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∗ Trans-Atlantic Aortic Research Consortium Investigators: Emanuel R. Tenorio, MD, PhD,a,b Gustavo S. Oderich, MD,a Andres Schanzer, MD,c Adam W. Beck, MD,d Mauro Gargiulo, MD,e Mark A. Farber, MD,f Bijan Modarai, MD, PhD,g Tomasz Jakimowicz, MD, PhD,h Luca Bertoglio, MD,i Roberto Chiesa, MD,j Enrico Gallitto, MD, PhD,k Giulianna B. Marcondes, MD,l F. Ezequiel Parodi, MD,m Fernando Motta, MD,m Panos Gkoutzios, MD,n and Katarzyna Jama, MDo; From the aDepartment of Cardiothoracic and Vascular Surgery, University of Texas Health Science Center at Houston, Houston, Tex; bDepartment of Vascular and Endovascular Surgery, Mayo Clinic, Rochester, Minn; cDivision of Vascular Surgery, Department of Surgery, University of Massachusetts Medical School, Worcester, Mass; dDivision of Vascular and Endovascular Surgery, Department of Surgery, University of Alabama at Birmingham, Birmingham, Ala; eVascular Surgery, University of Bologna, University Hospital Policlinico S. Orsola, Bologna, Italy; fDivision of Vascular Surgery, Department of Surgery, University of North Carolina, Chapel Hill, NC; gGuy's and St Thomas' NHS Foundation Trust, King's Health Partners, London, United Kingdom; hDepartment of General, Vascular and Transplant Surgery, Medical University of Warsaw, Warszawa, Poland; and iVita-Salute San Raffaele University, IRCCS San Raffaele Scientific Institute, Milan, Italy.
Trans-Atlantic Aortic Research Consortium Investigators
Footnotes
∗ Trans-Atlantic Aortic Research Consortium Investigators: Emanuel R. Tenorio, MD, PhD,a,b Gustavo S. Oderich, MD,a Andres Schanzer, MD,c Adam W. Beck, MD,d Mauro Gargiulo, MD,e Mark A. Farber, MD,f Bijan Modarai, MD, PhD,g Tomasz Jakimowicz, MD, PhD,h Luca Bertoglio, MD,i Roberto Chiesa, MD,j Enrico Gallitto, MD, PhD,k Giulianna B. Marcondes, MD,l F. Ezequiel Parodi, MD,m Fernando Motta, MD,m Panos Gkoutzios, MD,n and Katarzyna Jama, MDo; From the aDepartment of Cardiothoracic and Vascular Surgery, University of Texas Health Science Center at Houston, Houston, Tex; bDepartment of Vascular and Endovascular Surgery, Mayo Clinic, Rochester, Minn; cDivision of Vascular Surgery, Department of Surgery, University of Massachusetts Medical School, Worcester, Mass; dDivision of Vascular and Endovascular Surgery, Department of Surgery, University of Alabama at Birmingham, Birmingham, Ala; eVascular Surgery, University of Bologna, University Hospital Policlinico S. Orsola, Bologna, Italy; fDivision of Vascular Surgery, Department of Surgery, University of North Carolina, Chapel Hill, NC; gGuy's and St Thomas' NHS Foundation Trust, King's Health Partners, London, United Kingdom; hDepartment of General, Vascular and Transplant Surgery, Medical University of Warsaw, Warszawa, Poland; and iVita-Salute San Raffaele University, IRCCS San Raffaele Scientific Institute, Milan, Italy.
∗ Trans-Atlantic Aortic Research Consortium Investigators: Emanuel R. Tenorio, MD, PhD,a,b Gustavo S. Oderich, MD,a Andres Schanzer, MD,c Adam W. Beck, MD,d Mauro Gargiulo, MD,e Mark A. Farber, MD,f Bijan Modarai, MD, PhD,g Tomasz Jakimowicz, MD, PhD,h Luca Bertoglio, MD,i Roberto Chiesa, MD,j Enrico Gallitto, MD, PhD,k Giulianna B. Marcondes, MD,l F. Ezequiel Parodi, MD,m Fernando Motta, MD,m Panos Gkoutzios, MD,n and Katarzyna Jama, MDo; From the aDepartment of Cardiothoracic and Vascular Surgery, University of Texas Health Science Center at Houston, Houston, Tex; bDepartment of Vascular and Endovascular Surgery, Mayo Clinic, Rochester, Minn; cDivision of Vascular Surgery, Department of Surgery, University of Massachusetts Medical School, Worcester, Mass; dDivision of Vascular and Endovascular Surgery, Department of Surgery, University of Alabama at Birmingham, Birmingham, Ala; eVascular Surgery, University of Bologna, University Hospital Policlinico S. Orsola, Bologna, Italy; fDivision of Vascular Surgery, Department of Surgery, University of North Carolina, Chapel Hill, NC; gGuy's and St Thomas' NHS Foundation Trust, King's Health Partners, London, United Kingdom; hDepartment of General, Vascular and Transplant Surgery, Medical University of Warsaw, Warszawa, Poland; and iVita-Salute San Raffaele University, IRCCS San Raffaele Scientific Institute, Milan, Italy.
