Abstract
Objective
Ischemic stroke is a devastating complication of thoracic endovascular aortic repair (TEVAR). This risk may be higher in more proximal aneurysms that require arch manipulation. The purpose of this study was to (1) describe 30-day stroke and death rates in patients undergoing TEVAR, (2) compare stroke rates in patients undergoing TEVAR for arch versus descending aneurysm pathology, and (3) identify predictive factors associated with stroke after TEVAR.
Method
The Vascular Quality Initiative (VQI) registry was queried (2015–2021) for TEVAR procedures performed for degenerative aneurysms. Our primary outcomes were any stroke or death at 30-days. Patient-, procedure-, and hospital-level predictors of stroke were assessed using multivariable logistic regression.
Result
Among 3,072 patients with degenerative aneurysms (197 [6.4%] arch vs. 2,875 [93.6%] descending) treated with elective TEVAR, the median age was 73 (IQR 67–79) and 54.8% were male. Within the arch aneurysm group, there were 27.4% zone 0, 22.8% zone 1, and 49.8% zone 2 interventions. Overall 30-day stroke and death rates were 3.2% and 3.8%. The distribution of stroke events was bilateral (52.9%), left carotid (20.7%), left vertebrobasilar (11.5%), right carotid (9.2%), and right vertebrobasilar (5.7%). While mortality was similar between groups, the rate of ischemic stroke was higher for patient undergoing TEVAR for arch aneurysm versus descending aneurysms (7.1% arch vs. 2.9% descending, p=0.001). Factors that were associated with ischemic stroke after TEVAR included age (>79 years RR 1.79, 95% CI 1.08–2.98 vs. <79 years), dependent functional status (RR 1.73, 95% CI 1.07–2.78), procedural time (RR 1.25, 95% CI 1.15–1.36), and endovascular intervention for supra-aortic trunk revascularization (RR 2.66, 95% CI 1.06–6.70 vs. no intervention).
Conclusion
Ischemic stroke risk after TEVAR was increased for arch aneurysms compared to descending aneurysms. More proximal zone coverage and endovascular interventions on the supra-aortic trunks were associated with increasing risk for stroke. Adequate preparation for stroke prevention is necessary prior to TEVAR with supra-aortic trunk revascularization.
Keywords: TEVAR, thoracic endovascular aortic repair, stroke, neurological complication, aneurysm repair, endovascular repair
INTRODUCTION
Thoracic endovascular aortic aneurysm repair (TEVAR) has become the mainstay of therapy for diseases of the thoracic aorta, such as degenerative aneurysms and acute aortic syndromes over the last decade. This minimally invasive technique has been shown to reduce intensive care unit (ICU) length of stay, overall hospital length of stay, organ dysfunction, postoperative pain and overall costs.1 It also has allowed high risk, elderly patients to undergo treatment. Moreover, TEVAR is also more widely accepted by patients themselves.4 Studies have demonstrated an early mortality benefit of endovascular versus open procedures within early clinical trials of TEVAR1–3, but the rates of complications still ranged from 2.5%–17%.4–8 One of the most severely debilitating complications after TEVAR is a central neurologic event particularly an acute ischemic stroke, which occurs in 2.5–5% of patients.10 Additionally, neurological complications can be fatal in up to 30% of patients and are associated with long-term disability.9
Ischemic hemispheric strokes after TEVAR can present immediately or within the first few days after the procedure. The vast majority may occur in both the anterior and posterior cerebral regions, and most are believed to be due to an embolic source (air, atheroemboli, and/or clot) resulting from the passage of large devices through the arch and across the origins of the supra-aortic trunk vessels. While posterior circulation strokes due to hypoperfusion from coverage of the left subclavian artery (LSA) during TEVAR for distal arch and descending aortic aneurysms prompted surgeons to consider subclavian revascularization before TEVAR, less is known in regards to more proximal aortic pathology.10 Several studies have identified certain risk factors for ischemic stroke after TEVAR which included coverage of left subclavian artery, grade of the arch, the location of proximal coverage, the degree of atheroma in the arch, previous stroke history, age, chronic renal insufficiency, and female sex.11–14 However, what remains to be analyzed is the risk of stroke following TEVAR in conjunction with supra-aortic trunk revascularization to treat ascending aortic and arch aneurysms. The objectives of the study were (1) to describe 30-day stroke and death rates in patients undergoing TEVAR, (2) compare stroke rates in patients undergoing TEVAR for arch versus descending aneurysm pathology, and (3) to assess predictive factors associated with stroke after TEVAR.
