did so out of personal preference, and the other deteriorated clinically with dementia and died of respiratory failure at 25 months. The missing status of their grafts may therefore limit this analysis. Finally, although all patients were treated with endovascular repair, some of the failures were treated with open surgery.
CONCLUSIONS Treatment of complex aortic aneurysms has evolved, and the resolve to treat this patient group with a total endovascular approach, with its inherent reduced operative morbidity, is formidable. Studies from large and multiple centers have provided the foundation for continued use of these techniques. The midterm results presented here indicate that expansion of FEVAR and BEVAR to other centers is feasible. Long-term studies are needed to substantiate these results.
AUTHOR CONTRIBUTIONS Conception and design: JB-L, AW, KM Analysis and interpretation: JB-L, AW, KM Data collection: JB-L, JE, KM Writing the article: JB-L, KM
Critical revision of the article: AW, JE, KM Final approval of the article: JB-L, AW, JE, KM Statistical analysis: JB-L, KM Obtained funding: Not applicable Overall responsibility: KM
REFERENCES 1. Browne TF, Hartley D, Purchas S, Rosenberg M, Van Schie G, Lawrence-Brown M. A fenestrated covered suprarenal aortic stent. Eur J Vasc Endovasc Surg 1999;18:445-9. 2. Kouchoukos NT, Masetti P, Castner CF. Use of presewn multiple branched graft in thoracoabdominal aortic aneurysm repair. J Am Coll Surg 2005;201:646-9. 3. Adam DJ, Berce M, Hartley DE, Anderson JL. Repair of juxtarenal para-anastomotic aortic aneurysms after previous open repair with fenestrated and branched endovascular stent grafts. J Vasc Surg 2005;42:997-1001. 4. Eagleton M, Follansbee M, Wolski K, Mastracci T, Kuramochi Y. Fenestrated and branched endovascular aneurysm repair outcomes for type II and III thoracoabdominal aortic aneurysms. J Vasc Surg 2016;63:930-42. 5. Anderson JL, Berce M, Hartley DE. Endoluminal aortic grafting with renal and superior mesenteric artery incorporation by graft fenestration. J Endovasc Ther 2001;8:3-15. 6. Chuter TA, Gordon RL, Reilly LM, Goodman JD, Messina LM. An endovascular system for thoracoabdominal aortic aneurysm repair. J Endovasc Ther 2001;8:25-33. 7. Mastracci TM, Eagleton MJ, Kuramochi Y, Bathurst S, Wolski K. Twelve-year results of fenestrated endografts for juxtarenal and group IV thoracoabdominal aneurysms. J Vasc Surg 2015;61:355-64. 8. Premprabha D, Sobel J, Pua C, Chong K, Reilly LM, Chuter TA, et al. Visceral branch occlusion following aneurysm repair using multibranched thoracoabdominal stent-grafts. J Endovasc Ther 2014;21:783-90. 9. Panuccio G, Bisdas T, Berekoven B, Torsello G, Austermann M. Performance of bridging stent grafts in fenestrated and branched aortic endografting. Eur J Vasc Endovasc Surg 2015;50:60-70. 10. Mastracci TM, Greenberg RK, Eagleton MJ, Hernandez AV. Durability of branches in branched and fenestrated endografts. J Vasc Surg 2013;57:926-33. 11. Verhoeven EL, Vourliotakis G, Bos WT, Tielliu IF, Zeebregts CJ, Prins TR, et al. Fenestrated stent grafting for short-necked and juxtarenal abdominal aortic aneurysm: an 8-year single-centre experience. Eur J Vasc Endovasc Surg 2010;39: 529-36. 12. Dowdall JF, Greenberg RK, West K, Moon M, Lu Q, Francis C, et al. Separation of components in fenestrated and branched endovascular grafting - branch protection or a potentially new mode of failure? Eur J Vasc Endovasc Surg 2008;36:2-9. 13. Youssef M, Neufang A, Jungmann F, Vahl CF, Dorweiler B. Patency of renal and visceral vessels after open thoracoabdominal aortic replacement. J Vasc Surg 2015;62: 594-9. 14. Greenberg RK, Lu Q, Roselli EE, Svensson LG, Moon MC, Hernandez AV, et al. Contemporary analysis of descending thoracic and thoracoabdominal aneurysm repair a comparison of endovascular and open techniques. Circulation 2008;118:808-17. 15. Crawford ES, Crawford JL, Safi HJ, Coselli JS, Hess KR, Brooks B, et al. Thoracoabdominal aortic aneurysms: preoperative and intraoperative factors determining
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16.
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18.
19.
