Long-term outcomes of thoracic endovascular repair with quick fenestrater assisted in situ fenestration for type B aortic dissection

Abstract

Objectives

To report the long-term outcomes of patients with type B aortic dissection (TBAD) treated with thoracic endovascular aortic repair (TEVAR) and quick fenestrated (QF)-assisted in situ fenestration (ISF).

Methods

Between October 2017 and December 2018, 15 patients with TBAD requiring revascularization of the supra-aortic trunks underwent TEVAR with QF-assisted ISF at our institution.

Results

Thirteen of the 15 patients were male, and the mean age was 52.87 ± 11.26. The technical success rate was 100%. Thirty-day mortality rate was 0. The median follow-up period was 41 months (range, 35–49). During follow-up, one non-aortic-related death was recorded, no fenestration lost its alignment, and no stroke or stent graft migration was observed. Two patients underwent another successful endovascular repair. One case of type Ib endoleak occurred 19 months postoperatively. This was caused by aortic progression distal to the stent graft. Another stent graft with a larger diameter was implanted in the descending aorta. One case of type Ic endoleak was observed 35 months postoperatively. The patient was diagnosed during the annual follow-up without any symptoms. Another bridging stent graft was implanted into the left subclavian artery distal to the already existing one, and the type Ic endoleak was successfully treated.

Conclusions

TEVAR with QF-assisted ISF may be an effective treatment for ISF in type B aortic dissection.

Keywords

Aortic dissection thoracic endovascular aortic repair bridging stent in situ fenestration needle

Introduction

With the development of endovascular techniques and devices, zone 1/2 thoracic endovascular repair (TEVAR) is recommended for the treatment of aortic arch pathologies. Zone 1/2 TEVAR provides endovascular options for patients with insufficient landing zones, thereby reducing the rate of perioperative mortality and morbidity.^1,2 A major challenge of zone 1/2 TEVAR is revascularization of the supra-aortic trunks.

Different endovascular techniques have been used to revascularize supra-aortic trunks in different centers, including custom-made fenestrated or branched stent grafts, parallel grafts, physician-modified fenestrated stent grafts, and in situ fenestration (ISF).³ Custom-made fenestrated or branched stent grafts allow individualized treatment for each patient, which could realize the optimal stent graft design for even aberrant anatomical features. However, custom-made stent grafts usually take 2–3 months to design and manufacture and are associated with higher costs. These shortcomings prevent custom-made stent grafts from being used emergently.⁴ Parallel grafts are a viable option for emergent use; however, the major concern regarding parallel grafts is the high incidence of type I endoleak caused by the gutter, which is associated with a higher incidence of reintervention and poor outcome.⁵ Physician-modified fenestrated stent grafts can provide patients with individualized treatment and can be used in emergencies. This technique can be performed only in experienced centers because inaccurate alignment between fenestrations and supra-aortic arteries can lead to catastrophic results, such as a major stroke.⁶

In our center, ISF was used to revascularize the supra-aortic trunks. Various instruments, including needles, guidewires, lasers, and radiofrequency probes, have been used to create fenestrations. A new device (Quick Fenestrater (QF)) has been developed to improve the safety and effectiveness in creating fenestrations.⁷ In this study, we report the long-term outcomes of patients with type B aortic dissections (TBAD) treated using TEVAR with QF-assisted ISF.

Materials and methods

Patient population

Fifteen patients with TBAD requiring revascularization of the supra-aortic trunks were prospectively enrolled between October 2017 and December 2018. The inclusion criteria were (1) age >18 years; (2) at least one supra-aortic branch encroached by thoracic lesions; (3) landing zone that is not long enough for fixation of the aortic endograft; hence, coverage of the left subclavian artery (LSA) or left common carotid artery (LCCA) was performed; (4) aortic disease confirmed by at least one radiological examination (e.g. computed tomography angiography (CTA), magnetic resonance angiography (MRA)); (5) patent supra-aortic branch; and (6) type I/II aortic arch.