METHODS
Data Source and Patient Population
Patients who underwent TEVAR for degenerative aneurysm between January 1, 2015, and May 3, 2021 were identified from the Vascular Quality Initiative (VQI) registry. The VQI is a procedure-targeted database collected and maintained by the Society for Vascular Surgery (SVS) with more than 700 participating centers from 18 regional quality groups from the United States and Canada.15 Data are collected prospectively and include patients’ demographics, comorbidities, procedural details, in-hospital outcomes, and postoperative complications (VQI).
Patients were excluded from analysis if they underwent emergency surgery (n=979), indications other than degenerative aneurysm (n=2,053), no vascular device implanted (n=174), those with missing CVA information (n=34), and TEVAR for pathology distal to zone 5 (n=3,416). Based on these exclusion criteria, 6,656 were excluded from analysis.
Outcome Variables
The primary outcomes were any stroke or death at 30-days. Acute stroke was categorized as none, transient ischemic attack (TIA), ischemic, or hemorrhagic, and based on the ascending/arch aneurysm (zone 0–2) versus descending aneurysm (zone 3–5). Distribution of stroke based on location of pathology, and which supra-aortic branch vessel that was intervened upon were also analyzed.
Covariates
Patient variables including age, gender, race/ethnicity, body mass index (BMI), functional health status prior to surgery (independent vs. dependent), American Society of Anesthesiologist (ASA) classification, and patient comorbidities including hypertension, diabetes, prior cerebrovascular accident (CVA), coronary artery disease (CAD), congestive heart failure (CHF), chronic obstructive pulmonary disease (COPD), end-stage renal disease (ESRD), current smoker, and prior aortic surgery. Procedural factors included location of disease (ascending or arch aneurysm [zone 0–2] vs. descending aneurysm [zone 3–5]), number of branches intervenes for supra-aortic treatment, branch intervened (innominate, left common carotid artery [LCCA], and LSA), types of supra-aortic treatment, operation time, and estimated blood loss (EBL). Hospital variable included volume by quartile was used as a predictor.
Statistical Analysis
Bivariate analysis of individual patient, procedural, and hospital variables were assessed for association with incidence of CVA using chi-squared tests for categorical variables and student’s t-test for continuous variables. Statistical significant predictors on bivariate analysis with p < 0.1 or those with clinical significance were entered into a multivariable Poisson regression model. Statistical analyses were performed using Stata v16.1 (StataCorp, College Station, TX). This study utilized deidentified data, and thus was determined to be exempt from review by the Northwestern University Institutional Review Board.
RESULTS
Characteristics of the Cohort
During the study period, 3,072 patients underwent elective TEVAR for a degenerative aneurysm between January 2015 to May 2021. The median age of the study cohort was 73 (IQR 67–79). Most patients were male (54.8%), White (75.0%), independent functional status (61.7%), and ASA classification III/IV/V (98.0%). Additional patient demographics can be found in Table 1.
Table 1.
