Long-term results of treatment of infrarenal aortic aneurysms with low-profile stent grafts in a multicenter registry.

OBJECTIVE: In recent years, manufacturers have developed new stent grafts with lower profiles to increase the endovascular aneurysm repair applicability. As reported by the current European Society for Vascular Surgery guidelines, long-term evaluation of such low-profile platforms is strongly recommended. This study aims to report outcomes beyond 5 years from a multicenter registry, including a real-world cohort of patients electively treated with low-profile stent grafts. METHODS: A retrospective data collection of patients who had undergone elective implantation of low-profile endograft ≤16 Fr. (Zenith LP, Ovation, Incraft) was performed in nine centers. The primary endpoint was a long-term primary clinical success. Secondary endpoints were survival rate, freedom from abdominal aortic aneurysm (AAA)-related death, freedom from type I to III endoleak, limb patency, and freedom from all reinterventions. The Kaplan-Meier curves were stratified for investigative devices. A multivariate analysis evaluated predictors of primary clinical success and reintervention rate. RESULTS: A total of 619 patients were enrolled (Ovation, n = 373; Incraft, n = 111; and Zenith LP, n = 135), with a mean follow-up of 56.8 ± 22.8 months. The overall primary and the secondary clinical success rate at 8 years was 72.1% and 93.8%, respectively. At 8 years, overall survival was 53.2%, freedom from AAA-related death was 94.4%, freedom from reintervention was 74%, freedom from type I/III endoleak was 86.9%, and limb patency was 90.4%. A significantly worse primary clinical success of the Zenith LP was recorded as dependent on more limb-related events. No differences between platforms were registered in the rate of AAA-related deaths, open conversion, sac enlargement, and type I/III endoleaks (P = .26). Multivariate analysis identified iliac tortuosity (hazard ratio, 2.053) and Zenith LP (hazard ratio, 3.818) as significant independent predictors of clinical failure and reintervention. CONCLUSIONS: Low-profile stent grafts have acceptable long-term outcomes. Overall survival and AAA-related death were in line with those reported for traditional devices. Long-term surveillance and reintervention, when necessary, remain crucial to guarantee durability.

Revascularization of occluded renal artery stent grafts after complex endovascular aortic repair and its impact on renal function.

BACKGROUND: Acute occlusion of renal bridging stent grafts after fenestrated/branched endovascular aortic repair (F/B-EVAR) is an acknowledged complication with high morbidity that often results in chronic dialysis dependence. The feasibility and effect of timely or late (≥6 hours of ischemia) renal artery revascularization has not been adequately reported. METHODS: We performed a retrospective, multicenter study across 11 tertiary institutions of all consecutive patients who had undergone revascularization of renal artery stent graft occlusions after complex EVAR. The end points were technical success, association between ischemia time and renal function salvage, interventional complications, mortality, and mid-term outcomes. RESULTS: From 2009 to 2019, 38 patients with 46 target vessels (TVs; eight bilateral occlusions) were treated for renal artery occlusions after complex EVAR (mean age, 63.5 ± 10 years; 63.2% male). Six patients had a solitary kidney (15.8%). Of the 38 patients, 16 (42.1%) had undergone FEVAR and 22 (57.9%) had undergone BEVAR. The technical success rate was 95.7% (44 of 46 TVs). The recanalization technique used was sole aspiration thrombectomy in 5.3%, aspiration thrombectomy and stent graft relining in 52.6%, and sole stent graft relining in 36.8%. The median renal ischemia time was 27.5 hours (range, 4-720 hours; interquartile range, 4-36 hours). Most patients (94.4%) had been treated after ≥6 hours of renal ischemia time, and 55.6% had been treated after 24 hours. In 14 patients (36.8%), renal function had improved after intervention (mean glomerular filtration rate improvement, 14.2 ± 9 mL/min/1.73 m2). However, 24 patients (63.2%) showed no improvement. Improvement of renal function did not correlate with the length of renal ischemia time. Of the 14 patients with bilateral renal artery occlusion or a solitary kidney, 9 experienced partial recovery of renal function and no longer required hemodialysis. In-hospital mortality was 2.6%. The cause of renal stent graft occlusion could not be identified in 50% of the TVs (23 of 46). However, in 19 (41.3%), significant stenosis or a kink of the renal stent graft was found. The median follow-up was 11 months (interquartile range, 0-28 months). The estimated 1-year patient survival and patency rate of the renal stent grafts was 97.4% and 83.8%, respectively. CONCLUSIONS: Revascularization of occluded renal bridging stent grafts after F/B-EVAR is a safe and feasible technique and can lead to significant improvement of renal function, even after long ischemia times (>24 hours) of the renal parenchyma or bilateral occlusion, as long as residual perfusion of the renal parenchyma has been preserved. Also, the long-term patency rates justify aggressive management of renal artery occlusion after F/B-EVAR.

