scholarly journals Clinical Experience With a Shape Memory Polymer Peripheral Vascular Embolisation Plug: A Case Series

Author(s):  
Robert A. Morgan ◽  
Ian Loftus ◽  
Lakshmi Ratnam ◽  
Raj Das ◽  
Leto Mailli ◽  
...  

Abstract Background: Shape memory polymers are materials that are manufactured in a certain shape, can be stored in a temporary deformed shape, and then return to – or remember – their original shape upon exposure to external stimuli such as temperature and moisture. This property lends itself to application in endovascular medical devices. Peripheral vasculature embolisation devices incorporating this novel technology have become commercially available and this case series, where the data were collected as part of a post market registry, outlines initial clinical experience with these novel devices.Results: Eight cases are described in this series. The disease state/conditions for which embolisation was indicated were right common iliac artery aneurysms (n = 3), a type II endoleak into the thoracic aorta following thoracic endovascular aneurysm repair (n = 1), a left inferior gluteal artery aneurysm (n = 1), left internal iliac artery aneurysms (n = 2), and a case of splenomegaly, where splenectomy was planned after the embolisation procedure (n = 1). Target arteries were 5-10 mm in diameter. In each case, at least one IMPEDE Embolization Plug of an appropriate diameter was used. All procedures were technically successful and target vessel thrombosis was achieved in all cases. Follow-up imaging available during the 45-90-day data collection timeframe showed sustained vessel occlusion. This case series includes examples of situations commonly encountered when embolising the peripheral vasculature, namely, the use of one or multiple devices in a single vessel and in combination with the use of other embolic devices (e.g., microcoils, gelatin sponge, and PVA particles) in the same case. There were no adverse events related to the specific use of the device.Conclusions: This small series illustrates the safety and efficacy of this novel sponge-based embolic device for the embolisation of small and medium sized arteries and further experience will demonstrate the utility of the shape memory polymer devices.

2021 ◽  
Vol 4 (1) ◽  
Author(s):  
Robert A. Morgan ◽  
Ian Loftus ◽  
Lakshmi Ratnam ◽  
Raj Das ◽  
Leto Mailli ◽  
...  

Abstract Background Shape memory polymers are materials that are manufactured in a certain shape, can be stored in a temporary deformed shape, and then return to – or remember – their original shape upon exposure to external stimuli such as temperature and moisture. This property lends itself to application in endovascular medical devices. Peripheral vasculature embolisation devices incorporating this novel technology have become commercially available and this case series, where the data were collected as part of a post market registry, outlines initial clinical experience with these novel devices. Results Eight cases are described in this series. The disease state/conditions for which embolisation was indicated were right common iliac artery aneurysms (n = 3), a type II endoleak into the thoracic aorta following thoracic endovascular aneurysm repair (n = 1), a left inferior gluteal artery aneurysm (n = 1), left internal iliac artery aneurysms (n = 2), and a case of splenomegaly, where splenectomy was planned after the embolisation procedure (n = 1). Target arteries were 5–10 mm in diameter. In each case, at least one IMPEDE Embolization Plug (IMP-Device) of an appropriate diameter was used. All procedures were technically successful and target vessel thrombosis was achieved in all cases. Follow-up imaging available during the 45–90-day data collection timeframe showed sustained vessel occlusion. This case series includes examples of situations commonly encountered when embolising the peripheral vasculature, namely, the use of one or multiple devices in a single vessel and in combination with the use of other embolic devices (e.g., microcoils, gelatin sponge, and PVA particles) in the same case. There were no adverse events related to the specific use of the device. Conclusions This small series illustrates the safety and efficacy of this novel sponge-based embolic device for the embolisation of small and medium sized arteries and further experience will demonstrate the utility of the shape memory polymer devices.