Reoperative open surgical repair (OSR) of thoracoabdominal aortic aneurysms (TAAAs) is associated with high morbidity and mortality. The aim of this study was to analyze outcomes of fenestrated–branched endovascular aneurysm repair (F-BEVAR) for the treatment of intercostal or visceral aortic patch aneurysms after OSR of TAAAs.
Methods
We reviewed the clinical data and outcomes of consecutive patients treated at 8 academic centers by F-BEVAR for visceral and intercostal aortic patch aneurysms after OSR of TAAAs (2011-2019). All patients had involvement of at least one target vessel requiring incorporation by a fenestration or directional branch. End points were technical success, 30-day and/in-hospital mortality, major adverse events, patient survival, target vessel patency/instability, and freedom from reintervention.
Results
There were 29 patients with a median age of 70 (interquartile range, 63-74) years. Seven patients (24%) had connective tissue disorders. Technical success was 100%. There were no 30-day/in-hospital mortalities. Major adverse events occurred in 5 patients (17%), including estimated blood loss >1 L in 3 patients (10%), acute kidney injury and respiratory failure in 2 patients (7%) each, and transient paraparesis in 1 patient (3%). Median follow-up was 14 (interquartile range, 7-37) months. At 2 years, primary and secondary patency, freedom from target artery instability, freedom from reintervention, and patient survival were 95%, 100%, 83%, 61%, and 96%, respectively.
Conclusions
F-BEVAR could be considered as an alternative to reoperative OSR in patients with visceral or intercostal aortic patch aneurysms. This series showed no mortality and a low rate of major adverse events, but a significant need for reintervention.
Fenestrated–branched endovascular aortic repair is an alternative in patients with aneurysm recurrence after open repair due to intercostal or visceral aortic patch aneurysm degeneration. This may avoid the shortcomings of reoperative open surgical repair. This series showed no mortality and low rate of major adverse events but a significant need for secondary intervention.
See Commentaries on pages 1272 and 1273.
Open surgical repair (OSR) of thoracoabdominal aortic aneurysms (TAAAs) requires extensive exposure and reconstruction of the renal and mesenteric arteries.
The Carrel patch technique achieves this by using a full-thickness “island” patch of aortic tissue containing several orifices of the visceral arteries. Although the “island” patch or inclusion technique simplifies the procedure by allowing fast reconstruction of intercostal arteries and the celiac axis (CA), superior mesenteric artery (SMA), and renal arteries, the graft is anastomosed end-to-side to diseased aortic tissue. Whereas this strategy is highly efficient by minimizing end-organ ischemia and technical complexity, the segment of retained native aorta is at risk of aneurysmal degeneration, especially in patients with connective tissue disorders.
The prevalence of intercostal and visceral aortic patch aneurysms ranges from 1% to 8% and is 3-fold greater among patients with connective tissue disorders.
Visceral aortic patch aneurysms are one of the most common indications for secondary interventions after open surgical TAAA repair. However, reoperative OSR of TAAAs is associated with exceedingly high mortality rates ranging from 17% to 40%.
Outcomes of endovascular repair of chronic postdissection compared with degenerative thoracoabdominal aortic aneurysms using fenestrated-branched stent grafts.
Recent improvements in this technology allowed its indications to be expanded to more complex anatomy, such as visceral aortic patch aneurysms, where the degeneration of the patch generally leads to significant distortions of the typical anatomical configuration. There is paucity of data on outcomes of F-BEVAR for this indication, with scarce case reports and small series.
Use of fenestrated-branched endovascular aneurysm repair to treat Carrel patch aneurysmal degeneration after open thoracoabdominal aortic aneurysm repair.
The aim of this study was to analyze outcomes of F-BEVAR for patients treated in 8 international academic centers for intercostal or visceral aortic patch aneurysms after OSR of TAAAs. Furthermore, we hypothesized that F-BEVAR for repair of intercostal and visceral aortic patch aneurysms following prior OSR of TAAAs is feasible.
Methods
The study was approved by the institutional review board in all centers (19-010702/October 23, 2019). All patients consented for data collection using prospectively maintained databases at each of the 8 international academic centers. The clinical data and outcomes of all consecutive patients treated by F-BEVAR for visceral and intercostal aortic patch aneurysm between March 2011 and October 2019 were analyzed in a retrospective fashion using a standardized database (Table E1 and Figure E1). Based on the retrospective nature of the study, individual patient consent for this study was waived. All patients had at least 1 target vessel requiring incorporation by a fenestration or directional branch. Patch aneurysm was defined by an aortic diameter of 5 cm or more at the level of target vessels incorporated by island patch or beveled anastomosis during OSR (Figure 1).
Demographics, clinical characteristics, cardiovascular risk factors, imaging, and operative and follow-up data were collected at each institution. Aneurysm morphology was determined by high-resolution computed tomography angiography data sets analyzed in a 3-dimensional workstation. Aneurysm extent was categorized using the extension of the repair by the Safi's classification.
