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1 Dr. Mao and Dr. Luan contributed equally to this work and are co-first authors.
Le Mao
Footnotes
1 Dr. Mao and Dr. Luan contributed equally to this work and are co-first authors.
Affiliations
Department of Vascular Surgery, Zhongshan Hospital, Fudan University, Shanghai, ChinaInstitute of Vascular Surgery, Fudan University, Shanghai, ChinaNational Clinical Research Center for Interventional Medicine, Shanghai, ChinaShanghai Geriatric Medical Center, Shanghai, China
1 Dr. Mao and Dr. Luan contributed equally to this work and are co-first authors.
Jingyang Luan
Footnotes
1 Dr. Mao and Dr. Luan contributed equally to this work and are co-first authors.
Affiliations
Department of Vascular Surgery, Zhongshan Hospital, Fudan University, Shanghai, ChinaInstitute of Vascular Surgery, Fudan University, Shanghai, ChinaNational Clinical Research Center for Interventional Medicine, Shanghai, China
Department of Vascular Surgery, Zhongshan Hospital, Fudan University, Shanghai, ChinaInstitute of Vascular Surgery, Fudan University, Shanghai, ChinaNational Clinical Research Center for Interventional Medicine, Shanghai, China
Department of Vascular Surgery, Zhongshan Hospital, Fudan University, Shanghai, ChinaInstitute of Vascular Surgery, Fudan University, Shanghai, ChinaNational Clinical Research Center for Interventional Medicine, Shanghai, China
Department of Vascular Surgery, Zhongshan Hospital, Fudan University, Shanghai, ChinaInstitute of Vascular Surgery, Fudan University, Shanghai, ChinaNational Clinical Research Center for Interventional Medicine, Shanghai, China
Department of Vascular Surgery, Zhongshan Hospital, Fudan University, Shanghai, ChinaInstitute of Vascular Surgery, Fudan University, Shanghai, ChinaNational Clinical Research Center for Interventional Medicine, Shanghai, China
Corresponding authors at: Department of Vascular Surgery, Zhongshan Hospital, Institute of Vascular Surgery, National Clinical Research Center for Interventional Medicine, Shanghai Geriatric Medical Center, Fudan University, 180 Fenglin Road, Shanghai 200032, China.
Department of Vascular Surgery, Zhongshan Hospital, Fudan University, Shanghai, ChinaInstitute of Vascular Surgery, Fudan University, Shanghai, ChinaNational Clinical Research Center for Interventional Medicine, Shanghai, ChinaShanghai Geriatric Medical Center, Shanghai, China
Corresponding authors at: Department of Vascular Surgery, Zhongshan Hospital, Institute of Vascular Surgery, National Clinical Research Center for Interventional Medicine, Shanghai Geriatric Medical Center, Fudan University, 180 Fenglin Road, Shanghai 200032, China.
Department of Vascular Surgery, Zhongshan Hospital, Fudan University, Shanghai, ChinaInstitute of Vascular Surgery, Fudan University, Shanghai, ChinaNational Clinical Research Center for Interventional Medicine, Shanghai, ChinaShanghai Geriatric Medical Center, Shanghai, China
Both Valiant Captivia and CTAG can be safely performed for acute TBAD.
•
CTAG is suitable for type III arch with lower probability of type I endoleak.
•
dSINE rates were significantly lower with CTAG even with large oversizing.
Abstract
Background
To evaluate the safety and efficacy of the conformable thoracic aortic endograft (Conformable TAG Thoracic Endoprosthesis [CTAG]; W. L. Gore & Associates, Flagstaff, Ariz) and Valiant Captivia thoracic stent graft (Medtronic Inc., Santa Rosa, CA) for acute type B aortic dissection (TBAD).
Methods
The early and mid-term outcomes were analyzed for 413 patients undergoing TEVAR using conformable TAG thoracic endoprosthesis and Valiant Captivia thoracic stent graft for acute TBAD. 100 propensity-matched pairs of patients were generated, including 100 patients in the CTAG group and 200 patients in the Valiant Captivia group.
Results
Operative mortality were 2.33% (3 of 129) in the CTAG group and 1.76% (5 of 284) in the Valiant Captivia group. The median follow-up was 41.67 (26.00–60.67) months. No significant difference in mortality (9 [7.00%] vs. 36 [12.68%], P = 0.95) or re-intervention rate (3 [2.33%] vs. 20 [7.04%], P = 0.29) was observed between two groups. CTAG group have a lower incidence rate of distal stent graft-induced new entry tear than Valiant Captivia group (2.33% vs. 9.86%, P = 0.045). Lower incidence of type Ia endoleak was identified in the CTAG group (2.22%) than the Valiant Captivia group (14.41%) in patients with type III arch (P = 0.039).
