Secondary Endovascular Intervention Research Articles

Novel Surgeon-Modified Fenestrated Iliac Stent Graft.

We describe the feasibility and early results of a novel endovascular approach with a surgeon-modified fenestrated iliac stent graft to preserve pelvic perfusion in patients with iliac aneurysms not suitable for iliac branch devices (IBDs). Seven high-risk patients, median age 76 years (range 63-83), with a complex aortoiliac anatomy with contraindications for commercially available IBDs were treated with a novel surgeon-modified fenestrated iliac stent graft between August 2020 and November 2021. The modified device was built using an iliac limb stent graft (Endurant II Stent Graft; Medtronic), which was partially deployed, surgically fenestrated with a scalpel, reinforced, re-sheathed, and inserted via femoral access. The internal iliac artery was cannulated and bridged with a covered stent. Technical success rate was 100%. After a median follow-up period of 10 months, there was 1 type II endoleak and no migrations, stent fractures, or loss of device integrity. One iliac limb occlusion occurred after 7 months, which needed a secondary endovascular intervention, restoring patency. Surgeon-modified fenestrated iliac stent graft is feasible and might be used as an alternative in patients with a complex iliac anatomy not suitable to commercially available IBDs. Long-term follow-up is needed to evaluate stent graft patency and potential complications. Surgeon modified fenetrated iliac stent grafts might be a promising alternative to iliac branch devices, extending endovascular solutions to a broader patient population with complex aorto-iliac anatomies preserving antegrade internal iliac artery perfusion. It is possible to treat small iliac bifurcations and large angulations of the iliac bifurcation safely and there is no need for a contralateral or upper-extremity access.

Endovascular repair of aortic pathologies involving the aortic arch using castor stent-graft combined with in-vitro fenestration technology

BackgroundAortic arch pathologies are concerning clinical conditions with poor prognoses. The use of thoracic endovascular aortic repair (TEVAR) has been investigated to treat aortic arch pathologies. Nonetheless, cerebral blood flow regulation during endovascular aortic arch repair therapy remains challenging. Castor, a unique single-branched stent graft, has been proven effective for retaining the left subclavian artery (LSA). This study aimed to determine whether endovascular therapy for pathologies involving the aortic arch using Castor in combination with the in-vitro fenestration technique is promising, effective, and safe.MethodsEligible patients were enrolled between June 2018 and December 2021. All patients underwent TEVAR with an evaluated proximal landing zone for “Castor” located in Ishimaru zones 0–1. Moreover, the supra-aortic branches (SABs) were reconstructed using the Castor in combination with the in-vitro fenestration technique.ResultsHerein, 57 patients with aortic arch lesions were treated with Castor in combination with the in-vitro fenestration technique. Innominate artery and the left carotid artery (LCA) were reconstructed in 5 patients, LCA and left subclavian artery (LSA) were reconstructed in 22 patients, and the total SABs were effectively reconstructed in 30 patients (including a hybrid arch repair case). Among them (excluding a hybrid arch repair case) were in-vitro fenestration methodologies for LCA in 32 of 34 cases (2 switched to in-situ fenestration) and LSA in 51 of 56 cases (3 switched to in-situ fenestration and 2 converted to spring coil caulking); furthermore, LCA and LSA in-vitro fenestration were simultaneously successfully performed in 27 of 34 cases. There were no surgical-related neurological complications, and early mortality was estimated at 5.26%. At a mean follow-up of 3.75 months, computed tomography (CTA) images confirmed that each branch stent remained patent. There were no signs of endoleaks, migrative manifestations, or the need for secondary endovascular intervention or conversion to open surgical procedures.ConclusionCastor, in combination with in-vitro fenestration, reflects a feasible, efficient procedure for re-developing SABs.

Treatment of stent rupture after endovascular treatment of superior mesenteric aneurysm with open surgery.

The progress of visceral artery aneurysms (VAAs) after the endovascular repair of artery aneurysms is often accompanies by the potential risks of stent fracture. The clinical reported cases of VAAs stent fractures with stent displacement were extremely rare but severe complication, particularly for the superior mesenteric artery aneurysm (SMAA). We here reported a 62-year-old female patient with recurrent symptoms of SMAA 2 years after the successful endovascular repair using coil embolization and two partial overlapping stent-grafts in SMAA. The open surgery was performed instead of secondary endovascular intervention. The patient experienced a good recovery. As one of the complications after endovascular repair, stent fracture maybe more dangerous than SMAA itself, the stent fracture after endovascular repair treated by open surgery with satisfactory results is alternative and feasible.