The decision on specific device design varied according to the physician's preference. Device design options were manufactured patient-specific (Cook Medical, Brisbane, Australia), an off-the-shelf t-branch Cook device (Cook Medical), or physician modified stent-grafts. Bridging stent-graft choice also varied according to physician's preference (Figures 2 and 3). Protocols for spinal cord injury prevention were used in all centers. General guidelines included preservation of vertebral and internal iliac artery circulation whenever possible, and use of cerebrospinal drainage (CSFD). One center used intraoperative neuromonitoring with motor-evoked and sensory-evoked potential monitoring. Five centers used routine prophylactic CSFD, and 3 used therapeutic CSFD only in the presence of symptoms of spinal cord injury.
Figure 1Device design. Three-dimensional (3D) computed tomography angiography reconstruction and illustration show visceral patch aortic aneurysm after open surgical repair of an extent II thoracoabdominal aortic aneurysm (A). Schematic and illustration of the device design with 3 directional branches with preloaded wires to be accessed using upper extremity (Thoracoabdominal Preloaded Delivery System—TPDS; B). By permission of Mayo Foundation for Medical Education and Research. All rights reserved.
Figure 2Implantation. The right brachial artery is surgically exposed, and preclosure of femoral access is performed. After systematic heparinization, a 12-Fr DrySeal flex sheath (W. L. Gore & Associates, Inc, Flagstaff, Ariz) is advanced to the descending thoracic aorta from the right brachial approach. Brachial–femoral through-and-through access is established by snaring a 0.035-inch 480-cm Tracer Metro Direct Wire Guide (Cook Medical, Bloomington Ind, A). Advancement of the delivery system over the brachial–femoral wire, with externalization through the right brachial sheath (B), followed by unsheathing of top-cap of the delivery system exposing the preloaded wires (C) and cutting of preloaded wire loops to establish three preloaded wires, each labeled to its intended target vessel (D). The device is deployed in a staggered fashion, allowing sequential catheterization of each target vessel through the 12-Fr brachial sheath. First, a 6-Fr Flexor Shuttle sheath with 0.018-inch dilator is advanced into the celiac axis branch. Once the sheath is distal to the edge of the branch, a 4-Fr Berenstein catheter and soft glidewire are used as a “buddy system” to cannulate the vessel. A 0.035-inch Amplatzer wire is positioned in the splenic artery. The same steps are repeated leaving a 0.035-inch Amplatzer wire in the SMA, and 0.035-inch Rosen in the left renal artery. The distal portion of the fenestrated–branched device is deployed, followed Sequential vessel stenting using VBX balloon-expandable stent-grafts (W. L. Gore & Associates) with intra-aortic stent flaring to 10 mm (E-F) of the left renal artery, superior mesenteric artery (G-H) and celiac axis (I-J). Final angiography showing widely patent all branches (L). By permission of Mayo Foundation for Medical Education and Research. All rights reserved.
Figure 2Implantation. The right brachial artery is surgically exposed, and preclosure of femoral access is performed. After systematic heparinization, a 12-Fr DrySeal flex sheath (W. L. Gore & Associates, Inc, Flagstaff, Ariz) is advanced to the descending thoracic aorta from the right brachial approach. Brachial–femoral through-and-through access is established by snaring a 0.035-inch 480-cm Tracer Metro Direct Wire Guide (Cook Medical, Bloomington Ind, A). Advancement of the delivery system over the brachial–femoral wire, with externalization through the right brachial sheath (B), followed by unsheathing of top-cap of the delivery system exposing the preloaded wires (C) and cutting of preloaded wire loops to establish three preloaded wires, each labeled to its intended target vessel (D). The device is deployed in a staggered fashion, allowing sequential catheterization of each target vessel through the 12-Fr brachial sheath. First, a 6-Fr Flexor Shuttle sheath with 0.018-inch dilator is advanced into the celiac axis branch. Once the sheath is distal to the edge of the branch, a 4-Fr Berenstein catheter and soft glidewire are used as a “buddy system” to cannulate the vessel. A 0.035-inch Amplatzer wire is positioned in the splenic artery. The same steps are repeated leaving a 0.035-inch Amplatzer wire in the SMA, and 0.035-inch Rosen in the left renal artery. The distal portion of the fenestrated–branched device is deployed, followed Sequential vessel stenting using VBX balloon-expandable stent-grafts (W. L. Gore & Associates) with intra-aortic stent flaring to 10 mm (E-F) of the left renal artery, superior mesenteric artery (G-H) and celiac axis (I-J). Final angiography showing widely patent all branches (L). By permission of Mayo Foundation for Medical Education and Research. All rights reserved.
Figure 3Three-dimensional computed tomography angiography and illustration after one year follow up showing patent all branches without endoleak. By permission of Mayo Foundation for Medical Education and Research. All rights reserved.
