Multicenter Study on Physician-Modified Endografts for Thoracoabdominal and Complex Abdominal Aortic Aneurysm Repair
Abstract
BACKGROUND:
Physician modified endografts (PMEGs) have been widely used in the treatment of complex abdominal aortic aneurysm and thoracoabdominal aortic aneurysm, however, previous data are limited to small single center studies and robust data on safety and effectiveness of PMEGs are lacking. We aimed to perform an international multicenter study analyzing the outcomes of PMEGs in complex abdominal aortic aneurysms and thoracoabdominal aortic aneurysms.
METHODS:
An international multicenter single-arm cohort study was performed analyzing the outcomes of PMEGs in the treatment of elective, symptomatic, and ruptured complex abdominal aortic aneurysms and thoracoabdominal aortic aneurysms. Variables and outcomes were defined according to the Society for Vascular Surgery reporting standards. Device modification and procedure details were collected and analyzed. Efficacy outcomes included technical success and safety outcomes included major adverse events and 30-day mortality. Follow-up outcomes included reinterventions, endoleaks, target vessel patency rates and overall and aortic-related mortality. Multivariable analysis was performed aiming at identifying predictors of technical success, 30-day mortality, and major adverse events.
RESULTS:
Overall, 1274 patients were included in the study from 19 centers. Median age was 74 (IQR, 68–79), and 75.7% were men; 45.7% were complex abdominal aortic aneurysms, and 54.3% were thoracoabdominal aortic aneurysms; 65.5% patients presented electively, 24.6% were symptomatic, and 9.9% were ruptured. Most patients (83.1%) were submitted to a fenestrated repair, 3.6% to branched repair, and 13.4% to a combined fenestrated and branched repair. Most patients (85.8%) had ≥3 target vessels included. The overall technical success was 94% (94% in elective, 93.4% in symptomatic, and 95.1% in ruptured cases). Thirty-day mortality was 5.8% (4.1% in elective, 7.6% in symptomatic, and 12.7% in ruptured aneurysms). Major adverse events occurred in 25.2% of cases (23.1% in elective, 27.8% in symptomatic, and 30.3% in ruptured aneurysms). Median follow-up was 21 months (5.6–50.6). Freedom from reintervention was 73.8%, 61.8%, and 51.4% at 1, 3, and 5 years; primary target vessel patency was 96.9%, 93.6%, and 90.3%. Overall survival and freedom from aortic-related mortality was 82.4%/92.9%, 69.9%/91.6%, and 55.0%/89.1% at 1, 3, and 5 years.
CONCLUSIONS:
PMEGs were a safe and effective treatment option for elective, symptomatic, and ruptured complex aortic aneurysms. Long-term data and future prospective studies are needed for more robust and detailed analysis.
Clinical Perspective
What Is New?
•
This international multicenter study analyzed 1274 patients with complex abdominal and thoracoabdominal aortic aneurysms treated with physician modified endografts.
•
Physician modified endografts achieved 94% technical success and 5.8% 30-day mortality.
•
At 1, 3, and 5 years of follow-up, freedom from aortic-related mortality was 92.9%, 91.6%, and 89.1%, whereas freedom from reintervention was 73.8%, 61.8%, and 51.4%.
What Are the Clinical Implications?
•
Physician modified endografts appear to be a safe and effective treatment option for elective, symptomatic, and ruptured complex abdominal and thoracoabdominal aortic aneurysms.
•
Future comparative studies with other established techniques are needed in both the elective and urgent setting.
Endovascular repair of complex abdominal aortic aneurysms (CAAA) and thoracoabdominal aortic aneurysms (TAAA) has been shown to be a safe and effective treatment.1–5 It is now considered the first-line treatment strategy in most centers and has enabled treatment of higher surgical risk patients.5–8
Currently, the gold-standard for CAAA are fenestrated and branched custom-made devices (CMD), showing excellent results.1,2,9 However, CMDs are not widely available in all centers and require a planning and manufacturing time which may delay aneurysm treatment.10 Therefore, other treatment strategies such as the use of off-the-shelf (OTS) grafts, parallel grafts, and physician modified endografts (PMEGs) have been developed, the latter being the precursor for the CMD platforms. OTS devices are not widely available and may require anatomical compromises, such as increasing aortic coverage or dealing with narrow paravisceral segments.11,12 Parallel graft techniques include combinations of devices which are mostly available, however, have a risk of “gutter” endoleak and treatment failures are complex to resolve.13
PMEGs have been used either because CMDs are not yet licensed or due to time constraints associated with urgent repairs.14 If well planned and constructed, PMEGs are the closest alternative to CMDs; however, they do require significant expertise and technical skills. A recent systematic review and meta-analysis suggested that PMEGs may be a safe and effective technique, however, most studies were small single-center cohorts with a high degree of heterogeneity.14 To collect more robust data on outcomes of PMEGs in both, the elective and urgent setting, we conducted a multicenter, international study assessing the use of this technique. Our aim was to assess the safety and effectiveness of PMEGs in treatment of TAAAs and CAAAs.
METHODS
This study followed the reporting guidelines from the STROBE statement (Strengthening the Reporting of Observational Studies in Epidemiology) for cohort studies.15 The data that support the findings of this study are available from the corresponding author upon reasonable request.
Study Design, Setting and Participants
An international multicenter retrospective cohort study was performed on all consecutive patients who underwent endovascular repair of a CAAA or TAAA using a PMEG with fenestrations, branches, or scallops to preserve visceral arteries. Nineteen aortic centers participated, including centers from the United States (n=9), Europe (n=9), and Asia (n=1). Patients were treated from 2007 to 2022.
The study was approved by the local Ethics committee of the coordinating center (Ludwig Maximilian University Hospital, ref: 22-0155). In all participating centers, the study was approved by the Institutional Review Boards or waived for ethical approval in accordance with local practice.
Inclusion criteria included a diagnosis of TAAA (Extent I-V) or CAAA (short neck, juxtarenal, pararenal and suprarenal); elective, symptomatic, or ruptured aneurysms were included; at least 1 visceral artery (renal arteries, superior mesenteric artery, or celiac trunk) had to be involved in the repair with either a branch, fenestration, or scallop; repair had to be performed using a PMEG with branches, fenestrations, or scallops; branched modifications included short and long branches, antegrade, retrograde, or outer and inner branches; fenestration modifications included nonreinforced, reinforced, strut-free, or not; modification of the endograft had to be performed in a thoracic graft or main body of a bifurcated graft; all techniques for modification on the table were accepted (scalpel modification, cold cautery and other techniques); and all company devices and bridging stents were acceptable (Figure 1).
We excluded patients undergoing aortic arch fenestrated or branched repair; modifications performed to iliac limbs instead of the main body of the devices; patients undergoing open or hybrid repair; simultaneous parallel graft techniques; or modifications not performed on the table (such as in situ techniques).
Outcomes, Variables, and Definitions
Outcomes and variables were defined according to the Society for Vascular Surgery reporting standards.9 Data were gathered using a predesigned data collection sheet and included patient demographics, cardiovascular risk factors, aneurysm maximum diameter, aneurysm subtype (TAAA extent according to the Safi modified Crawford classification, and CAAA as pararenal or juxtarenal), indication for repair, previous history of aneurysm repair, aneurysm etiology and family history of aneurysmal disease. Procedure details collected included procedure time, radiation and contrast dose, blood loss, extent of the aortic repair, type and details of device modification, and devices used in the repair.
Main outcomes included technical success, 30-day mortality, and 30-day major adverse events.
Technical success was defined on an intention-to-treat basis as successful endovascular access and deployment of all devices, successful catheterization and stenting of all planned target vessels, no target vessel occlusion on control angiogram, and absence of persistent type I or III endoleak at first control CT-angiography within 30 days.
Major adverse events at 30-days were defined as all-cause mortality, myocardial infraction, respiratory failure requiring prolonged (>24 hours from anticipated) mechanical ventilation or reintubation, renal function decline resulting in >50% reduction in baseline eGFR or new-onset dialysis, bowel ischemia requiring surgical resection or not resolving with medical therapy, major stroke, and paraplegia (grade 3).9
Additionally, overall survival, freedom from aortic-related mortality, freedom from branch-related occlusion or reintervention, freedom from branch-related endoleak, and primary and secondary target vessel patency were assessed.
All outcomes were further analyzed according to the type of clinical presentation as elective, symptomatic or ruptured aneurysm repairs.
