O-101 - OUTCOMES OF THE COVERED ENDOVASCULAR RECONSTRUCTION OF THE AORTIC BIFURCATION (CERAB) TECHNIQUE USING BEGRAFT BALLOON-EXPANDABLE COVERED STENT - MULTICENTER OBSERVATIONAL STUDY

TOPIC:
New vascular techniques and devices
AUTHORS:
Kruszyna L. (Department of Vascular and Endovascular Surgery, Angiology and Phlebology, Poznan University of Medical Sciences ~ Poznań ~ Poland) , Strauss E. (Institute of Human Genetics, Polish Academy of Sciences, Poznan, Poland ~ Poznan ~ Poland) , Tomczak J. (Department of Vascular and Endovascular Surgery, Angiology and Phlebology, Poznan University of Medical Sciences ~ Poznań ~ Poland) , Slowinski P. (Department of Vascular Surgery and Angiology, Centre of Postgraduate Medical Education, Warsaw, Poland ~ Warsaw ~ Poland) , Madycki G. (Department of Vascular Surgery and Angiology, Centre of Postgraduate Medical Education, Warsaw, Poland ~ Warsaw ~ Poland) , Dzieciuchowicz L. (Department of Vascular Surgery, Institute of Medical Sciences, Collegium Medicum, University of Zielona Góra ~ Zielona Góra ~ Poland) , Krzeminski A. (Department of Vascular Surgery, Institute of Medical Sciences, Collegium Medicum, University of Zielona Góra ~ Zielona Góra ~ Poland) , Stanisic M. (Department of Vascular and Endovascular Surgery, Angiology and Phlebology, Poznan University of Medical Sciences ~ Poznań ~ Poland) , Kasprzak P. (Department of Surgery, Vascular and Endovascular Surgery, University Hospital, University of Regensburg, Germany ~ Regensburg ~ Germany) , Krasinski Z. (Department of Vascular and Endovascular Surgery, Angiology and Phlebology, Poznan University of Medical Sciences ~ Poznań ~ Poland)
Introduction:
Aortoiliac occlusive disease (AIOD) may cause arterial insufficiency leading to disabling intermittent claudication or even chronic limb-threatening ischemia (CLTI). According to the guidelines, aortoiliac TASC D lesions should be treated with a surgical bypass. The covered endovascular reconstruction of the aortic bifurcation (CERAB) technique offers an endovascular alternative for TASC C/D lesions involving the aortic bifurcation1. The studies about the primary use of polytetrafluoroethylene (PTFE) covered stents for the treatment of AIOD with CERAB provide low complication and mortality rates and excellent patency rates2-4. The purpose of this retrospective non-randomized multi-center observational study is to evaluate the outcomes of the CERAB technique for the treatment of extensive AIOD using the BeGraft balloon-expandable covered stent.
Methods:
This is a physician-initiated, multi-center, observational cohort study with a retrospective analysis of the collected data. Consecutive patients that underwent the CERAB procedure due to extensive AIOD in three high volume vascular centers between June 2017 and June 2021 were prospectively collected in a database and retrospectively analyzed. The clinical status of symptomatic patients was assessed and graded according to the Rutherford-Baker classification for chronic ischemia. The diagnosis of AIOD was confirmed by computed tomography (CT) scan and classified according to TASC-II classification. Lesions were treated with the CERAB technique by implantation of the BeGraft balloon-expandable covered stent (Bentley InnoMed, Hechingen, Germany) using transfemoral/brachial vascular access. Demographic data, medical history, clinical status, procedural data, perioperative complications, and follow-up information were collected and analyzed. Follow-up examinations were done at 1, 6, 12 months, and then annually with clinical assessment, ankle-brachial index (ABI), and duplex ultrasound. The primary efficacy endpoint was the patency at 12 months. Secondary endpoints included procedural-related complications (30-day morbidity and mortality), secondary patency, freedom from target lesion revascularization (TLR), and clinical improvement.
Results:
During the study period, a total of 120 consecutive patients (64 males and 56 females) with a median age of 65 years (range 34-84 years) that underwent elective CERAB procedures were included and retrospectively analyzed. For the last 12 months (during the COVID-19 pandemic crisis), we observed a significant increase in the number of patients treated with this technique. The indication for treatment was disabling intermittent claudication in 89 patients (74.2%) and CLTI in 31 patients (25.8%). Most patients had extensive AIOD, either severe stenosis or chronic total occlusions (40.0%). Preoperative CTA showed 32 (26.7%) cases of TASC II C and 81 (67.5%) cases of TASC II D lesions. The median duration of the procedure was 120 min (IQR 80-180 min), with a median fluoroscopy time of 23.0 min (IQR 15.2-45.6 min). All 454 BeGraft stents (137 aortic and 317 peripheral) were successfully delivered and deployed. An additional open surgical procedure (common femoral endarterectomy) was needed in 30 patients (25.0%). The overall procedural complication rate was 14 (11.7%), all of which were successfully resolved during the index procedure. The median hospital length of stay was five days (IQR 3-6 days). All patients improved clinically and the ABI increased significantly from 0.6 (range 0.2-0.8) preoperatively to 0.9 (range 0.4-1.0) at 1 month follow-up (p < 0.05). Clinical improvement with at least one Rutherford category occurred in 94% of initially symptomatic patients at a 1-month follow-up. The median follow-up was 19 months (range 6-56 months). The survival rate at the last follow-up was 96.7%. The primary patency rate, secondary patency rate, and freedom from TLR at 12 months were 94.5%, 97.3%, and 93.5%, respectively. The limb salvage for CLTI was 93.1%. There were no incidences of stent migration, twisting, or stent fracture over the follow-up.
Conclusion:
This is the largest study to examine the use of the BeGraft stents for the treatment of AIOD using the CERAB procedure. The procedure has a high technical success rate and low morbidity, even in relatively ill patients with TASC C/D lesions. Prospective randomized studies on the CERAB technique are definitely recommended.
References:
(1) Goverde PC, Grimme FA, Verbruggen PJ, et al. Covered endovascular reconstruction of aortic bifurcation (CERAB) technique: a new approach in treating extensive aortoiliac occlusive disease. J Cardiovasc Surg 2013;54:383-387. (2) Grimme FA, Goverde PC, Verbruggen PJ, Zeebregts CJ, Reijnen MM. Editor's Choice--First Results of the Covered Endovascular Reconstruction of the Aortic Bifurcation (CERAB) Technique for Aortoiliac Occlusive Disease. Eur J Vasc Endovasc Surg. 2015 Nov;50(5):638-47. (3) Taeymans K, Groot Jebbink E, Holewijn S, Martens JM, Versluis M, Goverde PCJM, Reijnen MMPJ. Three-year outcome of the covered endovascular reconstruction of the aortic bifurcation technique for aortoiliac occlusive disease. J Vasc Surg. 2018 May;67(5):1438-1447. (4) Saratzis A, Salem M, Sabbagh C, Abisi S, Huasen B, Egun A, Nash J, Lau PF, Chaudhuri A, Dey R, Patrone L, Malina M, Davies R, Zayed H. Treatment of Aortoiliac Occlusive Disease With the Covered Endovascular Reconstruction of the Aortic Bifurcation (CERAB) Technique: Results of a UK Multicenter Study. J Endovasc Ther. 2021 Oct;28(5):737-745.