A Revolutionary Device for Endovascular Aortic Repair of Abdominal Aortic Aneurysm: A Pilot Study

T&K B-EVAR procedure

The standard procedure requires two access sites from the bilateral common femoral arteries, which are achieved by surgical cutdown. Standard aortography was performed using a 5 Fr marker pigtail catheter through the contralateral femoral artery. The guidewires were placed in the ascending aorta. Both wires were replaced with an extra stiff wire. Subsequently, both contralateral and ipsilateral femoral artery sheaths are exchanged with larger sheath sizes ranging from 16 F to 18 F SEAL NOVUS Body Stent Graft™ (S&G Biotech, Yongin, Korea) deployment is performed through the more patent, more anatomically ideal access site. A balloon catheter is placed on the ipsilateral side. At the same time, the contralateral gate was cannulated using a 0.035 hydrophilic coated wire with the assistance of a multipurpose catheter, and another balloon catheter was placed. Both balloons were inflated simultaneously to ensure that they were in different lumens. If both balloons are successfully inflated, it can be inferred that both wires successfully cannulated the separate lumens. The contralateral and ipsilateral limb extensions were deployed using a SEAL NOVUS Limb stent graft™ (S&G Biotech, Yongin, Korea). The standard aortography evaluation procedure was performed to evaluate the graft stent position, apposition, endoleaks, and patency of the renal arteries. Many follow the same procedure in the six cases presented. However, certain cases have highlighted the applicability of T&K B-EVAR, even with challenging anatomical morphology.

Case 1

An 83-year-old man was admitted with sharp, pulsing abdominal pain 1 year prior to presentation. The patient also had a history of hypertension. Laboratory results showed normal hemoglobin counts (Hb 12.2 mg/dL) and mildly reduced eGFR (Ureum 35.6 mg/dL, Creatinine 1.33 mg/dL, and eGFR 53 ml/min/1.73 m²). A CT-Scan angiography (CTA) was performed. It revealed an AAA from the infrarenal region to the aortic bifurcation 79 mm in length and a maximum sac diameter of 58.2 mm, and dilatation of the right common iliac artery with a diameter of 21.1 mm (Figure 2A). A T&K B-EVAR procedure was then performed for the patient.

Figure 2. T&K B-EVAR on Patient 1.

(A) CT of the 1^st patient’s aortic pathology. (B) Diagnostic angiography. (C-H) T&K B-EVAR step-by-step with limb extension deployment using a ballerina technique. (I) Post-procedure follow-up CT.

Surgical cutdown was performed to gain access to the right and left femoral arteries. Initial aortography revealed an infrarenal fusiform abdominal aorta aneurysm (Figure 1B). A SEAL NOVUS Body Stent Graft 26(20) × 90 mm × 15 × 550 (S&G Biotech, Yongin, Korea) was deployed through the right femoral artery. Subsequent wiring was performed using a 0.035 hydrophilic coated wire, guided by an MP2/5F catheter. Deployment of the SEAL NOVUS Body Stent Graft 22¹⁰ × 120 mm 18 × 550 mm (S&G Biotech, Yongin, Korea) was performed through ipsilateral access (Figure 2C-G). Aortography showed the stent in a good position, a type 1 B endoleak, and stenosis in the intrastent abdominal aorta. Contralateral and ipsilateral limb extensions using the SEAL NOVUS Limb Stent Graft 12 (24) × 80 mm 15 × 550 mm (S&G Biotech, Yongin, Korea) were deployed (Figure 2H). When withdrawing the olive tip through ipsilateral femoral access, it was difficult to retract the apparatus. Hence, we continued to snare from the brachial access site, which allowed us to free the apparatus. Aortography revealed a minimal endoleak from the right iliac artery and intrastent stenosis at the abdominal aorta. Post-dilatation of the contralateral iliac stent was performed using a balloon catheter 10-46 mm inflated to 9 cc. Contralateral and ipsilateral intrastent post-dilatation were performed simultaneously using peripheral 10 × 60 mm and 10 × 60 mm balloons, respectively. Final angiography showed good stent position and no residual endoleaks or intrastent stenosis (Figure 2H). The total contrast was 130 mL hexiol, and the dose area product (DAP) was 205.48 Gy.cm². The total procedure time was 1 h and 50 min, and the fluoroscopy times were 41 min and 56 s, respectively.

The patient was discharged without any complaints after four days. Follow-up CTA performed 3 days and 2 months after the procedure showed a deployed stent in the infrarenal aorta until the left and right common iliac arteries without endoleaks (Figure 2I).

