Mid-term outcomes of the fenestration,branched stent-graft,and hybrid techniques in the treatment of thoracic aortic pathologies involving the left subclavian artery

Abstract

Objective

To compare the midterm outcomes of fenestration, branched stent-graft thoracic endovascular aortic repair, and hybrid procedures in treating aortic arch pathologies involving the left subclavian artery.

Methods

We collected the clinical data from 144 patients with aortic arch pathologies involving and only involving the left subclavian artery (LSA) who underwent fenestration, branched stent-graft thoracic endovascular aortic repair, and hybrid procedures from November 2015 and December 2022 at a single center. Among the patients, 68 were treated by fenestration, 61 by branched stent-grafts, and 15 by hybrid surgery. The clinical data was retrospectively analyzed and compared. The primary outcome indicators included technical success and in-hospital mortality; others included the incidence of endoleaks, spinal cord ischemia, LSA patency, stent-related entry tear, aortic-related reintervention, operative time, blood loss, and aortic remodeling.

Results

The technical success rate was 83.8%, 95.1%, and 100% (p = .046), and the in-hospital mortality rate was 1.5% (n = 1), 0%, and 0% (p = 1.000) in the fenestration, branched stent-graft, and hybrid surgery groups. Type I or III endoleaks occurred in 16.2% (n = 11), 4.9% (n = 3), and 0% of patients, respectively (p = .046). The operative time, blood loss, and hospitalization duration of the hybrid surgery group was significantly higher than those of the other two groups (p < .05). However, the surgery-related costs and total costs in the hybrid surgery group were lower than the other two groups (p < .001). The rate of LSA patency was 100% in the fenestration group and 98.3% in the branched stent-graft group (p = .475). The all-cause mortality rates were 10.9% (n = 7), 6.9% (n = 4), and 0%, respectively (p = .359). Spinal cord ischemia and other complications were not significantly different in each group, both in the perioperative and postoperative periods. In the subgroup analysis of patients with AD, the incidence of endoleaks was 28.9% (n = 13), 7.0% (n = 3), and 0%, respectively (p = .011), and stent-related new entry tears in each group were 2.2% (n = 1), 18.6% (n = 8), and 14.3% (n = 1), respectively, p = .032. The overall cumulative survival rate at 2 years was 90.0%, 92.4%, and 100%, respectively (p = .508). The true lumen area of the aortic arch and descending thoracic aorta in the stent segment was significantly larger postoperatively compared to that preoperatively in both of these three groups.

Conclusion

The fenestration technique is sophisticated with long learning curve and is prone to complications such as endoleaks with inexperience. Branched grafts are at greater risk of stent-related entry tears, which result in a higher rate of re-intervention. The hybrid technique broadens the indications for patients with aortic arch vessel variation and generally costs less, but the operative time is longer. Surgeons should select the optimal solution based on each patient’s condition to achieve satisfactory results.

Keywords

Endovascular procedures aneurysm aortic arch stents surgery subclavian artery

Introduction

Diseases of the thoracic aorta are dangerous, irreversible, and are associated with a poor prognosis, including thoracic aortic aneurysms (TAA), thoracic aortic dissections (TAD), penetrating aortic ulcers (PAU), and intramural hematomas (IMH).^1,2 Since its initial report in 1991,³ thoracic endovascular aortic repair (TEVAR) has gradually become the preferred surgical approach to treat thoracic aortic pathologies owing to its minimally invasive nature, low risk, and broad indications.⁴ However, conventional TEVAR has several limitations, such as proximal aortic endograft requires an adequate anchoring zone.⁵ The method used to manage lesions affecting the Z2 region according to the Ishimaru classification, where the LSA originates, remains highly debated. Although some authors remain skeptical, it is generally accepted that preserving blood flow to the LSA that can reduces the risk of stroke and spinal cord ischemia.⁶

The hybrid technique combines the traditional LCCA-LSA bypass and TEVAR to extend the proximal landing zone, but this method increases the risk of nerve injury and hematoma.⁷ Nowadays, the subsequent development of arch endografts with preloaded fenestrations and branched has become a viable option for patients with increased risk for open repair.⁸ However, the fenestration technique disrupts the original structure of the stent, and the use of physician-modified endografts (PMEGs) may result in higher rates of complications than the company-manufactured devices due to inconsistencies in stent modification standards.⁹ Branched grafts are associated with a lower risk of endoleaks and are better accommodated in the aortic arch curvature, but this new technique requires more clinical research to confirm its reliability.⁷

This study explored the feasibility of fenestration, branched stent–graft, and hybrid surgery in the treatment of aortic arch pathologies involving the LSA.

