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 22(12) × 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 72-year-old man was referred with an infrarenal abdominal aortic aneurysm. The patient also had a history of hypertension, diabetes, and dyslipidemia. Lab results showed anemia (Hb 10.9 mg/dL), elevated blood urea level (49.8 mg/dL), normal creatinine (1.23 mg/dL), and normal eGFR (62 ml/min/1.73 m²). CT-Scan Angiography (CTA) revealed abdominal aortic aneurysm with thrombus and irregular calcification from the infrarenal region below the bilateral renal arteries until aortic bifurcation around 121.4 mm in length and a maximum sac diameter of 71.2 mm, with thrombosed and dilated right common iliac artery with a diameter of 20.4 mm (Figure 3A). A T&K B-EVAR procedure was then scheduled.

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.

A standard T&K B-EVAR procedure was performed. After femoral artery access, a SEAL NOVUS Body Stent Graft was deployed, followed by limb extensions. Balloon dilation resolved stenosis in the left iliac artery. Final aortography confirmed good stent position with no endoleak, and renal arteries remained patent (Figure 3B-J). Total contrast used was 70 mL of Iopamiro 370, with a dose area product (DAP) of 201.02 Gy.cm². The total procedure time was 1 hour 10 minutes, and fluoroscopy time was 33 minutes 37 seconds.

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.

Aortography confirmed challenging anatomy, including a short neck, neck angulation, and a right common iliac aneurysm (Figure 4B-D). After deploying the main body, coils of 6 × 6.5 mm (2 coils), 5 × 5.5 mm (2 coils), and 4 × 3.7 (1 coil) were used to occlude the right internal iliac artery (Figure 4E-F). Ballooning was performed on both limbs; however, wire twisting in the contralateral limb required additional wiring through brachial access (Figure 4G-J). 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). Total contrast was 230 cc, fluoroscopy time 1 hour 23 minutes, and CT showed 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.

After femoral artery access, a SEAL NOVUS Body Stent Graft was deployed through contralateral access, followed by limb extensions through both ipsilateral and contralateral access (Figure 5D-I). Aortography confirmed good stent positioning with no endoleaks (Figure 5J). A total of 90 mL of Ultravist 370 contrast was used, with a dose area product (DAP) of 51.722 Gy.cm². The fluoroscopy time was 17 minutes and 9 seconds.

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.

A T&K B-EVAR procedure was performed with a sheathless approach due to the small right iliac artery. After deploying the SEAL NOVUS Body Stent Graft and limb extensions (Figure 6B-E), aortography revealed under-expansion near the left iliac artery, corrected by balloon inflation (Figure 6F-J). An additional stent was placed to ensure full coverage. Final aortography showed good stent positioning, no endoleak, and adequate flow in the left iliac artery (Figure 6K). Approximately 90 mL of Ultravist 370 contrast was used, with a DAP of 92.4 Gy.cm². Procedure time was 1 hour 32 minutes, and fluoroscopy time was 34 minutes 9 seconds.

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.

A T&K B-EVAR procedure was performed with access through the right and left femoral arteries. After deploying the SEAL NOVUS Body and limb Stent Grafts (Figure 7B-F), aortography revealed under-expansion, especially in the main body and right iliac artery area (Figure 7G-H). This was corrected with multiple balloon dilations at the proximal, main body, and iliac stents (Figure 7I-J). Final aortography showed good stent positioning, no endoleak, and improved flow in both iliac arteries (Figure 7K). A total of 180 mL of Metacosfar 320 contrast was used, with a DAP of 17.140 Gy.cm². Fluoroscopy time was 34 minutes 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.