Statistical Analysis
Statistical analysis was performed using STATA version 18.0 (Statistics/Data analysis, StataCorp LLC). Continuous variables are expressed as median, first, and third quartile (Q1–Q3) for nonnormal distribution and as mean±SD for normal distribution. Categorical variables are expressed in numbers (percentage). Complete case analysis was used for handling missing data. Both descriptive statistics and comparative analysis were performed using univariate tests, such as chi-square test (Fisher exact test when appropriate) for categorical variables and t test (Mann-Whitney rank sum test when appropriate) for continuous variables.
Multivariable analysis of association of demographic, anatomical, and clinical parameters with technical success, 30-day mortality, and major adverse event at 30-days was conducted using logistic regression. An initial univariable screen was performed to identify baseline variables that were significantly associated (P <0.05) with the outcome in addition with clinical assessment based on prior knowledge. Finally, a forward stepwise selection procedure was applied among the selected variables to build the prediction model, adding terms with P <0.1 and removing those with P≥0.2, while variables deemed to be of significant clinical relevance were kept in the model. Goodness-of-fit of the regression model was performed using the Hosmer-Lemeshow goodness-of-fit test and discrimination assessed with area under the receiver operating characteristic curve. The odds ratio (OR) with 95% CI were reported, when appropriate.
Time-to-event outcomes were analyzed using Kaplan-Meier curves and life tables. Survival was estimated by calculating Kaplan-Meier product-limit estimator with right-censoring of survival data. Median follow-up was reported as the observed follow-up in all subjects irrespective of outcome. All analyses were considered statistically significant if a 2-tailed P <0.05 was observed.
Subgroup analyses were performed according to the clinical presentation for elective, symptomatic, and ruptured patients and according to anatomical extension for CAAA and TAAA. Additional analysis was performed comparing patients treated before and after 2013.
RESULTS
Patient demographics and risk factors
Overall, 1274 patients were included (Figure 2). Patient demographics, risk factors, and American Society of Anesthesiology (ASA) physical status score are detailed in Table 1 and are also shown separately according to the clinical presentation and anatomic extension: 65.5% (n=834) patients presented electively, 24.6% (n=314) presented with a symptomatic aneurysm, and 9.9% (n=126) presented with a ruptured aneurysm. Median age was 74 years (68–79), and 75.7% of patients were men. The most common cardiovascular risk factors were hypertension (87.9%), smoking (71.5%), and hypercholesterolemia (63.6%). Most patients (93.6%) had an ASA score ≥3.
| Variable | Aneurysm extension | N* | Total N=1274 (CAAA= 582; TAAA=692) | Elective N=834 (CAAA= 405; TAAA=429) | Symptomatic N=314 (CAAA= 119; TAAA=195) | Rupture N=126 (CAAA= 58; TAAA=68) |
|---|---|---|---|---|---|---|
| Age (y)† | All patients | 1274 | 74 (68–79) | 74 (69–80) | 72.5 (64–78) | 74 (67.5–79) |
| CAAA | 582 | 75 (70–81) | 75.7 (70.5–81) | 75 (66–80) | 74 (69–79) | |
| TAAA | 692 | 72.9 (66.1–78) | 73 (67.4–78) | 71 (64–76) | 74 (66.5–79) | |
| Men | All patients | 1274 | 964 (75.7) | 639 (76.6) | 226 (72.0) | 99 (78.6) |
| CAAA | 582 | 477 (82.0) | 335 (82.7) | 95 (79.8) | 47 (81.0) | |
| TAAA | 692 | 487 (70.4) | 304 (70.9) | 131 (67.2) | 52 (76.5) | |
| BMI (kg/m2)† | All patients | 1088 | 27.3 (23.3–30.0) | 27.0 (23.8–30.5) | 25.2 (22–29) | 26 (22.5–29.2) |
| CAAA | 542 | 28.8 (23.6–30) | 27 (24–30.4) | 26 (23.2–29.5) | 26 (21.9–29) | |
| TAAA | 546 | 26 (23–30.1) | 26.7 (23.5–30.6) | 24.8 (22–28.6) | 25.2 (22.9–30.3) | |
| BMI>30 | All patients | 1088 | 271 (24.9) | 210 (27.2) | 41 (18.5) | 20 (20.8) |
| CAAA | 542 | 131 (24.2) | 106 (26.6) | 19 (20.0) | 6 (12.2) | |
| TAAA | 546 | 140 (25.6) | 104 (27.9) | 22 (17.5) | 14 (29.8) | |
| Coronary artery disease | All patients | 1274 | 560 (44.0) | 399 (47.8) | 113 (36.0) | 48 (38.1) |
| CAAA | 582 | 280 (48.1) | 211 (52.1) | 49 (41.2) | 20 (34.5) | |
| TAAA | 692 | 280 (40.5) | 188 (43.8) | 64 (32.8) | 28 (41.2) | |
| Chronic heart failure | All patients | 1274 | 197 (15.5) | 130 (15.6) | 45 (14.3) | 22 (17.5) |
| CAAA | 582 | 93 (16.0) | 64 (15.8) | 20 (16.8) | 9 (15.5) | |
| TAAA | 692 | 104 (15.0) | 66 (15.4) | 25 (12.8) | 13 (19.1) | |
| Hypertension | All patients | 1274 | 1120 (87.9) | 750 (89.9) | 263 (83.8) | 107 (84.9) |
| CAAA | 582 | 516 (88.7) | 369 (91.1) | 98 (82.3) | 49 (84.5) | |
| TAAA | 692 | 604 (86.3) | 381 (88.8) | 165 (84.6) | 58 (85.3) | |
| Hypercolesterolemia | All patients | 1050 | 668 (63.6) | 481 (66.7) | 130 (58.3) | 57 (53.8) |
| CAAA | 464 | 294 (63.4) | 214 (67.1) | 54 (60.0) | 26 (47.3) | |
| TAAA | 586 | 374 (63.8) | 267 (66.4) | 76 (57.1) | 31 (60.8) | |
| Smoking | All patients | 1266 | 905 (71.5) | 658 (79.4) | 169 (54.0) | 78 (62.9) |
| CAAA | 579 | 424 (73.2) | 320 (79.4) | 67 (56.8) | 37 (63.8) | |
| TAAA | 687 | 481 (70.0) | 338 (79.3) | 102 (52.3) | 41 (62.1) | |
| COPD | All patients | 1172 | 442 (37.7) | 322 (43.2) | 73 (24.0) | 47 (38.5) |
| CAAA | 535 | 209 (39.1) | 158 (43.5) | 31 (27.0) | 20 (35.1) | |
| TAAA | 637 | 233 (36.6) | 164 (42.8) | 42 (22.2) | 27 (41.5) | |
| Peripheral artery disease | All patients | 1150 | 215 (18.7) | 148 (20.4) | 46 (15.2) | 21 (16.9) |
| CAAA | 487 | 98 (20.1) | 71 (22.2) | 18 (16.4) | 9 (15.8) | |
| TAAA | 663 | 117 (17.6) | 77 (19.1) | 28 (14.6) | 12 (17.9) | |
| Previous stroke | All patients | 1006 | 130 (12.9) | 80 (13.4) | 30 (10.4) | 20 (16.8) |
| CAAA | 444 | 63 (14.2) | 42 (15.0) | 9 (8.5) | 12 (20.7) | |
| TAAA | 562 | 67 (11.9) | 8 (13.1) | 21 (11.5) | 38 (11.9) | |
| Diabetes mellitus | All patients | 1273 | 227 (17.8) | 145 (17.4) | 49 (15.6) | 22 (26.2) |
| CAAA | 582 | 116 (19.9) | 80 (19.7) | 22 (18.5) | 14 (24.1) | |
| TAAA | 691 | 111 (16.1) | 65 (15.2) | 27 (13.9) | 19 (27.9) | |
| Baseline creatinine (mg/dL)† | All patients | 1148 | 1.1 (0.9–1.3) | 1.1 (0.9–1.4) | 1.0 (0.7–1.2) | 1.0 (0.8–1.4) |
| CAAA | 527 | 1.1 (0.9–1.5) | 1.1 (0.9–1.5) | 1.1 (0.8–1.7) | 1.3 (0.8–2.0) | |
| TAAA | 621 | 1.1 (0.9–1.4) | 1.1 (0.9–1.4) | 1.0 (0.7–1.3) | 1.0 (0.8–1.8) | |
| eGFR (CKD-EPI, presented in mL/min per 1.73m2)† | All patients | 1148 | 68.8 (51.3–87.8) | 67.1 (50.1–84.5) | 74.8 (57.6–92.7) | 71.1 (47.8–91.7) |
| CAAA | 527 | 68.2 (51.5–86.9) | 66.3 (50.1–83.2) | 74.9 (59.7–93.7) | 75.5 (48.8–93.4) | |
| TAAA | 621 | 69.6 (51.2–87.9) | 68.3 (49.9–85.8) | 74.8 (56.9–92.3) | 69.2 (46.1–87.2) | |
| Dialysis | All patients | 1025 | 31 (3.0) | 17 (2.6) | 10 (3.8) | 4 (3.5) |
| CAAA | 488 | 11 (1.9) | 8 (2.4) | 2 (1.9) | 1 (1.9) | |
| TAAA | 537 | 20 (3.7) | 9 (2.8) | 8 (5.2) | 3 (4.8) | |
| ASA risk score (≥3) | All patients | 1052 | 985 (93.6) | 600 (94.0) | 267 (91.4) | 118 (96.7) |
| CAAA | 445 | 420 (94.4) | 266 (94.7) | 98 (92.4) | 56 (96.5) | |
| TAAA | 607 | 565 (93.1) | 334 (93.6) | 169 (90.9) | 62 (96.9) |
ASA indicates American Society of Anesthesiology; BMI, body max index; CAAA, complex abdominal aortic aneurysm; CKD-EPI, Chronic Kidney Disease Epidemiology Collaboration; COPD, chronic obstructive pulmonary disorder; eGFR, estimated glomerular filtration rate; and TAAA, thoracoabdominal aortic aneurysm.