Case 2

A surgical cutdown was performed to gain access to the right and left femoral arteries, a puncture of both arteries was subsequently performed, and 8F sheaths were inserted. Wiring via left femoral artery access was performed using an exchange wire 0.035” 260 mm, placed in the abdominal aorta, and then exchanged with a marker 5F Pigtail catheter. Wiring through the contralateral access site using an extra stiff wire was performed and placed in the abdominal aorta. Initial aortography revealed an infrarenal fusiform AAA. The contralateral femoral access sheath was exchanged between 8F and 16F. SEAL NOVUS Body Stent Graft 32(26) × 90 mm 18 × 550 mm (S&G Biotech, Yongin, Korea) was deployed through contralateral femoral access (Figure 3B-C). Balloon dilation was performed using a peripheral balloon catheter (10 mm × 80 mm) through the right access, placed inside the right side of the proximal main body, and inflated to 4 atm. Simultaneous cannulation of the main body was performed using a 0.035 hydrophilic coated wire, guided by an MP2/5F catheter (Figure 3D-E). Once subsequent wiring of the ipsilateral and contralateral lumens was ensured, limb extensions were deployed using the SEAL NOVUS Limb Stent Graft 12 (24) × 100 mm 15 × 550 mm (S&G Biotech, Yongin, Korea) and SEAL NOVUS Limb Stent Graft 12 × 120 mm 15 × 550 mm (S&G Biotech, Yongin, Korea), respectively. Stenosis of the left iliac artery was found during angiography (Figure 3F), and balloon dilatation was performed to resolve this issue (Figure 3G-I). Evaluation aortography showed that the stent was in a good position, with no visible endoleak or patent renal arteries (Figure 3J). Iopamiro 370 contrast medium was used, totaling 70 mL, and the dose area product (DAP) was 201.02 Gy.cm². The total procedure time was 1 h and 10 min, and the fluoroscopy times were 33 min and 37 s, respectively.

Figure 3.T&K B-EVAR on Patient 2.

(A) Pre-procedure CT of the 2^nd patient’s aortic pathology. (B-E) Deployment of T&K B-EVAR. (F-J) Stenosis of the left iliac artery and subsequent ballooning with good results. (K) Post-procedure CT scan evaluation.

After five days, the patient was discharged without any complaints. Follow-up CTA within the same month showed good graft position and no endoleak (Figure 3K).

Case 3

A 67-year-old male was initially suspected of having an abdominal aortic aneurysm due to recurrent abdominal pain. Ultrasonography revealed an abdominal mass. The patient had a history of hypertension, diabetes, and dyslipidemia. Laboratory results showed normal hemoglobin (14.3 Â g/dL) and mildly reduced eGFR (Ureum 37.3 mg/dL, Creatinine 1.19 mg/dL, eGFR 67 ml/min/1.73 m²). CT-scan Angiography (CTA) revealed a challenging infrarenal AAA anatomy with a very short neck (9 mm), a maximum aneurysm diameter of 70.6 mm, and a length of 127 mm (Figure 4A).

Figure 4. T&K B-EVAR on Patient 3.

(A) Pre-procedure CT scan of the 3^rd patient’s aortic pathology. (B) Diagnostic angiography. (C-D) Standard deployment of T&K B-EVAR with angiography evaluation. (E-F) Coiling of right internal iliac artery and coronary angiography evaluation. (G-H) The deployment of limb extensions and evaluation showed slow flow through the graph stent. (I-J) Balloon dilatation intrastent. (K) Evaluation angiography without endoleaks. (L) Post-procedure CT scan evaluation.

The Standard T&K B-EVAR procedure was performed in this patient, and surgical cutdown was performed for access to the right and left femoral arteries. Aortography confirmed several challenging anatomical features on the CT scan: a very short neck, neck angulation, and right common iliac aneurysm extending to the right internal iliac artery (Figure 4B-D). After the main body was deployed, a JR 3.5/6F catheter was introduced via ipsilateral femoral access and crossed over into the right internal iliac artery. To occlude the vessel, several coils were used: 6 × 6.5 mm (2 coils), 5 × 5.5 mm (2 coils), and 4 × 3.7 (1 coil) (Figure 4E-F). Standard cannulation of both lumens was successful and both balloons were successfully inflated. However, the balloon in the contralateral limb could not be inflated maximally because of wire twisting. An additional bail-out strategy was performed using antegrade wiring and guidewire via contralateral brachial access. The peripheral balloon was inflated to 4 atm in the ipsilateral limb. At the same time, the wire was advanced into the contralateral limb and externalized towards the ipsilateral femoral artery access (Figure 4G-H). Simultaneous ballooning of both ipsilateral and contralateral limbs was successful, and twisting of the wire was not observed, as confirmed by the LAO, AP, and RAO views (Figure 4I-J). Finally, limb graft extension using SEAL Novus Flared™ 12 (14) × 100 mm, 15 × 550 mm (S&G Biotech, Yongin, Korea) was deployed from the abdominal aorta with the distal portion right above the left internal iliac artery. The final aortography evaluation showed a good stent position and minimal type 1 B endoleak. After additional ballooning, final aortography showed no endoleaks (Figure 4K). The total contrast used was 230 cc, DAP 95350.47 mikroGy.m², and fluoroscopy time was 1 h and 23 min. CT scan tomography revealed promising results, good graft stent position, and no endoleaks.