Theoretical Feasibility of Using Arch Branched Endograft Devices for Repair of Post Type A Aortic Dissection in Patients With Prior Ascending Aortic Replacement

Purpose: Ascending aortic replacement is a common emergency procedure for treating acute type A aortic dissection. Secondary open or endovascular interventions for residual arch pathologies is difficult because of adhesions, short prosthetic grafts, and distorted anatomies. Aortic arch branched stent grafts have emerged as a potential solution for these patients if they have suitable anatomical conditions. This study aimed to evaluate the theoretical anatomical and technical feasibility of 2 currently used aortic arch branch endografts in patients who had prior replacement of the ascending aorta. Materials and Methods: All patients who had a prosthetic ascending aortic or hemiarch replacement for acute type A dissection in a single institution between January 2013 and December 2018 were included. Contrast computed tomography images on the most recent follow-up were analyzed on a 3-dimensional workstation. Morphological parameters were measured individually for the ascending aorta, aortic arch, supra-aortic branches, and access iliac arteries. The computed tomography scan of each patient was individually evaluated for anatomical suitability for the arch branched and double-branch devices according to set selection criteria. Results: Computed tomography images of 56 patients (median age of 57 years, 45 males) were reviewed. Based on our evaluation, 26 patients (46.4%) were good candidates for an endovascular arch branched device. It would be feasible for 13 patients (23.2%), but prudent preoperative planning was required due to complicated anatomy. The other 17 patients (30.4%) were unsuitable because they met at least 1 exclusion criterion. Short prosthetic grafts, extreme graft angulations, and extensive dissections in the supra-aortic branches were the main reasons for exclusion. Conclusion: Endovascular repair using arch branched endografts is feasible in patients with prior ascending aortic arch or hemiarch replacement for acute type A aortic dissection. The most common anatomical conditions that may influence the feasibility of the arch branched endograft procedure include insufficient proximal seal length, severe angulation of the graft, and extensive aortic dissection within the supra-aortic vessels.

Successful Secondary Endovascular Intervention in Pediatric Patients with Venous Thromboembolic Events.

In the past, pediatric patients with venous thromboembolic events (VTE) were treated with low-molecular-weight heparin (LMWH) which was successful in around 70% of the cases. However, anticoagulation alone might not restore patency in all patients, and advanced therapeutic options to prevent postthrombotic syndrome are needed. During recent years, endovascular interventions have become a treatment option for pediatric patients with persistent thrombotic occlusion, not only in life- or limb-threatening VTE. We evaluated 12 consecutive patients (11-17 years) with newly diagnosed VTE being treated at our department during the last 4 years (2017-2020). In case follow-up examination showed persistent venoocclusion under anticoagulation, patients received secondary interventional therapy like recanalization, percutaneous transluminal angioplasty with or without catheter-directed thrombolysis, and stenting. Patients with no clinical signs of venoocclusion or regredient thrombosis in imaging examination received anticoagulation alone. Six of 12 (50%) patients underwent catheter intervention. Median time from diagnosis to intervention was 4 months (0-12 months). Reintervention was necessary in one (8%) case and complete recanalization failed in one (8%) case. There were no major bleeding events or other major postinterventional complications, no acute or late local recurrence, and all patients reported clinical improvement after the procedure. If endovascular intervention is used in teenage patients with persistent symptomatic VTE, reduction of postthrombotic symptoms is possible, even if intervention is performed secondary to failure of anticoagulation. Multidisciplinary treatment decisions can be based on the clinical course and follow-up imaging.

Endovascular aneurysm repair for aorto-iliac artery pathologies in patients with autosomal dominant polycystic kidney disease

This study aims to evaluate the efficacy and safety of endovascular aneurysm repair (EVAR) of abdominal aortic or iliac artery pathologies in patients with autosomal dominant polycystic kidney disease (ADPKD).From January 2014 to December 2019, fifteen consecutive patients (13 men, mean age 69.3 years, range 56-82 years) with abdominal aortic or iliac artery pathologies coexisting with ADPKD underwent EVAR in our department. Their general data, perioperative results and follow-up outcomes were retrospectively reviewed and analyzed.Among the fifteen patients, eleven had abdominal aortic aneurysms, one had isolated abdominal aortic dissection and the other three had iliac artery aneurysms. Three patients had thoracic penetrating aortic ulcer and two had intracranial aneurysms as the comorbidities. All patients underwent EVAR with the aorto-iliac pathologies successfully excluded. The average operative time was 171±73 minutes and average contrast volume was 87±12mL. The average follow-up time was 38.4 months (range 6-60). Aorta-bi-iliac stent-grafts were deployed in fourteen patients, while one patient received tubular stent-graft. Two patients underwent simultaneous TEVAR and EVAR, and One underwent EVAR 3 months after TEVAR. One patient was found to have a hematoma at the site of femoral access 3 days after EVAR. One patient was found to have a Type Ib endoleak 5 months after EVAR, and he recovered well with a secondary endovascular intervention. Contrast-induced nephropathy was observed in two patients (13%) post EVAR. Another patient developed renal failure 20 months after EVAR and was treated with regular hemodialysis. All other patients did not have any reported significant deterioration of renal function during follow-up. No other adverse events, such as death, paraplegia, aneurysm rupture, or open surgery conversion occurred during operation and follow-up.For patients with abdominal aortic or iliac artery diseases coexisting with ADPKD, EVAR had satisfactory mid-term outcomes, without significantly exacerbating the decline of renal function. However, patients with ADPKD might have multiple vascular lesions, especially intracranial aneurysms, which should be paid enough attention in clinical practice.