*
N represents the number of cases with reported data available for complete case analysis.
†
Continuous data presented as median (interquartile range).
Diagnosis and anatomic characteristics
Aneurysm anatomic details and history of previous aortic repair is presented in Table 2. Median aneurysm diameter was 65 mm (58–76). Almost half (45.7%, n=582) were CAAAs, of which 18.0% (n=229) were short neck or juxtarenal, 27.1% (353) were pararenal abdominal aortic aneurysms, and 54.3% (n=692) were TAAAs (9.0% extent I, 24.9% extent II, 17.5% extent III, 43.4% extent IV, and 5.2% extent V). Eighty-two patients (6.4%) were treated for a postdissection TAAA aortic aneurysm.
| Variable | Aneurysm extension | N* | Total | Elective N=834 | Symptomatic N=314 | Rupture N=126 |
|---|---|---|---|---|---|---|
| Aneurysm Size (mm)† | Total | 1235 | 65 (58–76) | 65 (59–73) | 67 (56–85) | 69 (55–81) |
| CAAA | 555 | 65 (56–76) | 64 (57–74) | 67 (55–85) | 63 (49–77) | |
| TAAA | 680 | 65 (60–75.5) | 65 (60–71.5) | 66.5 (57–84) | 72.5 (60.5–84) | |
| Aneurysm subtype | CAAA | 582 | Short neck/Juxtarenal: 229 (18.0) | 177 (21.2) | 33 (10.5) | 19 (15.1.1) |
| Pararenal AAA: 353 (27.1) | 228 (27.3) | 86 (27.4) | 39 (30.9) | |||
| TAAA | 692 555 TAAAs with subtype reported | 692 (54.3) | 429 (51.4) | 195 (62.1) | 68 (54.0) | |
| Extent I | 50 (9.0) | 32 (10.8) | 15 (7.9) | 3 (4.3) | ||
| Extent II | 138 (24.9) | 78 (26.3) | 41 (21.7) | 19 (27.1) | ||
| Extent III | 97 (17.5) | 49 (16.5) | 30 (15.9) | 18 (25.7) | ||
| Extent IV | 241 (43.4) | 121 (40.9) | 92 (48.7) | 28 (40.0) | ||
| Extent V | 29 (5.2) | 16 (5.4) | 11 (5.8) | 2 (2.9) | ||
| Previous aortic repair | Total | 1274 | 529 (41.5) | 355 (42.6) | 114 (36.3) | 60 (47.6) |
| Open aortic repair | 244 (19.1) | 157 (18.8) | 57 (18.1) | 30 (23.8) | ||
| Endovascular aortic repair | 334 (26.2) | 236 (28.2) | 66 (21.0) | 32 (24.4) | ||
| CAAA | 582 | 184 (31.6) | 129 (31.8) | 33 (27.7) | 22 (31.6) | |
| Open aortic repair | 59 (10.1) | 36 (8.9) | 11 (9.2) | 12 (20.7) | ||
| Endovascular aortic repair | 129 (22.2) | 94 (23.2) | 24 (20.2) | 11 (19.0) | ||
| TAAA | 692 | 345 (49.8) | 226 (52.7) | 81 (41.5) | 38 (55.9) | |
| Open aortic repair | 185 (26.7) | 121 (28.2) | 46 (23.6) | 18 (26.5) | ||
| Endovascular aortic repair | 205 (29.6) | 142 (33.1) | 42 (21.5) | 21 (30.9) | ||
| Rescue of failed EVAR | Total | 1124 | 128 (11.4) | 93 (13.2) | 23 (7.6) | 12 (10.0) |
| CAAA | 538 | 103 (19.1) | 77 (21.1) | 18 (15.6) | (8 (13.8) | |
| TAAA | 586 | 3 (0.5) | 3 (0.9) | 0 (0) | 0 (0) | |
| Postdissection aneurysm | Total | 1274 | 82 (6.4) | 45 (5.4) | 31 (9.9) | 6 (4.8) |
| CAAA | 582 | 2 (0.3) | 1 (0.2) | 1 (0.8) | 0 (0) | |
| TAAA | 692 | 80 (11.6) | 44 (10.3) | 30 (15.4) | 6 (8.8) | |
| Connective tissue disease | Total | 1274 | 9 (0.7) | 4 (0.5) | 3 (1.0) | 2 (1.6) |
| CAAA | 582 | 0 (0) | 0 (0) | 0 (0) | 0 (0) | |
| TAAA | 692 | 9 (1.3) | 4 (0.9) | 3 (1.5) | 2 (2.9) | |
| Family history of aneurysmal disease | Total | 666 | 46 (6.9) | 40 (9.7) | 1 (0.6) | 5 (5.6) |
| CAAA | 330 | 16 (7.8) | 16 (7.8) | 0 (0) | 2 (4.0) | |
| TAAA | 336 | 28 (8.3) | 24 (11.4) | 1 (1.1) | 3 (7.7) |
AAA indicates abdominal aortic aneurysm; CAAA, complex abdominal aortic aneurysm; EVAR, endovascular aneurysm repair; and TAAA, thoracoabdominal aortic aneurysm.
*
N represents the number of cases with reported data available for complete case analysis.
†
Continuous data presented as median (interquartile range).
History of previous aortic surgery was present in 41.5% (15.3% had prior open aortic repair, 22.4% endovascular repair, and 3.8% both). Overall, 11.4% were treated due to a previous failed endovascular aneurysm repair (EVAR).
Device design and modification details
Device design and modification details are detailed in Table S1 and S2 and the type of devices used in Table S3.
Most patients (83.1%) were treated using fenestrated EVAR devices, 3.6% branched EVAR devices, and 13.4% using combined fenestrated EVAR and branched EVAR devices. Most patients (85.8%) had ≥3 target vessels included, with 65.1% having ≥4 target vessels included in the repair.
The device most used for the modification (where fenestrations, branches, or scallops were constructed) was a straight tube graft (94.3%). Of these, most of the grafts used were thoracic endografts, with the COOK TX2 (38.8% ZDEG and 14.2% ZTEG) and the COOK Zenith Alpha Thoracic (33.8%) endografts being the most common. An additional distal component was used in 59.4%, of which 48.9% was a bifurcated graft. Of these distal bifurcated grafts, 19.7% required removal of the proximal bare stent component. In 18.5% of cases, preloaded catheters or wires were used.
The fenestrated component design incorporated the celiac trunk in 77.0%, the superior mesenteric artery in 92.3%, the right renal artery in 80.8%, and the left renal artery in 86.4%. An additional artery was included in 4.1%.