Technical success was defined by successful implantation of the aortic endograft all-intended fenestration or directional branch target artery stents with successful target artery patency. Early outcomes were assessed at 30 days or within hospital stay if longer than 30 days and included mortality and major adverse events (MAEs). The latter was a composite end point of any cause mortality, estimated blood loss >1 L, myocardial infarction, respiratory failure, paraplegia, major stroke, bowel ischemia, new-onset dialysis, and acute kidney injury. Mid-term outcomes included secondary interventions, target artery patency, target artery instability, aortic-related mortality, and patient survival. Follow-up was similar in all centers and consisted of clinical examination, laboratory studies, and computed tomography angiography before discharge or within 1 to 2 months, 6 months, 12 months, and annually thereafter.
Statistical Analyses
Data were reported using the Society for Vascular Surgery reporting standards for F-BEVAR.
Categorical variables were presented as numbers and percentages, and continuous variables were expressed as median with interquartile ranges (25th-75th percentile). Time dependent outcomes were reported using Kaplan-Meier estimates. IBM SPSS statistics 25 (IBM Corp, Armonk, NY) was used for statistical analyses.
Results
Patient Study
A total of 2917 patients were treated by F-BEVAR in the 8 centers during the study period. From this group, 29 patients (1%), 21 men (72%) and 8 women (28%), with a median age of 70 (interquartile range [IQR], 63-74) years old were included in the analysis (Table 1). Indication for treatment of patch aneurysms occurred 9 ± 9 years after the index OSR of TAAA. The most common cardiovascular risk factors were hypertension in 27 patients (93%), hypercholesterolemia in 19 patients (66%), and cigarette smoking in 18 patients (62%). The American Society of Anesthesiologists score was class 2 in 11 patients (38%), class 3 in 12 (41%) patients, and class 4 in 6 patients (21%). Seven patients (24%) had known connective tissue disorders, including Marfan syndrome in 4 patients (14%), Loeys–Dietz in 2 patients (7%), and ACTA2 (actin alpha 2) autosomal-dominant genetic mutation in 1 patient (3%). Seven patients (24%) had previous aortic dissection, all of them classified as Stanford B. Three patients (10%) were treated for a postdissection TAAA. The maximum median aortic diameter was 62 (IQR, 57-69) mm. The most common aneurysm classifications were extent IV TAAA in 11 patients (38%) and extent II TAAA in 10 patients (35%). Seven patients (24%) had staged procedures.
Table 1Demographics, clinical, and anatomical characteristics of 29 patients treated by F-BEVAR for repair of intercostal and visceral aortic patch aneurysms after open surgical TAAA repair
Variable
Overall (n = 29)
n (%), median, or IQR (25%-75%)
Demographics
Age, y
70, 63-74
Age > 80 y
2 (7)
Male sex
21 (72)
Cardiovascular risk factors
Cigarette smoking
18 (62)
Hypertension
27 (93)
Hypercholesterolemia
19 (66)
Coronary artery disease
6 (21)
Chronic obstructive pulmonary disease
11 (38)
Peripheral arterial disease
8 (28)
Connective tissue disease
7 (24)
Chronic kidney disease stage III-V
10 (34)
Dialysis
2 (7)
Congestive heart failure
7 (24)
Stroke/TIA
4 (14)
Connective tissue disease
Marfan syndrome
4 (14)
Loeys–Dietz syndrome
2 (7)
ACTA2 autosomal-dominant genetic mutation
1 (3)
Preoperative evaluation
Serum creatinine, mg/dL
0.9, 0.8-1.3
eGFR, mL/min/1.73 m2
79, 52-93
Body mass index, kg/m2
28, 23-29
ASA score
Class 2
11 (38)
Class 3
12 (41)
Class 4
6 (21)
ASA score ≥3
18 (62)
Anatomical characteristics
Maximum aortic diameter
62, 57-69
Aneurysm type
Crawford extent I
3 (10)
Crawford extent II
10 (35)
Crawford extent III
4 (14)
Crawford extent IV
11 (38)
Crawford extent V
1 (3)
Prior aortic dissection
7 (24)
Stanford B
7 (24)
Postdissection TAAA
3 (10)
Status of aneurysm
Asymptomatic nonruptured
26 (90)
Symptomatic nonruptured
2 (7)
Contained ruptured
1 (3)
Staged procedure
7 (24)
IQR, Interquartile range; TIA, transient ischemic attack; ACTA2, actin alpha 2; eGFR, estimated glomerular filtration rate; ASA, American Society of Anesthesiologists; TAAA, thoracoabdominal aortic aneurysm.
Patient-specific devices were used in 24 patients (83%), off-the-shelf t-Branch stent grafts were used in 3 patients (10%), and physician-modified endografts in 2 patients (7%, Table 2). A total of 103 target arteries were incorporated by 54 fenestrations and 49 directional branches, including 28 CA, 27 SMAs, 45 renal arteries, 2 intercostal arteries, and 1 inferior mesenteric artery. The median number of target arteries per patient was 4 (IQR, 3-4). General endotracheal anesthesia was used in 23 patients (79%), and local anesthesia with sedation was used in 6 patients (21%). Cerebrospinal fluid drainage was used in 14 patients (48%) and neuromonitoring in 3 patients (10%). Technical success, defined by deployment of the aortic stent graft and all intended side branch components, was achieved in all patients. There were 11 patients (38%) who had a total percutaneous transfemoral approach, and 2 patients (7%) who required iliac conduits.
