Case Report AORTA, February 2017, Volume 5, Issue 1:21-26 Received: July 06, 2016 DOI: http://dx.doi.org/10.12945/j.aorta.2017.16.041 Accepted: October 28, 2016 Published online: February 2017 Occlusive Shrinkage of Ovation Endograft Presenting as Acute Lower Limb Ischemia Effective Endovascular Management Paolo Bianchi, MD1, Filippo Scalise, MD, FACC, FESC2, Andrea Mortara, MD3, Guido Lanzillo, MD, FECTS4, Giuseppe Scardina, MD3, Santi Trimarchi, MD, PhD5, Gianfranco Parati, MD, FESC6,7, Valerio Tolva, MD, PhD, FEBVS1,6* 1 Department of Vascular Surgery, Centro Cuore, Policlinico di Monza, Monza, Italy 2 Department of Interventional Cardiology, Centro Cuore, Policlinico di Monza, Monza, Italy 3 Department of Cardiology, Centro Cuore, Policlinico di Monza, Monza, Italy 4 Department of Cardiac Surgery, Centro Cuore, Policlinico di Monza, Monza, Italy 5 Department of Vascular Surgery, Policlinico San Donato IRCCS, San Donato Milanese, Italy 6 Department of Health Sciences, University of Milano-Bicocca, Milan, Italy 7 Istituto Auxologico Italiano IRCCS, San Luca Hospital, Milano, Italy Abstract shrinkage of proximal rings in the Ovation trivascular endograft. Angiographic and intravascular ultrasound The aim of this report is to describe the imaging and findings showed that covered stenting is effective and successful treatment of an acute shrinkage of the Ova- that the ring polymer is safely moldable. tion Abdominal Stent Graft System. The Ovation Prime Copyright © 2017 Science International Corp. system utilizes a polymer-filled sealing ring that is cast in situ at the margin of the aneurysm; however, the re- Key Words: sidual endograft inner volume after ring filling may re- duce volume and graft flow. Nevertheless, there are no Endovascular complication • EVAR • Aortic sealing reports about severe complications using the Ovation Prime system. A 75-year-old male presented to our hos- Introduction pital for acute lower limb ischemia. The patient reported a previous endograft for abdominal aortic aneurysm 1 Endovascular technology has significantly month previously, which utilized the Ovation device. changed the field of vascular surgery [1-3]. However, Computed tomography (CT) angiography demonstrat- approximately one-third of patients presenting with ed a critical narrowing of the endograft at the site of the abdominal aortic aneurysm (AAA) are deemed ineli- proximal sealing rings. We decided on urgent treatment, gible for standard endovascular aortic repair (EVAR) delivering a covered stent graft (CP STENT NUMED™). In- traoperative intravascular ultrasound showed effective because of anatomic constraints [1, 2], the majority compaction of the proximal rings. Nine-month follow-up of which involve inadequacy of the proximal aneu- with CT angiography demonstrated good patency with- rysmal neck. To cope with these challenges, different out ring recoil of the endograft. This is the first report of endovascular approaches have been developed that endovascular treatment for an acute and symptomatic either enhance stent graft fixation at the proximal © 2017 AORTA * Corresponding Author: Published by Science International Corp. Valerio Stefano Tolva, MD, PhD, FEBVS ISSN 2325-4637 Vascular Surgery Department Fax +1 203 785 3552 Centro Cuore E-Mail: [email protected] Accessible online at: Policlinico di Monza Via Amati 111, 20900, Monza, Italy http://aorta.scienceinternational.org http://aorta.scienceinternational.org Tel.: +1 39 039 281 0233; Fax: +1 39 039 281 0470; E-Mail: [email protected] Case Report 22 neck or extend the proximal landing zone to allow 14-F mounted covered stent with high radial force adequate apposition to the aortic wall and thus an- characteristics (CP Stent, NuMED Inc., Hopkinton, eurysm exclusion. Patients with aortic necks <10 mm NY, USA) with a total covered length of 45 mm. The have a 4-fold greater risk of proximal endoleak in the aortic neck measured 20 mm, and the Ovation stent first 30 days after operation compared with those graft was 29 mm (Figure 1B ). We observed circum- with necks >15 mm [1, 2]. Of the available endografts, ferential calcifications surrounding the proximal the Ovation Abdominal Stent Graft System (TriVascu- aortic neck. Under general anesthesia, a 4-F intro- lar Inc., Santa Rosa, CA, USA) is designed to overcome ducer was inserted through the left brachial artery, the limitations of currently available stent grafts. The and an angiogram performed. Intraoperative anti- Ovation graft is suitable for a broad range of aortoil- coagulation was achieved using 100 units/kg hep- iac characteristics and provides effective sealing for arin, with activating clotting time maintained for complex proximal infrarenal aortic neck morphology more than 250 s. The right femoral artery (which was [4, 5]. However, some authors have observed asymp- previously used for EVAR) was surgically exposed. tomatic inflow stenosis at the O-rings of the Ova- An artery pouch was prepared with a 5/0 polypro- tion stent graft [6, 7]. Here, we describe the imaging pylene stitch to close the arteriotomy at the end of and