Minimally invasive management of Stanford B aortic dissection involving the left subclavian artery

Abstract

Objectives:

This retrospective exploratory study evaluated outcomes of different management strategies of the left subclavian artery (LSCA) during TEVAR for Stanford type B aortic dissection.

Methods:

Thirty-six patients with Stanford type B aortic dissection with involvement of the LSCA were evaluated retrospectively and divided into three groups based on management strategy: direct LSCA coverage, right-to-left subclavian artery bypass (subclavian–subclavian artery bypass), and physician-modified fenestrated TEVAR. The primary outcomes were LSCA-related complications, including stroke, dizziness, and upper limb ischemia.

Results:

Thirty-six patients underwent TEVAR with an assigned management strategy for the LSCA. Two patients in the direct coverage group had transient dizziness, without experiencing a major embolic stroke or upper limb ischemia. Of the 16 patients undergoing LSCA reconstruction, the fenestrated intervention had a shorter operative time than the bypass (68 vs. 240 min, P = 0.001) and had lower total hospitalization costs (P = 0.001). Two type II endoleaks resolved spontaneously by 1-month follow-up. No 30-day mortality occurred, and 1-year survival was 100%.

Conclusions:

While we demonstrated that fenestrated TEVAR had a shorter operative time with reduced hospitalization costs compared to bypass, these findings should be reviewed with caution as a result of the retrospective nature of the study, and relatively small sample size. All patients had an intervention after institutional ethical approval. Multicenter prospective studies are needed to verify these early observations.

1 Introduction

An aortic dissection is a potentially deadly event that can lead to multi-organ dysfunction or death due to a ruptured aorta (1). While the management of Stanford type A dissection has been well defined, there continues to be debate surrounding the optimal management of Stanford type B aortic dissection (2). Specifically, thoracic endovascular aortic repair (TEVAR) typically requires the proximal landing zone to be extended into Zone 2, resulting in intentional coverage of the left subclavian artery (LSCA) (3).

Because TEVAR frequently requires intentional LSCA coverage to obtain an adequate proximal landing zone, the optimal management of the LSCA remains debated. Intentional LSCA coverage without revascularization may increase the risk of neurologic complications, posterior-circulation stroke, and upper-extremity ischemia (4, 5). Revascularization options include right-to-left subclavian artery bypass and physician-modified fenestrated TEVAR; however, consensus on the optimal strategy remains incomplete despite existing society recommendations, including the Society for Vascular Surgery (SVS) Practice Guidelines, which recommend routine LSCA revascularization in selected patients undergoing Zone 2 TEVAR (3). Comparative data on clinical outcomes among different revascularization techniques remain limited (5, 6). Although direct coverage, subclavian-subclavian bypass, and fenestrated TEVAR have each been described previously, direct comparative data on LSCA-specific outcomes, perioperative efficiency, and hospitalization costs among all three strategies within the same cohort remain scarce, particularly for physician-modified fenestrated devices in Asian patients with Stanford type B aortic dissection.

Thus, this study examined LSCA-specific clinical outcomes for patients treated with direct coverage, bypass, and fenestrated TEVAR, who underwent Zone 2 TEVAR for Stanford type B aortic dissection (7). However, comparative data on the outcomes of different LSCA management strategies—particularly physician-modified fenestration vs. conventional bypass—remain scarce. This study aims to provide preliminary data to inform future multicenter investigations.

2 Methods

2.1 Patients

Between February 2018 and January 2021, thirty-six patients with Stanford type B aortic dissection with left subclavian artery (LSCA) involvement were treated with thoracic endovascular aortic repair (TEVAR) at our institution. We enrolled patients who underwent Zone 2 TEVAR with LSCA coverage, whether revascularization was performed or not. Patients with Marfan syndrome were excluded. All patients underwent a computed-tomography angiography (CTA) for preoperative diagnosis, as well as received preoperative treatment to control blood-pressure with calcium-channel blockers and β-blockers.