Materials and methods

Study design

A retrospective comparison of clinical data of 144 patients with thoracic aortic pathologies who underwent fenestration TEVAR (f-TEVAR), branched stent-graft TEVAR (b-TEVAR), or hybrid techniques (HT) with remodeling of the LSA at a single center between November 1, 2015, and December 31, 2022, was conducted. The inclusion criteria were as follows: (1) patients were operated on for type B non-acute aortic dissection, aortic ulcer, intramural aortic hematoma, and thoracic aortic aneurysm; (2) operative treatment with fenestration stent, branched stent-graft, or hybrid techniques; and (3) operation to remodel the LSA. The exclusion criteria were as follows: (1) the landing zone involving the Z0 or Z1 zone in the Ishimaru partition; and (2) life expectancy <12 months. The primary outcome indicators included technical success and in-hospital mortality. The secondary outcome indicators were the incidence of type I or III endoleaks, spinal cord ischemia, LSA patency, stent-related entry tear, aortic-related reintervention, operative times, blood loss, and aortic remodeling. The study was conducted in accordance with the Declaration of Helsinki. The study was approved by the institutional ethics committee of our hospital (IRB2022–KY–406).

Surgical procedure

A detailed surgical procedure and intraoperative images were reported in our previous publication.¹⁰

Definitions

Technical success was defined as the successful isolation and intraoperative angiography had no prominent type I or III endoleaks. The aortic-related re-interventions takes place when there is a need for reoperation due to the persistence of endoleak or false lumen enlargement, or a stent-related entry tears was detected during follow-up with computed tomography angiography (CTA).

The research focuses on postoperative aortic remodeling. For patients included in the study with a TAD diagnosis, as shown in Figure 1, radiological data were analyzed using the 3mensio vascular measurement software (Pie Medical Imaging, The Netherlands); the true and false lumen areas were measured in six fixed planes as follows: L1, an aortic plane 10 mm distal to the LSA origin; L2, an aortic plane just below the tracheal bifurcation; L3, an aortic plane at the distal end of the TEVAR graft and its distal anchor zone; L4, an aortic plane at the level of the aortic tear; L5, an aortic plane just above the origin of the left renal artery; L6, an aortic plane at the bifurcation of the abdominal aorta; where L1, L2, and L3 belonged to the stent segment and L4, L5, and L6 belonged to the non-stent segment.

Figure 1.

Process of measuring the true and false lumen areas in different planes before and after surgery using 3mensio software. (A) The CTA image is straightened, and two-dimensional images are reconstructed. (B) Target planes are selected, and the software automatically calculates the areas by delineating the inner walls of the true and false lumens. (C, D) Three-dimensional images are reconstructed using 3mensio software to assist in locating planes L1 to L6. (E) The positions of planes L1 to L6 in the CTA three-dimensional reconstruction correspond to their locations. CTA, computed tomography angiography.

Postoperative follow-up

CTA was reviewed in our hospital before the patients were discharged. Patients were told to review the CTA in our outpatient clinic at 3, 6, and 12 months postoperatively; however, some patients could not be followed up in our hospital due to their place of residence and were telephoned to determine their postoperative status.

Statistical analysis

Continuous data were expressed as mean ± standard deviation (SD), and categorical data were presented as percentages. Data analysis was performed using SPSS version 27.0 (IBM software, Inc.; NY, USA). For two-group comparisons, the t test was used if the data followed a normal distribution and exhibited homogeneity of variance. The Wilcoxon rank-sum test was used if the data were not normally distributed. A one-way analysis of variance (ANOVA) was performed for comparisons involving three or more groups, followed by post hoc LSD/Tamhane pairwise comparisons to see if the data were normally distributed and exhibited homogeneity of variance. The Kruskal–Wallis test was used if the data were not normally distributed. Statistical significance was set at a bilateral p-value <.05. The chi-squared test was used to analyze non-ordered categorical data involving multiple groups. The long-term survival curve was plotted using the Kaplan–Meier method.