Feasibility and mid- to long-term results of endovascular treatment for portal vein thrombosis after living-donor liver transplantation.

We aimed to evaluate mid- to long-term results of endovascular treatment for portal vein thrombosis (PVT) after living-donor liver transplantation (LDLT). Thirty cases (14 males, 16 females; age range, 0.67-65 years) who underwent endovascular treatment including thrombolysis, angioplasty, stent placement, and/or collateral embolization for PVT after LDLT from 2001 to 2017 were retrospectively reviewed. Clinical and procedural data were collected and analyzed regarding the patency of the PVT site at the last follow-up date (PVT-free persistency) using Log-rank test. Results were considered statistically significant at P < 0.05. Median follow-up was 120 months. The technical success rate was 80% (n=24). Patency rates at 1 week and 1, 3, 6, 12, 36, and 60 months were 73%, 59%, 55%, 51%, 51%, 51%, and 51% for primary patency and 80%, 70%, 66%, 66%, 66%, 61%, and 61% for assisted patency after secondary endovascular treatment. PVT-free persistency rates regarding the subgroups were as follows: children under 12 years vs. adults, 50% vs. 68% (P = 0.42); acute vs. nonacute, 76% vs. 46% (P = 0.10); localized vs. extensive, 90% vs. 50% (P = 0.035); transileocolic approach vs. percutaneous-transhepatic approach, 71% vs. 54% (P = 0.39); and thrombolysis-based treatment vs. non-thrombolysis-based treatment, 71% vs. 44% (P = 0.12), respectively. Among technically successful cases, PVT-free persistency rate was 94% for those with hepatopetal flow in the peripheral portal vein vs. 17% for those without hepatopetal flow (P < 0.001). The only major complication occurring was pleural hemorrhage (n=1). Minor complications (i.e., fever) occurred in 18 patients (60%). In conclusion, mid- to long-term portal patency following endovascular treatment was approximately 50%-60% in PVT patients after LDLT. PVT site patency over three months after the first endovascular treatment, localized PVT, and hepatopetal flow in the peripheral portal vein were identified as key prognostic factors for mid- to long-term portal patency.

Multicentre experience with two frozen elephant trunk prostheses in the treatment of acute aortic dissection†.

The aim of this study was to evaluate early- and mid-term outcome and aortic remodelling in patients undergoing implantation of 2 different frozen elephant trunk prostheses, either the Thoraflex™ hybrid (Vascutek, Inchinnan, UK) and the E-vita Open (Jotec Inc., Hechingen, Germany) for acute aortic dissection. All consecutive patients [n = 88; median age 59 (49-67) years; 69% male] undergoing surgery with a frozen elephant trunk prosthesis for acute aortic dissection from August 2005 until March 2018 were included in this study. The Thoraflex™ device was implanted in 55 patients and the E-vita Open graft in 33 patients. Preoperative characteristics did not differ significantly between groups. There was also no statistically significant difference in postoperative outcome: in-hospital mortality (11% vs 12%; P > 0.99), stroke (18% vs 6%; P = 0.12) and spinal cord injury (6% vs 6%; P > 0.99). While there was no statistically significant difference in the occurrence of distal stent graft-induced new entries (16% vs 18%; P = 0.77), there was a significantly higher rate of secondary endovascular aortic interventions in the Thoraflex™ hybrid group (22% vs 0%; P = 0.003). There was a trend towards a higher rate of false lumen thrombosis at the level of the stent graft (74% vs 95%; P = 0.085) and was comparable at the thoraco-abdominal transition (53% vs 80%; P = 0.36) 1 year after implantation of the prostheses. In this comparison of 2 frozen elephant trunk prostheses, there is no evidence that different surgical techniques influence in-hospital outcome. At 1-year follow-up, patients who underwent implantation of the E-vita Open prosthesis showed a significantly reduced rate of secondary aortic interventions and a trend towards a higher rate of false lumen thrombosis which might be attributed to a longer coverage of the descending aorta due to a longer stent graft design and significantly more frequent implantation in zone 3.