Demographic, procedural characteristics, and outcomes of TEVAR for Degenerative Aneurysm
| Total N (%) | CVA N (%) | No CVA N (%) | P-value | |
|---|---|---|---|---|
| Median Age (IQR) | 73 (67 – 79) | 77 (72 – 80) | 73 (67 – 79) | <0.001 |
| Gender | ||||
| Male | 1683 (54.8) | 48 (49.5) | 1635 (55.0) | 0.286 |
| Female | 1389 (45.2) | 49 (50.5) | 1340 (45.0) | |
| Race/Ethnicity | ||||
| White | 2305 (75.0) | 77 (79.4) | 2228 (74.9) | 0.265 |
| Black | 440 (14.3) | 9 (9.3) | 431 (14.5) | |
| Hispanic | 120 (3.9) | 2 (2.1) | 118 (4.0) | |
| Asian | 82 (2.7) | 5 (5.2) | 77 (2.6) | |
| Unknown/other | 125 (4.1) | 4 (4.1) | 121 (4.1) | |
| BMI | ||||
| Underweight | 113 (3.7) | 6 (6.2) | 107 (3.7) | 0.225 |
| Normal or Healthy Weight | 1027 (34.0) | 40 (41.2) | 987 (33.8) | |
| Overweight | 1065 (35.3) | 32 (33.0) | 1033 (35.4) | |
| Obesity | 536 (17.8) | 14 (14.4) | 522 (17.9) | |
| Morbid Obesity | 277 (9.2) | 5 (5.2) | 272 (9.3) | |
| Functional Status | ||||
| Independent | 1884 (61.7) | 45 (46.9) | 1839 (62.1) | 0.002 |
| Dependent | 1172 (38.4) | 51 (53.1) | 1121 (37.9) | |
| ASA classification | ||||
| ASA I/II | 61 (2.0) | 0 (0) | 61 (2.1) | 0.154 |
| ASA III/IV/V | 3001 (98.0) | 97 (100.0) | 2904 (97.9) | |
| Comorbidities | ||||
| Hypertension | 2769 (90.6) | 93 (95.9) | 2676 (90.4) | 0.068 |
| Diabetes | 498 (16.2) | 20 (20.6) | 478 (16.1) | 0.231 |
| Prior CVA | 402 (13.1) | 16 (16.5) | 386 (13.0) | 0.312 |
| CAD | 721 (23.5) | 30 (30.9) | 691 (23.3) | 0.079 |
| CHF | 427 (13.9) | 12 (12.4) | 415 (14.0) | 0.658 |
| COPD | 1223 (39.8) | 42 (43.3) | 1181 (39.7) | 0.477 |
| ESRD | 75 (2.4) | 3 (3.1) | 72 (2.4) | 0.674 |
| Smoking Status | 2495 (81.2) | 79 (81.4) | 2416 (81.2) | 0.959 |
| Prior aortic surgery | 1216 (39.6) | 32 (33.0) | 1184 (39.8) | 0.176 |
| Zone of Intervention | ||||
| Arch Aneurysm (0–2) | 197 (6.41) | 14 (7.1) | 183 (92.9) | 0.001 |
| Zone 0 | 54 (27.4) | 4 (7.4) | 50 (92.6) | |
| Zone 1 | 45 (22.8) | 5 (11.1) | 40 (88.9) | |
| Zone 2 | 98 (49.8) | 5 (5.1) | 93 (94.9) | |
| Descending Aneurysm (3–5) | 2875 (93.59) | 83 (2.9) | 2792 (93.9) | |
| Number of Branch Intervened | ||||
| Single Branch | 651 (64.6) | 32 (51.6) | 619 (65.4) | 0.086 |
| Two branches | 161 (16.0) | 13 (21.0) | 148 (15.6) | |
| Three branches | 196 (19.4) | 17 (27.4) | 179 (18.9) | |
| Branch of Intervention | ||||
| Innominate | 202 (10.1) | 17 (8.4) | 185 (91.6) | 0.001 |
| L CCA | 358 (17.9) | 30 (8.3) | 328 (91.7) | <0.001 |
| L Subclavian | 1001 (50.1) | 62 (6.2) | 939 (93.8) | <0.001 |
| Supra-aortic treatment | ||||
| None | 167 (16.7) | 5 (8.2) | 162 (17.2) | 0.242 |
| Covered | 149 (14.9) | 8 (13.1) | 141 (15.0) | |
| Endovascular intervention | 125 (12.5) | 10 (16.4) | 115 (12.2) | |
| Open surgical revascularization | 561 (56.0) | 38 (62.3) | 523 (55.6) | |
| Median Operation Time (hr) (IQR) | 2.4 (1.5 – 4.1) | 4 (2.4 – 5.6) | 2.4 (1.4 – 4) | <0.001 |
| Median EBL (IQR) | 100 (50 – 300) | 200 (100 – 500) | 100 (50 – 300) | <0.001 |
| Quartile of Center Volume | ||||
| 1 | 36 (1.3) | 0 (0) | 36 (1.3) | 0.644 |
| 2 | 207 (7.4) | 5 (5.8) | 202 (7.5) | |
| 3 | 557 (20.0) | 17 (19.5) | 540 (20.0) | |
| 4 | 1983 (71.3) | 65 (74.7) | 1918 (71.1) |