The exclusion criteria were (1) cardiopulmonary and renal insufficiency contraindicating general anesthesia (according to the anesthesiologist); (2) severe infection causing high fever or organ dysfunction; (3) allergy to contrast medium; (4) adverse cardiovascular or cerebrovascular events within 3 months prior to intervention; (5) occlusion or stenosis of the supra-aortic branch or severe twisting of the arteries to be fenestrated; (6) no appropriate peripheral access; (7) Stanford A aortic lesions; (8) type III aortic arch; and (9) Marfan’s syndrome. The clinical trial was approved by the ethics committee and review board of the Shanghai Changzheng Hospital (2017SL038). Each patient provided informed consent for participation in the clinical trial.

Preoperative design and device

Centerline luminal reconstruction was used to measure aortic diameter at the proximal and distal landing zones. The diameter of each supra-aortic trunk was measured using axial imaging. A minimum of 15 mm of healthy aorta for the proximal and distal landing zones was ensured for every patient. The oversized ratio was 10%. The proximal component of the pathology was determined by either an intramural hematoma or a dissected aorta, based on which of the two was more proximal. Details about the Quick Fenestrater (QF) have been previously described.⁷ In brief, the QF (Innomed Medical Device Co, Ltd, Suzhou, China) used a flexible fenestrating needle to create a fenestration after deployment of the aortic endograft during ISF.

Intervention procedure

TEVAR with retrograde ISF to reconstruct the supra-aortic trunks was performed in all patients. Patients routinely took aspirin 100 mg qd and atorvastatin 20 mg qd for 1 week, and underwent CTA to clarify the dominant vertebral artery before the intervention. The LSA must be reconstructed if the left vertebral artery is dominant. All patients were treated under general anesthesia. The right femoral artery was punctured using the Seldinger technique. Two arterial closure devices (Abbott Co, Chicago, USA) were pre-positioned and a 12-Fr short sheath (Terumo Co, Tokyo, Japan) was introduced from the femoral artery.

For LCCA fenestration, the LCCA was accessed percutaneously under ultrasound guidance and a 7-Fr short sheath (Terumo Co, Tokyo, Japan) was cannulated into the LCCA. For the LSA fenestration, a 7-Fr 90 mm sheath (Cook Co, Bloomington, USA) was cannulated into the left brachial artery. Through the preserved sheath in the right femoral artery, a pigtail catheter (Cook Co, Bloomington, USA) was retrogradely advanced into the ascending aorta, and an angiogram was performed to measure the diameter of the aorta and double-check the appropriate selection of the endograft. A Lunderquist super-stiff guidewire (Cook Co, Bloomington, USA) was advanced through the right femoral artery, and the pigtail catheter was withdrawn. The Lunderquist guidewire was bent into loops at the aortic valve to provide adequate support. Another pigtail catheter was transported to the ascending aorta via the sheath in the left brachial artery or the LCCA for intraoperative angiography. An aortic endograft (Medtronic Co, Minneapolis, MN, USA, n = 1; Lifetech Co, Shenzhen, China, n = 15) was advanced using a Lunderquist guidewire. After arriving at the aortic arch, the aortic endograft was deployed to completely exclude aortic lesions, and the relative supra-aortic branches were covered. The QF was introduced through the left brachial artery and into the ostium of the LSA or the LCCA and into the ostium of the LCCA. Fenestration was performed using the QF, and a 0.035 inch loach guidewire (Terumo Co, Tokyo, Japan) was inserted into the LCCA or LSA and into lumen of the aortic endograft. The QF was retracted, and a 3–4 mm high-pressure balloon (Boston Scientific Co, Natick, MA, USA) was used to dilate the fenestration. Bridging stents (Boston Scientific Co, Natick, USA; Gore Co, Newark, USA) with an appropriate diameter (same size or 1 mm larger than the diameter of the fenestration) were advanced into the fenestration, with 5 mm protruding into the lumen of the aortic endograft and the rest protruding into the target artery. The length of the bridging stent was strictly selected so as to not interfere with or cover the vertebral artery. Post-dilation was performed if necessary. A completion angiogram was performed to ascertain the patency of all supra-aortic trunk and complete exclusion of the lesions without type I and III endoleaks (Figure 1). Finally, the LCCA and femoral artery accesses were sutured with arterial closure devices (Abbott Co, Chicago, IL, USA), and the brachial artery accesses were mechanically compressed to achieve hemostasis.