The management of pediatric renovascular hypertension: a single center experience and review of the literature

IntroductionRenal artery occlusive disease is poorly characterized in children; treatments include medications, endovascular techniques, and surgery. We aimed to describe the course of renovascular hypertension (RVH), its treatments and outcomes. MethodsWe performed literature review and retrospective review (1993–2014) of children with renovascular hypertension at our institution. Response to treatment was defined by National High Blood Pressure Education Program Working Group on High Blood Pressure in Children and Adolescents at most-recent follow-up. ResultsWe identified 39 patients with RVH. 54% (n=21) were male, with mean age of 6.93 ± 5.27 years. Most underwent endovascular treatment (n=17), with medication alone (n=12) and surgery (n=10) less commonly utilized. Endovascular treatment resulted in 18% cure, 65% improvement and 18% failure; surgery resulted in 30% cure, 50% improvement and 20% failure. Medication alone resulted in 0% cure, 75% improvement and 25% failure. 24% with endovascular treatment required secondary endovascular intervention; 18% required secondary surgery. 20% of patients who underwent initial surgery required reoperation for re-stenosis. Mean follow-up was 52.2 ± 58.4 months. ConclusionsRVH treatment in children includes medications, surgical or endovascular approaches, with all resulting in combined 79% improvement in or cure rates. A multidisciplinary approach and individualized patient management are critical to optimize outcomes. Type of StudyRetrospective comparative study Level of evidenceLevel III

PC022 Thoracic Endovascular Repair for Acute Complicated Type B Aortic Dissections

This study assessed in-hospital mortality and midterm results of emergency thoracic endovascular aortic repair (TEVAR) stent grafting for patients with life-threatening complications of acute type B aortic dissections (acTBD). Between March 2001 and Sept 2016, 53 patients (38 men; mean age, 55 ± 13) with an acTBD were treated with TEVAR for malperfusion (55%), aortic rupture (15%), or persistent untreatable pain (30%) as a sign of pending rupture. Four patients (8%) had undergone previous aortic surgery. Technical success (coverage of the primary tear site) was achieved in 48 patients (91%). Overall hospital mortality rate was 9% (n = 5). Causes of death were rupture during the procedure or on the first postinterventional day in two patients and redissection (ascending aorta n = 2, descending aorta n = 1) with consequent aortic rupture after TEVAR in the remaining three. Permanent neurologic dysfunction occurred in 3 patients (stroke n = 1, paraplegia n = 2). Nineteen patients (36%) developed early endoleaks (type Ia, n = 5; type Ib, n = 11; type II, n = 2; type Ib plus II, n = 1) and were observed throughout the postinterventional period. These seven patients (37%) needed secondary endovascular intervention (n = 3) or conventional surgery (n = 4) due to aortic progression (mean interval after procedure 92 ± 56 months). Secondary endoleaks were observed in nine patients with consequent reintervention in three patients. The actuarial survival was 88%, 76%, and 58% at 1, 5, and 10 years, respectively. Freedom from treatment failure at 1, 5, and 10 years (including reintervention, aortic rupture, device-related complications, aortic-related death, or sudden, unexplained late death) was 76 %, 74%, and 74%, respectively. TEVAR in the treatment of acute complicated type B aortic dissection proves to be an excellent treatment modality in this high risk patient cohort. Refinements, especially in stent design and application, may further reduce the rate of endoleaks and improve the prognosis of patients in this life-threatening situation.

The Natural History and Outcomes of Endovascular Therapy for Claudication

The natural history of claudication is well-characterized and traditional therapy includes risk factor modification and exercise protocols with revascularization reserved for patients who are severely impaired. However, the reduced periprocedural morbidity with endovascular therapy has led physicians to broaden the indications for intervention for peripheral artery disease, and more claudicants are undergoing procedures for disease that is moderately limiting to their lifestyle. This study sought to assess the natural history of patients who have undergone peripheral vascular intervention for claudication. All patients who underwent at least 1 peripheral vascular intervention (PVI) for claudication at a single institution from January 2007 to December 2013 were identified. Patient demographics were assessed using the hospital record. Outcomes included secondary endovascular intervention, secondary bypass intervention, amputation, and survival. Cox proportional hazards models were created to assess risk factors for further intervention. Five hundred fifteen patients were identified as having undergone PVI for claudication during the study period. Forty-three percent were female, 37% had diabetes, 31% had coronary artery disease, 26% were current smokers, 6.6% had congestive heart failure, 8.2% had a tibial lesion that was intervened upon, and 35% had a Trans-Atlantic Inter-Society Consensus Document (TASC) II C/D lesion. Actuarial survival at 5years was 79.9% and 62.5% of patients had primary patency. The limb salvage rate was 97.2%. Over the follow-up period, 21.8% required some type of further intervention: either endovascular (17.7%) or open bypass (7.2%). A Cox proportional hazards model adjusting for age, sex, and other comorbidities showed that the two largest risk factors for requiring reintervention were angioplasty only (no stent; hazard ratio [HR] 1.36, P=0.02) and TASC C/D lesion (HR 1.52, P=0.03). With 5-year follow-up, patients have a primary patency that is comparable to an open prosthetic bypass to an above knee target. In addition, the secondary patency rate was over 90% and the major amputation rate as less than 3%. The presence of a TASC C/D lesion was predictive of failure of endovascular therapy, and surgical bypass should be considered in these patients.