CVA Rate and Distribution of CVA
Overall, among the entire cohort the rate of ischemic CVA was 3.2% and rate of 30-day mortality was 3.8% over the 6-year period. Only 0.44% of patients suffered from hemorrhagic CVA in this cohort. Of those who died within 30 days, 24.7% suffered from an acute ischemic CVA. As shown in Table 1, the majority of patients underwent TEVAR for descending aneurysm (93.6%) versus ascending/arch aneurysm (6.4%). Patients who underwent TEVAR for ascending/arch aneurysm had an ischemic CVA rate of 7.1% versus 2.9% for descending aneurysm, p=0.001. For patients who underwent supra-aortic trunk revascularization, there was no difference in CVA rate and number of branches intervened on bivariate analysis (Table 1). Supplemental Table 1 demonstrates the patient characteristics for those who underwent supra-aortic trunk revascularization. The majority, 50.1%, of interventions were done on the LSA compared to 17.9% LCCA, and 10.1% innominate artery intervention. However, innominate artery intervention had the highest CVA rate compared to other branches of supra-aortic arteries (innominate 8.41% vs. L CCA 8.37% vs. LSA 6.2%, p<0.001). Median operative time was longer in cases complicated by CVA compared to those without CVA (CVA 4 hours [IQR 2.4 hour-5.6 hours] vs. no CVA 2.4 hours [IQR 1.4 hours-4 hours], p<0.001), and similarly, median EBL (CVA 200cc [IQR 100cc-500cc] vs. no CVA 100cc [IQR 50cc-300cc], p<0.001). Hospital center volume was not associated with CVA rate.
The distribution of ischemic CVA events after TEVAR was bilateral (52.9%), left carotid territory (20.7%), left vertebrobasilar (11.5%), right carotid (9.2%), and right vertebrobasilar (5.7%) (Figure 1). Table 2 demonstrated the distribution of stroke based on the branch of intervention.
Figure 1.
Distribution of all ischemic stroke in TEVAR for degenerative aneurysm
Table 2.
Distribution of ischemic stroke based on supra-aortic branch treated
| Type of CVA | Total | Innominate | LSA | L CCA |
|---|---|---|---|---|
| Right carotid | 8 (9.2) | 3 (17.6) | 4 (6.8) | 3 (10.0) |
| Left carotid | 18 (20.7) | 3 (17.6) | 15 (25.4) | 6 (20.0) |
| Right vertebrobasilar | 5 (5.7) | 1 (5.9) | 2 (3.4) | 1 (3.3) |
| Left vertebrobasilar | 10 (11.5) | 0 | 6 (10.2) | 1 (3.3) |
| Bilateral | 46 (52.9) | 10 (58.8) | 32 (54.2) | 19 (63.3) |
Characteristics Associated with Ischemic CVA after TEVAR
As shown in Table 3, on multivariable Poisson regression analysis, the primary predictor of ascending aorta/arch aneurysm pathology was not associated with increased risk of ischemic stroke compared to descending aneurysm pathology (RR 1.02, 95% CI 0.61–1.71) after adjusting for patient demographic, and procedure factors. Patient factors associated with ischemic CVA after TEVAR were advanced age >79 years old (RR 1.79, 95% CI 1.08–2.98 vs. >79 years old) and dependent functional status (RR 1.73, 95% CI 1.07–2.78 vs. independent). Gender was not associated with increased risk for ischemic CVA after TEVAR. Procedural factors associated with ischemic CVA after TEVAR included operative time (RR 1.25, 95% CI 1.15–1.36), and endovascular approach for supra-aortic trunk revascularization (RR 2.66, 95% CI 1.06–6.70 vs. no intervention).