This retrospective study was conducted in accordance with the Declaration of Helsinki and was approved by the Ethics Committee of Sir Run Run Shaw Hospital. Due to only de-identified data being analyzed, individual informed consent for this study was waived. Where applicable, consent for scientific use of anonymized data was obtained prior to publication.

Patients were consecutively enrolled between February 2018 and January 2021. Complete clinical and imaging follow-up data were collected through December 2022. The interval between study completion and manuscript submission was primarily attributable to the impact of the COVID-19 pandemic, final data maturation, statistical analysis, and manuscript preparation; this delay did not affect data consistency or patient selection.

2.2 Revascularization decision

All patients underwent preoperative computed-tomography angiography (CTA) to delineate anatomy and assess vertebral artery dominance and collateral circulation. Direct LSCA coverage without revascularization was selected for patients with low-risk features (non-dominant left vertebral artery, patent right vertebral artery, and no spinal artery origin from the false lumen). Revascularization was indicated for high-risk anatomy, including a dominant left vertebral artery, occluded right vertebral artery, or spinal artery arising from the false lumen. Within the revascularization cohort, the choice between subclavian–subclavian artery bypass and physician-modified fenestrated TEVAR was based on anatomical suitability (e.g., adequate LSCA ostium diameter, sufficient proximal landing zone, and arch morphology for fenestration) as well as surgeon preference and multidisciplinary team discussion. All decisions were made preoperatively and documented in the medical record. Subgroup sensitivity analyses stratified by the specific revascularization indications (vertebral artery dominance and spinal artery origin) were performed as described in the statistical analysis section and yielded consistent results.

2.3 Procedures

These cases were divided into three groups: left subclavian artery coverage, right-to-left subclavian artery bypass (subclavian–subclavian bypass), and fenestrated thoracic endovascular aortic repair. Angiography was conducted using a catheter, under which a stiff guide wire guided the release of the stent graft. The proximal landing zone was in Ishimaru Zone 2 (distal to the left common carotid artery origin and covering the left subclavian artery origin). The distal landing zone was placed in the descending thoracic aorta beyond the primary entry tear.

Physician-modified fenestration was performed according to the standardized institutional protocol, and the operative steps were documented to improve reproducibility. The stent graft platform used for all fenestrated cases was the Medtronic Valiant Captivia system (Medtronic, Minneapolis, MN, USA). Only CE-marked stent grafts were utilized. CE-marked devices were selected in accordance with institutional protocol and local regulatory requirements in China to ensure device safety and compliance. Patients were scheduled for follow-up visits at 1, 6, and 12 months to evaluate graft integrity, graft migration, and the occurrence of type I or type II endoleaks. Endoleaks were classified according to the Society for Vascular Surgery/ Society of Thoracic Surgeons reporting standards. No type III, IV, or V endoleaks were observed in this cohort. Type II endoleaks were not further subtyped because they were small-volume and self-resolving.

All inpatient costs were recorded in Renminbi (RMB) and converted to US dollars (USD 1 ≈ RMB 7.1 as of the average 2021 exchange rate) for international comparison.

2.4 LSCA management procedures

Right-to-left subclavian artery bypass (subclavian–subclavian artery bypass): After general anesthesia was induced, bilateral infraclavicular incisions were made to expose the right and left subclavian arteries. An 8 mm ringed expanded polytetrafluoroethylene (ePTFE) graft was anastomosed end-to-side to both subclavian arteries, creating a right-to-left extra-anatomic bypass conduit routed through a retrosternal tunnel. After the bypass, we performed TEVAR and intra-operative angiography to determine perfusion and successful procedure completion.