Procedure details
Procedural details are reported in Table 3 and are presented according to clinical presentation and anatomical extension. Total median procedural time was 260 minutes (193–350), median radiation dose measured as air kerma was 1761 mGy (974–3290), median fluoroscopy time was 72 minutes (51–103), and median contrast use was 130 mL (84–200). Median blood loss was 300 mL (150–500) with 10.9% had an estimated blood loss >1000 mL.
| Variable | Aneurysm extension | N* | Total | Elective N=834 | Symptomatic N=314 | Rupture N=126 |
|---|---|---|---|---|---|---|
| Percutaneous femoral access | Total | 879 | 645 (73.4) | 434 (71.6) | 148 (81.8) | 63 (68.5) |
| Unilateral | 122 (13.9) | 80 (13.2) | 27 (14.9) | 15 (16.3) | ||
| Bilateral | 523 (59.5) | 354 (58.4) | 121 (68.5) | 48 (52.2) | ||
| CAAA | 464 | 360 (73.3) | 234 (71.6) | 74 (84.1) | 32 (65.3) | |
| Unilateral | 49 (10.6) | 34 (10.4) | 7 (7.9) | 8 (16.3) | ||
| Bilateral | 291 (62.7) | 200 (61.2) | 67 (76.2) | 24 (52.0) | ||
| TAAA | 415 | 305 (73.5) | 200 (71.7) | 74 (79.6) | (72.1) | |
| Unilateral | 72 (17.3) | 46 (16.5) | 20 (21.5) | 7 (16.3) | ||
| Bilateral | 233 (56.1) | 154 (55.2) | 54 (58.1) | 24 (55.8) | ||
| Upper arm access | Total | 878 | 493 (56.1) | 341 (56.3) | 104 (57.5) | 48 (52.7) |
| CAAA | 463 | 207 (44.7) | 145 (44.3) | 39 (44.3) | 23 (47.9) | |
| TAAA | 415 | 286 (68.9) | 196 (70.2) | 65 (69.9) | 25 (58.1) | |
| CSF drainage | Total | 1274 | 366 (28.7) | 263 (31.5) | 75 (23.9) | 28 (22.2) |
| CAAA | 582 | 50 (8.6) | 36 (8.9) | 8 (6.7) | 6 (10.3) | |
| TAAA | 692 | 316 (45.7) | 227 (52.9) | 67 (34.4) | 22 (32.3) | |
| Femoral/iliac conduit | Total | 791 | 67 (8.5) | 48 (9.1) | 11 (6.3) | 8 (8.9) |
| CAAA | 425 | 24 (5.6) | 21 (7.2) | 2 (2.3) | 1 (2.0) | |
| TAAA | 366 | 43 (11.7) | 27 (11.4) | 9 (10.0) | 7 (17.5) | |
| Fusion imaging | Total | 701 | 427 (63.5) | 247 (63.3) | 133 (56.1) | 47 (63.5) |
| CAAA | 325 | 231 (71.1) | 150 (76.9) | 61 (61.6) | 20 (64.5) | |
| TAAA | 376 | 196 (52.1) | 97 (49.7) | 72 (52.2) | 27 (62.8) | |
| Total procedure time (min)† | Total | 1185 | 260 (193–350) | 264 (190–352) | 254 (203–330) | 267 (191–365) |
| CAAA | 544 | 237 (181–317) | 240 (180–320) | 232 (186–302) | 223 (187–326) | |
| TAAA | 640 | 284 (210–367) | 290 (210–377) | 270 (211–353) | 291 (208–386) | |
| Endovascular procedure time (min)† | Total | 103 | 189 (138–260) | 194 (142–252.5) | 220 (160–281) | 160 (103–252) |
| CAAA | 63 | 173 (138–242) | 184 (146–235) | 193 (156–247) | 147 (95–188) | |
| TAAA | 40 | 227 (142–370) | 215 (130–350) | 248 (160–465) | 196 (105–300) | |
| Radiation dose (air kerma, mGy)† | Total | 547 | 1761 (974–3290) | 1645 (943–3054) | 1770 (971–3691) | 2632 (1544–4274) |
| CAAA | 295 | 1611 (894–2827) | 1493 (785–2570) | 1908 (1047–3732) | 2724 (1430–4118) | |
| TAAA | 252 | 2000 (1112–3612) | 2002 (1083–3516) | 1670 (902–3214) | 2470 (1800–4274) | |
| Fluoroscopy time (min)† | Total | 1118 | 72 (51–103) | 73 (52.7–103.4) | 72 (51–102) | 61.3 (42–100) |
| CAAA | 534 | 70 (50–96) | 71 (52–96) | 71 (51–99) | 59 (41–94) | |
| TAAA | 584 | 75 (51–111) | 75 (53–110) | 75 (51–114) | 69 (45–115) | |
| Contrast used (mL)† | Total | 1050 | 130 (84–200) | 130 (82–198) | 120 (80–200) | 150 (110–226) |
| CAAA | 485 | 120 (75–180) | 120 (75–184) | 110 (75–159) | 129 (100–175) | |
| TAAA | 565 | 140 (90–205) | 140 (90–200) | 135 (90–225) | 160 (120–240) | |
| Blood loss (mL)† | Total | 1015 | 300 (150–500) | 250 (102–500) | 300 (200–500) | 375 (250–800) |
| CAAA | 464 | 250 (100–500) | 250 (100–500) | 200 (100–500) | 500 (250–800) | |
| TAAA | 551 | 300 (200–500) | 300 (150–500) | 300 (200–500) | 300 (200–700) | |
| Blood loss >1000 mL | Total | 1246 | 136 (10.9) | 91 (11.2) | 28 (9.1) | 17 (13.7) |
| CAAA | 572 | 65 (11.4) | 48 (12.1) | 9 (7.7) | 8 (14.0) | |
| TAAA | 674 | 71 (10.5) | 43 (10.3) | 19 (10.0) | 9 (13.4) |
CAAA indicates complex abdominal aortic aneurysm; CSF, cerebrospinal fluid; and TAAA, thoracoabdominal aortic aneurysm.
*
N represents the number of cases with reported data available for complete case analysis.
†
Continuous data presented as median (interquartile range).
30-day results (Table 4)
Technical success was achieved in 94.0% (94.0% in elective, 93.4% in symptomatic, and 95.1% in ruptured cases). Technical failures (n=71) occurred due do inability to catheterize and bridge 1 or more target vessels (n=49, 3.8%); 6 (0.5%) were type I or III endoleaks persistent at 30 days, and 3 (0.2%) were intraoperative occlusions of a target vessel following successful catheterization and stenting (2 renal artery ruptures and 1 celiac artery rupture requiring coil occlusion). The remaining 13 (1.0%) were not specified.
A multivariable analysis showed that a graft design including branches (OR, 0.48 [95% CI, 0.27–0.87]), including an additional target artery (such as accessory renal or additional visceral artery; OR, 0.35 [95% CI, 0.14–0.89]), or having a previous aortic repair (OR, 0.44 [95% CI, 0.26–0.75]) were independently associated with a lower rate of technical success. A higher eGFR was associated with technical success (OR for every 10-unit increase in eGFR, 1.17 [95% CI, 1.05–1.30]). The Hosmer-Lemeshow goodness-of-fit test showed a good fit (χ2=7.30, P =0.50) and the area under the receiver operating characteristic curve was 69% (Table S5 and Figure S1).
Seventy-four patients (5.8%) died in a hospital or within 30 days of the procedure: 4.1% for elective, 7.6% for symptomatic, and 12.7% for ruptured cases. After multivariable analysis, age (for every 10-year increase, OR, 1.60 [95% CI, 1.12–2.30]), peripheral arterial disease (OR, 2.06 [95% CI 1.07–0.76]), a symptomatic (OR, 2.00 [95% CI, 1.03–3.86]), and ruptured aneurysm (OR, 2.74 [95% CI, 1.26–5.92]) in comparison to an elective case, having a TAAA (vs CAAA, OR, 1.85 [95% CI,1.00–3.43]) and surgical procedure duration (for every 10min increase, OR, 1.03 [95% CI 1.00–1.05]) were associated with higher rates of 30-day mortality. Including ≥3 target vessels in the repair (OR, 0.37 [95% CI, 0.19–0.73]), achieving technical success (OR, 0.30 [95% CI, 0.13–0.69]), and tobacco use (OR, 0.41 [95% CI 0.22–0.76]) were associated with lower rates of death. The Hosmer-Lemeshow goodness-of-fit test showed a good fit (χ2=6.83, P =0.55), and the area under the receiver operating characteristic curve was 79% (Table S6 and Figure S2).
Major adverse events occurred in 277 patients overall (25.2%), 23.1% in elective, 27.8% in symptomatic, and 30.3% in ruptured aneurysms. After multivariable analysis, an ASA score ≥3 (OR, 3.05 [95% CI, 1.33–7.01]), having a TAAA (OR, 2.11 [95% CI, 1.48–2.98]), presenting with a symptomatic aneurysm (vs an elective case, OR, 1.54 [95% CI, 1.04–2.27]), and having a longer procedure duration (for every 10 minute increase in time, OR, 1.04 [95% CI, 1.02–1.05]) were all associated with an increased risk of developing a major adverse event. On the contrary, a higher eGFR (for every 10 mL increase, OR, 0.92 [95% CI, 0.85–0.99]), having ≥4 target vessels included (OR, 0.67 [95% CI;0.47–0.95]), and a procedure achieving technical success (OR, 0.40 [95% CI, 0.22–0.75]) were associated with a lower rate of postoperative major adverse events. The Hosmer-Lemeshow goodness-of-fit test showed a good fit (χ2=6.77, P=0.56), and the area under the receiver operating characteristic curve was 73% (Table S7 and Figure S3).