Failure modes and secondary endovascular interventions after endovascular aortic repair.

Endovascular repair has a firmly established role in the treatment of aortic disease. The development of endovascular devices to treat even complex aortic disease has broadened the panorama of repair significantly but has also introduced new forms of repair failure. Standard devices for EVAR and TEVAR have also been enhanced, providing better adaptation to the anatomy treated, smaller delivery systems, more intuitive delivery designs as well as improved features to facilitate precise delivery of the device. Improved imaging techniques also contribute to improved outcomes. The main subtypes of complications are still related to either endoleaks or stentgraft stenosis/occlusions. With more complex repairs also follow more complex failure modes. Choosing and planning a repair according to the specific patient anatomy without compromising the sealing zones of the repair remains vital to provide long-term durability. Continued surveillance is mandatory to improve not only repair durability but also to increase the knowledge of progressive aortic disease.

Late Open Surgical Conversion After Endovascular Abdominal Aortic Aneurysm Repair: A Review of 15 Years of Experience

Late open conversion following endovascular aneurysm repair (EVAR) represents a failure of therapy, used to treat complications refractory to secondary endovascular intervention. With liberalization of EVAR and expansion to populations outside of instructions for use (IFU), it is imperative to better understand predictors and to prevent this outcome. The objective of this study was to understand the patterns of presentation, graft-specific differences, outcomes of interventions, and relationship to IFU adherence among patients who underwent late open conversion of EVAR. Records of 1038 consecutive patients who underwent EVAR at The Ottawa Hospital between October 2000 and May 2015 were reviewed from a prospective database. Patients requiring conversion to open repair >1 month after implantation were identified. Patients who underwent fenestrated, branched, or thoracic endovascular repair were excluded. Variables analyzed included date of interventions, adherence to IFU, graft type, interval to open conversion surgery, reason for removal, operative technique, length of stay, hospital complications, and death. A total of 16 patients underwent EVAR that required subsequent late conversion to open repair. Initial grafts implanted included Medtronic (Santa Rosa, Calif) Talent (eight patients, 50.0%), Medtronic Endurant (three patients, 18.8%), Cook (Bloomington, Ind) Zenith (four patients, 25.0%), and Terumo (Somerset, NJ) Anaconda (one patient, 6.2%). Average time to intervention was 3.3 ± 2.5 years, and this interval decreased during the study period (4.6 ± 3.0 years for EVARs before 2007 vs 2.89 ± 1.37 years for EVARs after 2009). Indications for conversion were graft infection in four patients (25%), aneurysm rupture in two patients (12.5%), endograft migration in three patients (18.8%), sac expansion secondary to type Ia endoleak in three patients (18.8%), sac expansion secondary to type II endoleak in two patients (12.5%), and sac expansion without detectable endoleak in two patients (12.5%). Nine patients (56.2%) underwent open conversion by stent graft explantation with in situ graft reconstruction; the remaining seven patients were treated with open cerclage of the aneurysm sac around the device. The 30-day mortality was 18.8%. Major in-hospital complications occurred in 10 patients (62.5%). An additional two patients (12.5%) required postconversion surgical reintervention. During initial EVAR, operators were adherent to device IFU in seven cases (43.8%), which is markedly lower than IFU adherence rates of 88.0% among uncomplicated EVARs in our database. Conversion to open repair following EVAR is associated with significant morbidity and mortality. The rate of operator adherence to IFU at time of initial EVAR in this cohort of open conversions is markedly low in comparison to the overall EVAR cohort. The decreasing interval to open conversion is concerning and may be a reflection of increasing liberalization of EVAR to populations outside of IFU.