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immediate and long-term results of operations in 605 patients. J Vasc Surg 1986;3:389-404. Fillinger MF, Greenberg RK, McKinsey JF, Chaikof EL. Reporting standards for thoracic endovascular aortic repair (TEVAR). J Vasc Surg 2010;52:1022-33. 1033.e15. Mohabbat W, Greenberg RK, Mastracci TM, Cury M, Morales JP, Hernandez AV. Revised duplex criteria and outcomes for renal stents and stent grafts following endovascular repair of juxtarenal and thoracoabdominal aneurysms. J Vasc Surg 2009;49:827-37. Oderich GS, Greenberg RK, Farber M, Lyden S, Sanchez L, Fairman R, et al. Results of the United States multicenter prospective study evaluating the Zenith fenestrated endovascular graft for treatment of juxtarenal abdominal aortic aneurysms. J Vasc Surg 2014;60:355-64. Cowan JA, Dimick JB, Henke PK, Huber TS, Stanley JC, Upchurch GR. Surgical treatment of intact thoracoabdominal aortic aneurysms in the United States: Hospital and surgeon volume-related outcomes. J Vasc Surg 2003;37:1169-74. Swedvasc. The Swedish National Registry for Vascular Surgery 2016. Available at: http:www.ucr.uu.se/swedvasc/. Accessed December 29, 2016. Martin-Gonzalez T, Pinçon C, Maurel B, Hertault A, Sobocinski J, Spear R, et al. Renal outcomes following fenestrated and branched endografting. Eur J Vasc Endovasc Surg 2015;50:420-30. Kristmundsson T, Sonesson B, Dias N, Törnqvist P, Malina M, Resch T. Outcomes of fenestrated endovascular repair of juxtarenal aortic aneurysm. J Vasc Surg 2014;59:115-20. Hansen PA, Richards JMJ, Tambyraja AL, Khan LR, Chalmers RT. Natural history of thoraco-abdominal
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aneurysm in high-risk patients. Eur J Vasc Endovasc Surg 2010;39:266-70. Marzelle J, Presles E, Becquemin JP; WINDOWS trial participants. Results and factors affecting early outcome of fenestrated and/or branched stent grafts for aortic aneurysms: a multicenter prospective study. Ann Surg 2015;261: 197-206. Haddad F, Greenberg RK, Walker E, Nally J, O’Neill S, Kolin G, et al. Fenestrated endovascular grafting: the renal side of the story. J Vasc Surg 2005;41:181-90. Bicknell CD, Cheshire NJ, Riga CV, Bourke P, Wolfe JH, Gibbs RG, et al. Treatment of complex aneurysmal disease with fenestrated and branched stent grafts. Eur J Vasc Endovasc Surg 2009;37:175-81. Dias N, Sonesson B, Kristmundsson T, Holm H, Resch T. Short-term outcome of spinal cord ischemia after endovascular repair of thoracoabdominal aortic aneurysms. Eur J Vasc Endovasc Surg 2015;49:403-9. Mendes BC, Oderich GS. Endovascular repair of thoracoabdominal aortic aneurysm using the off-the-shelf multibranched T-branch stent graft. J Vasc Surg 2016;63: 1394-9.e2. Bisdas T, Donas KP, Bosiers MJ, Torsello G, Austermann M. Custom-made versus off-the-shelf multibranched endografts for endovascular repair of thoracoabdominal aortic aneurysms. J Vasc Surg 2014;60:1186-95. Pisimisis GT, Kougias P, Barshes NR, Bechara CF. Surgeonmodified fenestrated endograft to treat ruptured juxtarenal aneurysm. JAMA Surg 2014;149:447-9.
Submitted Dec 29, 2016; accepted Mar 11, 2017.