Table 2Procedural details and device design of 29 patients treated by F-BEVAR for repair of intercostal and visceral aortic patch aneurysms after open surgical TAAA repair
There were no 30-day or in-hospital deaths. Five patients (17%) had MAEs, including estimated blood loss >1 L in 3 patients (10%), acute kidney injury and respiratory failure in 2 patients (7%) each, and spinal cord injury in 1 patient (3%, Table E2). No patient presented new-onset dialysis, myocardial infarction, stroke, or bowel ischemia. The patient who presented with spinal cord injury had temporary reversible paraparesis. None of the patients developed paraplegia. Other adverse events were congestive heart failure in 2 patients (7%) and pneumonia in 1 patient (3%).
Four patients (14%) had access-site complications, including 1 brachial access hematoma (managed conservatively), 1 brachial access pseudoaneurysm (managed by local compression), 1 femoral access complication leading to limb ischemia, and 1 femoral access bleeding (both managed by operative procedures). Median length of stay in the intensive care unit and hospital were 1 (IQR, 0-3) and 5 (IQR, 4-7) days, respectively. All patients were discharged home.
Midterm Outcomes
Median follow-up was 14 (IQR, 7-37) months. There was 1 late death in the cohort due to pulmonary malignancy. At 2 years, patient survival was 96%. Secondary interventions were required in 9 patients (31%) and were performed using percutaneous endovascular technique in 8 patients (89% [8/9], Table 3). One patient required a left retroperitoneal exploration with evacuation of aortic aneurysm and repair of type IC endoleak in the SMA with extension of the branch stent distally. The indications for secondary interventions were type IIIC endoleak, type IC endoleak, and stent stenosis in 4 patients each and type IA or IIIB endoleak in 1 patient each. Two patients had multiple secondary interventions to treat endoleak or branch stenosis. At 2 years, freedom from secondary intervention was 61% (Figure E2).
Table 3Secondary intervention of 29 patients treated by F-BEVAR for repair of intercostal and visceral aortic patch aneurysms after open surgical TAAA repair
Patient
Device design
Timing of secondary intervention, d
Anesthesia type
Reason for secondary intervention
Description of secondary intervention
1
Patient-specific—4 fenestrations
280
Local
Type IIIC endoleak from RRA and SMA
Bare-metal balloon-expandable fenestration stenting of RRA and SMA
Patient had rupture of the aorta due a type IC endoleak from the SMA.
Relining SMA and CA stent/left retroperitoneal exploration with evacuation of aortic aneurysm and repair type IC endoleak in SMA with purse-string suture
9
Patient-specific—4 directional branches
176
Local
Type IC endoleak from SMA, SMA stent stenosis and LRA stent stenosis
Redo SMA and LRA stents
RRA, Right renal artery; SMA, superior mesenteric artery; CA, celiac axis; LRA, left renal artery.
∗ Patient had rupture of the aorta due a type IC endoleak from the SMA.
There were no branch occlusions. Stenosis occurred in 4 (4%) of the 103 targeted visceral arteries, including three renal arteries and one SMA. Overall, there were 14 target artery instabilities due to type IIIC endoleak in 4 patients (2 renal arteries, 2 SMA, 1 CA), type IC endoleak in 4 patients (3 SMA, 2 CA), type IIIB endoleak in 1 patient (1 CA stent fracture), and stent stenosis in 2 patients. Primary and secondary patency rates and freedom from target artery instability at 2 years were 95%, 100%, and 83%, respectively (Figure 4).
Figure 4Kaplan–Meier estimates of patency (A), and freedom from target vessel instability (B) of 29 patients treated by fenestrated–branched endovascular aortic repair for repair of intercostal and visceral aortic patch aneurysms after open surgical TAAA repair. The shaded area represents the 95% confidence interval.
There were 13 patients (45%) with any evidence of endoleaks. Four patients with isolated type II endoleak had a conservative approach with no aneurysm sac growth. Clinical data on aneurysm sac changes were analyzed in all patients; 20 patients (69%) had stable aneurysm diameter, 7 patients (24%) had >5 mm decrease in diameter, and 2 patients (7%) had >5 mm increase in diameter. The 2 patients with sac enlargement were treated successfully for endoleak type IA and type IIIC/IC one each. Mean aneurysm sac regression during follow up was −10 ± 6 mm for the entire cohort (−8, −11/−7).