Median length-of-stay was 7 days (4–12), being 5 days (3–9) for elective, 9 days (6–15) for symptomatic, and 11 days (6.7–18) for ruptured aneurysms.
Thirty-day results are reported in Table 4. Overall, 35.2% (n=354) developed a postoperative complication. The most common complications were acute kidney injury which occurred in 11.6%, access-related complications in 10.3%, and respiratory failure in 7.5%.
| Variable | Aneurysm extension | N* | Total | Elective N=834 | Symptomatic N=314 | Rupture N=126 |
|---|---|---|---|---|---|---|
| Technical Success | Total | 1175 | 1104 (94.0) | 703 (94.0) | 284 (93.4) | 117 (95.1) |
| CAAA | 538 | 507 (94.2) | 345 (94.5) | 106 (92.2) | 56 (96.5) | |
| TAAA | 637 | 597 (93.7) | 358 (93.5) | 178 (94.2) | 61 (93.8) | |
| 30-day mortality | Total | 1274 | 74 (5.8) | 34 (4.1) | 24 (7.6) | 16 (12.7) |
| CAAA | 582 | 24 (4.1) | 13 (3.2) | 8 (6.7) | 3 (5.2) | |
| TAAA | 692 | 50 (7.2) | 21 (4.9) | 16 (8.2) | 13 (19.1) | |
| Major adverse events at 30-days | Total | 1100 | 277 (25.2) | 157 (23.1) | 83 (27.8) | 37 (30.3) |
| CAAA | 489 | 92 (18.8) | 57 (17.8) | 23 (20.9) | 12 (20.7) | |
| TAAA | 611 | 185 (30.3) | 100 (27.9) | 60 (31.9) | 25 (39.1) | |
| Early reintervention (30-day) | Total | 1042 | 144 (13.8) | 85 (12.9) | 34 (12.7) | 25 (20.7) |
| Aortic/branch-related | 105 (10.1) | 62 (9.4) | 24 (9.0) | 19 (16.5) | ||
| Non-aortic/branch-related | 39 (3.7) | 23 (2.5) | 10 (3.7) | 6 (5.2) | ||
| CAAA | 494 | 54 (10.9) | 31 (9.3) | 10 (9.2) | 13 (24.5) | |
| Aortic/branch-related | 36 (7.3) | 20 (6.0) | 7 (6.4) | 9 (17.0) | ||
| Non-aortic/branch-related | 18 (3.6) | 11 (3.3) | 3 (2.8) | 4 (7.5) | ||
| TAAA | 548 | 90 (16.4) | 54 (16.5) | 24 (15.2) | 12 (19.4) | |
| Aortic/branch-related | 69 (12.6) | 42 (12.8) | 17 (10.8) | 10 (16.1) | ||
| Non-aortic/branch-related | 21 (3.8) | 12 (3.7) | 7 (4.4) | 2 (3.2) | ||
| Postoperative 30-day complications (any) | Total | 1107 | 354 (35.2) | 215 (31.3) | 96 (32.1) | 43 (35.2) |
| CAAA | 494 | 129 (26.1) | 86 (26.4) | 26 (23.6) | 17 (29.3) | |
| TAAA | 613 | 225 (36.7) | 129 (35.8) | 70 (37.0) | 26 (40.6) | |
| Myocardial infarction | Total | 1223 | 43 (3.5) | 31 (3.9) | 9 (2.9) | 3 (2.4) |
| CAAA | 582 | 23 (3.9) | 18 (4.4) | 2 (1.7) | 3 (5.2) | |
| TAAA | 641 | 20 (3.1) | 13 (3.4) | 7 (3.6) | 0 (0) | |
| Respiratory failure | Total | 1225 | 92 (7.5) | 50 (6.3) | 28 (9.0) | 14 (11.4) |
| CAAA | 582 | 35 (6.0) | 20 (4.9) | 9 (7.6) | 6 (10.3) | |
| TAAA | 643 | 57 (8.9) | 30 (7.8) | 19 (9.9) | 8 (12.3) | |
| Stroke | Total | 1224 | 59 (4.8) | 41 (5.2) | 16 (5.1) | 2 (1.6) |
| CAAA | 582 | 13 (2.2) | 10 (2.5) | 2 (1.7) | 1 (1.7) | |
| TAAA | 642 | 46 (7.2) | 31 (8.0) | 14 (7.3) | 1 (1.5) | |
| Spinal cord ischemia (any grade) | Total | 1274 | 84 (6.6) | 53 (6.3) | 19 (6.0) | 12 (9.5) |
| Grade 1 | 27 (2.1) | 12 (1.4) | 8 (2.5) | 7 (5.6) | ||
| Grade 2 | 25 (2.0) | 18 (2.2) | 7 (2.2) | 0 | ||
| Grade 3 | 32 (2.5) | 23 (2.8) | 4 (1.3) | 3 (4.0) | ||
| CAAA | 582 | 14 (2.4) | 9 (2.2) | 4 (3.4) | 1 (1.7) | |
| Grade 1 | 9 (1.5) | 4 (1.0) | 4 (3.4) | 1 (1.7) | ||
| Grade 2 | 2 (0.3) | 2 (0.5) | 0 (0) | 0 (0) | ||
| Grade 3 | 3 (0.5) | 3 (0.7) | 0 (0) | 0 (0) | ||
| TAAA | 692 | 70 (10.1) | 44 (10.3) | 15 (7.7) | 11 (16.2) | |
| Grade 1 | 18 (2.6) | 8 (1.9) | 4 (2.0) | 6 (8.8) | ||
| Grade 2 | 23 (3.3) | 16 (3.7) | 7 (3.6) | 0 (0) | ||
| Grade 3 | 29 (4.2) | 20 (4.7) | 4 (2.0) | 5 (7.3) | ||
| Acute kidney injury (any) | Total | 1151 | 134 (11.6) | 74 (10.2) | 47 (15.9) | 12 (9.6) |
| Increase in creatinine x2 (no dialysis) | 89 (7.7) | 58 (8.0) | 24 (8.0) | 7 (5.6) | ||
| Temporary dialysis | 22 (1.9) | 9 (1.2) | 11 (3.6) | 2 (1.6) | ||
| Permanent dialysis | 23 (2.0) | 7 (1.0) | 13 (4.3) | 3 (2.4) | ||
| CAAA | 489 | 43 (8.8) | 28 (8.7) | 12 (10.9) | 3 (5.2) | |
| Increase in creatinine x2 (no dialysis | 31 (6.3) | 24 (7.5) | 4 (3.6) | 3 (5.2) | ||
| Temporary dialysis | 8 (1.6) | 0 (0.9) | 5 (4.5) | 0 (0) | ||
| Permanent dialysis | 4 (0.8) | 1 (0.3) | 2 (2.7) | 0 (0) | ||
| TAAA | 662 | 91 (13.7) | 46 (11.4) | 36 (18.8) | 9 (13.4) | |
| Increase in creatinine x2 (no dialysis | 58 (8.8) | 34 (8.4) | 20 (10.5) | 4 (6.0) | ||
| Temporary dialysis | 14 (2.1) | 6 (1.5) | 6 (3.1) | 2 (3.0) | ||
| Permanent dialysis | 19 (2.9) | 6 (1.5) | 10 (5.2) | 3 (4.5) | ||
| Bowel ischemia | Total | 1223 | 71 (5.8) | 45 (5.7) | 16 (5.1) | 10 (8.1) |
| CAAA | 582 | 26 (4.5) | 14 (3.5) | 8 (5.9) | 5 (8.6) | |
| TAAA | 641 | 45 (7.0) | 31 (8.1) | 9 (4.7) | 5 (7.7) | |
| Access-related complications | Total | 1274 | 131 (10.3) | 93 (11.1) | 22 (7.0) | 16 (12.7) |
| CAAA | 582 | 55 (13.8) | 41 (10.1) | 6 (5.0) | 8 (13.8) | |
| TAAA | 692 | 76 (11.0) | 52 (12.1) | 16 (8.2) | 8 (11.8) |
All outcomes presented at 30-day follow-up. CAAA indicates complex abdominal aortic aneurysm; and TAAA, thoracoabdominal aortic aneurysm.
*
N represents the number of cases with reported data available for complete case analysis.
Early reinterventions (at 30-days) occurred in 13.8%, being 12.9% for elective, 12.7% for symptomatic, and 20.7% for ruptured aneurysms. Of these reinterventions, 10.1% were aortic-related or branch-related, being 9.4%, 9.0%, and 16.5% for elective, symptomatic, and ruptured aneurysms, respectively.