Table 3.
Factors associated with ischemic stroke after TEVAR
| Relative Risk | 95% CI | p-value | |
|---|---|---|---|
| Age | |||
| 40 – 79 | 1.00 (ref) | ||
| >79 | 1.79 | (1.08 – 2.98) | 0.024 |
| Gender | |||
| Male | 1.00 (ref) | ||
| Female | 0.74 | (0.50 – 1.09) | 0.125 |
| Functional Status | |||
| Independent | 1.00 (ref) | ||
| Dependent | 1.73 | (1.07 – 2.78) | 0.025 |
| Operation Time | 1.25a | (1.15 – 1.36) | < 0.001 |
| EBL | 1.00 | (1.00 – 1.00) | 0.400 |
| Types of SAT Intervention | |||
| None | 1.00 (ref) | ||
| Covered | 1.67 | (0.56 – 4.96) | 0.357 |
| Endovascular intervention | 2.66 | (1.06 – 6.70) | 0.037 |
| Open surgical revascularization | 2.14 | (0.84 – 5.44) | 0.109 |
| Zone of Intervention | |||
| Zone 3–5 | 1.00 (ref) | ||
| Zone 0–2 | 1.06 | (0.63 – 1.81) | 0.820 |
DISCUSSION
The risk of stroke after elective TEVAR has been established in the literature to be between 2–5%, which can be devastating for patients and providers.4–9,16 To our knowledge, few studies have evaluated the impact of supra-aortic trunk revascularization on risk of stroke in TEVAR. In our retrospective cohort study for patients undergoing TEVAR for degenerative aneurysms, we found that the overall rate of ischemic CVA was 3.2%, and endovascular approach for supra-aortic trunk revascularization was associated with increased risk for ischemic CVA. The VQI dataset offers an opportunity to examine specific vascular procedure related factors that may impact patient outcome. We were able to identify specific procedure factors associated with ischemic CVA for patients who underwent TEVAR for degenerative aneurysms which could be potential targets for future interventions.
CVA Rate and Distribution of CVA
First, we evaluated the overall ischemic CVA rate in this study cohort given the specific group of patients we were interested in examining. In our study, we found that the overall ischemic CVA rate was 3.2% which was concurrent with the findings in previous studies.12,16,17 However, when we compared the rate of ischemic CVA based on the location of disease, arch or ascending aneurysm (zone 0–2) had a higher rate of ischemic CVA rate than descending aneurysm (zone 3–5). In addition, we found that those patients who underwent supra-aortic trunk revascularization had more than three times the frequency of ischemic CVA rate. To our knowledge, this is the first study that looked specifically into the ischemic CVA rate and its relationship with supra-aortic trunk revascularization, whereas many previous studies have demonstrated that more proximal zone of involvement had higher rates of CVA and those with LSA involvement also had higher rates of CVA.18,19 While we did not find any difference in in the number of branches treated and CVA, we did find that intervention of any supra-aortic trunk arteries had increased rate of CVA and that innominate artery intervention had the highest rate compared to left CCA and LSA. Prior studies have demonstrated that stroke during TEVAR is related to cerebral embolization (air, clot, or atheroma), especially during aortic arch manipulation, our study concurred with this finding that any arch manipulation was associated with higher rate of CVA.16,20 The relationship between supra-aortic trunk revascularization and CVA is important for providers during surgical planning, as well as patient education.
Next, we wanted to understand the distribution of CVA after TEVAR based on the location of disease. We found that while the majority of CVA was bilateral (52.9%), there was a difference in distribution of CVA based on the location of disease and the branch intervened. For example, while both ascending or arch aneurysm and descending aneurysm both had high rates of bilateral ischemic CVA after TEVAR, ascending or arch aneurysm had higher rate of bilateral ischemic CVA than descending aneurysm. Ascending or arch aneurysm also had 20% higher rate of CVA than descending aneurysm for left carotid region of CVA, while descending aneurysm had more than 12% of left vertebrobasilar region of CVA. Furthermore, our study was able to delineate the region of CVA and the relationship to specific supra-aortic trunk arteries intervention. Most prior studies evaluated intervention of LSA and its association with CVA, where they found that coverage of LSA, staged vs. concomitant LSA revascularization were associated with higher CVA rate compared to grafts deployed distally to the LSA,17 however our study was able to evaluate the distribution of stroke based on the supra-aortic branch intervened. This should allow providers to be aware that supra-aortic trunk interventions have increased risk of CVA and that these risks should be taken into consideration in preoperative planning and risk assessment when performing TEVAR with supra-aortic trunk revascularization.