Results

Patient population

In total, 144 patients with a mean age of 56.9 ± 13.4 years were included, including 101 (70.1 %) with TAD, 20 (13.9 %) with TAA, 11 (7.6 %) with PAU, and 12 (8.3 %) with IMH, comprising 68, 61, and 15 cases in the f-TEVAR, b-TEVAR, and HT groups, respectively. There were no statistically significant differences in age (p > .05) and the proportion of males in each group (p > .05). In the HT group, three patients had a LVA arising from the aortic arch. In the f-TEVAR group, one patient had LVA arising from the aortic arch. The incidence of anatomic variants in the hybrid group was 20%, which was higher than that in the other two groups (p < .001). There were no statistically significant differences in the presence of underlying medical conditions or relevant surgical histories among the three groups (p > .05) (Table 1).

Table 1.

Baseline data for the three groups of patients.

Variables	Total (n = 144)	f-TEVAR (n = 68)	b-TEVAR (n = 61)	HT (n = 15)	P
Male (n, %)	123 (85.4%)	54 (79.4%)	56 (91.8%)	13 (86.7%)	0.130
Mean age (years)	57.1±13.4	56.9±13.2	57.7±14.3	57.3±13.6	0.855
Aortic disease (n, %)
TAD	101 (70.1%)	49 (72.1%)	45 (73.8%)	7 (46.7%)	0.126
TAA	20 (13.9%)	8 (11.8%)	8 (13.1%)	4 (26.7%)	0.360
PAU	11 (7.6%)	4 (5.9%)	4 (6.6%)	3 (20%)	0.180
IMH	12 (8.3%)	7 (10.3%)	4 (6.6%)	1 (6.7%)	0.822
Hypertension (n, %)	122 (84.7)	61 (89.7%)	50 (82.0%)	11 (73.3%)	0.193
Diabetes (n, %)	9 (6.3%)	3 (4.4%)	6 (9.8%)	0 (0%)	0.353
Coronary artery disease (n, %)	25 (17.4%)	15 (22.1%)	7 (11.5%)	3 (20%)	0.276
Marfan syndrome (n, %)	1 (0.7%)	1 (1.5%)	0 (0%)	0 (0%)	1
Peripheral artery disease (n, %)	4 (2.8%)	4 (5.9%)	0 (0%)	0 (0%)	0.207
Chronic obstructive pulmonary disease (n, %)	3 (2.1%)	3 (4.4%)	0 (0%)	0 (0%)	0.332
Renal Function deteriorations (n, %)	13 (9.0%)	8 (11.8%)	3 (4.9%)	2 (13.3%)	0.274
Dyslipidemia (n, %)	10 (6.9%)	7 (10.3%)	2 (3.3%)	1 (6.7%)	0.258
Variants of the aortic arch (n, %)	4 (2.8%)	1 (1.5%)	0 (0%)	3 (20%)	<0.001
f-TEVAR vs b-TEVAR					1
f-TEVAR vs HT					<0.001
b-TEVAR vs HT					<0.001

Aortic stent usage

The main stent grafts used in this study included the Castor (MicroPort, China), Relay (Bolton Medical, USA), Valiant (Medtronic, USA), Ankura II (LIFETECH, China), FaBulous (Dinova Medical, China), Zenith TX2 (Cook Medical, USA), MTAA (Endonom Medtech, China), Fabulous (Endonom Medtech, China), and Hercules (MicroPort, China).

Surgical conditions and perioperative complications

As shown in Table 2, the technical success rates of f-TEVAR, b-TEVAR, and HT were 83.8%, 95.1%, and 100%, respectively (p = .046). Type I or III endoleaks were observed (16.2% vs 4.9% vs 0%, p = .046), with statistically significant differences between the f-TEVAR and b-TEVAR groups (p = .049). In the f-TEVAR group, there were six cases of type Ia postoperative immediate endoleak and five of type III intraoperative immediate endoleaks. However, the b-TEVAR group had three cases of type Ib intraoperative immediate endoleak, which all showed a significant reduction in CTA progression at the 14-day follow-up.