Conclusions
Both Valiant Captivia thoracic stent graft and CTAG thoracic endoprosthesis can be safely performed for acute TBAD with low operative mortality, favorable mid-term survival and freedom from reintervention. CTAG thoracic endoprosthesis had fewer dSINE even with larger oversizing and potentially suitable for type III arch with fewer type Ia endoleaks.
Thoracic endovascular aortic repair (TEVAR) has been increasingly used in the treatment of type B aortic dissection (TBAD), including acute, chronic, complicated and uncomplicated TBAD [
]. Previous studies have shown that some types of stent-graft which do not conform to the anatomy of aortic arch may lead to the formation of a bird-beak configuration resulting in insufficient length of proximal landing zone (PLZ), and approximately 12.5% of patients with bird-beak configuration have type Ia endoleak [
As a conformable thoracic aortic graft, CTAG thoracic endoprosthesis has been shown to have favorable aortic arch anatomical adaptability with a low incidence (0–13.5%) of bird-beak configuration [
]. Regarding prognosis, however, large clinical evidence to support its favorable mid- and long-term clinical outcomes is still lacking. In this study, we compared the mid-term outcomes of CTAG thoracic endoprosthesis (WL Gore & Associates, Flagstaff, AZ) and the Valiant Captivia thoracic stent graft (Medtronic Inc., Santa Rosa, CA) used during TEVAR in patients with acute TBAD.
2. Methods
2.1 Study population
This study retrospectively enrolled patients with complicated and uncomplicated acute TBAD who were treated with TEVAR in Zhongshan Hospital of Fudan University from January 1, 2008 to December 1, 2018 (Fig. 1). Acute TBAD was defined as onset within 14 days before TEVAR, and all patients were treated during the acute phase [
Exclusion criteria: 1) patients with Marfan syndrome; 2) patients with Takayasu arteritis; 3) pregnancy; 4) allergic to contrast medium; 5) patients with severe tortuous access vessels or access vessels (femoral and iliac) diameter < 7 mm.
We performed a prespecified subgroup analysis of patients with type III arch.
The study was approved by the Institutional Review Board of our hospital.
2.2 Outcome
In this study, we compared 30-day and 5-year all-cause mortality, postoperative reintervention rates, and postoperative complication rates between two groups. The time origin for the above outcomes were the time of TEVAR. Postoperative complications reported in this study included endoleaks, TEVAR-related neurological complications (stroke and spinal cord injury), proximal stent graft-induced new entry tear (pSINE) and distal stent graft-induced new entry tear(dSINE).
Indications for postoperative reinterventions include severe Ia endoleak (resulted in false lumen enlargement), stent-graft infection, organ malperfusion, pSINE, dSINE, aortic rupture, and progression of aortic dissection. Postoperative re-interventions include open surgery, endovascular surgery, or hybrid surgery. The specific surgical procedures include secondary TEVAR, secondary balloon expansion, side-branch embolization, side-branch stenting, and supra-aortic revascularization.
The results were collected from: hospital chart, postoperative CTA examination in hospitalization, outpatient follow-up records, CTA examination during follow-up (performed in our center or at a local hospital and available through the hospital interconnect system), and contact the patient or immediate family by phone. If the patient is being followed up locally, we would contact the local physician for records. Data acquisition was from the hospital unit computer records system and manual enter data from obtained patient records.
2.3 Computed tomography imaging
The standard imaging follow-up timing for patients was 3 months, 6 months, 12 months, and yearly thereafter. We implemented 3Mensio Vascular software (3Mensio Medical Imaging 8.1 BV, Bilthoven, The Netherlands) to reconstruct the 3D geometry of the aorta and stent-graft, and to measure morphological parameters (see the Supplemental Fig. 1, Supplemental Fig. 2, Supplemental Fig. 3 for the detailed measurement methods). Specific measurement parameters include arch type, arch tortuosity, maximum aortic area, minimal true lumen area, maximum false lumen area, true lumen volume, false lumen volume, the length and aortic time of PLZ. All parameters were measured by an imaging specialist with 5 years of experience and a vascular surgeon with 7 years of experience.
Surgeons had no particular preference for using the two stent-graft, but the oversize ratios varied between the two groups. For Valiant Captivia, we applied oversize ratio of 10%. For CTAG, we used oversize ratios of 6%–33% according to instructions for use.