Discussion
This multicenter international study outlines the largest series of patients treated for intercostal and visceral aortic patch aneurysms after previous open surgical TAAA repair using F-BEVAR. The observation of high technical success (100%) with no 30-day or in-hospital mortality and low rates of MAEs supports the feasibility of the F-BEVAR for treatment of intercostal and visceral aortic patch aneurysms after previous open surgical TAAA repair. Although the numbers are small, the outcomes compare favorably with all reports of reoperative OSR of TAAA and serve as a benchmark for future comparisons. However, the high rates of secondary interventions highlight the anatomical complexity of these patients and their predisposition to progression of aortic disease, emphasizing the importance of long-term follow-up to assess the durability of F-BEVAR for this indication.
The premier centers with extensive experience in OSR of TAAAs have published their outcomes with reoperative open TAAA repair.
reported a 25-year experience with redo OSR for TAAAs in 266 patients. In that study, the 30-day or in-hospital mortality was 23%. The authors also elaborated a logistic regression model to predict 30-day or in-hospital mortality and demonstrated a minimum and maximum predicted probability of 30-day or in-hospital mortality of 11% and 82%, respectively. The risk factors associated with 30-day or in-hospital mortality in that model were age >70 years, estimated glomerular filtration rate <48 mL/min, Crawford extent III TAAA, and emergency presentation. Furthermore, morbidity was exceedingly high, with new-onset dialysis affecting 32% of patients and respiratory failure with need for tracheostomy in 18% of patients.
a subset analysis of patients with visceral patch aneurysms treated by redo OSR showed 30-day or in-hospital mortality rate of 11%, with new-onset dialysis occurring in 13% of patients (permanent dialysis in 10%), and respiratory failure in 29% of patients, requiring tracheostomy in 10%. Our results compare favorably with those reported in either series of redo OSR for TAAA. There were no 30-day or in-hospital mortality, new-onset or permanent dialysis, or respiratory failure requiring tracheostomy. In addition, 6 patients were treated under local anesthesia and sedation, and all patients were discharged home, showing that F-BEVAR also requires a less-invasive approach. Similar to other reports, we also identified a high prevalence of connective tissue disorder among those patients with intercostal and visceral aortic patch aneurysm (24%-26%).
Notably, 3 of the 9 patients who had secondary intervention in our series had underlying connective tissue disorders, but none developed type IA endoleak. Stent-graft use in patients with connective tissue disorder is usually contraindicated for those with native aorta because the pathologic process affects the stent-graft's lading zones. However, F-BEVAR for intercostal or visceral aortic patch aneurysms after OSR of TAAA, the lading zones are located inside the preexisting surgical aortic graft. They are resistant areas, thus limiting the risk of type I endoleak.
Treatment of visceral and intercostal patch aneurysms presents a formidable challenge, independent of which approach is selected.
have described technical aspects that should be emphasized to achieve satisfactory results to treat patients with visceral patch aneurysms using F-BEVAR. The landing zone, particularly the proximal landing zone, based on a previous open surgical graft seems to be adequate for sealing, even when associated with connective tissue disorders. However, device design should be planned carefully, taking into consideration the reduced compliance of the polyester grafts. We recommend not exceeding 4 mm or 20% oversizing to avoid infolding or kink in the stent-graft. Other challenges are the limited luminal space for guidewire and catheter manipulation, as well as the distortion in the origin of the visceral vessel anatomy induced by the patch aneurysmal degeneration or use of bypass reconstructions. Furthermore, the presence of a previous surgical graft might limit the possibility to rotate a partially opened endograft and might thus reduce the ability to orient the device in an adequate position. For these reasons, some adjuncts may help during the procedure. First, the implementation of double-diameter–reducing ties and an initial correct and precise opening of the device are paramount. A device design with preloaded guidewire systems should be used to allow immediate access to fenestration or directional branches facilitating vessel catheterization. In addition, the use of advanced imaging applications is critical during these complex endovascular aortic procedures. Onlay fusion mask and cone-beam computed tomography allow the accurate deployment of the aortic stent-graft and side branches and a thorough technical assessment.
Impact of onlay fusion and cone beam computed tomography on radiation exposure and technical assessment of fenestrated-branched endovascular aortic repair.
Another important consideration in the management of intercostal and visceral aortic patch aneurysms is prevention of spinal cord ischemia. The eventual presence of intercostal artery patches or selective reimplantation on the surgical graft at the level of the proximal sealing zone should be evaluated. While the patient specific custom-made stent-graft is being planned, any attempt of not covering the intercostal patch with either the fabric or the proximal bare-metal stent must be made. In our series, 2 patients had incorporation of an intercostal artery (one by fenestration and other by directional branch). In both cases, the intercostal arteries were greater than 5 mm in diameter, which allowed their inclusion into the repair. If sparing of this area is unachievable, a careful evaluation of risks and benefits needs to be carried out. A maneuver that can be used in the process of decision-making of preservation of the flow into an intercostal artery is a balloon test occlusion guides by neuromonitoring to assess spinal cord changes that reflect the importance of the intercostal artery for spinal cord perfusion (Figure E3 and Video 1).