Intravascular Lithotripsy for Treatment of Calcified Lesions During Carotid Artery Stenting.

PURPOSE: To report the use of intravascular lithotripsy (IVL) in the treatment of calcified carotid artery lesions. MATERIALS AND METHODS: The records of 21 high-surgical-risk patients (mean age 75.1±8.1 years; 17 men) who were treated at 8 centers for carotid artery stenosis ≥70% were retrospectively reviewed. Twelve patients had a history of cerebrovascular disease. All patients had heavily calcified carotid artery lesions: 19 de novo and 2 in-stent restenoses (ISR). The mean baseline stenosis was 82.3%±9.7%. IVL was utilized at the discretion of the operator, followed by balloon angioplasty. Embolic protection devices were used in all cases. RESULTS: In 19 patients, IVL was followed by stent implantation; the 2 ISR lesions were dilated only. The mean IVL balloon diameter was 4.64±1.13 mm, and the mean number of IVL pulses applied was 67.2±61.4 (range 10-180). All procedures were technically successful (<30% residual stenosis). No patients developed symptomatic bradycardia or hypotension due to IVL, and there were no adverse events associated with IVL delivery. All patients were discharged on dual antiplatelet therapy. Seventeen days after the procedure, 1 patient experienced an ischemic stroke that was deemed due to aortic arch manipulation during transfemoral access. Carotid duplex ultrasound examination identified significant restenosis (>70%) in 1 asymptomatic patient at 12 months after the index procedure. No patients required reintervention during a median follow-up of 6 months (range 1-12). CONCLUSION: This preliminary experience demonstrates that IVL can be a safe and effective approach for the management of severely calcified carotid lesions. Further research is warranted to determine the longer-term safety and efficacy of IVL for dilation of calcified carotid artery lesions as an adjunct to carotid artery stenting.

Could Gender Impact on Immediate and Long-term Carotid Artery Stenting Outcome? Insight from an Italian Single Center Experience.

BACKGROUND: Carotid artery stenting (CAS) has become a valid alternative to carotid endarterectomy in stroke prevention. However, female gender is still considered as an independent risk factor for CAS procedures, potentially limiting immediate and long-term benefits. Aim of present study was to evaluate gender differences in CAS submitted patients from an Italian high-volume center. MATERIAL AND METHODS: a retrospective monocentric study has been conducted on 568 patients (366 males and 202 females), submitted to CAS, between January 2000 and December 2019. Besides gender sex, clinical anatomical, and procedural data were collected as possible factors determining the outcome, when associated to sex gender itself. Primary endpoint of this study consisted in evaluating the technical and procedural success ratio, and the incidence of major and minor stroke, transient ischemic attack, acute myocardial infarction (AMI) peri-procedurally and at medium and long term, between the male and the female population. Secondary endpoint of this study consisted in evaluating the percentage ratio of minor complications happening peri-procedurally in both genders. RESULTS: Male patients were more likely to be octogenarians, clinical history of coronary artery disease, and smokers, while diabetes was more frequent in female patients. Anatomical and plaque morphology features were not different between the two groups. Technical success was obtained in all but two patients (99,6%), while procedural success was 95% (538/566 patients). During the peri-procedural time, no major stroke, 16 minor strokes (2,81%, 2,45% males vs. 3,45% females, P= 0,48), and 11 transient ischemic attack (2,18% males vs. 1,48% females, P= 0,56) were recorded. At a medium follow-up 57 months, 32 stroke (8 major strokes, 24 minor strokes) episodes (5,6%, males 5,7% vs. females 5,4%, P= 0,88), 24 AMIs (4,2%, males 4,6% vs. females 3,46%, P= 0,5;), 13 restenosis (2,8%, males 2,4% vs. females 1,9%, P= 0,71) and 223 deaths (39,2%, males 34,9% vs. females 47%, P= 0,0048) were noted. CONCLUSIONS: Our results showed no differences in immediate, and long-term CAS outcomes between gender. Larger, prospective studies are required to assess the real importance and significance of gender in determining CAS procedures' benefit and outcome.

Comparison of Outcomes Following EVAR Based on Aneurysm Diameter and Volume and Their Postoperative Variations.