Characteristics Associated with Ischemic CVA after TEVAR
In this study, we identified specific factors that were associated with increased relative risk for ischemic CVA after TEVAR in the context of supra-aortic trunk revascularization. Based on our findings, patient factors were associated with increased risk for CVA after TEVAR was age and dependent functional status. While age is a risk factor that was not previously commonly shown for ischemic CVA after TEVAR, however in previous studies, it has been demonstrated that older patients had increased odds of 30-day mortality.21 There has been a clear association between CVA after TEVAR and 30-day mortality rate, our study demonstrated that in this study cohort, age played a role in ischemic CVA after TEVAR.11,21,22
Procedure factors associated with ischemic CVA after TEVAR included procedural time, and endovascular intervention to the supra-aortic trunk. Previous studies have demonstrated that one of the risk factors for perioperative stroke after TEVAR is procedural time, this is likely related to the various adjunct procedures that were performed after TEVAR, such as coil occlusion, stent-graft deployment, or open debranching.19,21 Another interesting factor that we found were associated with increased risk for ischemic CVA after TEVAR is endovascular intervention to the supra-aortic trunk branches. Prior studies have demonstrated that endovascular intervention as compared to open total arch replacement, the gold standard for aneurysms and dissections involving the aortic arch, endovascular approach had higher stroke rate, which is likely due to several reasons, including increased aortic arch manipulation that led to cerebral embolization, requirement of a sufficient healthy landing zones to safely and effectively deploy a stent graft, branch vessel occlusion, and device failure.16,20,23,24 Patient optimization with proper medical management and judicious surgical techniques, especially in these degenerative aneurysm patient cohort, are particularly crucial in the prevention of ischemic CVA.
Limitations
There are several limitations in our study. First, the VQI is based on voluntary participation from different institutions, and represents a skew towards academic/teaching institutions. These institutions may present different resource profiles, referral patterns, and procedural characteristics than non-VQI participating institutions, thus limiting generalizability. Second, while the VQI is maintained as a prospective collected database, our study is a retrospective analysis, which may limit the number of factors that could have influenced stroke risk. However, the VQI has adequate information on supra-aortic trunk interventions which allowed us to analyze our study cohort effectively. Third, the exact timing of the CVA occurrence is not documented, whether it was intraoperative, immediately postoperative, or later in the postoperative period. This could be an area of improvement to further understand risks of CVA after TEVAR. Fourth, there may be inherent selection bias for patients who were undergoing TEVAR for arch aneurysm repair because they may not be suitable for open repair. Finally, VQI database does not provide details regarding atherosclerotic burden or the arch type which may play important roles of CVA risk after TEVAR.
CONCLUSION
Our study demonstrated increased ischemic CVA rate after TEVAR for arch aneurysms and supra-aortic arch intervention. More proximal zone coverage, and endovascular interventions for supra-aortic trunk revascularization were both associated with increased risk for CVA. These CVA risk factors should be considered in the clinical decision-making process when evaluating patients for TEVAR, and adequate preparation for providers and patients is necessary for CVA prevention.
Supplementary Material
Conflicts of Interest and Source of Funding:
The authors report no conflicts of interest or disclosures related to the content of this study. RDL and MCC are supported by a grant by the National Heart, Lung, and Blood Institute of the National Institutes of Health (T32HL094293). MKE has received honoraria from Silk Road Medical, Inc. for service on the Roadster Clinical Events Committee; and from W. L. Gore & Associates as a TEVAR course director and Data Safety Monitoring Board member.
Footnotes
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Presentation Information: This study was presented at VESS, Snowmass CO 1/27/2021 – 1/30/2021
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