Follow-up outcomes
Median follow-up was 21 months (5.6–50.6). The overall survival rate (Figure 3A) was 82.4% (95% CI, 80.1–84.5), 69.9% (95% CI, 66.9–72.7), and 55.0% (95% CI, 51.2–58.7) at 1, 3, and 5 years. Regarding clinical presentation, overall survival rate for elective patients was 83.9% (95% CI, 81.1–86.4), 71.8% (95% CI, 68.1–75.2), and 55.9% (95% CI, 51.2–60.2) at 1, 3, and 5 years; for symptomatic patients, the overall survival rate was 82.9% (95% CI, 77.9–86.8), 69.7% (95% CI, 63.2–75.3), and 55.5% (95% CI, 47.0–63.2) at 1, 3, and 5 years; and for ruptured cases, the rate was 70.7% (95% CI, 61.0–78.4), 57.3% (95% CI, 46.4–66.8), and 48.8% (95% CI, 36.7–59.8) at 1, 3, and 5 years. Overall survival rate is detailed according to anatomic extension in the Figures S4A and S4B. Of the 344 nonaortic or procedure-related deaths, specific cause of death was only ascertained in 143 patients (41.6%). In these reported cases, the most common cause of death were cardiovascular complications (25.2%), followed by cancer (20.1%), infection-related complications (15.4%), and respiratory complications (14.7%) (Table S8).
Freedom from aortic-related mortality (Figure 3B) was 92.9% (95% CI, 91.3–94.3), 91.6% (95% CI, 89.8–93.1), and 89.1% (95% CI, 86.6–91.1) at 1, 3, and 5 years. For elective patients, it was 94.4% (95% CI, 92.6–95.8), 93.8% (95% CI, 91.8–95.3), and 91.3% (95% CI, 88.4–93.5) at 1, 3, and 5 years; for symptomatic patients, it was 91.7% (95% CI, 88.0–94.3), 89.0% (95% CI, 84.5–92.3), and 85.4% (95% CI, 78.9–90.1); and for ruptured patients, it was 83.9% (95% CI, 75.5–89.7), 82.5% (95% CI, 73.5–88.6), and 82.5% (95% CI, 73.5–88.6). Freedom from aortic-related mortality is detailed according to anatomic extension in the Figures S5A and S5B.
The overall freedom from reintervention (Figure 3C) at 1, 3, and 5 years was 73.8% (95% CI, 70.7–76.7), 61.8% (95% CI, 57.8–65.4), and 51.4% (95% CI, 46.2–56.3). For elective patients, it was 74.3% (95% CI, 70.4–77.8), 60.0% (95% CI, 55.0–64.7), and 50.3% (95% CI, 44.1–56.2) at 1, 3, and 5 years; for symptomatic patients, it was 76.5% (95% CI, 70.3–81.6), 69.1% (95% CI, 61.8–75.3), and 57.1% (95% CI, 45.7–67.1); and for ruptured patients, it was 64.1% (95% CI, 52.6–73.5), 53.6% (95% CI, 39.7–65.7), and 41.7% (95% CI, 23.5–59.0). Freedom from reintervention is detailed according to anatomic extension in the Figures S6A and S6B.
Freedom from any branch occlusion or branch-related reintervention (Figure S7) was 89.4% (95% CI, 86.6–91.7), 79.5% (95% CI, 75.1–83.3), and 72.1% (95% CI, 66.0–77.3) at 1, 3, and 5 years. For elective patients, it was 90.3% (95% CI, 87.0–92.8), 80.8% (95% CI, 75.5–85.0), and 72.6% (95% CI, 64.9–78.8) at 1, 3, and 5 years; for symptomatic patients, it was 86.4% (95% CI, 78.1–91.7), 74.2% (95% CI, 63.0–82.5), and 65.7% (95% CI, 51.5–76.6); and for ruptured patients, it was 89.2% (95% CI, 76.9–95.1), 81.3% (95% CI, 63.4–91.0), and 81.3% (95% CI, 63.4–91.0). Freedom from any branch occlusion or branch-related reintervention is detailed according to anatomic extension in the Figures S8A and S8B.
Regarding endoleaks, overall, 26.9% (n=295) developed or had a persistent endoleak during follow-up (28.5% in elective, 22.9% in symptomatic, and 26.5% in ruptured cases). Of these endoleaks, 14.7% (n=161) were type I or III (14.7% in elective, 12.5% in symptomatic, and 19.5% in ruptured cases). Type I endoleaks were present in 6.3% (n=69), of which 22 (2.0%) were type Ia, 15 (1.4%) type Ib, and 32 (2.9%) type Ic (of these, 5 had more than 1 type of endoleak, and 6 patients did not have the subtype specified). Type III endoleaks were present in 9.8% (n=107), of which 100 were branch- related. Overall, type Ic and/or IIIc endoleaks (fenestration/branch-related) were observed in 111 patients (10.2%).
Freedom from any fenestration/branch-related endoleak (Figure S9) was 86.6% (95% CI, 83.5–89.2), 79.4% (95% CI, 74.8–83.2), and 73.9% (95% CI, 67.5–79.2) at 1, 3, and 5 years. For elective patients, it was 87.7% (95% CI, 84.0–90.6), 79.4% (95% CI, 73.6–84.1), and 73.7% (95% CI, 65.4–80.2) at 1, 3, and 5 years. For symptomatic patients, it was 84.3% (95% CI, 75.6–90.1), 79.3% (95% CI, 69.1–86.5), and 76.2% (95% CI, 64.1–84.7), and for ruptured patients, it was 83.7% (95% CI, 71.6–91.0), 79.7% (95% CI, 64.6–88.9), and 73.0% (95% CI, 52.4–85.8). Freedom from any fenestration/branch-related endoleak is detailed according to anatomic extension in the Figures S10A and S10B.
A stable sac was recorded in 42.5% (n=397); 43.2% (n=403) had >5 mm sac regression, and 14.3% (n=133) had a sac enlargement >5 mm. For elective patients, a stable, shrinking, and enlarging aneurysm sac during follow-up was observed in 41.9%, 41.9%, and 16.2%; for symptomatic patients, this was 43.9%, 44.7%, and 11.4%, and for ruptured cases, this was 43.1%m 47.1%, and 9.8%. Aortic rupture during follow-up occurred in 10 patients (1.0%, n=10/1017) and conversion to open repair in 6 patients (0.6%, n=6/924). Aortic graft infection was observed in 54 patients (6.9%, n=54/777), occurring in 1.1% (n=5/442) of elective cases, 15.3% (n=37/241) of symptomatic cases, and 12.8% (n=12/94) of ruptured cases.
Target vessel patency
Primary target vessel patency (Figure 4A) was 96.9% (95% CI, 96.1–97.5), 93.6% (95% CI, 91.9–94.6), and 90.3% (95% CI, 88.1–92.1) at 1, 3, and 5 years. For elective patients, primary target vessel patency was 96.7% (95% CI, 95.7–97.5), 93.7% (95% CI, 92.0–95.0), and 90.0% (95% CI, 86.8–92.4) at 1, 3, and 5 years; for symptomatic patients, it was 97.0% (95% CI, 95.2–98.1), 92.0% (95% CI, 88.1–94.6), and 87.8% (95% CI, 81.6–92.0); and for ruptured patients, it was 97.2% (95% CI, 94.0–98.7), 94.2% (95% CI, 88.4–97.2), and 92.3% (95% CI, 84.7–96.3).
Secondary target vessel patency (Figure 4B) was 98.5% (95% CI, 98.0–98.9), 96.4% (95% CI, 95.3–97.3), and 95.3% (95% CI, 93.8–96.5) at 1, 3, and 5 years. For elective patients, secondary target vessel patency was 98.4% (95% CI, 97.7–98.9), 97.1% (95% CI, 95.8–98.0), and 96.0% (95% CI, 93.9–97.4) at 1, 3, and 5 years; for symptomatic patients, it was 98.4% (95% CI, 97.0–99.2), 94.4% (95% CI, 90.8–96.6), and 92.4% (95% CI, 87.2–95.5); and for ruptured patients, it was 98.9% (95% CI, 96.7–99.7), 95.2% (95% CI, 89.1–97.6), and 95.2% (95% CI, 89.1–97.9).
Primary and secondary target vessel patencies are detailed according to anatomic extension in the Figures S11A and S11B and Figures S12A and S12B.