PURPOSE: to evaluate the impact of bi- and 3-dimensional preoperative aortic morphological features and their immediate postoperative variations on the outcome of abdominal aortic aneurysms (AAA) treated by endovascular exclusion with standard devices (EVAR). MATERIALS AND METHODS: Double centre retrospective analysis of prospectively collected registry data of EVAR patients. For all patients, preoperative and 30-day computed tomographic angiography images (CTA) were reviewed. Preoperative maximum AAA diameter >59 mm and volume >159 cm3, and any 30-day postoperative increasing at CTA, were considered as potentially influencing the outcome. The outcome measures were: primary technical success; 30-day, 1-year, and mean follow-up reintervention, all-cause and AAA-related mortality rates, and also endoleak-related reinterventions. RESULTS: Three hundred and thrity-three patients were enrolled. Mean preoperative and 30-day AAA diameter and volume were 50.4 mm ± 11.8 vs. 49.1 mm ± 12.1, and 112.9 cm3 ± 79.5 vs. 112.1 cm3 ± 80.5, respectively. Primary technical success was achieved in all cases. At 34.9 months follow-up, cumulative reintervention rate was 12.0%, mortality rates 7.2%, without AAA-related deaths. Endoleak-related reintervention rate was 7.5%. At uni- and multi-variate analysis, preoperative AAA diameter >59 mm, and AAA volume >159 cm3 were significantly associated to reintervention (P = 0.012; P = 0.002), and reintervention and death (P = 0.002; P = 0.001) during follow-up. Additionally, any increase in postoperative AAA diameter or volume was significantly associated with reintervention (P = 0.001, P = 0.001) and reintervention and death (P = 0.006, P = 0.001). Endoleak-related reintervention were also significantly associated with all of the analysed morphological parameters (P = 0.019, P = 0.005, P = 0.005, and P = 0.002, respectively). CONCLUSIONS: Patients with larger baseline AAA size and volume as well as unfavourable early remodelling of the sac are associated to worse long-term EVAR outcome.

Urgent Mechanical Thrombectomy by Indigo System® in Acute Thrombosed Popliteal Artery Aneurysms: A Report of Two Cases.

The aim of this study is to report the outcome of immediate and direct revascularization by mechanical thrombectomy in acute limb ischemia due to thrombosed popliteal artery aneurysm (PAA). Two patients with acute limb ischemia due to PAA thrombosis were admitted at our hospital, and immediately treated by mechanical thrombectomy (Indigo System). The first patient had a complete recanalization after thrombectomy, while the second one required urokinase infusion (12 hr) due to a suboptimal result. After revascularization, both patients were treated by a polytetrafluoroethylene bypass to definitively exclude PAA. Follow-up showed the patency of the femoropopliteal bypass with good distal outflow. In these 2 reported cases, the Indigo System® has proven to be safe and effective, allowing an immediate limb reperfusion, reducing the necessity for thrombolytic drug infusion.

Expert Opinion on Hostile Neck Definition in Endovascular Treatment of Abdominal Aortic Aneurysms (a Delphi Consensus).

BACKGROUND: Endovascular aneurysm repair (EVAR) is currently accepted as an alternative to open repair for the treatment of abdominal aortic aneurysm (AAA). Approximately 40-60% of AAA patients are not considered eligible for EVAR due to unfavorable anatomy. There is currently no consensus on the definition of "hostile" aortic neck for EVAR procedure. METHODS: An Expert Panel (EP), made up of 9 Italian vascular surgeons from high-volume centers (>50 EVAR procedures/year), was assembled to share their opinion about the definition of hostile aortic neck anatomy for EVAR procedure. The process included a review of the current literature by the EP, a face-to-face meeting, and an on-line survey completed by the EP prior to and following the face-to-face meeting, using the Delphi method. RESULTS: Of the 66 reviewed studies, only 38 (58%) reported at least 1 aortic neck hostility criterion. Five anatomic parameters were identified, namely, aortic neck length, aortic neck angulation, aortic neck diameter, conical neck, and presence of circumferential calcification. Based on the results of the first survey round, these criteria and related definitions were discussed in depth during the face-to-face meeting. For 3 parameters (aortic neck diameter, aortic neck angulation, conical neck), the agreement among the EP members was already high during the first survey round while for the remaining 2 (aortic neck length, circumferential calcification) it remarkably increased from the first to the second survey round. For each of these criteria, as well as combinations of at least 2 of these criteria, specific threshold values were identified above or below which a standard EVAR approach was not considered ideal by the EP due to high/moderate risk of complications. CONCLUSIONS: EP agreed on the definition of 5 aortic neck hostility criteria, according to which they gave their opinion on the feasibility and risks of a standard EVAR approach. Further agreement will be needed and examined on the best nonstandard EVAR technique which may be offered in the presence of different combinations of hostility criteria.