Table 2.

Perioperative complications for the three groups of patients.

Perioperative outcomes	f-TEVAR (n = 68)	b-TEVAR (n = 61)	HT (n = 15)	p
Technical success (n, %)	57 (83.8%)	58 (95.1%)	15 (100%)	0.0.046
f-TEVAR vs b-TEVAR				0.049
f-TEVAR vs HT				0.201
b-TEVAR vs HT				1
Type I or III endoleaks (n, %)	11 (16.2%)	3 (4.9%)	0 (0%)	0.046
f-TEVAR vs b-TEVAR				0.049
f-TEVAR vs HT				0.201
b-TEVAR vs HT				1
Operation time (minutes)	128.4±24.2	117.9±61.7	260.3±128.6	<0.001
f-TEVAR vs b-TEVAR				0.029
f-TEVAR vs HT				<0.001
b-TEVAR vs HT				<0.001
Intraoperative blood loss (mL)	82.5±57.3	68.7±43.9	123.3±70.4	0.002
f-TEVAR vs b-TEVAR				0.131
f-TEVAR vs HT				0.019
b-TEVAR vs HT				<0.001
Perioperative complications (n, %)
Upper Limb numbness	0 (0%)	0 (0%)	0 (0%)	-
Stent-Related new entry tears	0 (0%)	3 (4.9%)	0 (0%)	0.103
Spinal cord ischemia	2 (2.9%)	0 (0%)	0 (0%)	0.597
Stroke	2 (2.9%)	1 (1.6%)	1 (6.7%)	0.437
Cardiovascular complications	0 (0%)	1 (1.6%)	0 (0%)	0.528
Renal function deterioration	4 (5.9%)	0 (0%)	0 (0%)	0.207
Stent Infections	0 (0%)	0 (0%)	0 (0%)	-
Access-related complications	1 (1.5%)	0 (0%)	1 (6.7%)	0.198
aortic-Related re-interventions	0 (0%)	3 (4.9%)	0 (0%)	0.103
Surgical wound infection	0 (0%)	0 (0%)	0 (0%)	-
Death (<30days) (n, %)	1 (1.5%)	0 (0%)	0 (0%)	1
Postoperative Hospital stays (days)	9.7±4.3	10.3±11.8	10.7±3.8	0.047
f-TEVAR vs b-TEVAR				0.067
f-TEVAR vs HT				0.031
b-TEVAR vs HT				0.294
ICU Duration (hours)	32.3±49.6	42.0±96.0	51.5±58.5	0.582
Surgery-Related costs (in RMB 10,000)	18.7±5.2	20.5±3.1a	12.1±6.8	<0.001
f-TEVAR vs b-TEVAR				0.084
f-TEVAR vs HT				0.004
b-TEVAR vs HT				0.001
Total Costs (in RMB 10,000)	23.0±6.0	26.1±7.4^a	18.1±6.7	0.011
f-TEVAR vs b-TEVAR				0.161
f-TEVAR vs HT				0.028
b-TEVAR vs HT				0.022

^aIn the b-TEVAR group, six patients received free stents (Fabulous®) due to their participation in the clinical trial, so we excluded these six cases from the cost-related statistics.

During the hospitalization period, one patient in the f-TEVAR group died from respiratory failure. The operation times in the f-TEVAR, b-TEVAR, and HT groups were 128.4 ± 24.2, 117.9 ± 61.7, and 260.3 ± 128.6 min, respectively (p < .001). The intraoperative blood loss (82.5 ± 57.3 vs 68.7 ± 43.9 vs 123.3 ± 70.4 mL) showed significant differences between the endovascular groups and HT groups (p < .05). In addition, one case in each of the f-TEVAR and HT groups developed pseudoaneurysms of the left brachial artery approximately 24 h postoperatively and subsequently underwent elective pseudoaneurysm excision and repair procedures.