Figure 1.

Quick Fenestrater (QF)-assisted in situ fenestration (ISF) of the left subclavian artery (LSA) during thoracic endovascular aortic repair (TEVAR). (a) The QF was used to puncture the fabrics after the implantation of the aortic endograft (26 − 34 × 200 mm, Lifetech, Shenzhen, China). (b) A 0.035 inch loach guidewire was inserted from the LSA into lumen of the aortic endograft through the fenestration made using the QF. (c) A bridging stent (8 × 37 mm, Boston Scientific Co, Natick, USA) was placed in the LSA. (d) Final angiogram demonstrating total exclusion of the dissection with successful reconstruction of the LSA.

Follow-up

Follow-up surveillance was performed with serial CTA in the first week at 3, 6, 12 months, and annually thereafter. Any death, complication, and reintervention occurring within 30 days and the index hospitalization were reported as 30-day outcomes. Any death, complication, and reintervention occurring after 30 days and the index hospitalization were reported as follow-up outcomes. Technical success was defined as successful puncturing, complete exclusion of the lesion, and fenestrations successfully created with QF, patent supra-aortic trunks, and no type I endoleak.

Statistics

Categorical data are reported as absolute numbers and percentages, continuous data are reported as mean ± standard deviations, and nonparametric data (e.g. follow-up time) are given as median and range. Statistical analysis was performed using IBM SPSS Statistics (version 22.0; IBM Corp., Armonk, NY).

Results

Baseline characteristics

From October 2017 to December 2018, 15 patients with TBAD requiring revascularization of the supra-aortic trunks underwent TEVAR with QF-assisted ISF in our center. The mean age was 52.87 ± 11.26 years, and 13 (86.7%) patients were male. In 12 cases, the distance (distal to the LSA) between the primary entry tear and the ostium of the LSA was less than 10 mm. In 1 case, the primary entry tear was in Ishimaru zone 3 (proximal to the LSA). In two cases, the LSA was involved in the lesions.

The details of the patients’ baseline characteristics are summarized in Table 1. The average lesion length was 24.99 ± 23.99 cm, and the average proximal landing zone was 20.93 ± 4.07 mm.

Table 1.

Baseline demographics and comorbidities.

Age, years	52.87 ± 11.26
Male sex	13 (86.67%)
Comorbidities
Hypertension	8 (53.33%)
Smoke history	7 (46.67%)
Arrhythmia	1 (6.67%)
Diabetes	3 (20.00%)
Previous endovascular repair	1 (6.67%)
Hyperlipemia	5 (33.33%)
Chronic obstructive pulmonary disease (COPD)	2 (13.33%)
Chronic kidney disease	1 (6.67%)
History of cancer	1 (6.67%)
Coronary heart disease	1 (6.67%)

Aortic configuration and stent graft configuration

Detailed information regarding QF-assisted ISF and aorta in each case is listed in Table 2. Based on the principles mentioned in the Materials and Methods section and our previous report, 17 sets of QFs were used. All the QFs functioned well, and all the fenestrations were successfully created the moment the operator triggered the switch. Twelve patients had a single fenestration for LSA, and one patient had a single fenestration for LCCA. In two cases, there were two fenestrations for LCCA and LSA. An average of 2.2 stent grafts were implanted. Fifteen fenestrated aortic endografts were implanted in the aortic arch. In two cases, a distal restrictive stent-graft was implanted because no tapered aortic endograft was available. Eighteen bridging stents (16 balloon-expandable bare stents and two covered stents) were implanted in 14 LSAs and three LCCAs. Even with variations in the anatomy of the LSA, such as different clock positions of supra-aortic trunks or origins at the aortic arch, tortuosity, and diameters of the LSA, the fabrics can be bifurcated smoothly.