Infrarenal Abdominal Aortic Aneurysm Endovascular Treatment: Long-term Results From a Single-Center Experience in an Unselected Patient Population.

BACKGROUND: The aim of the present study was to evaluate early-, mid-, and long-term outcomes in an unselected population of patients treated for abdominal aortic aneurysms (AAAs) by endovascular aneurysm repair (EVAR) with different commercially available off-the-shelf devices. MATERIALS AND METHODS: A retrospective study was conducted on a prospectively compiled computerized database on patients presenting an infrarenal AAA treated between January 2008 and December 2015 in a high-volume Italian tertiary referral Center. Demographic, clinical, and specific morphological features were considered as potentially influencing the outcomes and the type of the implanted device. Outcome measures were procedure-related reintervention, AAA-related, and all-cause mortality rates at 30-day, 12-month, and long-term follow-up. Reinterventions considered for the analysis were AAA rupture, graft infection, type I or III endoleaks, type II endoleaks with sac enlargement > 5 mm, graft stenosis or occlusions, procedures related to renal or visceral ischemia, and reintervention for access vessel injury. RESULTS: Of 498 EVAR procedures performed for elective infrarenal AAA treatment during the entire study period, 479 patients were enrolled, the mean age was 73.5 ± 7.34 years (range 51-91), and 416 (86.84%) were men. The mean maximum AAA diameter was 52.02 ± 8.04 mm (range 39-90.2), a maximum AAA diameter ≥59 mm was recorded in 107 patients (22.33%), and an aortic neck length was <10 mm in 137 (28.60%). Technical success was achieved in all patients. At a mean follow-up of 52.97 ± 26.16 months (range 1-120), overall reintervention and death rates were 8.14% and 20.04%, respectively, without AAA-related deaths. At univariate analysis, hypertension was the only demographical variable found to be associated with higher risk of reintervention, P = 0.04 (OR: 2.34; CI 95%: 1.00-5.42). Furthermore, male sex (P = 0.02; OR: 2.62; CI 95%: 1.09-6.27) and chronic renal insufficiency (P = 0.003; OR: 2.08; CI 95%: 1.27-3.42) were associated with higher mortality rates. AAA diameter ≥59 mm was statistically associated with a higher rate of both reintervention and mortality: P < 0.001 (OR: 9.05; CI 95%: 4.52-18.11) and <0.001 (4.00; 2.46-6.49), respectively. CONCLUSIONS: Our experience seems to suggest that EVAR could be safely and effectively performed in an unselected patients' population, with encouraging results up to a ten-year follow-up.

Short- and Midterm Outcomes of Open Repair and Fenestrated Endografting of Pararenal Aortic Aneurysms in a Concurrent Propensity-Adjusted Comparison.

PURPOSE: To compare outcomes of patients treated for pararenal aortic aneurysms using fenestrated endovascular aneurysm repair (fEVAR) vs open surgical repair (OSR) in 3 high-volume centers. MATERIALS AND METHODS: A multicenter retrospective analysis was conducted of 200 pararenal abdominal aortic aneurysm patients electively treated with OSR (n=108) or fEVAR (n=92) from 1998 to 2015 at 3 tertiary institutions. Endpoints were 30-day morbidity and mortality, late reinterventions, visceral artery occlusion, and mortality. Analysis was conducted on the entire population and on a propensity score-matched population constructed on age, gender, coronary artery disease (CAD), and chronic renal failure. RESULTS: In the total cohort, fEVAR patients were significantly (p<0.001) older and had higher frequencies of CAD (p<0.001) and previous stroke (p=0.003). OSR patients had higher risk of perioperative morbidity (OR 2.5, 95% CI 1.09 to 5.71, p=0.033), specifically respiratory failure (OR 4.06, 95% CI 1.12 to 4.72, p=0.034). These findings were confirmed in the propensity-adjusted analysis, where cardiac complications were also higher after OSR (OR 12.8, 95% CI 0.07 to 0.21, p=0.02). No difference in perioperative mortality (2.2% in fEVAR vs 1.9% in OSR) was identified. Mean follow-up was 50 months (range 0-119). Four-year results showed higher survival (91.2% vs 69.3%, p=0.02) and freedom from reintervention (95.6% vs 77.8%, p=0.01) after OSR in the unmatched population, with a small but significant (p=0.021) difference in the risk of late visceral artery occlusion/stenosis after fEVAR. On propensity analysis, no differences in late survival were found between groups. CONCLUSION: fEVAR and OSR may afford similar early and midterm survival rates. Higher risks of perioperative systemic complications after OSR are counterbalanced by higher risks of late visceral vessel patency issues and need for reintervention after fEVAR. Both procedures are safe and effective in the long term in experienced centers, where patient evaluation should drive the treatment strategy.