Results of primary stent therapy for femoropopliteal peripheral arterial disease at 7 years

ObjectivePrimary stenting is a well-established treatment option for femoropopliteal arterial disease. However, there is a paucity of data concerning the performance of this modality at ≥5 years. This study evaluated the long-term clinical and radiologic outcomes of primary stent therapy in patients with femoropopliteal arterial disease. MethodsA prospective data collection and analysis was conducted in patients undergoing primary stent placement in femoropopliteal lesions between September 2006 and September 2007. The EverFlex (Medtronic/Covidien, Plymouth, Minn) bare-metal stent was used. The primary outcome of this study was the primary patency rate. Secondary outcomes were secondary patency rate, amputation-free-survival (AFS), and freedom from target lesion revascularization (TLR). A Cox regression analysis identified risk factors for the primary and the secondary measure outcomes. ResultsIncluded were 89 patients (102 stents). The prevalence of critical limb ischemia was 34% (n = 30). The initial angiography revealed a TransAtlantic Inter-Society Consensus for the Management of Peripheral Arterial Disease C/D lesion in 31 patients (35%). Occlusions were present in 49 patients (55%), and the mean lesion length was 116 ± 33 mm. Popliteal artery disease was present in 39 treated limbs (35%). The primary patency rate at 1, 3, 5, and 7 years was 73%, 64%, 47%, and 33% respectively. At 7 years, secondary patency rate was 67%, freedom from TLR was 47%, and the AFS was 73%. Cox regression analysis revealed a decreased AFS among diabetic patients (hazard ratio [HR], 2.6; 95% confidence interval [CI], 1.08-6.28; P = .03), whereas secondary endovascular interventions showed a protective effect for AFS (HR, 0.14; 95% CI, 0.03-0.65; P = .01). Popliteal artery disease was identified as independent risk factor for secondary interventions (HR, 2.07; 95% CI, 1.05-4.06; P = .04) and TLR (HR, 1.99; 95% CI, 1.03-3.83; P = .04). Critical limb ischemia was associated with an increased incidence of surgical conversion owing to endovascular treatment failure (HR, 5.46; 95% CI, 2.44-12.17; P < .001). ConclusionsThis study found primary stenting was associated with acceptable clinical and radiologic long-term outcomes. Diabetes was associated with poor AFS, and popliteal artery involvement correlated with an increased need for reinterventions. AFS was better among patients undergoing secondary procedures.

Late Rupture of Abdominal Aortic Aneurysm After Previous Endovascular Repair

Purpose: To report a systematic literature review of late rupture of abdominal aortic aneurysm (AAA) after endovascular aneurysm repair (EVAR) and the results of a pooled analysis of causes, treatment, and outcomes. Methods: Electronic information sources and bibliographic reference lists were interrogated using a combination of free text and controlled vocabulary searches; 11 articles were ultimately identified that fulfilled the inclusion criteria. The articles reported a total of 190 patients who were included in the qualitative and quantitative synthesis. Mortality within 30 days or during the admission with aneurysm rupture was a primary endpoint; major perioperative morbidity was a secondary endpoint. A meta-analysis was performed for 30-day/in-hospital mortality using the random effects model. Results: A total of 152 ruptures occurred after 16,974 EVAR procedures reported by 8 of the case series, giving an incidence of 0.9% [95% confidence interval (CI) 0.77 to 1.05]. The mean time to rupture was 37 months. Twenty-nine percent (95% CI 20 to 39) of the patients had at least one previous secondary endovascular intervention following the initial EVAR, and 37% (95% CI 30 to 45) were not compliant with surveillance. Type I and III endoleaks were the predominant causes of rupture. Open surgical treatment was undertaken in 61% (95% CI 53 to 68) of the patients who underwent treatment. The pooled estimate for perioperative mortality was 32% (95% CI 24 to 41). A significantly lower mortality was found with endovascular treatment than open surgical management (p=0.027). Conclusion: Graft-related endoleaks appear to be the predominant causes of late aneurysm rupture. Quality of and compliance with post-EVAR surveillance are important factors in late rupture; a large proportion of late ruptures are amenable to endovascular treatment.

Endovascular treatment for symptomatic stent failures in long-segment chronic total occlusion of femoropopliteal arteries

The objective of this study was to evaluate the outcomes of the secondary endovascular treatment (SEVT) for symptomatic recurrences in long-segment chronic total occlusion (CTO) of femoropopliteal arteries (FPAs) and to investigate the factors affecting the outcomes. Data of patients undergoing FPA stent implantation for primary, long-segment (>10 cm) CTO lesions and receiving endovascular intervention for symptomatic recurrences more than once in our institution from July 1, 2008, to September 1, 2012, were reviewed. Follow-up results referring to SEVT procedures were analyzed, including primary patency, limb salvage (LS) rate, technical success rate, and prevalence of procedure-related complications. Primary patency and LS were analyzed with Kaplan-Meier curves. Univariate and multivariable analyses were performed to identify factors associated with recurrent restenosis with a Cox proportional hazards model. Ninety-one patients (mean age, 75.1 years) were included. The indications for SEVT were claudication (38.5%) and critical limb ischemia (61.5%). Preprocedural ankle-brachial index was 0.37 ± 0.16. The median time between initial endovascular treatment and SEVT was 6.5 months (range, 1.0-24.4 months). The arteries in 63 limbs were totally occluded. Fractures were found in 30 (18.8%) of the initially placed stents. Successful recanalization was achieved in 82 limbs (90.1%). The mean postprocedural ankle-brachial index was 0.84 ± 0.15 in those limbs that were successfully recanalized. The complication rate was 9.9%. One patient died of cerebral hemorrhage during catheter-directed thrombolysis. Other complications included the development of a groin hematoma (n = 5), distal embolization (n = 1), formation of a femoral pseudoaneurysm (n = 1), and development of acute heart failure (n = 1). The mean follow-up period was 11.0 ± 5.6 months. The cumulative primary patency rate after SEVT was 66.9% and 52.0% at 12 and 24 months. The LS rate since SEVT was 91.2% and 81.1% at 12 and 24 months. The multivariate analysis showed that stent fracture and stent overlap were independent predictors of recurrent restenosis (hazard ratio, 3.07; 95% confidence interval, 1.40-6.74; P = .005; hazard ratio, 4.75; 95% confidence interval, 1.77-12.75; P = .002). Endovascular treatment is feasible for FPA stent failure in long-segment CTO. However, SEVT does not achieve durable patency. Stent fracture and overlap are related to recurrent restenosis.