2019 ◽  
Vol 43 (1) ◽  
pp. 18-24
Author(s):  
Joshua D. Lee ◽  
Courtney Webb ◽  
Mark W. Fugate

Abdominal aortic disease affects more than 3 million people per year. For vascular sonographers, imaging aortic disease can become routine. Therefore, it is necessary to expand the knowledge that we have of aortic disease, diagnosis, and treatment. We present 4 cases with new or worsening conditions diagnosed by duplex ultrasound (DUS). Our first case is a 79-year-old woman returning for surveillance of an endovascular aneurysm repair (EVAR). The DUS findings reveal an increasing abdominal aortic aneurysm (AAA) sac, with evidence of flow originating from an incomplete seal at the attachment suggesting type I endoleak. Next, is a 56-year-old man returning 1 month after type A dissection repair, now presenting with unilateral claudication. The DUS findings of the left lower extremity demonstrated an early systolic deceleration waveform, suggesting more proximal disease. Upon further imaging, an abdominal aortic dissection was identified terminating into the left internal iliac artery, causing the true lumen to be compressed. The third case was a 75-year-old man returning for follow-up of an EVAR and iliac repair. The DUS findings show an increase in iliac artery sac size and anechoic area that was filled with color Doppler flow. These findings are suggestive of type I endoleak involving the distal attachment. The last case is a 56-year-old man returning for EVAR and iliac artery repair surveillance. The common iliac artery aneurysm sac had increased in diameter and length. The distal attachment of the left iliac extension cuff terminated within the aneurysm sac, causing a type I endoleak. Accurate DUS diagnosis of aortic disease is crucial for patient care. Meticulous analysis of the vessels and surrounding structures can make a difference in diagnostic outcomes. Vascular sonographers should continually review and revise vascular laboratory protocols to increase their diagnostic accuracy and improve patient care. It is important to extend the vascular laboratory protocols when complex cases arise to better demonstrate complicated diagnoses and challenging anatomy.


2021 ◽  
pp. 28-30
Author(s):  
Prashant Raman ◽  
Prathap Kumar S ◽  
Velladuraichi B ◽  
N Sritharan

Objective: To review the experience of our institution in repairing isolated iliac artery aneurysm (isolated IAA) in the last 10 years. Introduction: Unlike abdominal and combined aortoiliac artery aneurysms, isolated iliac artery aneurysms (IIAAs) are uncommon. An isolated iliac artery aneurysm is dened as a twofold increase in the diameter of the iliac artery without a coexisting aneurysm at another location. IIAA was encountered infrequently in the past, comprising 0.9% to 4.7% of all intra-abdominal aneurysms according to a review of previous studies; however, in recent times, many asymptomatic IIAAs have been detected incidentally because of the widespread use of abdominal ultrasonography and computed tomography. Methods: The medical records of patients who underwent isolated IAA repair at Institute of vascular sciences, MMC and RGGGH, Chennai, India, were reviewed, to obtain information on patients' demographics, vascular risk factors, type of treatment and outcome Results: A total of 13 patients with 18 aneurysms, 11 men(84.6%) 2 women(15.4%), with a mean age of 58.1±6 years, and two paediatric patients of age 11yrs (Female) and 3 months (Male) were treated. The mean diameter was 4.6 ± 1.0 for non-ruptured at elective repair; 5.5±2.1 cm on the emergency cases. The majority of aneurysms were at the common iliac artery. All of them except one, underwent open repair.Ten (84%) had elective operations, and two (16%) emergency repair for ruptured aneurysm. Hypertension and diabetes were seen as the most common risk factors with most of the patients were smokers. One was a known case of CKD and the paediatric female was a known case of RHD. There was one postoperative death in this series, patient succumbed on POD 1. Conclusion: This case series reviews the literature with regard to the natural history, diagnostic workup, and treatment of iliac artery aneurysms. For patients undergoing elective repair, preoperative imaging with computed tomography or magnetic resonance is advocated. Repair is recommended for good-risk patients with aneurysms larger than 3.5 cm as there is high chances of rupture with increasing diameter.


Vascular ◽  
2020 ◽  
pp. 170853812094932
Author(s):  
George Joseph ◽  
Albert Kota ◽  
Viji Samuel Thomson ◽  
Harsha Teja Perla ◽  
Shyamkumar N Keshava