Endovascular Treatment of an Anterior Tibial Artery Pseudoaneurysm Secondary to Penetrating Trauma in a Young Patient: Case Report and Literature Review.

We report a case of an 18-year-old woman who developed a delayed pseudoaneurysm of the right anterior tibial artery (ATA), 14 days after a knife accidental trauma. The patient was admitted to our emergency department for acute onset of pain in the right limb after a domestic trauma. At a physical examination, the limb was tense and tender, with a pulsatile mass in the anterior compartment. Femoral, popliteal, and distal pulses were palpable on both limbs. Duplex ultrasound scan (DUS) and computed tomography angiography showed the presence of an ATA pseudoaneurysm. An urgent endovascular treatment was performed under local anesthesia via percutaneous access. Pseudoaneurysm was excluded implanting 2 coronary covered balloon-expandable stents (BeGraft; Bentley Innomed GmbH, Hechingen, Germany). Postoperative course was uneventful and the patient was discharged on the second postoperative day under dual antiplatelet therapy. One- and 13-month scheduled follow-up visits and DUS revealed the presence of a normal pedal pulse, complete pseudoaneurysm exclusion, and patency of the stent grafts and the entire ATA with triphasic waveforms. In conclusion, endovascular treatment of an ATA pseudoaneurysm seems to be a feasible option. Further experience with this technique is needed to validate its safety and long-term patency, especially in young and healthy subjects.

Type 2 Endoleak Incidence and Fate After Endovascular Aneurysms Repair in a Multicentric Series: Different Results with Different Devices?

BACKGROUND: The aim of this work is describing incidence and fate of type 2 endoleaks (T2ELs) in a multicentric cohort of patients treated by endovascular aneurysms repair using the Ovation device (Endologix) and comparing them with a group treated using the Excluder (W. L. Gore & Associates). METHODS: This is a retrospective study conducted on 261 patients treated using the Ovation device and 203 using the Excluder. Outcomes were intraprocedural, 30-day, 12-month, and mean time follow-up T2EL incidence and related reinterventions. Patent inferior mesenteric artery (IMA), ≥3 lumbar arteries (LAs), intrasac thrombus volume, the mean diameter of common and external iliac arteries, external iliac artery stenosis (>70%), diameter ≤5 mm, iliac tortuosity ratio ≤0.5, thrombosis, and calcification were noted and considered as potentially influencing outcomes. RESULTS: Patients of the Ovation group presented significantly more thrombosed, calcified, and tortuous iliac vessels than those in the Excluder group. No significant differences were noted in sac thrombosis, IMA, and LA patency. At completion angiography, T2EL was evident in 57 Ovation and 46 Excluder patients (P = 0.832). At 1 month, it was evident in 33 Ovation group and 28 Excluder group patients (P = 0.726). At 12-month and mean time (30.14 months) follow-up, no differences were evident between the 2 groups (P = 0.940 and 0.951, respectively). The log-rank test showed that the rate of T2EL-related reintervention was not different between the 2 groups (P = 0.46). Regarding anatomical characteristics, a statistically significant difference was not observed between patients presenting or not with T2EL (P > 0.05). CONCLUSIONS: Data showed no significant differences in terms of T2EL incidence between the 2 study groups. None of preoperative anatomical features were found to be significantly associated with the appearance of T2EL.

Standard "off-the-shelf" multibranched thoracoabdominal endograft in urgent and elective patients with single and staged procedures in a multicenter experience.