Comparing patients treated before and after 2013
Table S9 details the comparison between patients treated up to 2013 (n=324) and after 2013 (n=950). This is mostly represented by patients treated in US centers (P <0.001). Overall, in the early period (≤2013) more repairs, including branches, were used (P <0.001); however, less target vessels were included in the repair (P\ <0.001), and there was no difference regarding anatomical extension. Elective patients were more frequently repaired in the early period (79.6% vs 60.6%, P <0.001).
Although technical success (P =0.09), 30-day mortality (P =0.96) and early reintervention (P=0.08) were not statistically different, major adverse events occurred more frequently in the early period (33.1% vs 22.0%, P <0.001). Additionally, procedural outcomes, including total procedure time (P<0.001), fluoroscopy time (P <0.001), contrast use (P <0.001), and estimated blood loos (P <0.001), were all significantly better in the second period (>2013).
Missing data
Results are shown as complete case analysis. Complete cases available for each analysis are shown in the results table. Detailed rates for missing data of each variable and outcome are shown in Table S10.
DISCUSSION
In this international multicenter study on the outcomes of PMEGs for the treatment of CAAAs and TAAAs, 1274 patients from 19 different centers were analyzed. Based on our results, PMEGs appear to be safe and effective in both elective and urgent settings, when used in experienced centers. Overall, technical success was achieved in 94.0%, 30-day mortality occurred in 5.8%, and major adverse event rates occurred in 25.2%.
A recent systematic review analyzing the outcomes of PMEGs reached similar conclusions regarding their safety and effectiveness.14 However, pooling published data runs the risk of heterogeneity and publication bias. In fact, the results from our study were slightly inferior when compared to the meta-analysis findings, with the most striking difference observed in the rate of major adverse event rate, which were reported as 15.5% (95% CI,10.8–20.8, I2=63%) compared to our findings of 25.2%.14
Given the nature of our study, which reflects the outcomes of this technique in experienced and high-volume centers, caution is required when extrapolating our results to other contexts because they may not reflect current outcomes in less experienced and low-volume centers and data from these centers are mostly unknown and not published.16 Thus, one should not extrapolate our results or the results of the previous systematic review to the universe of PMEG use.
In one of the largest single-center cohort studies published to date on this matter,17 PMEGs were found to have a major adverse event rate of 48%, with most of these cases being performed before 2014, showing a significant shift for CMDs with increasingly better results. This may also occur due to the learning curve effect in addition to better patient selection.18 We analyzed procedures performed between 2007 and 2022. The majority of these were performed in the last 5 years of the study period (Figure 2); therefore, we believe our results reflect the current best-practice and results regarding PMEGs. When comparing results in our cohort before and after 2013, we observed an improvement in the late period regarding procedural outcomes, such as procedure/fluoroscopy times, contrast use and blood loss, and major adverse events. However, outcomes such as technical success, 30-day mortality, and early reinterventions were not statistically different. In the late period, we observed a tendency towards the use of PMEGs in more urgent cases compared to elective ones, which may reflect a tendency to replace PMEGs with CMDs in elective cases in the included centers. Additionally, devices with branches were used more frequently in the early period. As branched OTS devices have also become more available, this may be related to having alternative options to PMEGs. Moreover, the data, which was majority from the United States, came from the investigational device exemptions centers, and the worst outcomes probably represent the learning curve of US centers, while European centers, which already had access to CMDs, did their learning curve with customized grafts.
When looking at our results, it is important to recognize that both elective and urgent cases were included. These patients should be analyzed separately due to the clearly different clinical presentation but also because they might reflect differences in practice.
For elective cases, PMEGs are mostly used in centers where CMDs were not available, and therefore, results should be assessed in the light of alternatives as CMDs or open surgical repair. Currently, there are no available randomized clinical trials that compare PMEGs to CMDs. Although one would expect CMDs to have better outcomes because planning is assisted by highly experienced teams and graft manufacturing is standardized, there is no level 1 evidence supporting its use over PMEGs. Moreover, CMDs have current regulatory restrictions and manufacturing time may delay repair. O´Donnel et al recently analyzed the US trends in the utilization of PMEGs and found them to be the dominant and growing endovascular repair technique outside of investigational device exemptions centers.16 This calls for broader publication of PMEG techniques and results as well as comparison studies with CMDs.16
On the contrary, in urgent cases, PMEGs should be considered in the light of other techniques such as open repair, OTS grafts or parallel grafts. We did not perform a comparative analysis with other techniques; however, in both the elective and urgent setting, our results compare favorably with published results.4,5,8,11,13,17,19–26 Table S11 provides a summary of the published results in the literature.
We found previous aortic repair and a graft design including branches to be associated with a lower rate of technical success. Endovascular repair with fenestrated or branched endografts of patients with previous open or endovascular aortic repair has been shown to be safe; however, similar to our study, an increase in the complexity of the repair requires a higher level of expertise and experience.27–31
According to a recent systematic review on PMEGs, studies reporting the use of branches showed higher rates of technical success than those only reporting fenestrations.14 The authors discussed the possibility of this result being related to selection bias or perhaps reflecting the fact that branches are usually more forgiving of measurement and deployment errors. In our study, we found the exact opposite with the use of branches being related with a lower rate of technical success, even after multivariable analysis.
Interestingly, although 52% of the cases were classified as TAAAs, fenestrated repairs were used in 83%. As fenestrations are easier to construct, this could be a compromise in the repair, which may explain some of the type III endoleaks.32
Furthermore, we found that ASA score ≥3, a TAAA (vs CAAA), a lower eGFR, an urgent procedure, a longer operation time, or a technical failure was associated with a higher rate of major adverse events. Both high ASA scores and low eGFR may be related to patient frailty and therefore be associated with worse outcomes and may serve as tool for better patient selection.33,34 Concerning urgent repairs using PMEGs, we included 314 patients with a symptomatic aneurysm and 126 patients with a ruptured aneurysm. Overall, results were excellent with 30-day mortality for symptomatic and ruptured cases of 7.6% and 12.7%. Additionally, the rate of spinal cord ischemia was 6.0% and 9.5%, with a permanent spinal cord ischemia (grade 3) rate of 1.3% and 4.0%, respectively. Previous studies on the use of OTS devices in urgent/emergent setting, report a 30-day mortality of 16% to 24% and spinal cord injury of 10% to 38%.35 These differences may be explained by a selection bias as patients, allowing time for PMEG planning and modification, may include a less urgent and more stable patient population compared to patients treated with an OTS device. However, by using a PMEG device, one may tailor the exact length of aortic coverage necessary and thus lower the risk for spinal cord ischemia, especially for juxtarenal or pararenal aortic aneurysms.36 In a retrospective single-center study, Spath et al found that para-renal aneurysms using an OTS device would require a mean of 74 mm of additional healthy aortic coverage which would lead to sacrificing a mean of 2.5 additional segmental arteries.12
A major flaw in the previous data on PMEGs was the lack of adequate time-to-event analysis. The recent systematic review published was unable to adequately assess this data.14 In our study, we analyzed overall survival, freedom from aortic-related mortality, freedom from reintervention, freedom from branch occlusion or related reintervention, freedom from branch-related endoleak, and target vessel patency, and overall results were acceptable as described above.
However, reintervention rates, which also occur with other endovascular techniques,19 were common. Freedom from reintervention was 73.8%, 61.8%, and 51.4% at 1, 3, and 5 years respectively, which is consistent with the results reported on CMDs.4,5,19,37 Additionally, looking at our freedom from aortic-related mortality which was 92.9%, 91.6%, and 89.1% at 1, 3, and 5 years, these reinterventions may not affect survival significantly. This has also been demonstrated previously by Zettervall et al which showed that out of 1681 patients who had combined fenestrated EVAR and branched EVAR devices, freedom from reintervention was 59% at 5 years, with most secondary interventions being minor, low magnitude procedures.38 This has also been analyzed specifically in PMEGs with similar findings, emphasizing the need for lifelong surveillance and timely reinterventions.39
One of the striking aspects found was the rate of graft infections in the symptomatic (15.3%) and ruptured cases (12.8%), although there was a significant rate of missing data on this outcome (39.0%). Contamination of the graft during the modification process is a concern with the use of PMEGs, and it might explain, at least partially, the high rate of infections. However, these were very rare in the elective setting (1.1%), which makes it difficult to ascertain all the infections to manipulation issues. One possible explanation is that some of these symptomatic and ruptured aneurysms might have been mycotic in first place; however, this is not possible to confirm because it was not reported in the data collection.
This study has some limitations. The retrospective nature of the study increases the risk of missing data and reporting and recall bias. As shown throughout our results, we did have missing data and were not able to have all case variables collected. This precluded some of the analysis such as analyzing some of the specific modification details. Ideally, a prospective multicenter study would allow to collect all these variables in a validated and universal way, allowing more granular and robust analysis.