ABSTRACT Objective: This study reports the feasibility of adopting a total endovascular approach for the treatment of complex abdominal aortic aneurysms (AAAs) at a European aortic center and compares the short- and midterm results against those from large and multicenter studies. Methods: All patients treated endovascular aortic repair (EVAR) for juxta/pararenal AAAs or thoracoabdominal aortic aneurysms (TAAAs), both elective and acute, as well as reoperations, from 2010 to 2015 were included. Treatment was fenestrated (FEVAR) or branched (BEVAR), and outcomes were analyzed for technical success and mortality at 30 and 90 days and by Kaplan-Meier curve estimates at 3 years. Outcomes on target vessels were reported as freedom from branch instability in the follow-up period. Reinterventions, endoleaks and perioperative and postoperative morbidities were analyzed. Results: A total of 71 patients were treated for juxta/pararenal AAA (n ¼ 40) or TAAA (n ¼ 31): 14 type II, 4 type III, and 13 type IV. There were 47 FEVAR (including 2 physician-modified fenestrated grafts) and 24 BEVAR procedures performed. Four TAAAs were ruptured. No open repairs were performed for these pathologies in this period. Mortality was 2.8% (n ¼ 2) at 30 days and 9.9% at 90 days (n ¼ 7). One late rupture occurred in a patient whose treatment was a technical failure. Survival at 3 years was 77.9% 6 5.6% overall, 90.9% 6 5.2% for juxta/pararenal AAAs, and 60.7% 6 10.3% for TAAAs. Graft deployment was successful in 69 of 71 patients. Revascularization was successful in 205 of 208 target vessels (98.6%): 51 of 51 superior mesenteric arteries, 27 of 27 celiac arteries, and 127 of 130 renal arteries. There were 131 fenestrated bridging stent grafts and 74 branched bridging stent grafts. Technical success was 68 of 71 (95.7%). There were nine cases of branch instability (5 BEVARs, 4 FEVARs) in five patients (7.0%). Seven vessels (5 renal arteries and 2 superior mesenteric arteries) underwent reintervention: 5 for stenoses, 1 for occlusion, and 1 for stent migration. Freedom from branch instability at 3 years was 92.7% 6 2.5% overall, 88.6% 6 6.4% for BEVAR, and 94.6% for FEVAR. Conclusions: The short- and midterm results obtained here indicate that the benefits of a total endovascular treatment for complex aortic aneurysms, as demonstrated by large and multicenter studies, can be adapted and replicated at other centers with a dedicated aortic service. This may help guide future considerations of how to refer or treat this complex patient group. (J Vasc Surg 2017;-:1-8.)
The extension of endovascular aortic stent graft treatment above the renal arteries is not uncommon, typically for extension of aneurysmal disease but also to obtain adequate sealing or for failure of previous endovascular stent graft treatment.1-4 The use of fenestrated endovascular abdominal aortic aneurysm (AAA) repair (FEVAR) and branched EVAR (BEVAR) has grown, and outcomes analyses from large centers have been favorable.5-7 Measurements of success, however, are somewhat hindered by the differing patient groups, pathologies,
From the Section of Vascular Surgery, Department of Surgical Sciences, Uppsala University. Author conflict of interest: none. Correspondence: Jacob Budtz-Lilly, MD, Department of Surgical Sciences, Section of Vascular Surgery, Uppsala University, Uppsala 75023, Sweden (e-mail: [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 2017 by the Society for Vascular Surgery. Published by Elsevier Inc. http://dx.doi.org/10.1016/j.jvs.2017.03.422
and even outcomes of focus. Outcomes for branch vessel patency and instability, for example, are of particular concern but are also difficult to interpret because of the heterogeneity of technique and graft construction.8,9 Some authors have called for a unique nomenclature for target vessel follow-up.10-12 Comparisons against open surgical repair are also difficult. Only recently have data been published on the patency of visceral arteries after open thoracoabdominal aortic aneurysm (TAAA) repair.13 In 2008, Greenberg et al14 reported similar rates of mortality and spinal ischemia for patients with TAAAs treated with EVAR or open surgical repair. The results were confounded, however, by indications of how to treatdpatients deemed clinically appropriate for open surgery were treated as such.14 As the application of FEVAR and BEVAR grows, documenting the “real-world” results of these procedures becomes increasingly important as they expand away from the pioneering larger centers of expertise. The vascular surgical aortic center at Uppsala University has previously treated complex aneurysmal disease with both open and hybrid surgery, but a total endovascular 1
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approach was adopted beginning in 2010. The objective of the present analysis was to assess the midterm outcomes of these procedures and thereby validate and guide other centers in considerations of this endeavor.
