Gender Related Access Complications After TEVAR: Analysis from the Retrospective Multicentre Cohort GORE® GREAT Registry Study.

OBJECTIVE: The Global Registry for Endovascular Aortic Treatment (GREAT), a retrospective sponsored registry, was queried to determine the incidence and identify potential predictors of access related complications after TEVAR. METHODS: This is a multicentre, observational cohort study. For the current study, all patients were treated only with the Conformable GORE® TAG® Thoracic Endoprosthesis and GORE® TAG® Thoracic Endoprosthesis devices for any kind of thoracic aortic disease. All serious adverse events within 30 days of the procedure were documented by sites. The following were considered access related complications: surgical site infection, pseudoaneurysm, avulsion, dissection, arterial bleeding, access vessel thrombosis/occlusion, seroma, and lymphocoele. RESULTS: A total of 887 patients was analysed: most of the cases had an operative indication for TEVAR of degenerative atherosclerotic aneurysm (n = 414, 46.7%) and type B dissection (n = 270, 30.4% either complicated or uncomplicated). Two hundred and ninety-five patients (33.3%) were female. The overall access related complication rate was 2.8% (n = 25): 4.7% (n = 14) in women and 1.8% (n = 11) in men (p = .013). After adjustment for age, urgency, device diameter, introducer sheath (≥24Fr vs. ≤ 24Fr), access vessel diameters, and access method, female gender was significantly associated with the risk of access complications (OR 2.85; p = .038). Brachial artery for access was also found to be an independent predictor of access related complications (OR 8.32; p < .001). CONCLUSION: This analysis suggests that women may have a higher access related complication rate after TEVAR, irrespective of the clinical setting, type of aortic disease, and device sizing.

Long-term results of hybrid repair techniques for Kommerell's diverticulum.

OBJECTIVE: The aim of this study was to evaluate early and late results of hybrid repair techniques for Kommerell's diverticulum (KD). METHODS: All patients who underwent hybrid repair (thoracic endovascular aortic repair + supra-aortic debranching) for KD between 2009 and 2018 were included in this retrospective multicenter study (three Italian centers). A proximal landing zone (PLZ) of at least 2 cm of healthy aorta was considered adequate for the deployment of a standard thoracic stent graft. The early end points were technical success, in-hospital mortality, and cerebrovascular events. Late outcomes included survival, reintervention, and patency of supra-aortic debranching. We used an embryogenetic anomaly based aortic arch classification for PLZ evaluation to identify the most appropriate hybrid adjunct. RESULTS: Sixteen patients with KD were included. According to the aforementioned classification, stent graft deployment was required in six patients (37.5%) in PLZ 0, nine patients (56.3%) in PLZ 1, and one patient (6.3%) in PLZ 2. Technical success was achieved in all patients. One patient (6.3%) died in the hospital because of posterior cerebral hemorrhage after total debranching (PLZ 0). No further cerebrovascular events were observed. One patient (6.3%) had an asymptomatic left subclavian artery-right left subclavian artery bypass occlusion and required early reintervention. The 30-day secondary patency of supra-aortic debranching was 100%. Two type II endoleaks (12.5%) were detected at 1 month through computed tomography angiography. Further transient complications were found in three cases: hemidiaphragm paralysis in one patient and recurrent laryngeal nerve paralysis in two patients. At a mean follow-up of 48 months, four patients had died because of nonaortic reasons, and one RCCA-right subclavian artery bypass had lost its patency. None of the patients reported any growth of KD after hybrid repair. Ten patients (62.5%) showed aneurysmal sac shrinkage of at least 5 mm. CONCLUSIONS: Hybrid repair is confirmed to be a safe and effective approach for KD. Operative risk is associated primarily with the invasiveness of the hybrid adjunct.

iTalian RegIstry of doUble inner branch stent graft for arch PatHology (the TRIUmPH Registry).

OBJECTIVE: The objective of this study was to assess early and midterm results after endovascular aortic arch repair using a double inner branch stent graft (DIBSG) in patients with aortic arch aneurysm or dissection unfit for open surgery. METHODS: Between 2012 and 2018, there were 24 patients with aortic arch disease who were treated with a single model of a DIBSG (Terumo Aortic, Glasgow, United Kingdom) in nine Italian cardiovascular centers. We investigated technical success, mortality, occurrence of major complications, and need for reintervention in a multicenter, nonrandomized, retrospective fashion. RESULTS: The in-hospital mortality rate was 16.7%. Cerebrovascular events occurred in 25% of patients and major strokes in 12.5%. Two patients experienced a retrograde dissection (8.3%), whereas none reported any type I or type III endoleak. During a mean follow-up of 18 months (range, 1-60 months), one patient died of a nonaortic cause and one reported a nonarch-related major stroke. No late secondary intervention was needed during the follow-up. Excluding from the analysis the first six patients treated until 2014 as part of the learning curve, in-hospital mortality, major stroke, and retrograde dissection rates were 11.1%, 11.1%, and 5.6%, respectively. CONCLUSIONS: Endovascular aortic arch repair using this model of DIBSG is feasible, and results are acceptable for a new technique in a high-risk subset of patients. Operative mortality suffers the effect of a learning curve, whereas midterm aorta-related survival is promising. Endovascular repair of aortic arch disease with a DIBSG should always be considered to give high-risk patients a chance of repair. Large-scale studies are needed to assess the long-term durability of this technique.

Isolated Common Iliac Artery Aneurysms Treated Solely With Iliac Branch Stent-Grafts: Midterm Results of a Multicenter Registry.