OBJECTIVE: The objective of this study was to assess immediate and midterm outcomes for urgent/emergent and elective patients with thoracoabdominal aortic aneurysms (TAAAs) treated with the first commercially available "off-the-shelf" multibranched endograft for endovascular aneurysm repair, with a single-step or a staged surgical approach. METHODS: A multicenter, nonrandomized, retrospective study was conducted of TAAA patients grouped by urgent/emergent and elective treatment with multibranched endograft for endovascular aneurysm repair at 13 Italian centers from November 2012 to August 2016. Urgent/emergent repair was classified as rupture in 16%, impending rupture in 9%, pain in 53%, or a maximum TAAA diameter ≥80 mm in 22%. Study end points were technical success, mortality, spinal cord ischemia, target visceral vessel (TVV) patency, and procedure-related reinterventions at 30 days and at follow-up. RESULTS: Seventy-three patients (274 TVVs) were enrolled. Treatment was performed in elective (n = 41 [56%]) or urgent/emergent (n = 32 [44%]) settings, according to a single-step (n = 30 [41%]) or staged (n = 43 [59%]) approach. Technical success was 92%. Mortality within 30 days was 4% (n = 3 urgent/emergent patients) due to myocardial infarction. Spinal cord ischemia was recorded in two patients (3%; elective group). The primary patency of TVVs was 99% (three renal branch occlusions). Procedure-related reinterventions were required in five cases (7%). At least one adverse event from any cause ≤30 days was registered in 42% (n = 31). At a median follow-up of 18 months (range, 1-43 months), eight (11%) deaths (elective vs urgent/emergent, 2% vs 22%; P = .018), three (1%) cases of branch occlusion or stenosis, and five (7%) reinterventions were recorded. A survival of 88% (standard error [SE], 4%), 86% (SE, 4%), and 82% (SE, 5%) was evidenced at 12, 24, and 36 months, respectively. Urgent/emergent repair and female gender were identified as independent risk factors for all-cause mortality (P < .001 and P = .015, respectively), and the staged approach was identified as protective (P = .026). Freedom from reintervention was 86% (SE, 4%) and 83% (SE, 5%) at 12 and 24 months. CONCLUSIONS: The first off-the-shelf multibranched endograft seems safe in both urgent/emergent and elective settings. The staged surgical approach appears to positively influence overall survival. This unique device and its operators will usher in a new treatment paradigm for TAAA repair.

Unexpected Complication of a Nitinol-Constrained Balloon Angioplasty (Chocolate) in Rutherford Class 3 Patient Presenting Challenging Aorto-Iliac Anatomy.

We report an unusual complication of Chocolate nitinol-constraining structure after right superficial femoral artery (SFA) angioplasty. The procedure was performed by vascular surgeons in an operating theater equipped by a portable fluoroscopy unit. Under local anesthesia, by a contralateral approach, a 7F introducer sheath was advanced through the proximal portion of the right common iliac artery. Owing to the severe aorto-iliac vessels calcification, it was not possible to place the introducer sheath into a more distal vessel, as planned. After external iliac artery (EIA) stenting (7 × 80 mm Eluvia), SFA obstruction was intraluminal crossed, and a 6 × 120 mm nitinol-constrained balloon (Chocolate; Medtronic) was advanced in place and inflated. Once the balloon came out, the nitinol-constraining structure was not attached to the balloon surface. Under fluoroscopy, the crashed nitinol mesh was identified at distal edge of previously positioned EIA stent. To prevent mesh migration, it was fixed by covering with a 7 × 40 mm stent. The procedure was then successfully completed, as planned. One-month, postoperative computed tomography angiography showed complete expansion of the stents and no significant residual stenosis (>30%) in EIA, and SFA. Chocolate's mesh was still evident between the stent and the iliac artery wall, in absence of further complications. A 3 months follow-up, patient was still completely asymptomatic for claudication.

Results of AFX Unibody Stent-Graft Implantation in Patients With TASC D Aortoiliac Lesions and Coexistent Abdominal Aortic Aneurysms.

PURPOSE: To describe results of AFX unibody stent-graft treatment for TransAtlantic Inter-Society Consensus (TASC) D aortoiliac occlusive disease (AIOD) with coexistent abdominal aortic aneurysm (AAA). METHODS: A retrospective analysis was conducted of 21 consecutive patients (mean age 73.6±6.4 years; 17 men) with TASC D AIOD plus AAA (diameter >3.5 cm) treated electively using the AFX stent-graft. Common iliac artery (CIA) and external iliac artery (EIA) stenosis or occlusion was reported. Outcome measures were technical and clinical success, improvement in ankle-brachial index (ABI), and improvement in Rutherford category. Immediate and midterm patency, AAA exclusion, major adverse events (MAE), and mortality were also evaluated. RESULTS: After AFX deployment (100% technical success), 18 EIAs required adjunctive stenting (none required in the CIA). One patient required a reintervention for closure device failure. At 30-day follow-up, no death or MAE was recorded. Improvement in ABI was registered in all patients (mean 0.91±0.11), with 100% primary patency. At a mean follow-up of 25.2±11.1 months, primary patency was maintained in all cases. No death or amputation occurred; 2 patients had a myocardial infarction. Improvement in ABI was maintained (0.88±0.13) as well as Rutherford category. CONCLUSION: This study examined the use of the AFX unibody stent-graft for the treatment of TASC D AIOD with concomitant AAA. The AFX stent-graft appears to be a safe and effective solution for these complex lesions, with low morbidity and mortality.