treatment of an acute complication in a patient the procedure. We recorded a clinically significant treated for AAA with an Ovation stent graft, leading cycle-averaged pressure drop along the inflow ste- to acute limb ischemia. nosis and further in the endograft main body (45.5 ± 15 mmHg). Mean arterial pressure dropped from 110 to 45 mmHg when measured above and below Case Presentation the stenosis. A Visions PV .035 Digital Intravascular A 75-year-old man presented to our hospital for Ultrasound (IVUS) Catheter was placed to calcu- acute lower limb ischemia. The patient was referred late the residual lumen and area close to the ring 2 to our hospital with leg pain at rest as well as foot (39.3 ± 3.5 mm ) and to visualize the echogenicity numbness and hypoesthesia. One month previous- of the polymer compared with the aortic thrombus ly, he was treated in another hospital for a rapidly (Figure 2). The median area above and below the ste- enlarging AAA (from 40 to 48 mm in 6 months) us- nosis was 409 mm2. CP stent deployment was per- ing an Ovation Abdominal Stent Graft System. His formed in a two-stage sequence. Final delivery was comorbidities were mild chronic obstructive pulmo- obtained with high-pressure second stage balloon- nary disease, obesity (body mass index, 29.3), and ing (10 ATM) followed by further post-dilation with a hypertension. His symptoms occurred a few hours Z-MED II™ Balloon (NuMED Inc., Hopkinton, NY, USA) before he arrived at our emergency room. He com- ( Figure 3A). Post-implantation IVUS showed good 2 plained of severe ankle and calf pain at rest that in- results in terms of restored area (439 ± 22 mm ) creased over a 2-hour time span. His femoral arteries and reduced ring polymer volume (Figure 3B). The were pulseless, and distal bilateral acrocyanosis was pressure gradient along the endograft neck was present. Blood samples showed increased creatine eliminated. The patient recovered from limb isch- phosphokinase (4500 U/L). Critical post-stenotic emia and was discharged 5 days after the operation flowmetric findings were evident upon ultrasound with good bilateral femoral pulses. Nine months scanning of the femoral arteries. Ankle-brachial later (Figure 3C and 3D), CT angiography showed pressure index was 0.22 bilaterally. Urgent comput- good patency of the endograft with no neck recoil. ed tomography (CT) angiography was performed, Outpatient ultrasound evaluation showed normal which showed severe narrowing of the proximal flowmetric patterns. aortic neck where the endograft rings sealed the AAA (Figure 1A). Discussion Based on these clinical and imaging findings, we decided to perform urgent revasculariza- The management of juxtarenal aortic aneurysms tion. We used an endovascular approach with a with EVAR remains controversial due to the high risks in- AORTA, February 2017 Volume 5, Issue 1:21-26 23 Case Report Figure 1. Panel A. Computed tomography angiography showing narrowing of the proximal neck (1 - Bare metal stent of the endog- raft. 2 - Rings filled with polymer). Panel B. Endograft dimensions. volved. Therefore, several endovascular techniques have ogies have expanded the applicability of endovascular been proposed to ensure a secure proximal landing aneurysm treatment to cases with anatomically adverse zone [1-3]. The morphology of the aneurysm neck is conditions. However, as the indications for mini-invasive especially important in this process [1, 3]. New technol- techniques have expanded, complications and techni- Bianchi, P. et al. Acute Shrinkage of Ovation Endograft Case Report 24 Figure 2. Intravascular ultrasound scanning of the proximal neck. Panel A1. True lumen of the upper part of the endograft just above the ring. Panel B1. Superior ring filled with polymer. Panel B2: Endograft residual lumen. Panel C1 Inferior ring filled with polymer almost occluding the lumen, and the 6-F intravascular ultrasound occupying the residual lumen. Panel D1. True lumen of the lower part of the neck below the inferior ring. The aneurysmal thrombus showed similar echogenicity as the polymer. cal failure rates have also increased [4, 5, 8]. range of aorto-iliac anatomy with a proximal aortic neck In our case, we observed a complication originating seal mechanism designed to conform to and accom- from the technical core of the endograft. The Ovation modate the aortic neck [4, 5]. The aortic body contains stent graft was conceived to accommodate a broader a network of inflatable channels that fill dedicated rings AORTA, February 2017 Volume 5, Issue 1:21-26 25 Case Report Figure 3. Final result and 9-month computed tomography angiography. Panel A. Angiography results after high-pressure ballooning (10-15 ATM). Panel B. Intravascular ultrasound showing the (Panel A) inner endograft lumen and (Panel B) proximal ring. Panel C and Panel D. Nine-month follow-up showing good patency and sealing of the device. during deployment with a low-viscosity, radiopaque fill expands externally even though a residual volume polymer that remains in situ to create an effective seal to occupies the endograft lumen [6, 7].