Fig. 2The in vitro appearance of CTAG thoracic endoprosthesis (WL Gore & Associates, Flagstaff, AZ) (A) and Valiant Captivia thoracic stent graft (Medtronic Inc., Santa Rosa, CA) (D); digital subtraction angiogram before TEVAR using CTAG thoracic endoprosthesis (B) and Valiant Captivia thoracic stent graft (E); digital subtraction angiogram after TEVAR using CTAG thoracic endoprosthesis (C) and Valiant Captivia thoracic stent graft (F). Completion angiography demonstrated that both stent-graft were sufficient to cover the primary entry tear thereby redirect flow into the true lumen inducing false lumen thrombosis.
All TEVAR procedures were performed in the hybrid operating room, and patients underwent TEVAR under general anesthesia. According to preoperative CTA, true lumen access was approached after an inguinal cutdown or percutaneous puncture preloaded with two ProGlides (Abbott Vascular, Abbott Park, Ill). The entire aortography was performed using 320 mg/mL contrast medium (Visipaque320; GE Healthcare, Madison, WI) through a 5F pigtail catheter. Intravascular ultrasound was used in TEVAR to determine the true and false lumens, the number of distal re-entry tear, and the number of involved side-branch. The diameter of the stent-graft was selected based on the preoperative CTA. If the length of PLZ is <20 mm, complete surgical debranching of the supra-aortic vessels, partial endovascular supra-aortic revascularization combined with surgical debranching, or total endovascular supra-aortic revascularization (parallel stents technique, fenestrated and branched stent technique) should be considered to achieve the purpose of extending the length of PLZ. Parallel stents techniques and fenestrated stent techniques are often used in the following situations: 1) emergent bailout techniques; 2) investigational IRB approved studies.
2.5 Statistical analysis
All statistical analyses were prespecified. Missing data were imputed using multiple imputation before statistical analysis. Twenty-three patients (7.3%) had no preoperative CTA at our center, and data on their preoperative CTA at other centers were not available in electronic format, so their preoperative aorta morphological parameters could not be measured.
Data are presented as mean + − standard deviation(SD), median(interquartile range), or count(%). Baseline information, morphological information, and procedure information between the two groups were matched by propensity score match (PSM). A propensity score was calculated for treatment (Valiant Captivia vs. CTAG) using multivariable logistic regression and adjustment for confounding factors (cerebrovascular disease, congestive heart failure, dialysis-dependent renal failure, and smoking history) and aortic characteristics (arch type, arch tortuosity, minimal true lumen area, true lumen volume and false lumen volume), complicated or uncomplicated TBAD, procedure information (PLZ, the revascularization of the supra-aortic vessels, the revascularization of side-branch).
The Valiant Captivia group and the CTAG roup were matched in a 2:1 ratio using nearest neighbors [
]. We set a caliper value of 0.2. The balance between two groups before and after matching was measured by standardized mean differences (SMD). When the SMD was >10%, it was considered unbalanced.
After obtaining matched datasets, we plotted mortality and reintervention kaplan-meier curves and performed log-rank tests. Cox regression was established to observe the differences in mortality and postoperative reintervention between two groups, while adjusting for proximal oversize ratio and aortic area of PLZ. The proportional hazards assumption was checked using schoenfeld residual test before cox regression and it was violated. We compared the difference in postoperative complications between two groups using the cumulative incidence function, mortality as a competing risk of complications [
A p < 0.05 was considered statistically significant. Statistical analysis of this study was performed using SPSS for Windows, version 21.0 (IBM Corporation, Armonk, NY) and R software, version 3.6.2(https://www.r-project.org/).
3. Results
3.1 Study cohort
This study enrolled 413 patients, including 129 in the CTAG group and 284 in the Valiant Captivia group. The PSM cohort included 100 patients in the CTAG group and 200 in the Valiant Captivia group. Baseline, procedure and morphological information were matched between the two groups, except for oversize ratios, aortic area of PLZ, and time interval from the onset of dissection to TEVAR (Table 1). Cox regression analysis showed that the time interval from the onset of dissection to TEVAR was not associated with the risk of death (HR 0.99, 0.93–1.07, P = 0.870), reintervention (HR 0.96, 0.87–1.07, P = 0.484), I endoleak (HR 0.99, 0.91–1.08, P = 0.837), dSINE (HR 1.01, 0.93–1.10, P = 0.809), RTAD (HR 0.99, 0.86–1.15, P = 0.919). In the CTAG group, there were 10 cases of complicated TBAD. Among them, 3 had aortic rupture, 5 had malperfusion including superior mesenteric (2), renal (1), and iliofemoral (3) arterial distributions. 1 had refractory hypertension, and 1 had persistent pain. In the Valiant Captivia group, there were 24 cases of complicated TBAD. Among them, 8 had aortic rupture, 12 had malperfusion including celiac (1), superior mesenteric (5), renal (3), and iliofemoral (5) arterial distributions. 3 had refractory hypertension, and 1 had persistent pain.