Objective To report a technique of creating mini-cuff-augmented fenestrations in endografts for use in endovascular aneurysm repair. Methods Circular fenestrations are made in Dacron thoracic (Valiant Captivia, Medtronic) or tapered iliac limb (Endurant, Medtronic) endografts using thermal cautery and the edges are strengthened with radio-opaque wire sutured on with 6–0 polypropylene. Straight thin-wall expanded polytetrafluoroethylene vascular graft of the same diameter as the fenestration is affixed to its edge with nonlocking 5–0 polypropylene suture, everted, trimmed, balloon-dilated to its nominal diameter and prevented from invaginating by relaxed external stay sutures. Mini-cuff-augmented fenestrations are often pre-cannulated with looped or externalized nitinol guidewires to facilitate catheter crossing. Successful use of mini-cuff-augmented fenestrations is illustrated in a symptomatic patient with Crawford extent-3 thoracoabdominal aortic and bilateral common iliac artery aneurysm undergoing endovascular repair. Seven mini-cuff-augmented fenestrations were created to preserve flow into five visceral arteries (celiac, superior mesenteric, left and dual right renal; all arising from the aneurysm) and both internal iliac arteries (arising at the aneurysm edge). Results Effective sealing was achieved immediately at all mini-cuff-augmented fenestrations. At 6-month follow-up there were no endoleaks, all fenestration stents were patent and undistorted, and the aneurysm sac size had decreased. Conclusion Mini-cuff-augmented fenestrations accomplish effective fenestration sealing, despite being in aneurysmal zones, while preserving the advantages of fenestrations over cuffed branches.


2020 ◽  
Vol 27 (5) ◽  
pp. 828-835
Author(s):  
Shota Ohba ◽  
Masashi Shimohira ◽  
Takuya Hashizume ◽  
Masahiro Muto ◽  
Kengo Ohta ◽  
...  

Purpose: To evaluate the feasibility and safety of sac embolization with N-butyl cyanoacrylate (NBCA) in emergency endovascular aneurysm repair (EVAR) for ruptured abdominal aortic aneurysm (AAA) and iliac artery aneurysm (IAA) in comparison to EVAR without sac embolization. Materials and Methods: Between February 2012 and December 2019, among 44 consecutive patients with ruptured AAA or IAA, 29 underwent EVAR. Of these, 22 patients (median age 77.5 years; 18 men) had concomitant sac embolization using NBCA; the remaining 7 patients (median age 88 years; 6 men) underwent EVAR without sac embolization and form the control group. The technical success, clinical success (hemodynamic stabilization), procedure-related complications, and mortality were compared between the groups. Results: All EVAR procedures and embolizations were successful. The clinical success rates in the NBCA and control groups were 95% (21/22) and 71% (5/7), respectively (p=0.14). There was no complication related to the procedure. Type II endoleak occurred in 4 of 21 patients (19%) in the NBCA group vs none of the control patients. One patient (5%) died in the NBCA group vs 3 (43%) in the controls (p=0.034). Conclusion: Sac embolization using NBCA in emergency EVAR appears to be feasible and safe for ruptured AAA and IAA.


2021 ◽  
Vol 108 (Supplement_7) ◽  
Author(s):  
Arindam Chaudhuri ◽  
Ramita Dey ◽  
Weronika Stupalkowska

Abstract Aim Stent-grafts are finding a place in the treatment of femoral pseudoaneurysms (FpsAs), having been described in the treatment of infected pseudoaneurysms. We present the results of endovascular treatment of non-infected FpsAs using stent-grafts. Methods Case series of patients who underwent stent-graft coverage of FpsAs from January 2016 to December 2020. Stent-graft fractures, occlusions and reinterventions, length of stay (LOS) and 30-day mortality were assessed. Results 11 patients (mean age 75±10.3 years, 7 males; all ASA 3 or 4) underwent stent-graft coverage of FpsAs. Original procedures linked to the formation of FpsA were iliofemoral bypass (n = 3), femorofemoral crossover (n = 3), percutaneous coronary interventions (n = 2), aortobifemoral bypass (n = 1), endovascular aneurysm repair (n = 1) and femoral endarterectomy (n = 1). 3 patients had previous open FpsA repair. Technical success of deployment was 100%. Stent-grafts used included Viabahn Endoprosthesis (WL Gore & Associates, Flagstaff USA; n = 8), Viabahn VBX (WL Gore & Associates; n = 1) and BeGraft (Bentley InnoMed GmbH, Hechingen, Germany; n = 2). All patients were maintained on either antiplatelets or anticoagulant. 10 patients were available for analysis (1 lost to follow-up); radiological follow-up included initial computed tomography angiography and later combined duplex ultrasonography/plain radiography. Median LOS was 4 days (IQR 4). 30-day mortality was 0%. Median survival was 12 months (IQR 17). There was one stent-graft occlusion requiring thrombectomy but no fractures were observed in this series. Conclusions This small series suggests that there may be a role for stent-grafts in treatment of FpsAs in carefully selected patients. Given lack of data on long-term outcomes, continued surveillance is recommended.