ARTICLE HIGHLIGHTS d
d
METHODS Data collected prospectively for 71 consecutive patients who underwent FEVAR or BEVAR at the Uppsala University Hospital from January 2010 to December 2015 were analyzed. The vascular surgical center in Uppsala is a tertiary referral center with particular focus on aortic research and surgical repair. The tertiary referral catchment area for complex aortic disease encompasses 1.8 million inhabitants in mid-Sweden. The geographic area covered includes six counties in mid-Sweden, each of which has a dedicated vascular unit covering standard aortic pathology. All patients and procedures were discussed at a multidisciplinary meeting, which included vascular surgeons, cardiothoracic surgeons, radiologists, and angiologists. Indications for treatment, aneurysm pathology, and relevant patient demographic information were included. All patients underwent preoperative highresolution computed tomography (CT) imaging with 1-mm sections. The type of TAAA was determined according to the Crawford-Safi classification, notably according to the aortic pathology and not the extent of aortic endovascular coverage.15 All procedures were performed with Cook Medical endografts (Bloomington, Ind), including the physicianmodified grafts. Bridging stent grafts were balloonexpandable Advanta V12 (Atrium Medical Corp, Hudson, NH) or self-expandable Fluency (Bard, Tempe, Ariz) or Gore Viabahn (W. L. Gore and Associates, Flagstaff, Ariz) stent grafts, as well as extensions with nitinol selfexpandable Protégé Everflex stents (Covidien, Plymouth, Minn) in case of kinking. Data regarding radiation are reported as duration of fluoroscopy (minutes) and accumulated skin dose (Gy). Outcomes. Outcomes included technical success, defined as placement of both the main-body graft and successful stenting of target vessels in an intent-to-treat manner, further defined by the absence of an endoleak type I or III or graft obstruction, absence of the need to convert to open surgical repair, and survival >24 hours.16 Data on mortality are reported at 30 and 90 days and as Kaplan-Meier curve estimates at 3 years. Morbidity is reported with data on perioperative adverse events, including spinal ischemia (transient and permanent), permanent stroke, myocardial infarct, renal insufficiency requiring dialysis (transient and permanent), abdominal compartment syndrome requiring surgical decompression, and lower extremity compartment syndrome requiring fasciotomy. Finally, outcomes on target vessels are reported as branch instability, which include
2017
d
Type of Research: Retrospective analysis of prospectively collected single center data Take Home Message: Complex endovascular aneurysm repair in 71 patients was performed with a mortality of 2.8% at 30 days and 9.9% at 90 days, with relatively low reintervention rates, and a 77.9% 3-year survival. Recommendation: The authors suggest that branched and fenestrated endografts are a preferred choice of treatment of complex aneurysms in centers with appropriate expertise.
occlusion, stenosis, and stent migration or fracture, as previously suggested by the Cleveland group.10 The protocol for the prevention of ischemic spinal ischemia included cerebral spinal fluid drainage in all BEVAR procedures, all FEVAR procedures with four fenestrations, all procedures in which the anticipated aorta coverage was >20 cm, and in any patient who had previously undergone surgery of the descending or abdominal aorta. Procedures were also staged whenever possible. The postoperative protocol consisted of clinical followup with mandatory CT and duplex ultrasound imaging at 1 month and then yearly, provided there were no findings of concern, which then increased the frequency of imaging.17 Some patients were evaluated clinically at their center of referral, but all imaging was sent to the primary operators for individual evaluation. Data regarding the living status of patients was obtained from the electronic journal, which is cross-matched with the population registry, using a unique personal identification number for each patient. Data on target vessels were based on ultrasound and CT imaging, not on clinical status. The study complied with the Declaration of Helsinki. The regional Ethical Review Board approved the study, and informed patient consent was not required.
STATISTICS Continuous data are presented as mean values 6 standard deviation or median values with the range or interquartile range (IQR) and were compared using the Student t-test or Mann-Whitney U test. Categoric variables are reported as absolute numbers (%) and were compared using the c2 test. Data on survival and branch vessel instability were analyzed using Kaplan-Meier curves and compared using the log-rank test. All data analysis was performed using SPSS 23.0 software (IBM Corp, Armonk, NY).
RESULTS The analysis included 71 consecutive patients (49 men and 22 women). No patients were excluded for anatomic
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Table I. Patient demographics Juxta/pararenal AAA (n ¼ 40)
Variablea Age, years
TAAA (n ¼ 31)
Table II. Aneurysm characteristics and treatment modality P value
70 (44-82)
<.01
34 (85.0)
15 (48.4)
<.01
6 (15.0)
16 (51.6)
73 (52-83)
b
Variable
Juxta/pararenal TAAA AAA (n ¼ 40) (n ¼ 31)
Procedure
Sex Men Women 2
BMI, kg/m
25.2 (23.3-29.7) 25.7 (22.8-27.7)
c
b
.66
Smoking, No. Never
3
6
Previous
9
12
Active Previous aorta surgery Hypertension Diabetes mellitus Ischemic heart disease
28 7 (17.5) 33 (82.5) 4 (10.0) 16 (40.0)
26 (83.9)
38
9
Fenestrations, No.
94
27
Scallops, No.
24
2
Balloon-expandable stents, No.
95
26
0
1
2
22
Self-expanding stents, No. BEVAR, No.
13 14 (45.2)
FEVAR, No.
c
.01
c
.88
c
0 (0)
.07
7 (22.6)
.12c
Fenestrations, No.
2
8
Branches, No.
6
68
Balloon-expandable stents, No.
4
20
Self-expanding stents, No.
4
56
6.7 6 0.6
6.2 6 1.3
Aneurysm diameter, mean 6 SD, cm Rupture, No.
c
0
4
5 (12.5)
4 (12.9)
.92
Previous dissection, No.
1
5
12 (30.0)
3 (9.7)
.04c
EVAR leak, No.