Table 1baseline, procedure and morphological information.
The whole cohort
After propensity matching
CTAG group (n = 129)
Valiant Captivia group (n = 284)
SMD
CTAG group (n = 100)
Valiant Captivia group (n = 200)
SMD
Age (years)
57(48–67)
57.5(49–66)
0.017
57(47.25–68.75)
57.5(49.25–66)
0.055
Sex, n
Male
111 (86.04)
244 (85.92)
0.004
83 (83.00)
171 (85.50)
0.069
Female
18(13.95)
40(14.08)
17(17.00)
29(14.50)
Comorbidities, n(%)
Hypertension
95 (73.64)
212(74.65)
0.023
74(74.00)
145(72.50)
0.034
Congestive heart failure
3(2.33)
17(5.99)
0.184
2(2.00)
3(1.50)
0.038
Cerebrovascular disease
1(0.78)
11(3.87)
0.207
1(1.00)
2(1.00)
<0.001
Diabetes mellitus
7(5.43)
18(6.34)
0.039
3(3.00)
9(4.50)
0.079
Dialysis-dependent renal failure
14(10.85)
41(14.44)
0.108
14(14.00)
28(14.00)
<0.001
Smoking history
31 (24.03)
27(9.51)
0.396
11(11.00)
25(12.50)
0.047
Aortic morphology
Arch type
1
2(1.55)
3(1.06)
0(0.00)
0(0.00)
2
82(63.57)
163(57.39)
0.090
64(64.00)
121(60.50)
0.072
3
45(34.88)
118(41.55)
36(36.00)
79(39.50)
Aortic arch tortuosity
1.71 (1.60–1.89)
1.70 (1.57–1.80)
0.173
1.68 (1.59–1.85)
1.69 (1.59–1.81)
0.088
Maximal aortic area
1183.11 (919.00–1444.50)
1110.60 (930.62–1330.00)
0.133
1195.35 (935.23–1439.88)
1152.00 (934.32–1347.33)
0.012
Minimal true lumen area
141.00 (82.25–206.00)
128.00 (78.89–203.72)
0.104
138.55 (87.11–202.47)
129.30 (80.13–145.36)
0.034
Maximal false lumen area
740.89 (526.35–940.00)
674.48 (509.25–901.37)
0.123
562.82 (732.43–948.78)
693.00 (550.5–908.8)
0.022
True lumen volume
103.35 (81.43–142.00)
111.35 (81.43–143.52)
0.090
105.98 (82.08–141.85)
109.4 (81.5–138.8)
0.035
False lumen volume
156.2 7 (116.37–201.77)
151.35 (104.87–195.21)
0.023
158.38 (127.85–201.02)
152.8 (123.92–193.97)
0.018
Operative details
PLZ, n(%)
0
2(1.55%)
3(1.06%)
0.398
1(1.00%)
2(1.00%)
<0.001
1
3(2.33%)
12(4.23%)
3(3.00%)
6(3.00%)
2
72(55.81%)
213(75.00%)
70(70.00%)
146(73.00%)
3
42(32.56%)
53(18.66%)
26(26.00%)
46(23.00%)
Supra-aortic vessels revascularization
6(4.65%)
16(5.63%)
0.045
4(4.00%)
9(4.50%)
0.025
Diameter of the stent-graft, mm
34 (31–37)
32 (32–36)
0.112
34 (31–37)
32 (32–36)
0.160
Oversizing of the proximal stent graft
13% (7%–20%)
11% (0%–12%)
0.612
12% (6%–19%)
6% (0%–14%)
0.387
The aortic diameter of the PLZ, mm
32(26–38)
34(27–38)
0.457
32 (26–38)
34 (26–38)
0.255
Time interval (onset to TEVAR), days
8(6–11)
9(7–12)
0.193
9(6–11)
10(7–12)
0.189
Procedure success, n(%)
129(100%)
284(100%)
<0.001
106(100%)
184(100%)
<0.001
Data are represented as median (interquartile range).
PLZ: proximal landing zone; SMD: Standardized mean differences.