The rate of secondary intervention in this study was high (31%), which reflects the complexity of these patients. Although freedom from secondary intervention was 61% at 2 years, 89% of the procedures were performed using a percutaneous endovascular approach with local anesthesia in 79%. Intercostal and visceral aortic patch aneurysms are primarily late complications of the OSR of TAAA, and redo open approach to treat these patients is associated with a 30-day or in-hospital mortality up to 20%.
In our series, there were no MAEs among patients who had a secondary intervention. Furthermore, the most common indication was treatment of endoleaks. Bertoglio and colleagues
reported an unexpectedly high rate of type IIIC endoleaks using LifeStream stent-graft (Bard Peripheral Vascular, Tempe, Ariz) as bridging stent for fenestration. The authors hypothesized that LifeStream stent-graft appears to have an excessive recoil at the perifenestration level, possibly due to a lack of sufficient radial force to obtain/maintain an effective seal after flaring within the fenestration. Three patients from that study were included in the present study. This fact explains in part the high rate of secondary interventions in our study, highlighting areas that need further improvement.
Limitations inherent to this study should be considered. These results represent the experience of highly skilled centers and are not easily generalized. The small number of patients and relative short follow-up also limit subgroup analysis. Patients with visceral or intercostal patch aneurysms may be young and present connective tissue disorders when comparing with patients with degenerative TAAAs. Therefore, long-term durability of F-BEVAR should be considered in the discussion of treatment selection between open and endovascular repair. In addition, no comparison with OSR was included and as such statements regarding safety or efficacy of F-BEVAR versus OSR are not possible based on these data. Lastly, the majority of patients included in the present study were referred from other centers, which made impossible to determine the real prevalence of intercostal and visceral aortic patch aneurysm.
Conclusions
Despite the small number of patients included in this study, it is the largest report of F-BEVAR for visceral or intercostal aortic patch aneurysms. This series showed no mortality and a low rate of MAEs, but a significant need for secondary intervention. Although open repair has traditionally been the first line of treatment in most patients, F-BEVAR could be considered as a viable alternative. Larger clinical experience and longer follow-up are needed to determine indications, results, and to confirm durability, particularly in young patients or with connective tissue disorders.
Conflict of Interest Statement
Dr Gustavo S. Oderich has received consulting fees and grants from Cook Medical, W. L. Gore, Centerline Biomedical and GE Healthcare; Dr Mauro Gargiulo, Dr Tomasz Jakimowicz, Dr Katarzyna Jama, and Dr Luca Bertoglio have received consulting fees and grants from Cook Medical; Dr Andres Schanzer has received consulting fees and grants from Cook Medical and Phillips (all paid to UMass Memorial Foundation with no personal income); Dr Mark A. Farber has received consulting fees and grants from Cook Medical, W.L. Gore, Centerline Biomedical and Getinge; Dr Bijan Modarai has received consulting fees from Cook Medical, Phillips, and Cydar Medical. These organizations did not have any part in this study. All other authors reported no conflicts of interest.
The Journal policy requires editors and reviewers to disclose conflicts of interest and to decline handling or reviewing manuscripts for which they may have a conflict of interest. The editors and reviewers of this article have no conflicts of interest.
Intercostal artery patch aneurysm treated using physician modified technique to create a branch to preserve the flow into the intercostal artery. By permission of Mayo Foundation for Medical Education and Research. All rights reserved. Video available at: https://www.jtcvs.org/article/S0022-5223(21)00747-9/fulltext.
Intercostal artery patch aneurysm treated using physician modified technique to create a branch to preserve the flow into the intercostal artery. By permission of Mayo Foundation for Medical Education and Research. All rights reserved. Video available at: https://www.jtcvs.org/article/S0022-5223(21)00747-9/fulltext.
Appendix E1
Table E1Number of cases performed per center using F-BEVAR for intercostal and visceral aortic patch aneurysms after previous open surgical TAAA repair
Center
No. of cases (%)
Vita-Salute San Raffaele University, IRCCS San Raffaele Scientific Institute, Milan, Italy
10 (36)
University of Massachusetts Medical School, Worcester, Mass
04 (14)
University of Alabama at Birmingham, Birmingham, Ala
Table E2Mortality and MAEs of 29 patients treated by F-BEVAR for repair of intercostal and visceral aortic patch aneurysms after open surgical TAAA repair
Figure E2Kaplan–Meier estimates of patient survival (A) and freedom from secondary intervention (B) of 29 patients treated by fenestrated–branched endovascular aortic repair for repair of intercostal and visceral aortic patch aneurysms after open surgical thoracoabdominal aortic aneurysm repair. The shaded area represents the 95% confidence interval.