3
0
Peripheral arterial disease
2 (5.0)
3 (9.7)
.45c
Previous aortic treatment, No. Open AAA surgery
2
4
Previous stroke or TIA
3 (7.5)
3 (9.7)
.74c
EVAR
3
1
Renal insufficiency
6 (15.0)
7 (22.6)
.41c
TEVAR
1
3
COPD
9 (22.5)
13 (41.9)
.08c
Open ascending aortic/arch repair
0
6
Heart failure Atrial fibrillation
AAA, Abdominal aortic aneurysm; BMI, body mass index; COPD, chronic obstructive pulmonary disease; TAAA, thoracoabdominal aortic aneurysm; TIA, transient ischemic attack. a Continuous data are shown as the median (interquartile range [IQR]) and categoric data as number (%) or as indicated. b Mann-Whitney U test. c 2 c Test.
or technical reasons. There were 40 patients treated for juxta/pararenal AAAs and 31 treated for TAAAs: 14 type II, 4 type III, and 13 type IV. The median age was 71.9 years (range, 44-83 years). The median follow-up on patient living status was 25.0 months (IQR, 14-39 months), and the median follow-up for target vessel imaging was 17.0 months (IQR, 5-32 months). Two patients refused follow-up imaging. No patients underwent open surgical repair for these pathologies during this period. Further patient demographic information is provided in Table I. There were 47 FEVARs (including 2 physician-modified fenestrated grafts) and 24 BEVARs performed. There were no ruptures while awaiting treatment. The median operative time was 432 minutes (IQR, 325-557 minutes) for FEVAR procedures and 476.5 minutes (IQR, 408.3601.5 minutes) for BEVAR procedures. The median fluoroscopy time was 95 minutes (IQR, 60-129.5 minutes) for FEVAR and 110 minutes (IQR, 90.5-141 minutes) for BEVAR. The median accumulated skin dose was 4.3 Gy (IQR, 2.4-6.5 Gy) for FEVAR procedures and 5.0 Gy (2.3-8.1 Gy) for BEVAR procedures. Finally, the median hospital length of stay was 8.0 days (IQR, 5-15 days).
AAA, Abdominal aortic aneurysm; BEVAR, branched endovascular aortic repair; EVAR, endovascular aortic repair; FEVAR, fenestrated endovascular aortic repair; SD, standard deviation; TAAA, thoracoabdominal aortic aneurysm; TEVAR, thoracic endovascular aortic repair.
Of the 71 patients, 21 (29.6%) had undergone previous aortic treatment. There were four ruptured TAAAs. Mean aneurysm diameter was 6.1 6 0.8 cm. Aneurysmal and procedural details are summarized in Table II. Most of the FEVAR procedures used balloon-expandable stents, and self-expanding stents were primarily used for bridging in the BEVAR procedures. Table III details information on supplementary and staged procedures. Notably, all previous thoracic endovascular aortic repairs (TEVAR) and left subclavian artery (LSA) revascularizations were performed in patients with TAAAs. Graft deployment was successful in 69 patients. A persistent intraoperative type IIIb endoleak in one FEVAR procedure led to conversion to an aortouniiliac stent graft with supplementary femoral-femoral crossover bypass revascularization. The other failure was in an acute patient in which a physician-modified fenestrated graft was placed. Intraoperative endograft migration led to coverage of both renal arteries and subsequent Viabahn open revascularization technique to the right renal artery. Revascularization was successful in 205 of 208 target visceral vessels (98.6%): 51 of 51 superior mesenteric
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Table III. Supplementary and staged procedures Variable
Juxta/pararenal TAAA AAA (n ¼ 40), No. (n ¼ 31), No.
Total
Staged TEVAR
0
5
LSA revascularization
0
7
5 7
Conduit
4
7
11
Target vessel PTA
2
0
2
AAA, Abdominal aortic aneurysm; LSA, left subclavian artery; PTA, percutaneous transluminal angioplasty; TAAA, thoracoabdominal aortic aneurysm; TEVAR, thoracic endovascular aortic repair.