There were no statistically significant differences in stent-related new entry tears, spinal cord ischemia, new-onset strokes, cardiovascular complications, renal function deterioration, and access-related complications among the three groups. None of the patients experienced symptoms, such as upper limb numbness, or stent infections during the perioperative period. Postoperative hospitalization duration (9.7 ± 4.3 vs 10.3 ± 11.8 vs 10.7 ± 3.8 days, p = .047) showed statistical significance, with pairwise comparisons revealing differences between the f-TEVAR and HT groups (p = .031). Surgical-related costs and total costs in f- and b-TEVAR groups were more expensive than in the HT group (p < .05). The duration of the intensive care unit (ICU) stays showed no statistically significant difference among the three groups (p > .05).

Mid-term follow-up results

The average follow-up time was 55.2 ± 27.4, 35.4 ± 18.3, and 42.2 ± 12.3 months in the f-TEVAR, b-TEVAR, and HT groups, respectively (p < .001). The median follow-up times were 64, 32, and 47 months, respectively. During the follow-up period, there were no significant differences in the loss-to-follow-up rates (4 [5.9%] vs 3 [4.9%] vs 0 [0%], p > .05). In total, 137 of 144 patients were successfully contacted.

The total mortality rates were 10.9%, 6.9%, and 0%, respectively (p = .359), and there were no statistically significant differences in the incidence of new deaths among the three groups (p = .647). The f-TEVAR group had six new deaths, including one case of abdominal aortic aneurysm-related death, one acute kidney failure-related death, two cardiac-related deaths, one death due to a malignant lung tumor, and one thrombocytopenia-related death due to retroperitoneal bleeding. The b-TEVAR group had four new deaths, including one liver cancer-related death, one acute myocardial infarction-related death, one retrograde dissection, and one death at home from unspecified causes.

The LSA patency was 100% in the f-TEVAR group and 98.3% in the b-TEVAR (p = .475). There were no statistically significant differences in the incidence of new endoleaks, stent-related new entry tears, spinal cord ischemia, new-onset strokes, cardiovascular complications, renal function deterioration, or aortic-related re-interventions among the three groups (all p > .05) (Table 3). None of the three groups experienced stent infections or access-related complications throughout the follow-up period.

Table 3.

Mid-term follow-up results.

	f-TEVAR (n = 64)	b-TEVAR (n = 58)	HT (n = 15)	p
Follow-up (months)	55.2±27.4	35.4±18.3	42.2±12.3	<0.001
f-TEVAR vs b-TEVAR				<0.001
f-TEVAR vs HT				0.042
b-TEVAR vs HT				0.475
Occurrence of new complications (n, %)
Type I or III endoleaks (n, %)	3 (4.7%)	2 (3.4%)	0 (0%)	1
LSA patency (n, %)	64 (100%)	57 (98.3%)	-	0.475
The brachial plexus injury (n, %)	0 (0%)	0 (0%)	4 (26.7%)	<0.001
f-TEVAR vs b-TEVAR				0.475
f-TEVAR vs HT				<0.001
b-TEVAR vs HT				<0.001
Stent-related new entry tears (n, %)	1 (1.6%)	6 (10.3%)	1 (6.7%)	0.172
Spinal Cord ischemia (n, %)	0 (0%)	0 (0%)	1 (6.7%)	0.109
Stroke (n, %)	1 (1.6%)	1 (1.7%)	1 (6.7%)	0.469
Cardiovascular complications (n, %)	2 (3.1%)	1 (1.7%)	0 (0%)	1
Renal function deterioration (n, %)	3 (4.7%)	1 (1.7%)	0 (0%)	0.763
Stent Infections (n, %)	0 (0%)	0 (0%)	0 (0%)	-
Access-related complications (n, %)	0 (0%)	0 (0%)	0 (0%)	-
Aortic-Related re-interventions (n, %)	2 (3.1%)	7 (12.1%)	1 (6.7%)	0.176
All-cause mortality (n, %)	7 (10.9%)	4 (6.9%)	0 (0%)	0.359

The overall cumulative survival rate at 2 years was 90.0%, 92.4%, and 100% in the three groups. There was no statistically significant difference between the three groups (p = .508) (Figure 2).

Figure 2.

Kaplan–Meier graph of the cumulative survival rates of different treatment methods during the follow-up.