Figure E3Device modification and implantation. The stent-graft was unsheathed and oblique 5 × 7-mm fenestration was created in the predetermined location using ophthalmic cautery. A 5 × 25-mm Viabahn was beveled and anastomosed end-to-side to create a directional branch (DB) using 5-0 running Gore sutures (A); The radiopaque gold markers (arrows) around the branch and at 12 and 6o'clock of the stent-graft for anterior–posterior orientation (B); The DB was preloaded with 0.018-inch V18 guidewire and resheathed into the original delivery system using 2-0 silk ties and Silastic tape (C and D). The left proximal brachial artery was surgically exposed and percutaneous femoral access was established using pre-closure technique (E). A 20-Fr sheath was advanced via the femoral approach into the infrarenal aorta over a 0.035-inch Lunderquist wire. Through-and-through brachiofemoral access was established and a 5-Fr × 110-cm sheath was advanced via the brachial access and exteriorized via the right femoral sheath. The femoral sheath was removed over the wire and the 5-Fr brachial sheath while maintaining hemostasis with manual compression on the femoral access site. The device was loaded into the Lunderquist wire and the preloaded 0.018-inch guidewire into the 5-Fr sheath (F). The device was positioning with the distal edge of the DB 2-cm above the level of the target intercostal artery (IA, G); The device was partially deployment and the IA was catheterized (H). The stent-graft was fully deployed and a balloon occlusion test was performed using a 5 × 60-mm angioplasty balloon which was temporarily inflated in to occlude the DB. After 5 minutes of balloon inflation, there was decline in right lower-limb motor-evoked potentials, with normalization after balloon deflation (EDC, extensor digitorum communi; Ham, hamstring; AT, anterior tibial; AH, abductor hallucis; I). The IA was incorporated with placement of two 6 × 50-mm Viabahn stent-grafts in the DB (J and K). Final angiography showed widely patent stent-graft, DB and renal-mesenteric bypass grafts (L). Three-dimensional computed tomography angiography reconstruction and illustration showing the intercostal branch artery patent after four years follow up with aneurysm sac shrink (M). By permission of Mayo Foundation for Medical Education and Research. All rights reserved.
Figure E3Device modification and implantation. The stent-graft was unsheathed and oblique 5 × 7-mm fenestration was created in the predetermined location using ophthalmic cautery. A 5 × 25-mm Viabahn was beveled and anastomosed end-to-side to create a directional branch (DB) using 5-0 running Gore sutures (A); The radiopaque gold markers (arrows) around the branch and at 12 and 6o'clock of the stent-graft for anterior–posterior orientation (B); The DB was preloaded with 0.018-inch V18 guidewire and resheathed into the original delivery system using 2-0 silk ties and Silastic tape (C and D). The left proximal brachial artery was surgically exposed and percutaneous femoral access was established using pre-closure technique (E). A 20-Fr sheath was advanced via the femoral approach into the infrarenal aorta over a 0.035-inch Lunderquist wire. Through-and-through brachiofemoral access was established and a 5-Fr × 110-cm sheath was advanced via the brachial access and exteriorized via the right femoral sheath. The femoral sheath was removed over the wire and the 5-Fr brachial sheath while maintaining hemostasis with manual compression on the femoral access site. The device was loaded into the Lunderquist wire and the preloaded 0.018-inch guidewire into the 5-Fr sheath (F). The device was positioning with the distal edge of the DB 2-cm above the level of the target intercostal artery (IA, G); The device was partially deployment and the IA was catheterized (H). The stent-graft was fully deployed and a balloon occlusion test was performed using a 5 × 60-mm angioplasty balloon which was temporarily inflated in to occlude the DB. After 5 minutes of balloon inflation, there was decline in right lower-limb motor-evoked potentials, with normalization after balloon deflation (EDC, extensor digitorum communi; Ham, hamstring; AT, anterior tibial; AH, abductor hallucis; I). The IA was incorporated with placement of two 6 × 50-mm Viabahn stent-grafts in the DB (J and K). Final angiography showed widely patent stent-graft, DB and renal-mesenteric bypass grafts (L). Three-dimensional computed tomography angiography reconstruction and illustration showing the intercostal branch artery patent after four years follow up with aneurysm sac shrink (M). By permission of Mayo Foundation for Medical Education and Research. All rights reserved.
Outcomes of endovascular repair of chronic postdissection compared with degenerative thoracoabdominal aortic aneurysms using fenestrated-branched stent grafts.
Use of fenestrated-branched endovascular aneurysm repair to treat Carrel patch aneurysmal degeneration after open thoracoabdominal aortic aneurysm repair.
Impact of onlay fusion and cone beam computed tomography on radiation exposure and technical assessment of fenestrated-branched endovascular aortic repair.
Tenorio and colleagues1 provide an excellent analysis demonstrating promising results for the treatment of a complication that infrequently appears in any given single aortic practice. In this edition of the Journal, they present a retrospective analysis of a prospective multinational database consisting of 8 specialized aortic centers that characterizes the results of 29 patients undergoing fenestrated branched endovascular aortic repair of either visceral or intercostal artery aneurysms who have undergone past open abdominal aortic aneurysm repair.
Intercostal and visceral patch aneurysm after previous open surgical repair (OSR) of thoracoabdominal aortic aneurysm (TAAA) is a challenging problem.1,2 The use of endovascular and hybrid techniques as an alternative to OSR for this indication is increasing, but the challenges remain formidable irrespective of the treatment modality.3 However, the literature is limited to small series or case reports.
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