arteries, 27 of 27 celiac arteries, and 127 of 130 renal arteries (left and right in one patient). Thus, the technical success rate was 68 of 71 patients (95.7%). Two failed renal vessel catheterizations were in the abovementioned acute procedure with endograft migration. The other failed vessel catheterization was a severely stenosed left renal artery in a FEVAR procedure performed for a juxtarenal/pararenal AAA; revascularization was later performed with open surgery. There were two patients (2.8%) with permanent spinal cord ischemia (both treated with BEVAR for TAAAs, and neither surviving at 1 year), one permanent stroke (1.4%, treated with FEVAR), and two myocardial infarctions (2.8%, both treated with FEVAR). There were three cases of abdominal compartment syndrome, two for bleeding and one for mesenteric ischemia, resulting in an open left hemicolectomy. All three were procedurerelated and in patients treated electively for their aneurysm. There were two cases of lower extremity compartment syndrome requiring bilateral fasciotomies (both FEVARs, one for a juxta/pararenal AAA and one for a TAAA). Eight patients required temporary dialysis, two permanent (both BEVARs for TAAA). Mortality was 2.8% (n ¼ 2) at 30 days. One patient died of multiorgan failure (juxta/pararenal AAA/FEVAR), and the second (TAAA BEVAR) died out-of-hospital of sudden death and unknown causes. The 90-day mortality was 9.9% (n ¼ 7). In addition to the two deaths #30 days, the remaining deaths were procedurally related, in-hospital, and a result of multiorgan failure, including permanent spinal ischemia (n ¼ 2), mesenteric ischemia and sepsis (n ¼ 1), and heparin-induced thrombocytopenia (n ¼ 1). Five of these seven deaths were in patients with TAAAs (4 BEVAR, 1 FEVAR) and two were in patients with juxta/pararenal AAAs (both FEVAR). During the entire study period there were 15 deaths, comprising 10 TAAAs (7 BEVARs and 3 FEVARs) and five juxta/pararenal AAAs (all FEVARs). Causes of deaths were multiorgan failure in 6, an unknown cause in 5, bladder cancer in 1, hemorrhagic stroke in 1, and worsening dementia and respiratory failure in 1. Finally, one patient, whose aneurysm was unsuccessfully excluded during the primary operation (see below), returned 25 months after the failed procedure with a rupture
Fig 1. Kaplan-Meier survival estimates for juxta/pararenal abdominal aortic aneurysm (AAA) and thoracoabdominal aortic aneurysm (TAAA) patients.
and died after refusal of treatment. There were otherwise no late aneurysm ruptures after successful treatment. Kaplan-Meier estimates showed the combined survival at 3 years was 77.9% 6 5.6%. The 3-year estimate was 90.9% 6 5.2% for juxta/pararenal AAAs and 60.7% 6 10.3% for TAAAs (log-rank P ¼ .01; Fig 1). In the follow-up period, there were nine cases of branch instability (5 BEVARs and 4 FEVARs) in six patients. There were three cases of target vessel occlusion (3 right renal arteries), all in patients who underwent BEVAR procedures (2 TAAAs, 1 juxta/pararenal AAA). Only one of these patients, who preoperatively had one functional kidney, underwent reintervention with thrombolysis and stent relining. The other two renal occlusions were observed at follow-up imaging at 2 months and 2 years, respectively, and appeared to have no clinical significance and were thus not treated. Of the nine unstable branches, one vessel (left renal artery) in a patient treated with BEVAR for a juxta/pararenal AAA was identified with a stenosis at 30 days. At 1 year, there were seven unstable branches (5 renal arteries and 2 superior mesenteric arteries [4 FEVARs and 3 BEVARs]). Two of these were the abovementioned renal artery occlusions. One stent migration (FEVAR) occurred at 1 year within the left renal artery that required supplementary self-expanding stent placement. The remaining cases were stenoses and underwent percutaneous transluminal angioplasty or percutaneous transluminal angioplasty with supplementary stent placement. Seven target vessels underwent reintervention in five of 71 patients (7.0%). Five of the seven (71.4%) reinterventions were performed on renal arteries. The 3-year Kaplan-Meier estimate for freedom from branch instability was 92.7% 6 2.5% overall, 88.6% 6 6.4% for branched bridging stent grafts, and 94.6% 6 2.4% for fenestrated bridging stent grafts (logrank P ¼ .28; Fig 2).
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Fig 2. Kaplan-Meier estimates of freedom from branch instability for branched and fenestrated bridging stent grafts among those surviving 90 days and available for follow-up imaging.
Of the 62 patients who underwent follow-up imaging, there were 12 type II endoleaks at 30 days (8 FEVARs, 4 BEVARs), none with significant aneurysm diameter changes and thus no reintervention. One of these showed aneurysm growth at 1 year and underwent three coil-embolizations of lumbar arteries. One type Ib endoleak at 22 months was treated with distal graft extension of a previously placed BEVAR. There were no type III endoleaks. Regarding the ruptured TAAAs, one FEVAR (physicianmodified) and three BEVARs were performed acutely, with no technical failures. None of the patients required laparotomy for abdominal compartment syndrome or bleeding. One patient required further stent grafting of the right iliac artery because of a small rupture from the large introducing sheath. One patient presented with symptoms suggestive of spinal cord ischemia, but this resolved after postoperative cerebral spinal fluid drainage and blood pressure elevation. One patient (FEVAR) died at 3 months, and the remaining three were alive at 2 years with stable branch vessels. One of these patients, however, requires permanent dialysis.