Future studies are needed to assess the safety and durability of PMEGs. Ideally, prospective studies including the modification details and differences in techniques, would allow for better assessment of which PMEG technique, graft combinations, and device is better.
Furthermore, with the growing rate of PMEG use in elective patients, it is important to compare results with those of the current CMD platforms. Ideally, this would call for a randomized clinical trial or, alternatively, for a well-designed observational study or registry. Additionally, the best technique for urgent cases is unknown, and a comparative study looking at open repair, OTS devices, parallel grafts, and PMEGs would be important.
In conclusion, an international multicenter study on the use of PMEGs for treatment of CAAAs and TAAAs was performed. Overall, PMEGs were a safe and effective treatment option for elective, symptomatic, and ruptured complex aortic aneurysms. Long-term data and future prospective studies are needed for more robust and detailed analysis.
ARTICLE INFORMATION
Supplemental Material
Table S1–S11
Figure S1–12
Footnote
Nonstandard Abbreviations and Acronyms
- ASA
- American Society of Anesthesiology
- CAAA
- complex abdominal aortic aneurysm
- EVAR
- endovascular aneurysm repair
- OR
- odds ratio
- OTS
- off-the-shelf
- PMEG
- physician modified endografts
- TAAA
- thoracoabdominal aortic aneurysms
Supplemental Material
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- 2.17 MB
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History
Received: 29 December 2023
Accepted: 7 June 2024
Published online: 11 July 2024
Published in print: 22 October 2024
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Disclosures
The following authors declare conflicts of interest regarding consulting, research grants, advisory boards and/or any compensation fees from the mentioned companies. N. Tsilimparis (Proctor fees, speaking fees and institutional research support), D.J. Adam (speaking, research and proctor fees), L. Mendes Pedro (speaking and proctor fees), L. Bertoglio (speaking and proctor fees), T. Kölbel (speaking and proctor fees, institutional research support, royalties and consulting), and G. Panuccio (proctor and speaking fees) are supported by Cook Medical. R. Gouveia e Melo is supported by Cook Medical (speaking fees), Cordis (speaking fees), and Abbott Laboratories (travel and accommodation for congress). S. Scali is supported by Medtronic Inc, Boston Scientific Corporation, and Cook Medical (food and beverage). B. Mendes is supported by WL Gore & Associates Inc, Cook Medical (consulting, speaker and research fees, all proceeds towards Mayo Clinic), Medtronic Inc (aortic advisory board); and Bolton Medical Inc (food and beverage). S. Han is supported by WL Gore & Associates Inc, Cook Medical, Bolton Medical Inc (research support and consulting with all proceeds towards University of San Diego); Medtronic Inc (travel and lodging); Artivion Inc (food and beverage), Guard Medical Inc (consulting fees), Bolton Medical Inc (food and beverage), Endologix LLC (food and beverage), Silk Road Medical Inc (food and beverage), and Viz.ai Inc(food and beverage). M. Schermerhorn is supported by WL Gore & Associates Inc, Silk Road Medical Inc (travel and lodging), Shape Memory Medical Inc and Medtronic Inc (food and beverage). M. Farber is supported by Cook Medical (research support, honoraria and clinical trial support), Centerline Biomedical Inc, WL Gore & Associates Inc and Merck Sharp & Dohme LLC (consulting), Medtronic Inc and Getinge USA Sales LLC (food and beverage). B. Starnes is supported by Bolton Medical Inc, Terumo Aortic (consulting and travel and lodging), Surmodics Inc, Abbott Laboratories and Medtronic Inc and Cook Medical(food and beverage). D. Branzan is supported by Artivion, Bentley InnoMed, Cook Medical, Endologix, Getinge, and Medtronic (consulting and research support).C. Timaran is supported by Cook Medical, WL Gore & Associates Inc, and Philips Healthcare (research support and consulting). F. Verzini is supported by Cook Medical, WL Gore & Associates Inc, and Medtronic (proctor and speaking fees). A.W. Beck is supported by Artivion, Cook Medical, Medtronic, Philips Healthcare, Terumo, and WL Gore & Associates (research and consulting fees with all proceeds towards the University of Alabama). J. Chait is supported by WL Gore & Associates, Bard Peripheral Vascular, and Medtronic Inc (food and beverage). A. Pyun is supported by Silk Road Medical Inc (food and beverage) and Medtronic Inc (education). G. Magee is supported by Silk Road Medical Inc (consulting, travel and lodging, food and beverage), Medtronic Inc (consulting fees, travel and lodging), WL Gore & Associates (consulting fees, food and beverage), ShockWave Medical Inc (travel and lodging and food and beverage), Penumbra Inc, Boston Scientific Inc and Bolton Medical Inc (food and beverage). N. Swerdlow is supported by Silk Road Medical Inc and Shape Memory Medical Inc (food and beverage). M. Juszczak is supported by Cook Medical (research support) and Terumo (research grant). A. Barleben is supported by Cook Medical (consulting; travel and lodging fees), Endologix LLC (consulting; food and beverage), WL Gore & Associates (food and beverage), Silk Road Medical Inc (food and beverage), Penumbra Inc (consulting; travel and lodging), Musculoskeletal Transplant Foundation Inc (food and beverage), Abbott Laboratories (food and beverage), Surmodics Inc (food and beverage), and Cagent Vascular Inc (food and beverage). R. Patel is supported by Silk Road Medical Inc (food and beverage). M.P. Sweet is supported by Artivion Inc and Bolton Medical Inc (food and beverage). S.L. Zettervall is supported by WL Gore & Associates Inc, Bolton Medical Inc, Cook Medical, and Terumo Aortic (consulting and research support), Silk Road Medical Inc and Artivion Inc (food and beverage). G.S. Oderich is supported by Cook Medical (consulting, travel and lodging, speaking fees), WL Gore & Associates (consulting, travel and lodging, education, food and beverage), GE HealthCare (speaking fees, food and beverage), Centerline Biomedical Inc (consulting), Atrium Medical Corporation, Silk Road Medical Inc, Bard Peripheral Vascular Inc, Medtronic Inc (food and beverage). The remaining authors have no conflict of interest to declare.
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- Application of off-the-shelf thoracoabdominal multibranch endoprosthesis for urgent repair of pararenal and thoracoabdominal aortic aneurysms with occluded target vessels, Journal of Vascular Surgery Cases, Innovations and Techniques, 11, 3, (101689), (2025).https://doi.org/10.1016/j.jvscit.2024.101689
- Indications, Planning, and Technical Aspects in Physician-Modified Endografts Based on a Cross-Sectional Global Survey, Journal of Vascular Surgery, (2025).https://doi.org/10.1016/j.jvs.2025.05.019
- Spinal Cord Ischemia Prevention and Management in Thoracoabdominal Branched Endovascular Aortic Repair, Seminars in Thoracic and Cardiovascular Surgery, (2025).https://doi.org/10.1053/j.semtcvs.2025.03.003
- Physician Modified Endografts in Aortic Care: Urgency for Updated Guidelines, European Journal of Vascular and Endovascular Surgery, 69, 4, (655-656), (2025).https://doi.org/10.1016/j.ejvs.2024.12.043
- Physician-Modified Endografts Inner Branches Technique Using a Thoracic Endograft for Urgent Thoracoabdominal Aneurysm Repair, Journal of Endovascular Therapy, (2025).https://doi.org/10.1177/15266028251325075
- Clinical frailty predicts long-term survival and return to functional status following fenestrated and branched aortic repair for thoracoabdominal aortic aneurysm, Journal of Vascular Surgery, (2025).https://doi.org/10.1016/j.jvs.2025.03.058
- A systematic review and meta-analysis comparing single-stage versus multistaged approaches for endovascular repair of extensive thoracoabdominal aortic aneurysms, Journal of Vascular Surgery, (2025).https://doi.org/10.1016/j.jvs.2025.01.234
- Physician-Modified Endografts for Non-deferrable Complex Abdominal Aortic Aneurysm Repair Using the Endurant Platform: Templates and Initial Results, Journal of Endovascular Therapy, (2025).https://doi.org/10.1177/15266028251318952
- A standardized physician-modified endograft workflow utilizing the punch card technique and the Hungaroring reinforcement to treat complex abdominal aortic aneurysms, Journal of Vascular Surgery Cases, Innovations and Techniques, 11, 1, (101649), (2025).https://doi.org/10.1016/j.jvscit.2024.101649
- Cause of death among patients following repair of juxtarenal aneurysm with physician-modified endografts, Journal of Vascular Surgery, (2025).https://doi.org/10.1016/j.jvs.2025.02.016
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