The overall in-hospital mortality rate was 1.94% (n = 8), of which the mortality rate in the CTAG group was 2.33% (n = 3), and the mortality rate in the Valiant Captivia group was 1.76% (n = 5). Of the 3 deaths in the CTAG group, two patients with pleural effusion and partial atelectasis on admission. One of them succumbed to a sudden death (cause unknown) after discharge, another suffered aorto-bronchial fistula, resulting hemoptysis and asphyxia and eventually death. And the other patient underwent double fenestration in left common carotid artery and left subclavian artery to acquire a sufficient PLZ and died of severe stroke. Of the 5 deaths in the Valiant Captivia group, 2 patients with mesenteric ischemia and lower extremity ischemia suffered reperfusion injury after TEVAR with iliac artery revascularization, resulting in multiple organ dysfunction syndrome and eventually death. One patient had mesenteric ischemia and lower extremity ischemia underwent TEVAR with superior mesenteric artery revascularization. Although postoperative angiography showed the recovery of bowel blood perfusion, intestinal necrosis still occurred within 24 h after procedure, resulting in death. One patient underwent TEVAR with double fenestration in common carotid artery and left subclavian artery due to Ia endoleak 10 days after TEVAR and died of respiratory failure and hypernatremia at 18 days after re-intervention. Last patient with pleural effusion and partial atelectasis on admission succumbed to a sudden death (cause unknown) after discharge.
In addition, another patient in the Valiant Captivia group developed pSINE 4 days after TEVAR and underwent successful ascending aorta and arch replacement; his progress was uneventful during subsequent follow-up.
Within 30 days after TEVAR, 2 and 10 patients in the CTAG group and Valiant Captivia group, respectively, developed Ia endoleaks. All the patients with Ia endoleaks in CTAG group were asymptomatic during follow-up. Apart from the foregoing patient, Ia endoleak occurred in 1 patient in the Valiant Captivia group at 30 days after TEVAR. He suffered back pain and underwent a second TEVAR 3 years postoperatively; his progress was uneventful during subsequent follow-up. The remaining Ia endoleaks were stable or healed spontaneously during follow-up. 3 patients in the CTAG group had type II endoleaks, and they were asymptomatic during follow-up. Postoperative major stroke occurred in 3 patients in the CTAG group and the Valiant Captivia group, respectively. Apart from the foregoing patient, the remaining patients recovered gradually. Two patients in the Valiant Captivia group developed dSINE within 30 days after TEVAR. One patient refused any reintervention and died from rupture of the aorta 4 months postoperatively, and the other patient was treated medically because the FL was stable, and he was asymptomatic during follow-up. Two patients in the Valiant Captivia group developed pSINE within 30 days after TEVAR, apart from the foregoing patient, another patient refused any reintervention and died 40 days postoperatively. Paraplegia occurred in one patient each in the CTAG group and the Valiant Captivia group. After spinal drainage and rehabilitation training, both patients had their myodynamia reverted to grade 5, and they were asymptomatic during follow-up.
3.3 Mid-term outcome
The median follow-up was 41.67 (26.00–60.67) months. The completeness of follow-up at 1 year, 2 years, 3 years, and 5 years was 97.58%, 84.50%, 68.04, and 34.62%, respectively.
The number of all-cause deaths in the two groups were 9 and 36, respectively (Table 2), and the number of reinterventions in the two groups was 3 and 20, respectively (Table 3). No significant difference was found in the all-cause mortality (P = 0.95, Fig. 3) or reintervention (P = 0.29, Fig. 3) between the 2 groups. Cox regression analysis showed that CTAG was not associated with a lower risk of death (HR 0.93, 0.42–2.04, P = 0.855) or reintervention (HR 0.43, 0.09–1.93, P = 0.268) compared with Valiant Captivia.
Table 2detailed information about the cause of death.
Fig. 3Kaplan–Meier survival analysis estimates of 5-year cumulative freedom from all-cause death and aortic-related reintervention in the patients using Valiant™ Captivia Stent Graft or Conformable GORE® TAG® Thoracic Endoprosthesis. A, Freedom from all-cause death among the 2 groups. No significant difference in all-cause death was seen between 2 groups. (P = 0.95). B, Freedom from aortic-related reintervention among the 2 groups. No significant difference in aortic-related reintervention was seen between 2 groups. (P = 0.29).