Table 2.

Individual details.

Ient no.	Type of arch	Extent of dissection	Revascularization strategy	Size of aortic endograft (diameter/length) (mm)	Length of proximal landing zone	Distance between fenestrated branch vessels and adjacent branch vessels (mm)	Clock position of supra-aortic trunks (°)	Diameter of supra-aortic trunks (mm)	Size of bridging stent (diameter/length) (mm)	Time of puncturing/branch artery reconstruction
1	I	Z2–Z9	LSA	Ankura 32 * 200	15.2	LSA is 7.5 mm from LCCA	LSA: 35	27.7	LSA viabhan 7 * 50	3 s/230 s
1	I	Z2–Z9	LSA	Ankura 32 * 200	15.2	LSA is 7.5 mm from LCCA	LSA: 35	27.7	LSA express LD 7 * 19	3 s/230 s
2	I	Z2–Z9	LSA	Ankura 32 * 26 * 200	18	LSA is 3.6 mm from LCCA	LSA: 70	30.1	LSA express LD 8 * 37	3 s/230 s
3	I	Z2–Z9	LSA	Ankura 34 * 200	21	LSA is 6.5 mm from LCCA	LSA: 103	27.5	LSA express LD 10 * 37	4 s/245 s
4	II	Z2–Z4	LSA	Ankura 34 * 200	12	LSA is 3.8 mm from LCCA	LSA: 33	28.9	LSA express LD 10 * 37	6 s/252 s
4	II	Z2–Z4	LSA	Ankura 34 * 80	12	LSA is 3.8 mm from LCCA	LSA: 33	28.9	LSA express LD 10 * 37	6 s/252 s
5	I	Z1–Z4	LCCA+LSA	Ankura 36 * 28 * 200	18	LCCA is 8.1 mm from IA, 5.2 mm from LSA	LCCA: 56; LSA: 75	26.4	LCCA express LD 8 * 37	3 s/23 5s
5	I	Z1–Z4	LCCA+LSA	Wallsten 24 * 80	18	LCCA is 8.1 mm from IA, 5.2 mm from LSA	LCCA: 56; LSA: 75	26.4	LSA express LD 8 * 27	8 s/259 s
6	II	Z2–Z7	LSA	Ankura 34 * 26 * 200	20.8	LSA is 10.7 mm from LCCA	LSA: 97	27.6	LSA express LD 8 * 37	6 s/258 s
7	I	Z2–Z4	LSA	Ankura 36 * 200	23.4	LSA is 12.9 mm from LCCA	LSA: 68	27.7	LSA express LD 10 * 37	5 s/240 s
8	II	Z2–Z9	LSA	Ankura 40 * 200	19.3	LSA is 9 mm from LCCA	LSA: 55	31.1	LSA express LD 10 * 37	4 s/250 s
8	II	Z2–Z9	LSA	Wallsten 24 * 70	19.3	LSA is 9 mm from LCCA	LSA: 55	31.1	LSA express LD 10 * 37	4 s/250 s
9	I	Z2–Z10	LSA	Ankura 36 * 200	22.8	LSA is 3.5 mm from LCCA	LSA: 73	29.4	LSA express LD 10 * 38	6 s/261 s
9	I	Z2–Z10	LSA	Wallsten 24 * 71	22.8	LSA is 3.5 mm from LCCA	LSA: 73	29.4	LSA express LD 10 * 38	6 s/261 s
10	II	Z2–Z5	LSA	Ankura 32 * 200	21.4	LSA is 4.7 mm from LCCA	LSA: 55	26.9	LSA express LD 8 * 38	5 s/257 s
11	II	Z2–Z3	LSA	Ankura 34 * 200	20.7	LSA is 3.5 mm from LCCA	LSA: 60	28.7	LCCA express LD 8 * 37	4 s/244 s
12	I	Z2–Z4	LSA	Ankura 32 * 200	22.5	LCCA is 12.3 mm from IA, 41 mm from LSA	LSA: 56	27.3	LSA express LD 8 * 37	3 s/236 s
13	II	Z2–Z3	LSA	Ankura 32 * 28 * 200	23	LSA is 3.2 mm from LCCA	LSA: 60	25.6	LSA express LD 9 * 25	4 s/242 s
13	II	Z2–Z3	LSA	Medtronic 36 * 200	23	LSA is 3.2 mm from LCCA	LSA: 60	25.6	LSA express LD 9 * 25	4 s/242 s
14	II	Z2–Z5	LCCA + LSA	Ankura 32 * 24 * 200	28.7	LCCA is 10.4 mm from IA, 2.6 mm from LSA	LCCA: 31; LSA: 40	27.1	LCCA express SD 7 * 19	3 s/239 s
14	II	Z2–Z5	LCCA + LSA	Ankura 32 * 24 * 200	28.7	LCCA is 10.4 mm from IA, 2.6 mm from LSA	LCCA: 31; LSA: 40	27.1	LSA express LD 10 * 37	38 s/255 s
15	I	Z2–Z3	LSA	Ankura 38 * 200	27.2	LSA is 16.8 mm from LCCA	LSA: 94	30.4	LSA 10 * 50	5 s/255 s