When Not to Implant the Multilayer Flow Modulator: Lessons Learned From Application Outside the Indications for Use in Patients With Thoracoabdominal Pathologies

To scrutinize registry data on thoracoabdominal repairs performed using the Multilayer Flow Modulator (MFM) outside the indications for use (IFU) and analyze the adverse outcomes. Of 380 patients from Europe registered in the MFM Global Registry after treatment for thoracoabdominal aortic aneurysm (TAAA) or dissection, 38 (10%) patients (30 men; median age 71 years, range 30-91) treated on a compassionate basis outside the IFU were analyzed. Thirteen patients had chronic Stanford type B dissection with aneurysmal dilatation >6 cm. There were 6 mycotic and 4 saccular aneurysms in addition to 15 primary TAAAs. The mean aneurysm diameter was 7.1 cm. Ten patients presented with rupture, and 23 patients had previous open or thoracic endovascular aortic repair (TEVAR). Although no death, paraplegia, stroke, or renovisceral compromise was documented during the initial hospital stay, technical success was zero. There were 31 (81.6%) cases in which there was failure to land the device in normal aorta. Other violations of the IFU included 12 with inadequate stent overlap and 11 cases involving a small MFM being deployed inside a larger one. Five of the 9 cases in which an undersized device was used resulted in a type I endoleak (failure mode I). During a mean follow-up of 10.0±6.9 months, all-cause mortality was 89.5% (34/38), of which 27 (71.1%) were aneurysm-related deaths. Overall survival, freedom from aneurysm-related death, and rupture-free survival estimates were 17.5%, 25.0%, 31.5%, respectively, at 18 months. There were 8 visceral branch complications; in all, 14 secondary endovascular interventions were required in 11 patients for endoleak (failure modes I and II) or stent foreshortening. No false lumen was completely thrombosed in the dissecting aneurysms. All aneurysms showed a mean sac growth rate of 0.12±0.16 cm/month. Factors having a significance influence on risk of aneurysm-related death included maximum aneurysm diameter (p=0.025, HR 1.37, 95% CI 1.04 to1.82), previous TEVAR (p=0.03, HR 2.44, 95% CI 1.10 to 2.08), and inadequate overlap between MFM devices (p<0.002, HR 4.02, 95% CI 1.70 to 9.49). There are clinical scenarios in which the MFM does not perform well. The MFM is not a solution for patients living on borrowed time and should not be used indiscriminately in patients in whom other modalities of aortic repair are not feasible. Its use must adhere to the IFU, and robust clinical data are required before constructing a randomized controlled trial.

Secondary Interventions After Endovascular Thoracic Aortic Repair

Endovascular stent grafting of the descending thoracic aorta has evolved rapidly and is now the standard of care for certain patient subsets. However, the durability of this technique is limited by the development of technique-specific complications at mid-term follow-up. The aim of this study was to evaluate the incidence, techniques, and outcomes of secondary intervention for complications after stent grafting of the descending thoracic aorta. Between March 2001 and November 2011, 152 patients underwent endovascular thoracic aortic repair (TEVAR). We identified 19 (12.5%) patients from this cohort who required secondary interventions. The indications for TEVAR were type B aortic dissection in 12 patients, thoracic aortic aneurysm in six patients, and intramural hematoma in one patient. The mean time between TEVAR and secondary intervention was 20.49 ± 24.90 months (range, 1.2-83 months). A secondary endovascular intervention was required in eleven patient, six patients required secondary surgical therapy, and hybrid procedures were performed in two patients. Endoleaks were the most common indication for a secondary intervention. The 30-day mortality rate was 10.5% (2/19). Two perioperative deaths were observed following surgical therapy. During the mean follow-up of 78.06 ± 37.37 months (range, 23-142 months) after TEVAR, four unrelated deaths occurred, two patients were lost to follow-up, and four patients required a further intervention. Secondary intervention after endovascular stent grafting of the descending thoracic aorta was not infrequently required and can be performed with acceptable risks. However, serial, systematic follow-up is essential to detect late complications and to perform secondary procedures, preferably under elective circumstances.