The number of Ia endoleaks in the CTAG group and Valiant Captivia group were 5 and 25, respectively. In the CTAG group, cumulative incidence rates of Ia endoleaks at 30 days, 1 year, 2 years, 3 years, and 5 years were 2.00%, 5.00%, 5.00%, 5.00% and 5.00%. In the Valiant Captivia group, cumulative incidence rates for Ia endoleaks at 30 days, 1 year, 2 years, 3 years, and 5 years were 3.5%, 8.7%, 8.7%, 9.3%, and 9.3%. And delayed Ia endoleaks occurred in 2 patients. Gray's Test showed no statistical difference between the two groups (P = 0.218, Fig. 4).
Fig. 4The cumulative incidence of distal stent graft-induced new entry (dSINE) and Ia endoleaks with all-cause death as a competing risk in the in the Valiant Captivia group and CTAG group. A, the cumulative incidence of dSINE with all-cause death as a competing risk among the 2 groups were different (P = 0.045). B, the cumulative incidence of Ia endoleaks with all-cause death as a competing risk among the 2 groups were not different (P = 0.218).
The number of dSINE in the CTAG group and Valiant Captivia group were 3 and 28, respectively. In the CTAG group, cumulative incidence rates of dSINE at 30 days, 1 year, 2 years, 3 years, and 5 years were 0.0%, 2.0%, 3.0%, 3.0% and 3.0%. Delayed dSINE occurred in 1 patient, with oversize ratio of 3%. In the Valiant Captivia group, cumulative incidence rates of dSINE at 30 days, 1 year, 2 years, 3 years, and 5 years were 0.5%, 6.7%, 8.3%, 9.5%, and 11.0%. Delayed dSINE occurred in 10 patients, with oversize ratio range of 0.2%–15.9%. Gray's Test showed statistical difference between the two groups (P = 0.045, Fig. 4).
There was no significant difference in the incidence of II endoleak (6 vs. 3, P = 0.08), stent-related stroke (4 vs. 4, P = 0.06), paraplegia (1 vs. 1, P > 0.99), and pSINE (1 vs. 10, P = 0.58) between CTAG group and Valiant Captivia group.
The aortic remodeling process after TEVAR using both stent-graft was shown in Fig. 5.
Fig. 5Aortic remodeling process during follow-up in a 71-year-old man using Valiant Captivia thoracic stent graft (Medtronic Inc., Santa Rosa, CA) and a 65-year-old man using CTAG thoracic endoprosthesis (WL Gore & Associates, Flagstaff, AZ). Their progresses were uneventful during follow-up. For the patient in Valiant Captivia group, computed tomography angiography (CTA) demonstrated type B aortic dissection with a primary entry tear in the descending aorta and the presence of a false lumen involving the thoraco-abdominal aorta (from the left subclavian artery to the left renal artery). Three months after the TEVAR, the stent-graft expanded to its full diameter and the false lumen thrombosis was reabsorbed in the stent-graft segment (aortic remodeling occurred). There was still residual flow at the level of the celiac trunk. The false lumen of the dissected aorta was completely thrombosed at 1 year after TEVAR; the false lumen thrombosis was basically reabsorbed 2 years after TEVAR. For the patient in CTAG group, CTA demonstrated type B aortic dissection with a primary entry tear in the descending aorta and the presence of a false lumen involving the thoraco-abdominal aorta (from the left subclavian artery to the left external iliac artery). Three months after the TEVAR, residual flow was observed in false lumen at the level of the distal edge of stent-graft; the false lumen was completely patent at stent's distal aortic segments; the false lumen thrombosis was reabsorbed in the stent-graft segment. One year after the TEVAR, the stent-graft expanded; the false lumen was completely thrombosis from the proximal edge of stent-graft to celiac trunk and was patent at the level of the right renal artery. No remarkable alteration of the aortic modeling was found at 2 years postoperatively compared to 1 year after TEVAR.
In the CTAG and Captivia groups, 45 (34.88%) and 118 (41.55%) of patients, respectively, had a type III arch. There was no significant difference in all-cause mortality (3 vs. 15, P = 0.859) and reintervention rate (1 vs. 9, P = 0.834) between CTAG group and Valiant Captivia group. There were significant differences in the incidence of type Ia endoleak (1 vs. 17, P = 0.039), type II endoleak (3 vs. 0, P = 0.037), and postoperative stroke (1 vs. 0, P = 0.022) between the two groups. No significant difference was shown in the incidence of dSINE (1 vs. 9, P = 0.299), pSINE (1 vs. 5, P = 0.447) and paraplegia (0 vs. 0, P > 0.999) between the two groups.
3.5 The association between oversize and adverse events
The median oversize ratio of the CTAG group and Valiant Captivia group is 13%(7%–20%) and 11%(0%–12%), respectively. We found that the incidence of adverse events in both groups was not related to oversize (Table 4).