Notes: Type I aortic arch: The origin of all three great vessels is located in the same horizontal plane as the outer curvature of the aortic arch; Type II aortic arch: Innominate artery originates between the horizontal planes of the outer and; the distance from the LSA to the LCCA refers to the distance from the proximal end of the LSA to the distal end of the LCCA; the distance from the LCCA to the INA refers to the distance from the proximal end of the LCCA to the distal end of the INA.

INA: Innominate artery; LCCA: Left common carotid artery; LSA: Left subclavian artery. PAU: Penetrating aortic ulcer.

The mean time for puncturing the aortic endograft and the whole fenestration process (from puncturing the endograft to full deployment of the bridging stents) was 6.47 ± 8.00 s and 246.35 ± 10.03 s, respectively.

Outcomes

The technical success rate of TEVAR with QF-assisted ISF is 100%. The average length of in-hospital stay was 11.40 ± 1.89 days. During the perioperative period, no adverse cerebrovascular or cardiovascular events, death, thrombosis in the brachial artery, acute aortic injury, or branch artery occlusion occurred. None of the patients underwent reintervention or conversion to open surgery (Figure 2). Three type III endoleaks (20.0%) occurred at the fenestration site, but resolved with no treatment within 3 days after the intervention. One patient (6.67%) had an access-related hematoma in the left brachial artery that resolved with conservative treatment before discharge.

Figure 2.

Preoperative and follow-up three-dimensional (3D) reconstruction of computed tomography angiography (CTA) images. (a) and (b), preoperative images showing aortic dissection involving aortic arch and descending aorta. (c) and (d), follow-up postoperative CTA images showing thoracic aortic lesions are excluded, and the supra-aortic arteries are patent with no endoleaks and no migration of the stents.

None of the patients were lost to follow-up. The completeness of follow-up was 100%. All patients underwent annual CT scans. Detailed outcomes are presented in Table 3. During the follow-up, one non-aorta-related death was recorded. Patient seven died 19 months after surgery. The patient had a history of colorectal cancer and developed an unexplained infection 17 months postoperatively, which then rapidly progressed to infectious shock, and the patient died during treatment. During a median follow-up of 41 (36–49) months, no adverse cardiovascular events, bridging stent occlusion, or stenosis occurred, thoracic aortic lesions were excluded, and all supra-aortic arteries were patent. No fenestrations lost alignment, and all patients were free from stroke. No migration of the endografts was observed. Representative perioperative and follow-up images are presented in.

Table 3.

Thirty-day and follow-up outcomes.