Chimney Technique with the INCRAFT® AAA Stent Graft System to Treat Pararenal Aortic Aneurysm in Narrowed Iliac Axes.

To report a case of pararenal aortic aneurysm (PAAA) with narrowed iliac arteries treated by the chimney technique combined with the INCRAFT® AAA stent graft system. A 75-year-old man was diagnosed with a 55-mm PAAA. Patient was judged unfit for open repair and for standard endovascular aneurysm repair (EVAR) due to its clinical and anatomical requirements. Custom-made fenestrated device (FEVAR) was excluded due to the presence of narrowed and heavily calcified iliac axes. Consequently, patient underwent auspicious endovascular aneurysm repair with the INCRAFT System and chimney grafts in the superior mesenteric artery and both renal arteries. At 12 months' follow-up, patient was in good clinical condition, with preserved renal function. Computed tomographic angiography revealed inceptive shrinkage of the aneurysm with patency of aortic and visceral grafts even in the presence of a low-flow type Ia endoleak. Chimney grafts (CGs) combined with the low-profile INCRAFT System seem to be feasible for treating PAAA, in high-risk patients unfit for standard EVAR or FEVAR devices.

Emergent Treatment of a Ruptured Thoracoabdominal Aortic Aneurysm by Off-Label Rescue Implantation of the Ovation Stent Graft in Nonagenarian Patients.

We report a case of a compassionate treatment of a ruptured thoracoabdominal aortic aneurysm in a 92-year-old patient. The patient was admitted to our emergency department for acute onset of pain irradiating to the back. Computed tomography angiography showed the presence of a thoracoabdominal aortic aneurysm with a contained rupture at infrarenal level. Given the presence of a relative healthy visceral aorta, we decided to treat the patient by Ovation (Endologix, Irvine, CA) implantation in an off-label fashion. Procedure was performed by bilateral percutaneous access. Completion angiography showed the good stent-graft apposition with complete aneurysm exclusion. The patient was discharged on the third postoperative day. The 1-month follow-up confirmed the good procedural result; aneurysm was completely excluded without further thoracic dilatation.

Endovascular Solution of Acute Limb Ischemia Engendered by Persistent Sciatic Artery Pseudoaneurysm due to Stent Fracture.

We report a case of acute limb ischemia (ALI) due to a thromboembolism from a persistent sciatic artery (PSA) pseudoaneurysm precipitated by a fractured stent. Patient, previously treated for ALI by fibrinolysis and stent implantation, presented with a PSA pseudoaneurysm (undetected during first hospitalization), stent fracture (SF), and occlusion of vessels below the knee. Fibrinolysis was performed, restoring direct flow to the foot. A week later, an endovascular procedure was attempted to reline SF and exclude the PSA pseudoaneurysm by deployment of two 13 × 100-mm peripheral endografts (Viabahn; W.L. Gore & Associates, Flagstaff, AZ). At 1-year follow-up, patient was asymptomatic without further clinical events.

Real-Life Experience with Ovation Stent Graft: Lesson Learned from the First One Hundred Fifty Treated Patients.