The patient was discharged without any complaints after five days. Follow-up CTA 3 months after the procedure showed an excellent stent position at the infrarenal aorta until the left and right common iliac arteries without endoleaks (Figure 4L).

Case 4

A 71-year-old man was admitted for EVAR due to a pulsing sensation in the stomach. The patient had a history of undergoing a CABG procedure approximately 11 years ago and had a history of hypertension. Laboratory results revealed a normal hemoglobin level (13.6 g/dL) and slightly decreased eGFR (Ureum 38.7 mg/dL, Creatinine 1.41 mg/dL, and eGFR 53 ml/min/1.73 m²). CT-Scan Angiography (CTA) was performed. It showed an AAA with thrombus from the infrarenal region after the bilateral renal arteries to the aortic bifurcation around 103.55 mm in length with a maximum sac diameter of 40.9 mm, and right common iliac artery aneurysm with thrombus, as well as intermittent subtotal thrombus with irregularity in the bilateral internal iliac artery (Figure 5A-C). The T&K B-EVAR procedure was performed.

Figure 5. T&K B-EVAR on Patient 4.

(A) Pre-procedural CT scan. (B) Axial CTA. (C) Sagittal CTA. (D-I) T&K B-EVAR step-by-step. (J) Post-procedure aortography with good stent apposition and no endoleaks. (K) Post-procedural CT scan evaluation had good results with no signs of endoleaks.

Surgical cutdown was performed to gain access to the right and left femoral arteries. Initial aortography revealed an infrarenal fusiform abdominal aortic aneurysm (Figure 5D-E). A SEAL NOVUS Body stent graft (24 × 90 mm 18 × 550 mm (S&G Biotech, Yongin, Korea) was deployed through contralateral femoral access (Figure 5F). After successful wiring, the SEAL NOVUS Limb Stent Graft 12 (16) × 80 mm 15 × 550 mm (S&G Biotech, Yongin, Korea) was deployed through contralateral femoral access. The SEAL NOVUS Limb Stent Graft 12 × 100 mm 15 × 550 mm (S&G Biotech, Yongin, Korea) was deployed through ipsilateral femoral access (Figure 5G-I). Aortography evaluation showed the stent in a good position and no endoleaks (Figure 5J). The total contrast was 90 mL Ultravist370, and the dose area product (DAP) was 51.722 Gy.cm². The fluoroscopy times were 17 min and 9 s, respectively.

After four days, the patient was discharged without any complaints. A follow-up CTA 1 month after the procedure revealed promising results: a well-expanded and apposed graft stent without an endoleak (Figure 5K).

Case 5

A 67-year-old man was admitted to our hospital with AAA and a history of hypertension and dyslipidemia. Laboratory results showed normal hemoglobin level (15.3 g/dL) and signs of renal insufficiency (Ureum 56.2 mg/dL, Creatinine 1.85 mg/dL, and eGFR 40 ml/min/1.73 m²). A CT-Scan angiography (CTA) revealed a challenging AAA morphology with a conical-shaped neck, thrombus throughout the whole aneurysm from the infrarenal region to the aortic bifurcation around 113.7 mm in length, a maximum sac diameter of 58 mm, a very short common iliac artery (15.4 mm), and a small access diameter (Figure 6A).

Figure 6. T&K B-EVAR on Patient 5.

(A) Pre-procedure CT scan. (B-C) Procedural diagnostic angiography. (D-E) Deployment of main body stent. (F) Angiographic evaluation revealing the expansion of graft stent. (G-H) deployment and ballooning of extensions. (I) Angiographic evaluation with reduced flow through the left extension limb. (J) Ballooning of limb extension. (K) After the angiography evaluation after additional limb extension deployment, the results showed good flow and no endoleak. (L) Post-procedure CTA was showing promising results.