	N = 15 (%)
Thirty-day outcomes
Technical success		15 (100%)
In-hospital stay, days		11.40 ± 1.89
ICU-stay, days		0
Complications		—
Acute aortic injury		0
Type III endoleak		3 (20.00%)
Stroke		0
Thrombosis in the brachial artery		0
Access-related hematoma		1 (6.67%)
Cerebral infarction		0
TIA		0
AF		0
Myocardial infarction		0
Arrhythmia		0
Heart failure		0
Death		0
Follow-up outcomes		0
Median follow-up, months		41 (35–49)
Mortality		1 (6.67%)
Branch artery occlusion		0
Migration		0
Stroke		0
Reintervention		2 (13.33%)
Type Ib endoleak		1 (6.67%)
Type Ic endoleak		1 (6.67%)

Notes: Acute aortic injury mainly refers to the risk of aortic perforation or dissection caused by the needle during the fenestrating process. ICU: Intensive care unit; TIA: Transient ischemia attack; AF: Amaurosis fugax.

One case of type Ic endoleak occurred 35 months postoperatively. The patient was diagnosed during the annual follow-up without any symptoms. Another bridging stent graft was implanted into the LSA distal to the existing one. No endoleak was observed on the completion angiography. One case of type Ib endoleak occurred 19 months after the operation and was caused by aortic progression distal to the stent graft. Another stent graft with a larger diameter was implanted in the descending aorta, and the type Ib endoleak was successfully treated.

Discussion

This study reported the long-term outcomes of TEVAR with QF-assisted ISF to revascularize the supra-aortic trunks while treating TBAD involving the aortic arch. The 15 patients reported here include the 13 patients already reported in Bai et al.,⁷ with a mean follow-up of 22 months. It could be a useful tool not only in aneursymal and dissection disease but also aortic transection where the left SCA often needs to be covered, emergently, usually in a young patient.

The QF was developed to have an integrated design with a delivery sheath and puncturing system specialized for ISF. The advantages of QF were as follows: (1) QF is easy to manipulate and only requires a smooth and short learning curve; (2) on creating the fenestration, the needle is perpendicular to the polytetrafluoroethylene or Dacron membrane, allowing the most effective transmission of force, thus minimizing the possibility of unexpected vascular damage owing to tortuous arteries; (3) no evident particles were observed in the angiography performed after creation of the fenestration; and (4) no adverse cerebrovascular or cardiovascular complications occurred during the perioperative period and long-term follow-up.⁷

Cauteries, including laser and radiofrequency electrodes,^8,9 and mechanical forces, including needles, trimmed guidewires, and catheters^10–12; are the most widely used methods for the creation of fenestrations during ISF. Evans et al. reported the outcomes of laser ISF for supra-aortic trunk revascularization. The technical success rate was 100%; three patients had stroke, and two patients died during the perioperative period. During the mean follow-up of 261 days, seven patients (32%) required reintervention.¹³ Laser has been used in endovascular repair of retrograde type A aortic dissection in patients unfit for or declined to open surgery. The technical success rate was 100% and the primary fenestration success rate was 86.7%. One case of stroke occurred, and none of the patients died during the perioperative period. During a follow-up of 13 ± 5 months, two type Ia endoleaks were found, but no late occlusion and migration of the supra-aortic branch arteries stents occurred.¹⁴ A major concern about laser, despite its effectiveness and advantage in tortuous arteries, is its invisibility under DSA. In addition, similar to needles, lasers also require appropriate manipulation to puncture the endograft perpendicularly to create fenestrations.

The outcomes of mechanical options are promising. Luo et al.¹⁵ reported the outcomes of retrograde in situ needle fenestration for aortic arch pathologies. Technical success rate was 96% and no perioperative major adverse events occurred. Four type III endoleaks (8%) were observed. During a median follow-up of 15 months, one patient died of cerebral hemorrhage (probably a non-aortic-related death) and two patients required reintervention. In one case, the operator failed to create a fenestration owing to the tortuosity of the LSA. Mechanical methods require short and straight access arteries. In cases where the access artery is long and tortuous, maintaining the needle or guidewire perpendicular to the aortic endograft and coaxial with the branch artery remains challenging. With QF, we aimed to solve this problem as follows: (1) the positioned stent can be released by varying degrees to adjust to the diameter (<15 mm) of supra-aortic branches and maintained coaxial with branch vessels in most cases; (2) the QF can rapidly penetrate the PTFE or Dacron fabric in the first attempt, and the second fenestration can be achieved through the tip of the delivery sheath, which facilitates passage of the balloon; and (3) the QF only needs the delivery sheath to have a 6-Fr or 7-Fr outer diameter, which permits access following puncture.