Table 4The association between oversize and adverse events (stratifying incidence of adverse events by quartiles of oversize ratio).
CTAG group (n = 129)
P
Valiant Captivia group (n = 284)
P
Oversize ratio
4.3%–6.8% (n = 33)
6.8%–12.7% (n = 32)
12.7%–19.6% (n = 32)
19.6%–30.7% (n = 32)
0%–0.3% (n = 71)
0.3%–11.2% (n = 71)
11.2%–11.9% (n = 71)
11.9%–13.6% (n = 71)
Death
3(9.1%)
2(6.3%)
2(6.3%)
2(6.3%)
>0.99
9(12.7%)
10(14.1%)
7(9.9%)
10(14.1%)
0.862
Reintervention
1(3.0%)
0(0.0%)
1(3.1%)
1(3.1%)
>0.99
6(8.5%)
4(5.6%)
4(5.6%)
7(9.9%)
0.769
I endoleak
3(9.1%)
1(3.1%)
0(0.0%)
1(3.1%)
0.398
10(14.1%)
4(5.6%)
7(9.9%)
5(7.0%)
0.360
II endoleak
4(12.1%)
0(0.0%)
2(6.3%)
0(0.0%)
0.055
1(1.4%)
0(0.0%)
1(1.4%)
1(1.4%)
>0.99
Stent-related stroke
2(6.1%)
0(0.0%)
1(3.1%)
1(3.1%)
0.902
1(1.4%)
1(1.4%)
1(1.4%)
1(1.4%)
>0.99
dSINE
1(3.0%)
0(0.0%)
1(3.1%)
1(3.1%)
>0.99
8(18.3%)
5(7.0%)
7(9.9%)
8(18.3%)
0.813
pSINE
0(0.0%)
0(0.0%)
0(0.0%)
1(3.1%)
0.744
3(4.2%)
2(4.2%)
2(4.2%)
3(4.2%)
>0.99
paraplegia
0(0.0%)
0(0.0%)
1(3.1%)
0(0.0%)
0.744
0(0.0%)
0(0.0%)
0(0.0%)
1(1.4%)
>0.99
pSINE: proximal stent graft-induced new entry tear; dSINE: distal stent graft-induced new entry tear. Data are presented as count(%).
This study reported the early and mid-term outcomes of acute TBAD patients with the implement of Valiant Captivia thoracic stent graft and CTAG thoracic endoprosthesis. 3 and 5 patients in the CTAG and Valiant Captivia group died within 30 days after TEVAR, respectively. During the 5-year follow-up period after TEVAR, the number of deaths in the two groups was 9 and 36, and the number of re-interventions in the two groups was 3 and 20, respectively. All-cause mortality and reintervention rate showed no significant difference, and there was a significant difference in the incidence of dSINE between the two groups. In the subgroup analysis of patients with type III arch, the incidence of type Ia endoleak, type II endoleak, and postoperative stroke were significantly different between the two groups.
Bavaria JE, et al. reported 5-year freedom from all-cause mortality and reintervention rates of 83% and 86% in a large population treated with the Valiant Captivia thoracic stent-graft for acute TBAD [
]. In our previous study, we have reported that the 1-year all-cause mortality and reintervention rates for acute TBAD patients with the implement of CTAG thoracic endoprosthesis were 0% and 3%, respectively [
]. In the present study, the 5-year all-cause mortality and reintervention rates were comparable to previously reported results, and there was no significant difference between the two groups. The results showed that both Valiant Captivia thoracic stent graft and CTAG thoracic endoprosthesis are suitable for the treatment of acute TBAD, and have favorable effects in terms of safety and durability.
Previous study reported that CTAG thoracic endoprosthesis can conform to the inner curvature of the aortic arch thereby reducing the incidence of bird-beak(0–13.5%) [
].Our results showed that Ia endoleak occurred in both groups after TEVAR, and there was no significant difference in the incidence of Ia endoleak between the two groups at 30 days, 1 year, 2 years, 3 years, and 5 years after TEVAR. However, in the subgroup analysis of patients with type III arch TBAD, there was a statistically significant difference in the incidence of Ia endoleak between the two groups (P = 0.039). The results indicated that for TBAD with unfavorable morphology and sharp arch anatomy, a more conformable stent-graft, such as CTAG, thereby reducing the incidence of bird-beak and Ia endoleak. Meanwhile, two patients in the Valiant Captivia group experienced delayed Ia endoleaks. It was reported that the progression of the bird beak configuration and aneurysmal degeneration of the seal zones contributed to delayed type 1a endoleak [
]. Further PLZ morphology studies are needed to explore the cause of the occurrence of delayed Ia endoleaks.