2020 ◽  
Vol 8 ◽  
pp. 2050313X2094306
Author(s):  
Siddhartha Rao ◽  
Brad J Martinsen ◽  
Joseph Higgins ◽  
Henisha Dhandhusaria ◽  
Dwijesh Patel

The current standard of care for the treatment of flow-limiting calcific iliac artery disease is balloon angioplasty and subsequent stent placement. However, the presence of calcified lesions may prevent adequate stent expansion or impede the delivery of large bore devices, such as those for transcatheter aortic valve replacement or endovascular aneurysm repair implants. Plaque modification through vessel preparation with orbital atherectomy may enable stent expansion and subsequent proper large device delivery with low rates of procedural complications. A retrospective, single center, case series of 13 subjects treated with orbital atherectomy in iliac arteries to enable large bore device delivery was conducted. Patients were selected for treatment based on iliac artery disease or inability to deliver devices. The procedural complication rate was defined as the composite of flow-limiting dissection, perforation, slow flow, vessel closure, spasm, embolism, and thrombosis. Technical success was assessed as angiographic luminal gain and subsequent successful delivery of large bore devices through the treatment area, as well as freedom from procedural complications. Orbital atherectomy vessel preparation of severely calcified iliac artery lesions resulted in adequate stent expansion safely and enabled delivery of rigid/large profile devices. Further studies are warranted to evaluate patient selection criteria, as well as long-term efficacy and safety rates of orbital atherectomy in the iliac artery.


Vascular ◽  
2008 ◽  
Vol 16 (6) ◽  
pp. 316-320 ◽  
Author(s):  
Obekieze Agu ◽  
Dee Boardley ◽  
Mohan Adiseshiah

The purpose of this article is to describe a hitherto underreported late complication of infrarenal endovascular aneurysm repair (EVAR), namely type Ib endoleakage resulting from aneurysmal degeneration at the iliac artery landing site. In a prospectively recorded audit, between 1994 and 2007, 297 patients underwent EVAR. All cases that developed iliac artery aneurysm (IAA) were studied. Ten cases of IAA in seven patients (2.4% of the cohort) developed 5 to 9 years after EVAR. Eight of the 10 involved the lower landing site of the stent graft. Landing site diameter before EVAR was 12 mm (range 10–15 mm). Three IAAs presented as emergencies with rapidly expanding sacs and impending rupture. All cases underwent further endovascular intervention with no < 30-day mortality. Iliac artery landing site aneurysm formation after EVAR occurs uncommonly after 5 or more years. It should be regarded as an indication for intervention prior to type Ib endoleakage development. The need for lifelong surveillance is highlighted.


2019 ◽  
Vol 53 (7) ◽  
pp. 613-616 ◽  
Author(s):  
Yusuke Date ◽  
Tamaki Takano ◽  
Taishi Fujii ◽  
Takamitsu Terasaki ◽  
Masayuk Sakaguchi

Purpose: Endovascular aneurysm repair (EVAR) for an isolated common iliac artery aneurysm (iCIAA) sometimes requires a bifurcated stent graft (SG). In EVAR, it is essential to preserve the renal artery (RA). However, this is challenging in cases of anatomical variation. The double D technique (DDT) can be used in anatomically inadequate cases with a commercially approved bifurcated SG. Here, we report the repair of iCIAA in the presence of a challenging RA anatomy, through EVAR using the DDT. Case Report: An 84-year-old woman was diagnosed with a maximal 35-mm diameter left iCIAA and a nonaneurysmal aorta by computed tomography (CT), which also showed that the right RA arose 50-mm above the aortic bifurcation. The DDT was chosen because commercially approved bifurcated SGs typically require a distance of >70 mm from the proximal position to the aortic bifurcation. Postoperative CT showed excellent results with no endoleaks or SG kinking and occlusion, as well as preservation of robust blood flow to the right RA. Conclusion: Endovascular aneurysm repair using the DDT can be an alternative option for treatment of iCIAA with a challenging RA anatomy.


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