DISCUSSION Treatment of aneurysmal disease proximal to the renal arteries is a challenge because these patients often have significant comorbidities as well as anatomic obstacles that limit therapeutic options. Open surgical repair has been the conventional therapy for TAAAs and juxta/pararenal AAAs until the development of FEVAR and BEVAR treatment for more complex aortic aneurysms.5,6 A persistent and important concern has been the elevated risk of perioperative mortality and spinal cord ischemia, hitherto found to be similar between open surgery and endovascular treatment.14 However, gradual technologic development and increased expertise have
led to documented positive outcomes as well as expanded patient selection.7,18 An important question, then, is whether other aortic centers, outside the largest centers of expertise, can replicate these results. For open repair, the excellent results reported from single very high-volume open thoracoabdominal repair centers were not achieved in a broader setting.19 Although the volumes at Uppsala University Hospital are not comparable to the very high-volume centers, such as Cleveland or Houston, this is the second largest complex aortic center in Sweden, indicating that these annual repairs numbers are on the level of what can be expected at dedicated aortic units outside major high-volume centers.20 In addition, as a tertiary referral center affiliated with a major university, younger trainees are almost always involved in the operation and care of these patients. There were two senior attending physicians (A.W. and K.M.) responsible for the transition to total endovascular treatment, and often both were present for all of the procedures. The favorable midterm results presented here (Table IV) indicate that a total endovascular approach to juxta/pararenal AAAs and TAAAs is achievable at other aortic centers. The 30-day mortality of 2.8% fares well compared with previous reports ranging from 1% to 8% for endovascular or open surgical repair, as summarized in Table V.4,7,11,13,21,22 The midterm mortality rates displayed in Fig 1 are satisfactory and, notwithstanding treatment modality, importantly reflect the increased mortality of TAAAs. Greenberg et al14 pointed this out in their analysis; that is, the overwhelming predictive factor of risk in the treatment of TAAAs was the anatomic extent of the disease. Moreover, the natural history of TAAAs is lamentable, a consequence of aneurysmaland nonaneurysmal-related mortality, an implication of the severe concurrent comorbidities present in these patients.22,23 The technical success rate of 95.7% also accords well with previous reports, ranging from 82% to 100%, particularly when it is recalled that cases of rupture and physician-modified grafts were included.17,24-26 Only one of the technical failures was a result of failed target-vessel catheterization. The concern, however, in endovascular treatment of complex aneurysms is the patency and stability, or freedom from instability, of the target vessels over time. An interesting observation is that the cases of branch instability in the above patient group were well balanced between those treated with BEVAR and FEVAR. The three occlusions, however, were observed in right renal arteries in patients treated with BEVAR. Furthermore, most of the reinterventions were performed on renal arteries. That the renal arteries are typically the most vulnerable to instability has been well documented.8,10 Whether BEVAR or FEVAR
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Table IV. Summary of outcomes after fenestrated endovascular aortic repair (FEVAR) and branched endovascular aortic repair (BEVAR) treatment for 71 patients
Patients, No.
Technical success, %
30-day mortality, %
3-year survival,a mean 6 SD, %
3-year freedom from branch instability, mean 6 SD, %
Elective TAAA
27
96
3.7
56.7 6 11.7
92.1 6 4.6a
Elective J/PAAA
40
95
2.5
90.9 6 5.2
92.2 6 2.4a
Ruptured TAAA
4
100
0
75.0 6 21.7
100
Variable
J/PAAA, Juxta/pararenal abdominal aortic aneurysm; SD, standard deviation; TAAA, thoracoabdominal aortic aneurysm. a Kaplan-Meier curve estimate.
Table V. Summary of results on recent reports for both open and endovascular repair of complex aortic aneurysms Study, year of publication Verhoeven et al,11 2010 21
Martin-Gonzalez et al,
2015
Youssef et al,13 20151
Survival
Target vessel results
100 FEVAR, JRAAA
87%
5 years, 58%
5 years, 93%a
235 BEVAR
95%
2 years, 73%
2 years, 86%b
214 FEVAR, TAAA and JRAAA
99%
2 years, 82%
2 years, 95%
.