Wang et al.¹⁶ have reported the application of a novel adjustable device for ISF in six patients. Similar to QF, the device has an integrated steerable sheath, needle with three puncture depths, and a balloon that can be inflated to stabilize penetration. The main difference between the reported equipment and QF is that the device requires an 8-Fr sheath, which necessitates incision of the access artery, whereas the 7-Fr outer diameter of the QF delivery sheath permits access through a puncture.

The long-term outcomes of QF-assisted ISF are promising. The technical success rate was 100%, and no acute aortic injury (e.g. aortic perforation or dissection) was noted on DSA; all the supra-aortic branches were patent. The rate of early complications requiring treatment was 6.67%, which is comparable with that reported in studies of other instrument-guided approaches to ISF.^10,17 In our study, no vascular-related complications or deaths occurred, and all supra-aortic branches were patent during follow-up. A local hematoma developed, but it was not ISF-related and resolved after conservative treatment. Three non-specific endoleaks resolved within 3 days after the intervention, without additional treatment. Therefore, the complication rate of QF appears to be acceptable.

In our cohort, the mean puncturing time was 6.47 s. However, in one case of LSA fenestration, 38 s was required to penetrate the membrane owing to the tortuosity of the LSA. The take-off angles of the LSA ranged from 33° to 103° according to the preoperative CTA and intraoperative multi-angle angiography, and the morphology of the positioned stent of the QF varied with the LSA anatomy. It was convenient to fenestrate at angles greater than 50°. At an angle of approximately 35°, the LSA can also be successfully fenestrated by adjusting the appliance. Stabilized by the positioning stent, the direction of penetration of the QF is parallel to the long axis of the supra-aortic arteries, thus preventing the needle from damaging the vessels. Therefore, the effectiveness of QF merits further studies with a tortuous LSA or a more acute take-off angle.

Balloon-expandable bare metal stents were implanted in the supra-aortic trunks as bridging stent grafts. According to our previous research,⁷ bare stents can be used for Stanford type B dissection. The position of bare metal stents can be fixed precisely with gradual deployment, and post-dilation is not required. With 5 mm protruding into the fenestrated aortic endografts and the rest in the branch arteries, the bridging stent grafts could serve as an anchor and prevent migration of the fenestration stent grafts in the long run. Meanwhile the protruding portion of bare metal stents in the aortic lumen may impose fewer effects on local hemodynamics; No stent graft migration occurred during follow-up, and all supra-aortic trunks were patent. In this study, most supra-arch branch arteries did not have severe dilation or dissection; therefore, the risk for endoleaks was low. However, we recommend the use of covered stents for arch aneurysms.

Our study has several limitations. First, the fenestration of the PTFE and Dacron endografts was not examined using an electron microscope to evaluate the effects of QF on the microstructure of the filaments during puncturing. Second, this was a single-center study with a small sample size and a short follow-up period. Third, the effectiveness and safety of QF were not evaluated in aortic endografts from other manufacturers, such as Gore and Microport.

Conclusion

The QF is a well-designed, easily maneuverable instrument specialized for ISF. QF-assisted ISF during TEVAR is safe and effective for endovascular treatment of TBAD involving the aortic arch, with favorable long-term follow-up results. Longer follow-up evaluations of QF-assisted ISF in larger populations and multiple centers should be conducted.

Footnotes

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.

Funding

The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This work was supported by the grant from National Natural Science Foundation of China (81870347).

Author note

All authors have contributed significantly to the content of the article.

ORCID iD

Lefeng Qu

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