Surgical cutdown was performed to gain access to the right and left femoral arteries. A double puncture was performed in the right and left femoral arteries. Initial aortography showed an infrarenal fusiform abdominal aortic aneurysm (Figure 6B-C). For this patient, a sheathless approach was used because of the relatively small size of the right iliac artery. A SEAL NOVUS Body Stent Graft 24 × 90 mm 18 × 550 mm (S&G Biotech, Yongin, Korea) was deployed, and subsequently, both limb extension grafts were deployed (Figure 6D-E). Aortography evaluation showed under-expansion of the contralateral limb extension, particularly near the left common iliac artery, suspected to be due to arterial stenosis (Figure 6F). Balloon inflation was performed using a 10 mm × 40 mm peripheral balloon catheter, inflated several times up to a maximum pressure of 6 atm, at the main graft stent up to the left common iliac artery (Figure 6G-J). Aortography revealed that the stent coverage was insufficient; hence, another 12 × 40 mm 8 × 900 mm (S&G Biotech, Yongin, Korea) was deployed through the left femoral artery. Final aortography revealed good stent position, no endoleak, and good flow in the left iliac artery (Figure 6K). Ultravist 370 contrast was used at approximately 90 mL, and the dose area product (DAP) was approximately 92.4 Gy.cm². The total procedure time was 1 h and 32 min, and the fluoroscopy times were 34 min and 9 s, respectively.

The patient was discharged without any complaints after six days. A follow-up CTA 4 months after the procedure revealed promising results, a well-expanded and apposed graft stent without any endoleak (Figure 6L).

Case 6

A 76-year-old man was admitted with a burning sensation in the chest and epigastric areas. He was suspected to have AAA and had a history of hypertension. Laboratory results showed a normal hemoglobin level (13.4 g/dL) and signs of chronic kidney disease (Ureum 26.1 mg/dL, Creatinine 1.83 mg/dL, and eGFR 38 ml/min/1.73 m²). CT-Scan Angiography (CTA) was then performed, and it showed an AAA from the infrarenal region to the aortic bifurcation around 114.4 mm in length and a maximum sac diameter of 45.1 mm, and dilatation of the right common iliac artery with a diameter of 21.1 mm (Figure 7A).

Figure 7. T&K B-EVAR on Patient 6.

(A) Pre-procedure CTA. (B) Angiography reveals an infrarenal fusiform aneurysm. (C-F) T&K B-EVAR step-by-step. (G-H) Underexpansion of graft stent. (I-J) Balloon dilatation of main body graft and limb extensions. (K) Evaluation angiography reveals good graft placement and no endoleak. (L) Post-procedure CTA shows good results.

Surgical cutdown was performed on the right and left femoral arteries. Initial aortography revealed an infrarenal fusiform abdominal aortic aneurysm (Figure 7B). A SEAL NOVUS Body Stent Graft 30 (24) × 90 mm 18 × 550 mm (S&G Biotech, Yongin, Korea) was deployed from the ipsilateral femoral access, and subsequently, a SEAL NOVUS limb Stent Graft 12 (20) × 100 mm 15 × 550 mm (S&G Biotech, Yongin, Korea) was deployed in the right common iliac artery. A SEAL NOVUS limb Stent Graft 12 (24) × 100 mm 15 × 550 mm (S&G Biotech, Yongin, Korea) was placed in the left common iliac artery. Aortography evaluation revealed under-expansion of the graft stent, particularly in the main body and areas covering the right common iliac artery (Figure 7C-H). Balloon dilation was performed using a 10 × 46 mm peripheral balloon inflated several times up to 10 cc in the right common iliac artery. The proximal and main body graft stents were expanded using a 10 × 80 mm peripheral balloon catheter and inflated up to 10 cc several times. Double-inflated balloon dilatation was performed using a 10 × 80 mm peripheral balloon catheter, inflated several times at the right and left common iliac arteries (Figure 7I-J). Evaluation aortography showed that the stent was in a good position, with no endoleak and better flow in the left and right iliac arteries (Figure 7K). The total contrast was 180 mL Metacosfar 320, and the dose area product (DAP) was 17.140 Gy.cm². The fluoroscopy times were 34 minutes and 38 seconds.

After six days, the patient was discharged without any complaints. Follow-up CTA approximately 2 weeks after the procedure revealed minimal contrast leakage at the 4th and 5th lumbar vertebrae and a penetrating atherosclerotic ulcer (PAU) in the aortic isthmus (Figure 7L).

Ethics and consent

Written informed consent was obtained from the patient for the publication of the case series and accompanying images. We have obtained ethical approval to conduct this study from the National Cardiovascular Center Harapan Kita Hospital.