One-stage repair in complex multisegmental thoracic aneurysmal disease: results of a multicentre study†

Patients with thoracic aneurysmal disease involving the arch and the descending or thoracoabdominal aorta may require more than one surgical intervention. The results of one-stage repair using a hybrid stent-graft in the frozen elephant trunk manner are presented. Between January 2005 and March 2012, 113 (age 67 ± 10 years) of 358 registered patients in the International E-Vita Open Registry were operated on for combined arch and descending and thoracoabdominal aortic aneurysm. Thirty-one (27%) patients had a previous cardiothoracic, abdominal aortic surgery or endovascular repair. The E-Vita Open hybrid stent-graft was used in all cases. Postoperatively and during the follow-up (100%), aortic image examinations were performed. Combined arch replacement and antegrade stent-grafting distally (graft diameter 34 ± 4 mm) were performed under selective cerebral perfusion (72 ± 27 min) and hypothermic visceral ischaemia (65 ± 27 min). Postoperatively, aneurysm exclusion was completely and partially achieved in 80% and 20%, respectively. In-hospital mortality and survival rate after 5 years were 12% (13 of 113) and 78%, respectively. Latest aortic imaging demonstrated 93% complete aneurysm exclusion. Freedom from secondary endovascular intervention and open surgery were 88 and 90%, respectively. In multisegmental thoracic aneurysmal disease, combined arch replacement with distal repair by a hybrid stent-graft enables one-stage treatment with acceptable mortality. Aneurysm exclusion by the stent-graft seems to be primarily curative and allows easier access for distal open or endovascular reintervention.

Patient outcomes and thoracic aortic volume and morphologic changes following thoracic endovascular aortic repair in patients with complicated chronic type B aortic dissection

True and false lumen changes and patient outcomes following thoracic endovascular aortic repair (TEVAR) for patients with stable type B dissection have been described by the The Investigation of Stent Grafts in Aortic Dissection (INSTEAD) trial. However, these changes have not been described in TEVAR patients treated for complications of chronic dissection. A single-institution study was conducted of 73 prospectively evaluated patients treated for complications of chronic type B dissection from 2002 to 2010. Spiral computed tomography reconstructions using M2S (Medical Media Systems, West Lebanon, NH) were analyzed for sequential changes in aortic volume and diameter during patient follow-up. Changes in aortic volume and diameter were tabulated as a percent change from preoperative values. Patient outcomes were determined by sequential evaluations postprocedure. TEVAR was successfully performed in 72 out of the 73 patients (99%). Indications for intervention were aortic enlargement (n = 62), failure of medical management (n = 7), and perforation (n = 4). The 30-day all-cause mortality rate was 14%; events were due to retrograde dissection (n = 4), cardiac-related (n = 4), and rupture (n = 2). Eleven out of the 72 patients (15%) required a secondary procedure for endoleak (n = 7) and persistent distal perfusion of the false lumen (n = 4). Mean percentage expansion of the thoracic true lumen was noted during the follow-up period: 38%, 46%, 71%, and 114% at 1-, 3-, 6-, and 12-month follow-up, respectively. Concomitant regression of the thoracic false lumen of -65%, -68%, -84%, and -84% was observed at the same intervals, respectively. Patients with an initial extension of the thoracic dissection into the infrarenal aorta (n = 46) had an increase in mean percentage change of aortic diameter and volume to 21% and 17% at 1 year, respectively. By contrast, in the patient group without infrarenal dissection (n = 14), the infrarenal aortic diameter and volume remained relatively unchanged at 3% and -0.9%, respectively, at 1-year postintervention. TEVAR is a potential treatment option for patients experiencing complications of chronic type B dissection. During follow-up, there is a predictable expansion of the thoracic true lumen and regression of the thoracic false lumen. These findings correlate with those of the INSTEAD trial, which demonstrated false lumen regression and true lumen expansion in a cohort of patients with stable type B dissection. However, many patients with extension of thoracic dissection into the infrarenal aorta demonstrate continued aortic dilation and, on occasion, the need for secondary intervention for persistent distal perfusion. Further analysis is needed in this subgroup of patients so as to better determine potential predictors and the clinical significance of post-TEVAR infrarenal expansion. Moreover, further investigations may support a role for secondary endovascular intervention in remedying persistent infrarenal aortic expansion after TEVAR for chronic dissection.