Sub-analysis for the three groups of AD patients

In the sub-analysis of AD patients, the incidence of type I or III endoleaks were 28.9% (n = 13), 7.0% (n = 3), and 0%, respectively (p = .011). Stent-related entry tears were 2.2% (n = 1), 18.6% (n = 8), and 14.3% (n = 1), respectively (p = .032). There were no significant differences between the three groups in spinal cord ischemia, aortic-related re-interventions and all-cause mortality. (Table 4)

Table 4.

Sub-analysis for the three groups of AD patients.

	f-TEVAR (n = 45)	b-TEVAR (n = 43)	HT (n = 7)	p
Follow-up (months)	54.4±27.7	35.7±18.0	46.0±5.4	0.004
f-TEVAR vs b-TEVAR				<0.001
f-TEVAR vs HT				0.003
b-TEVAR vs HT				<0.001
Type I or III endoleaks (n, %)	13 (28.9%)	3 (7.0%)	0 (0%)	0.011
f-TEVAR vs b-TEVAR				0.012
f-TEVAR vs HT				0.171
b-TEVAR vs HT				1
Stent-related entry tears	1 (2.2%)	8 (18.6%)	1 (14.3%)	0.032
f-TEVAR vs b-TEVAR				0.014
f-TEVAR vs HT				0.253
b-TEVAR vs HT				1
Spinal cord ischemia	1 (2.2%)	0 (0%)	1 (14.3%)	0.143
Aortic-related re-interventions	2 (4.4%)	8 (18.6%)	1 (14.3%)	0.096
All-cause mortality (n, %)	5 (11.1%)	3 (7.0%)	0 (0%)	0.849

Aortic remodeling status in the near-to-mid-term

CTA measurements were collected from 70 of 101 patients with TAD preoperatively and 6–12 months postoperatively, including 39 f-TEVAR, 26 b-TEVAR, and five HT group cases. Measurements were taken in different planes, the areas of the true and false lumens were measured in different planes pre- and post-operatively, and the difference in the areas between the postoperative and corresponding preoperative measurements was calculated.

Table 5 shows that the true lumen area of the aortic arch and descending thoracic aorta in the stent segment was significantly larger postoperatively compared to that preoperatively (p < .05). Similarly, the false lumen area was significantly smaller postoperatively (p < .05). This indicates that the three surgical techniques achieved satisfactory aortic remodeling in thoracic aortic disease involving the LSA. However, as shown in Table 6, there were no statistically significant differences among the three groups regarding aortic remodeling (p > .05).

Table 5.

Comparison of true and false lumen areas before and after surgery in patients.

	True lumen			False lumen
	Preoperative	Postoperative	p	Preoperative	Postoperative	p
L1 (mm²)	503.1±186.9	780.5±202.0	<0.001	528.0±343.0	243.3±358.3	<0.001
L2 (mm²)	420.0±251.2	687.4±189.1	<0.001	631.4±272.5	302.5±341.3	<0.001
L3 (mm²)	281.8±118.9	480.6±147.1	<0.001	491.4±235.6	303.0±312.8	<0.001
L4 (mm²)	272.2±117.2	357.6±134.2	<0.001	394.5±206.3	357.7±398.5	0.004
L5 (mm²)	246.4±100.7	271±96.4	<0.001	272.4±182.1	292.8±233.1	0.588
L6 (mm²)	211.9±146.3	215.2±139.0	0.143	164.2±150.6	180.5±161.3	0.091

Table 6.

Comparison of the differences in true and false lumen areas after surgery compared to preoperative values among the three groups of patients.

	True lumen				False lumen
	f-TEVAR	b-TEVAR	HT	p	f-TEVAR	b-TEVAR	HT	p
L1 (mm²)	243.5±227.2	314.1±178.0	307.9±245.3	0.472	−299.7±180.4	−267.1±253.9	−282.6±265.4	0.948
L2 (mm²)	272.6±189.7	253.3±232.5	311.2±138.6	0.870	−330.4±330.8	−315.5±314.6	−396.7±267.3	0.466
L3 (mm²)	192.5±124.6	187.9±147.6	307.8±176.8	0.285	−155.2±292.1	−207.7±187.7	−315.9±195.5	0.312
L4 (mm²)	99.5±98.9	60.3±145.9	129.4±125.4	0.078	−6.5±456.3	−44.2±147.1	−211.3±312.1	0.385
L5 (mm²)	30.7±59.4	14.8±51.3	39.2±50.6	0.330	51.2±159.6	0.4±74.3	−38.9±56.4	0.250
L6 (mm²)	3.8±36.4	1.35±29.2	−4.6±57.0	0.253	21.0±61.2	15.8±52.6	−14.5±50.9	0.616