Fenestration: After anesthesia was completed, angiography was performed through femoral arterial access. The diameter of the left subclavian artery and the anatomical distances were measured using intraoperative angiography and CTA. A physician-modified fenestration was performed on the Medtronic Valiant Captivia thoracic stent graft system. After partially deploying the stent graft at the appropriate landing zone, we created a fenestration manually with a modified needle under fluoroscopic guidance (approximately at the 6 o'clock orientation facing the femoral artery and the noon orientation facing the aortic arch). Balloon dilatation was used to enlarge the fenestration to match the diameter of the LSCA ostium (typically 8–10 mm). A self-expanding covered stent (Fluency Plus vascular stent graft, Bard Peripheral Vascular, Tempe, AZ, USA; 8 mm × 40 mm) was deployed as a bridging stent through the fenestration into the LSCA to maintain long-term patency and seal the fenestration margin. The graft was then carefully resheathed and repositioned as needed under fluoroscopic guidance to ensure precise fenestration-ostium alignment before final deployment. Completion angiography confirmed brisk antegrade flow into the LSCA, as shown in Figure 1.

Figure 1

2.5 Outcomes

Operative time, hospitalization costs, mortality, and complications, including stroke, spinal cord ischemia, and other organ ischemia, were recorded. Operative time was defined as the total duration from anesthesia induction to skin closure and included both the bypass procedure and TEVAR when performed in the same session. Stroke was defined according to the American Heart Association/American Stroke Association criteria as a new neurological deficit lasting >24 h or with imaging confirmation of cerebral infarction, regardless of symptom duration. Spinal cord ischemia was defined as new postoperative paraplegia, paraparesis, or lower-limb sensory/motor deficit not attributable to intracranial cerebral infarction or another primary cerebral cause (8). All patients received antiplatelet therapy for 6 months unless contraindicated.

2.6 Statistical analysis

Continuous variables were reported as median (interquartile range [IQR]) and analyzed using non-parametric tests. Categorical variables were reported as a number (percentage) and analyzed using Fisher's exact test. Post-operative survival was evaluated using the Kaplan–Meier method. To address baseline balance in vertebral-artery dominance, subgroup sensitivity analysis was performed, and results were reported descriptively rather than inferentially. A two-sided P < 0.01 was selected as the significance threshold to reduce the risk of type I error given the small sample size, multiple comparisons across three treatment groups, and the exploratory nature of this study; this more conservative threshold aligns with recommendations for small-sample exploratory surgical studies where replication data are not yet available (9). Owing to the retrospective and exploratory nature of the study, no formal a priori power calculation was performed. All eligible consecutive patients treated at our institution during the study period were included. Analyses were performed using the SPSS software (Version 22.0, IBM Corp., USA).

2.7 Ethics approval and consent

The study protocol was reviewed and approved by the Ethics Committee of Sir Run Run Shaw Hospital. All procedures were in accordance with the ethical standards of the institution and with the Declaration of Helsinki. The study utilized de-identified data collected during routine clinical practice and was therefore exempt from obtaining individual consent. Consent for publication of aggregated data was obtained if applicable.

3 Results

3.1 Patient demographics and treatment groups

Among all patients, left subclavian artery (LSCA) coverage was performed in 20 cases, while LSCA reconstruction was performed in 16. Ten patients underwent subclavian-subclavian artery bypass, and six underwent physician-modified fenestrated thoracic endovascular aortic repair (TEVAR). Table 1 summarizes the demographic and baseline clinical characteristics of the study population.

3.2 LSCA-specific and operative outcomes

Two patients (10%) in the direct-coverage group developed dizziness symptoms consistent with posterior-circulation ischemia; one subsequently required vascular bypass, and the other recovered spontaneously within 2 weeks. The overall median operative time was 85 min (IQR 60–218). The diagnosis of posterior-circulation ischemia was based on clinical symptoms (transient dizziness and vertigo) in the absence of focal anterior-circulation findings. Both patients underwent urgent cranial computed tomography (CT) and subsequent magnetic resonance imaging (MRI), including diffusion-weighted imaging (DWI), which excluded acute cerebral infarction. Transcranial Doppler ultrasonography was performed in both cases and demonstrated reduced flow velocity in the posterior cerebral arteries, consistent with posterior-circulation hypoperfusion. Alternative causes of postoperative dizziness, including vestibular dysfunction, medication-related effects, and anesthesia-related complications, were systematically evaluated and excluded through bedside vestibular examination and clinical assessment. No patients experienced left-upper-limb ischemia, loss of radial pulse, or significant postoperative inter-arm blood-pressure difference. No perioperative strokes occurred.