2 years, 71%
5 years, 95%c
354 FEVAR and BEVAR, type II and III TAAA
94%
3 years, 57%
3 years, 54%d
54 FEVAR
91%
5 years, 60%
5 years, 93%e
62 open TAAA
Eagleton et al,4 2016 22
Kristmundsson et al, 7
Technical success
Procedures and patients included
2014
Mastracci et al, 2015
610 FEVAR, type IV TAAA and JRAAA
Present study
47 FEVAR, 24 BEVAR (40 JRAAA, 31 TAAA)
97%
8 years, 20%
N/A
95.7%
3 years, 77.9%
3 years, 92.7%b
BEVAR, Branched endovascular aortic repair; FEVAR, fenestrated endovascular aortic repair; JRAAA, juxtarenal abdominal aortic aneurysm; N/A, not available; TAAA, thoracoabdominal aortic aneurysm. a Cumulative visceral branch patency. b Freedom from branch instability. c Primary patency. d Freedom from unplanned secondary intervention. e Primary-assisted patency.
performs better in this regard is not entirely resolved, primarily as a result of differing treatment indications, anatomic and stent configurations, as well as patient selection. The most recent multicenter analysis, however, found that occlusions of the renal arteries were greater after BEVAR than after FEVAR.21 As evident in Table II, most of the bridging stent grafts in the current series were balloon-expandable stent grafts in FEVAR and self-expandable stent grafts in BEVAR procedures. If the branch or fenestration ended in a kinked artery, the bridge was extended with a self-expanding nitinol stent. Permanent spinal ischemia occurred in two patients. Both had been treated with BEVAR, and both died #12 months. The spinal ischemia prevention program has evolved during this period, and the protocol in place at our institution is described above. Experience and the establishment of protocols are critical in the prevention of spinal ischemia, and this appears to be well supported by the low numbers of cases in this patient cohort.27 Whether revascularization of the LSA plays a role in the prevention of spinal ischemia is difficult to ascertain. Revascularization was performed if coverage of the LSA was anticipated, and this was true also for those patients in whom the LSA was covered during a previous TEVAR.
Specifying optimal surgical treatments is difficult because of the heterogeneity of these patients and their disease; however, the following generalized observations can be made: A fenestrated solution for branch vessel revascularization was preferred for patients with juxta/pararenal aneurysms, where there was often limited room for deployment of a branch in a nonaneurysmal distal descending aorta. A branched solution was favored in TAAAs with disease in the distal descending and paravisceral aorta to increase stent graft overlap and reduce the risk of a type III endoleak. In all elective patients, access procedures (eg, iliofemoral bypass for stent graft insertion) and supra-aortic deviations (eg, carotid-subclavian bypass) for acquisition of a safe proximal landing zone were performed as staged procedures, separate from the main F/BEVAR procedure. In patients with thoracoabdominal aneurysms requiring extensive aortic coverage including a TEVAR in addition to a F/BEVAR, the thoracic endografting was performed as a staged procedure separate from the F/BEVAR procedure. Generally, 2 to 4 weeks was allowed for recovery between each stage of the procedure. No ruptures occurred during these staging episodes.
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Although careful planning and staging are optimal to perform these procedures, it is encouraging to note the technical success and outcomes of the four ruptured TAAAs in this cohort. Further refinement of branched or fenestrated grafts may enable increased patient treatment considerations.28-30 Although data were collected prospectively, the analysis by nature is retrospective and thus exposed to selection biases. The period of analysis was from the implementation of endovascular treatment for complex aortic disease, and there are undoubtedly aspects of a learning curve that may have affected the results reported here. This may, however, strengthen or validate the essence of this analysis in sharing the experience of adapting to complex treatments. In addition, various minor technical developments occurred during the study period, for example, the use of two-dimensionalthree-dimensional fusion, which may have affected outcomes. No formal analysis was performed to evaluate changes or improvements over time. Although no patients were refused treatment because of anatomic constraints, no information was available on the number of patients refused treatment for reasons of comorbidities. Furthermore, there are no precise data on anatomic measurements or criteria for selection of a specific procedure, which could be explored in an analysis of branch instability. Also of note is that there was a natural lag between the follow-up of the patient’s living status and the status of the graft patency. None of the patients who died #90 days, for example, underwent specific imaging for these purposes. Of the two patients who refused follow-up imaging, one did so out of personal preference, and the other deteriorated clinically with dementia and died of respiratory failure at 25 months. The missing status of their grafts may therefore limit this analysis. Finally, although all patients were treated with endovascular repair, some of the failures were treated with open surgery.
CONCLUSIONS Treatment of complex aortic aneurysms has evolved, and the resolve to treat this patient group with a total endovascular approach, with its inherent reduced operative morbidity, is formidable. Studies from large and multiple centers have provided the foundation for continued use of these techniques. The midterm results presented here indicate that expansion of FEVAR and BEVAR to other centers is feasible. Long-term studies are needed to substantiate these results.
AUTHOR CONTRIBUTIONS Conception and design: JB-L, AW, KM Analysis and interpretation: JB-L, AW, KM Data collection: JB-L, JE, KM Writing the article: JB-L, KM
Critical revision of the article: AW, JE, KM Final approval of the article: JB-L, AW, JE, KM Statistical analysis: JB-L, KM Obtained funding: Not applicable Overall responsibility: KM
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Submitted Dec 29, 2016; accepted Mar 11, 2017.