Discussion

Thoracic aortic lesions are very dangerous and can progress rapidly, posing a significant challenge to vascular surgery. Over the years, the techniques for treating thoracic aortic lesions have been continuously improved. TEVAR is a rapidly developing and constantly improving technology widely used to treat thoracic aortic lesions.¹¹

Initially, TEVAR was primarily used to treat diseases of the descending aorta because cumulative diseases of individual or multiple arterial branches were considered contraindications.¹² However, with technological advancements, updates in consumables, and changes in treatment concepts, the scope of TEVAR has expanded to include complex conditions involving the LSA and all aortic arch. branches.^13–15

Many studies have adopted the method of covering the LSA in aortic diseases involving Z2 to achieve stent stability and reduce the occurrence of complications such as endoleak or stent-related new entry tears. However, this affects the left upper limb as it increases the risk of paraplegia and loss of the compensatory ability of the left vertebral artery, increasing the incidence of long-term cerebral infarction.^16–18 Therefore, to overcome the traditional “forbidden zone” of TEVAR, various strategies have emerged to reconstruct aortic arch branches, including hybrid, chimney, fenestration, and branched stent–graft techniques.¹⁹ However, none of these techniques provide a perfect solution for reconstructing aortic arch branches. Surgeons should be familiar with the advantages and limitations of each technique and develop a reasonable surgical plan based on the specific anatomical characteristics of the patient’s condition, advantages of various auxiliary techniques, economic factors, and the surgeon’s experience.²⁰ Moreover, an assessment of the effectiveness and safety of TEVAR in treating aortic arch lesions requires several cases and a longer follow-up time.

In a meta-analysis, the success rate of intraluminal surgery was 94% (95% confidence interval [CI], 93%–96%), with an average surgical time of 349.4 min, an average hospital stay of 9.51 days, and an ICU duration of 48.2 h.²⁰ In another meta-analysis, the surgical success rates of fenestrated and branched stents were 96.8% (95% CI, 92%–99%) and 96% (95% CI, 92%–99%), respectively.²¹ At our center, the surgical success rates for the f-TEVAR, b-TEVAR, and HT groups were 83.8%, 95.1%, and 100%, respectively. In f-TEVAR group, there were six cases of type Ia endoleak and five of type III endoleaks, in which two cases experienced suboptimal device deployment owing to inaccurate positioning and were successfully treated using the chimney technique. Notably, both failed cases occurred early, and with increased proficiency, the mortality and major adverse events associated with intraluminal treatment significantly decreased, consistent with findings from other centers.^20,22 Three cases of stent-related new entry tears were seen in the b-TEVAR group, which were treated by stent remediation, and the patients recovered well after the procedure. The length of the postoperative hospital stays in the f-TEVAR, b-TEVAR, and HT groups was 9.7 ± 4.3, 10.3 ± 11.8, and 10.7 ± 3.8 days, respectively. There was no significant difference between intraluminal treatment and hybrid surgery, mainly because some patients receiving the former were observed because of continued hospitalization for CTA despite clinical readiness for discharge. Regarding surgery-related and total costs during the hospitalization period, endovascular, as expected, was significantly higher than hybrid surgery.

Endoleaks are relatively common and potentially serious complications specific to endovascular repair procedures. Research has shown that the incidence of postoperative endoleaks is approximately 14%; however, most cases resolve spontaneously without treatment. Endoleaks often originate from the false lumen or target vessels within the aneurysm and are more likely to occur after the procedure.⁹ In other studies, the occurrence rate of endoleaks in fenestrated stents ranged from 5% to 10%,^23–25 whereas in branched stents, the rates ranged from 0% to 7%.^26–30 A recent meta-analysis shows that the fenestrated TEVAR is more prone to endoleaks than the branch-stent TEVAR.³¹ Our center had a higher incidence of immediate endoleaks postoperatively, which may be attributed to different definitions. In our study, any type I or III endoleak identified on contrast imaging immediately after the procedure was defined as an immediate postoperative endoleak; another reason may be that we have calculated the early patients who were operated in our center, and there were some cases of inaccurate positioning or mismatch during the operation owing to the lack of experience. The incidence of immediate postoperative endoleak in the f-TEVAR group was significantly higher than that in the b-TEVAR group; however, a follow-up CTA performed at week 2 postoperatively revealed a significant improvement in the endoleak and a reduced aortic diameter.