3.3 Comparison of reconstruction strategies

Among the 16 patients who underwent LSCA reconstruction (10 with subclavian-subclavian bypass and 6 with fenestrated TEVAR), the fenestration group had a significantly shorter operative time than the bypass group (68 min [60–83] vs. 240 min [218–273]; P = 0.001) and lower hospitalization costs (RMB 148,677 [143,001–158,378], approximately USD 20,940, vs. RMB 212,572 [194,721–232,488], approximately USD 29,940; P = 0.001). The longer operative time in the bypass group reflects the additional open surgical component; baseline anatomical complexity was comparable between groups (Table 2). No statistically significant differences were found in perioperative complications between groups (Table 2).

3.4 Comparison of overall treatment strategies

Procedural complications occurred in 3 of 36 patients (8.3%). One developed acute renal failure requiring temporary dialysis, one experienced an inguinal lymphatic fistula, and one had a cerebral infarction complicated by gastrointestinal hemorrhage. The patient with cerebral infarction survived the index hospitalization and was discharged in stable condition but subsequently died at 20 months of follow-up due to sequelae of the cerebral event compounded by pre-existing comorbidities. A second patient in the direct-coverage group died after 12 months of follow-up from non-aortic comorbidity. Accordingly, Table 3 reports zero 30-day perioperative mortality, whereas the survival row reports overall survival at the last available follow-up. No cases of spinal-cord ischemia were observed (Table 3). No cases of other organ ischemia (mesenteric, visceral, or additional renal ischemia) were observed.

3.5 Long-term follow-up

Primary patency of the LSCA reconstruction was assessed at each follow-up visit using computed-tomography angiography. In the bypass group, primary patency at 12 months was 100% (10/10). In the fenestration group, primary patency at 12 months was 100% (6/6). Secondary patency was also 100% in both groups, as no reinterventions for LSCA-related occlusion or stenosis were required during the follow-up period.

Two type II endoleaks were detected on postoperative imaging and resolved spontaneously within 1 month. The 1-year survival rate among discharged patients was 100%. During longer follow-up, two late non-aortic deaths occurred after the 12-month assessment, resulting in overall survival at last follow-up of 34/36 (94.4%). The median rate of aortic-diameter dilation was 1.33 mm/year (0.55–2.82), although this was not a primary endpoint of the study.

4 Discussion

Adequate management of the left subclavian artery (LSCA) during a Zone 2 thoracic endovascular aortic repair (TEVAR) may mitigate the risk of posterior-circulation stroke, upper-extremity ischemia, and spinal-cord ischemia (10, 11). Two patients treated with LSCA coverage in this study experienced transient postoperative dizziness associated with posterior-circulation ischemia, one of which recovered spontaneously and the other underwent additional vascular intervention.

While our findings suggest that fenestrated TEVAR may reduce operative time and cost compared with subclavian-subclavian bypass, the retrospective design and small sample size of this study do not allow any definitive conclusions to be made. Both procedures provided excellent short-term outcomes, with no major strokes or limb ischemia; the two type II endoleaks observed during follow-up resolved spontaneously within 1 month. Therefore, individualized management of LSCA can be performed safely after careful preoperative anatomical assessment.

Fenestrated TEVAR appeared to provide practical advantages in perioperative efficiency and cost savings without compromising safety, consistent with previous reports describing the advantages of minimally invasive procedures (12, 13). Although fenestrated TEVAR demonstrated shorter operative times and lower hospitalization costs, these findings must be interpreted with caution given the small sample size in the fenestration group, the retrospective study design, and the lack of long-term outcome data on graft durability and reintervention rates. Our cohort included two type II endoleaks that resolved spontaneously within 1 month, suggesting that minor type II endoleaks after fenestrated TEVAR can be monitored conservatively when no aortic expansion or clinical deterioration is present.