The incidence of dSINE in the CTAG group is lower than Valiant Captivia group in perioperative and midterm outcomes. The first and most widely accepted theory is that excessive oversizing ratio is a major contributor to the dSINE, causing excessive radial force [
]. In this study, neither Valiant Captivia thoracic stent graft nor CTAG thoracic endoprosthesis is tapered stent-graft, and we only included patients with acute TBAD. Interestingly, although we used larger oversizing for the CTAG group, the incidence of CTAG dSINE was lower than that of Valiant Captivia. The reason for this phenomenon is that the new design of the CTAG has undergone several modifications to improve its adaptable radial force with regard to acute aortic disease. The radial force of the CTAG thoracic endoprosthesis is directly proportional to the size of the CTAG in the same vessel lumen. Another advantage of this feature is that surgeons can choose a wide range of oversizing (6%–33%) as they are not concerned about dSINE related to excessive oversizing. This further increases the scope of suitability for CTAG. Meanwhile, delayed dSINE occurred in 1 and 10 patients in the CTAG and CAPTIVIA groups, respectively. In the present study, we found that the oversize of patients with delayed dSINE were not large, and there may be a correlation between distant dSINE and aortic morphology. Previous studies have reported that aortic remodeling mismatch could be significant factors with regard to late dSINE [
Factors predictive of distal stent graft-induced new entry after hybrid arch elephant trunk repair with stainless steel-based device in aortic dissection.
]. Therefore, factors associated with delayed dSINE need to be further investigated.
5. Limitation
PSM method was used to balance the baseline, procedure and morphological information of the two groups. However, oversize ratios, aortic area of PLZ, time interval from the onset of dissection to TEVAR failed to match between the two groups. As mentioned above, according to the instructions for use, we have applied different oversize ratios to the two groups. The diameter of the aorta in PLZ was different between the two groups, but both were adequate (i.e. <40 mm) for endograft deployment [
Thoracic endovascular aortic repair (TEVAR) for the treatment of aortic diseases: a position statement from the European Association for Cardio-Thoracic Surgery (EACTS) and the European Society of Cardiology (ESC), in collaboration with the European Asso.
]. The time interval from the onset of dissection to TEVAR differed slightly between the two groups, but both were in the acute phase and therefore did not differ clinically [
]. Cox regression analysis showed that the time interval from the onset of dissection to TEVAR was not associated with the incidence of adverse outcomes. This is most likely due to the fact that the majority of patients in this study had a time interval concentrated in the range of 6–12 days.
The following are the supplementary data related to this article.
Supplemental Fig. 1A.B. semiautomated vascular segmentation; C.D. semiautomated centre lumen line construction.
Supplemental Fig. 2A. demarcated areas were perpendicular to the center line. B. we adjusted the region of interest based on the automatic aortic segmentation, and demarcated the whole aorta (including true lumen and false lumen). C. The software will automatically measure and derive the aortic area of each plane according to the semi-automatically delineated aorta and calculate the longitudinal change curve of the aortic area. We selected the maximum aortic area based on this change curve. D. we adjusted the region of interest and demarcated the true lumen. E. We selected the minimal true lumen area based on the change curve of the true lumen. F. We measured the volumes of the true lumen and false lumen by a semi-automated volume algorithm separately.
Supplemental Fig. 3A.B. the length of the centerline between the proximal edge of the innominate artery the distal edge of the left subclavian artery; C. the linear distance between the proximal edge of the innominate artery the distal edge of the left subclavian artery.
This study was supported by the Shanghai Municipal Health Commission (No. 202140273), the National Natural Science Foundation of China (No. 51925603) and the National Natural Science Foundation of China (No. 82001636). We would like to thank the team of scientific editors in Elsevier for the English language editing and Mr Jiawei Chen for providing technical editing for this research.
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Randomized comparison of strategies for type B aortic dissection: the INvestigation of STEnt grafts in aortic dissection (INSTEAD) trial.
Factors predictive of distal stent graft-induced new entry after hybrid arch elephant trunk repair with stainless steel-based device in aortic dissection.
Thoracic endovascular aortic repair (TEVAR) for the treatment of aortic diseases: a position statement from the European Association for Cardio-Thoracic Surgery (EACTS) and the European Society of Cardiology (ESC), in collaboration with the European Asso.
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