During the follow-up, one patient in the b-TEVAR group complained of numbness and tingling in the left upper limb and LSA stenosis was identified on imaging. Six months later, the patient underwent stent placement in the LSA; patients in the f-TEVAR group were asymptomatic in the left upper limb. The LSA patency rates were 100% and 98.3% in the f-TEVAR and b-TEVAR groups, respectively (p < .05), indicating no significant difference in the LSA patency rate between the two methods. The brachial plexus injury rates were 0%, 0%, and 26.7% in each group, indicating that open surgery caused greater damage and patients were more prone to brachial plexus injuries.

Measurements showed that in the midterm, all three treatments significantly enlarged the true lumen of the stented segment of the aorta and reduced the false lumen, with no statistical difference observed between the three groups, indicating that the three procedures all had a good remodeling effect on the aortic arch. In the non-stented segment, only enlargement of the true lumen at L4 and L5, and enlargement of false lumen at L4, were observed; there were no statistical differences between the three groups.

Our experience has shown that hybrid surgery is a favorable treatment option if patients have a good overall condition and complex diseases involving the aortic arch. Hybrid surgery is also suitable for cases of aortic arch anomalies. Expanding the indications for endovascular therapy has provided effective treatment and reduced the economic burden on patients. Endovascular therapy is also a viable treatment option; however, it requires surgeons with extensive experience and precise preoperative assessment. Selecting an appropriate stent based on imaging examinations and the patient’s specific condition can improve the success rate of surgery and reduce the occurrence of adverse postoperative events.

Limitations

Endovascular procedures require a high requirement of proficiency on the part of the surgeon, and most of the important adverse events in our study occurred early, which may have had some impact on the results. The fact that some of the patients did not reside in our city and could not be assured of regular follow-up at our hospital, as well as our inability to obtain timely information on the impact of the patient’s postoperative follow-up, again has some impact on the results, but we have obtained imaging information for the majority of patients during the follow-up period whenever possible. Economic factors may also be an impact on the results, we may recommend participation in a clinical trial of branch stents for some patients who are not in a good financial situation, but we ensure that these patients receive the same treatment in the perioperative period, and that the different groups of patients are treated no differently.

Conclusion

Overall, the fenestration, branched stent–grafting, and hybrid techniques showed excellent efficacy in treating aortic arch diseases involving the LSA. However, the fenestration technique requires accurate preoperative measurements and precise intraoperative positioning. Furthermore, it is sophisticated with long learning curve and is prone to complications such as endoleak with inexperience. Branched grafts are at greater risk of stent-related entry tears, which result in a higher rate of re-intervention. The hybrid technique broadens the indications for patients with aortic arch vessel variation and generally costs less, but the operative time is longer. Therefore, surgeons should select the optimal solution based on each patient’s condition to achieve satisfactory results.

Footnotes

Acknowledgments

We are thankful for the useful discussion and comments from each member of Dai’s group.

Author contributions

The authors confirm contribution to the paper as follows: DXC, BJX, and LP contributed to the conception and design of the study. CDS, CJH, WJX, and ZB organized the database. CDS, LZA, and WSS performed the statistical analysis. CDS, LX, and GJY wrote the first draft of the manuscript. All authors contributed to the article and approved the submitted version.

Declaration of conflicting interests

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article. The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Funding

The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: National Natural Science Foundation of China; 82070489; National Natural Science Foundation of China; 82241207; Tianjin Medical University General Hospital Clinical Research Program; No. 22ZYYLCZD04.

ORCID iDs

Dongsheng Cui

Zhian Liang

Junhang Chen

Jiaxue Bi

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