BACKGROUND: The objective of the study was to report immediate and midterm results of an unselected population of patients treated for abdominal aortic aneurysms (AAAs) by endovascular aneurysm repair (EVAR) using the Ovation stent graft. METHODS: A double-center retrospective study was conducted on a prospectively collected database between 2012 and 2015. One hundred fifty-six elective patients were included. The outcome measures considered for analysis were primary technical success, 30-day and midterm reinterventions, and all-cause and AAA-related mortality rates. The presence of an aortic neck ≤10 mm, and of a noncylindrical aortic neck, as well as a narrowed aortic bifurcation was defined as an aortic bifurcation average diameter (ABaverage) ≤ 18 mm or an ABarea ≤ 20 mm2, and an external iliac artery diameter ≤5 mm was considered as independent factors potentially influencing the outcome. RESULTS: Male patients totaled 128 (82.1%), and mean age was 74.83 ± 6.76 years (range: 56-91). Mean aortic diameter was 57.15 ± 8.77 mm, mean diameter at inferior renal artery level + 13 was 24.44 ± 3.31 mm, and mean aortic neck length was 18.77 ± 8.45 mm. Fifty-four patients (34.6%) had an aortic neck ≤10 mm, and cylindrical aortic neck shape was present in 34 patients (21.8%). Regarding the aortic bifurcation (AB), 31 patients (19.9%) presented ABaverage ≤ 18 mm, and 35 (22.4%) an ABarea ≤ 20 mm2. Technical success was achieved in all cases. At 30-day follow-up, 2 type I endoleaks (1.3%) were detected. One patient was successfully treated endovascularly by proximal aortic cuff implantation, while the other patient refused further treatment. Three-month unscheduled computed tomographic angiography shows endoleak resolution and complete aneurysm seal. One patient suffered from a limb graft occlusion, managed by medical treatment. At a mean follow-up time of 20.4 ± 8.8 (1-60) months, 6 reinterventions were reported, including 2 embolizations for type II endoleak and 4 for iliac and femoral vessel occlusive disease. Log-rank test on preoperative anatomical features showed no significant differences in terms of freedom from reinterventions, and P values were 0.653 for aortic neck length ≤10 mm, 0.309 for noncylindrical aortic neck length shape, 0.520 for ABaverage ≤ 18 mm, 0.604 for ABarea ≤ 20 mm2, and 0.421 for external iliac artery diameter ≤5 mm. CONCLUSIONS: Our initial experience suggests that in an unselected patient population undergoing AAA repair, EVAR by Ovation stent graft can be performed safely with satisfactory immediate and midterm outcomes.

Results from the Multicenter Study on Aortoenteric Fistulization After Stent Grafting of the Abdominal Aorta (MAEFISTO).

OBJECTIVE: This study investigated the frequency, clinical features, therapeutic options, and results of aortoenteric fistulas (AEFs) developing after endovascular abdominal aortic repair (EVAR). METHODS: Eight Italian centers with an EVAR program participated in this retrospective multicenter study and collected data on AEFs that developed after a previous EVAR. RESULTS: A total of 3932 patients underwent EVAR between 1997 and 2013 at the participating centers. During the same period, 32 patients presented with an AEF during EVAR follow-up, 21 with original EVAR performed for atherosclerotic aneurysmal disease (ATS group) and 11 with the original EVAR performed for a postsurgical pseudoaneurysm (PSA group). The incidence of AEF development after EVAR was 0.46% in the ATS group and 3.9% in the PSA group. Anastomotic PSA as the indication to EVAR (P < .0001) and urgent/emergency EVAR (P = .01) were significantly associated with AEF development. Median time between EVAR and the AEF diagnosis was 32 months (interquartile range, 11-75 months) for the ATS group and 14 months (interquartile range, 10.5-21.5 months) for the PSA group. Among five AEF patients treated conservatively, two (40%) died, at 7 and 15 months, and the remaining three were alive at a median follow-up of 12 months. The AEF was treated surgically in 27 patients, including aortic stent graft explantation in all cases, in situ aortic reconstruction in 14 (52%), and extra-anatomic bypass in 13 (48%). Perioperative mortality was 37% (10 of 27). No additional aortic-related death was recorded in operated-on patients at a median follow-up of 28 months. CONCLUSIONS: Late AEFs rarely occur during EVAR follow-up, but the risk is significantly increased when EVAR is performed for PSA after previous aortic surgery and EVAR is performed as an emergency. Conservative and surgical treatment of post-EVAR AEF are both associated with high mortality. However, beyond the perioperative period, surgical correction of AEFs appears to be durable at midterm follow-up.

Spontaneous Sealing of a Type Ia Endoleak after Ovation Stent Graft Implantation in a Patient with On-Label Aortic Neck Anatomy.

We report a case of an early type Ia endoleak after endovascular aneurysm repair (EVAR) of an abdominal aortic aneurysm by Ovation Stent Graft implantation and spontaneously resolved without further reintervention. The patient presents a conical aortic neck, but EVAR was performed within the instruction for use proposed by manufactory. At completion angiography, a low-flow type Ia endoleak was present and left untreated. Computed tomographic angiography performed on the third postoperative day showed infolding of the 2 sealing rings. The patient was dismissed without further treatment. At 3-month follow-up, the leak appeared spontaneously sealed with partial expansion of the 2 rings.