Contemporary options for LSCA preservation during Zone 2 TEVAR include commercially available branched arch devices (e.g., the Gore TAG Thoracic Branch Endoprosthesis), chimney or parallel graft techniques, and physician-modified fenestrated devices as described in this study. Branched arch devices offer the advantage of off-the-shelf availability and standardized deployment; however, their applicability is limited by stringent anatomical requirements, longer lead times for custom devices, and restricted availability in many regions including China (14). Chimney techniques provide a versatile alternative but have been associated with higher rates of type Ia endoleak due to gutter formation between the parallel grafts (15). Physician-modified fenestrated TEVAR, as employed in this cohort, offers the flexibility of on-site customization, shorter operative times compared with open bypass, and avoidance of gutter-related endoleak; however, it requires substantial operator expertise and lacks the regulatory standardization of commercially manufactured devices. Future studies comparing these approaches in larger, multicenter cohorts are warranted to define the optimal strategy for LSCA management.

Changes in aortic diameter were evaluated as a secondary exploratory observation. The median aortic-diameter dilation rate of 1.33 mm/year observed in our cohort was modest and did not affect the primary procedural or clinical outcomes. False lumen thrombosis was assessed on follow-up CTA at 12 months: complete false lumen thrombosis at the level of the stent graft was observed in 25 of 36 patients (69.4%), partial thrombosis in 8 patients (22.2%), and persistent false lumen patency in 3 patients (8.3%). The rate of complete thrombosis was comparable between the reconstruction group (11/16, 68.8%) and the direct-coverage group (14/20, 70.0%). No patient required aortic reintervention during the follow-up period; the overall freedom from aortic reintervention at 12 months was 100%. These remodeling findings, although encouraging, should be interpreted cautiously given the limited follow-up duration and small sample size.

From a procedural perspective, the timing of TEVAR after sufficient stabilization of blood pressure may have contributed to successful remodeling of the aorta without ischemic complications, which supports earlier conclusions that the timing can affect outcome (16, 17). LSCA revascularization deferral was assessed in an appropriate fashion for selected patients, particularly those with nondominant left vertebral arteries but preserved sufficient collateral circulation. This approach is consistent with the SVS Practice Guidelines (3), recent European Association for Cardio-Thoracic Surgery (EACTS)/Society of Thoracic Surgeons (STS) guidelines (14), and contemporary TBAD-specific evidence on LSCA management during TEVAR (18), all of which support selective revascularization based on individual anatomical risk factors including vertebral artery dominance and collateral adequacy (19, 20).

Avoidance of endoleaks in TEVAR remains an important consideration. In this series, strict attention was given to device sizing and operative intrafluoroscopic guidance with all cases of LSCA reconstruction, with outcome and consideration of type I/II endoleaks supported indirectly in the earlier literature (21, 22).

Ethical approval for this study and compliance were considered and approved by the institutional review board, in addition to the Declaration of Helsinki. All patient data was de-identified as necessary and then reviewed retrospectively without intervention or direct contact with patients.

5 Limitations

This study is limited by its single-center retrospective design, small overall sample size (n = 36), and particularly small fenestration subgroup (n = 6). Owing to the small sample size inherent to a single-center retrospective study of this relatively uncommon procedure, the study is underpowered to detect small differences in rare outcomes. Non-randomized assignment of treatment strategies introduces the possibility of selection bias, despite similar baseline demographics. The short follow-up duration precludes robust assessment of long-term durability, graft patency, and reintervention rates. In addition, the physician-modified fenestration technique may limit generalizability to centers using commercially available branched or fenestrated devices. Multicenter prospective studies with standardized protocols and larger cohorts are required to confirm these findings (17, 23).

6 Conclusion

The left subclavian artery (LSCA) can be adequately treated during thoracic endovascular aortic repair (TEVAR) for Stanford type B aortic dissection with either subclavian-subclavian bypass or physician-modified fenestrated TEVAR. In this study, fenestrated TEVAR was associated with shorter operative time and lower hospitalization costs; however, these findings should be interpreted cautiously because of the retrospective study design and small sample size. Prospective multicenter studies evaluating standardized devices are warranted to confirm these early findings and better define optimal LSCA treatment strategies.

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