PURPOSE: To assess early and midterm outcomes of iliac branch device (IBD) implantation without an aortic stent-graft for the treatment of isolated common iliac artery aneurysm (CIAA). METHODS: From December 2006 to June 2016, 49 isolated CIAAs in 46 patients were treated solely with an IBD at 7 vascular centers. Five patients were lost to follow-up, leaving 41 male patients (mean age 72.5±7.8 years) for analysis. Mean CIAA diameter was 39.1±10.5 mm (range 25-65). Thirty-two patients (2 with bilateral CIAAs) were treated with a Cook Zenith iliac branch device; 9 patients (1 bilateral) received a Gore Excluder iliac branch endoprosthesis. Primary endpoints were technical success, survival, aneurysm exclusion, device patency, and freedom from reintervention at 1 and 5 years. Freedom from major adverse events and aneurysm shrinkage at 1 year were also assessed. RESULTS: Thirty-day mortality and the IBD occlusion rate were 2.4% and 2.3%, respectively. At a mean follow-up of 40.2±33.9 months, no patient presented buttock claudication, erectile dysfunction, or bowel or spinal cord ischemia. Three patients died within 6 months after the procedure. Estimates of cumulative survival, device patency, and freedom from reintervention were 90.2%, 95.2%, and 95.7%, respectively, at 1 and 5 years. At 1 year, CIAA shrinkage ≥5 mm was recorded in 21 of 38 survivors. No evidence of endoleak, device migration, or disconnection was found on imaging follow-up. CONCLUSION: The use of IBDs without an aortic stent-graft for isolated CIAAs resulted in excellent patency, with low morbidity and mortality. This, in conjunction with no endoleak or migration and a low reintervention rate, supports the use of isolated IBDs as a stable and durable means of endovascular reconstruction in cases with suitable anatomy. Longer follow-up and a larger cohort are needed to validate these results.

Endovascular arch replacement with a dual branched endoprosthesis.

BACKGROUND: In the light of current evidence, endovascular repair of aortic arch pathologies with custom-made devices should be considered a valid alternative to decrease operative mortality and morbidity associated with open or hybrid repair. Currently, two double inner branch devices are available on the market. Some papers from multicenter experiences have been published about the use of Cook device. We report our single-center experience with Bolton double branch stent graft in the treatment of aortic arch disease. METHODS: Between 2013 and 2016, nine high-risk patients with arch pathology were treated in our center with a Bolton custom-made branched device. Among these, two with a single branch model were excluded, leaving a subgroup of seven patients of this study. RESULTS: Out of the seven male patients (mean age, 76; range, 70-85) included in the study, two (28%) died perioperatively after stroke (14%) and retrograde dissection (14%), respectively. No other death, major complications, including aneurysmal diameter evolution and branch related complications, or secondary intervention was recorded at a mean follow up of 24 [6-53] months. CONCLUSIONS: Despite the small sample size, our results are in line with the early experiences published on this technique. Endovascular repair of aortic arch disease with custom-made branched devices should always be considered to give high-risk patients a chance of repair.

The incidence and effect of noncylindrical neck morphology on outcomes after endovascular aortic aneurysm repair in the Global Registry for Endovascular Aortic Treatment.

BACKGROUND: The Gore Global Registry for Endovascular Aortic Treatment (GREAT) was designed to evaluate real-world outcomes after treatment with Gore aortic endografts used in a real-world, global setting. We retrospectively analyzed the GREAT data to evaluate the incidence and effects of noncylindrical neck anatomy in patients undergoing endovascular aortic aneurysm repair. METHODS: The present analysis included patients with data in the GREAT who had been treated with the EXCLUDER endograft from August 2010 to October 2016. A noncylindrical neck was defined when the proximal aortic landing zone diameter had changed ≥2 mm over the first 15 mm of the proximal landing zone, indicating a tapered, conical, or hourglass morphology. Cox multivariate regression analyses were performed for any reintervention (including reinterventions on aortic branch vessels), device-related reinterventions, and reintervention specifically for endoleak. Independent binary (cylindrical vs noncylindrical necks) and continuous (percentage of neck diameter change) variables were assessed. The abdominal aortic aneurysm (AAA) diameter, proximal neck length, maximal infrarenal neck angle, gender, and use of aortic extender cuffs were also assessed. RESULTS: Of 3077 GREAT patients with available proximal aortic landing zone diameter measurements available, 1765 were found to have cylindrical necks and 1312 had noncylindrical necks. The noncylindrical neck cohort had a significantly greater proportion of women (17.4% vs 12.6%; P < .001) and more severe infrarenal angulation (33.8° vs 28.4°; P < .001). A total 14.7% of noncylindrical neck patients and 11.2% cylindrical neck patients underwent implantation outside of the EXCLUDER instructions for use regarding the anatomic inclusion criteria (P = .004). The procedural characteristics were similar between the two cohorts; however, noncylindrical neck patients required significantly more aortic extender cuffs (P = .004). The average follow-up was 21.2 ± 17.5 months and 17.8 ± 15.8 months for the cylindrical and noncylindrical cohorts, respectively (P < .001). The Cox multivariate regression models demonstrated female gender and maximum AAA diameter were significant risk factors for subsequent reintervention (overall, device-related, and endoleak-specific). Women were 2.2 times as likely to require device-related intervention during the follow-up period compared with men (P < .001). Neck shape morphology was not a significant predictor, except for device-related intervention, for which cylindrical necks (binary definition) resulted in a slightly elevated risk (1.5 times; P = .03). CONCLUSIONS: Noncylindrical neck morphology was more common in women and was associated with an increased use of aortic extender cuffs but did not increase the risk of intervention. Female gender and AAA diameter were associated with an increased need for reintervention.

Endovascular repair of aortic arch disease with double inner branched thoracic stent graft: the Bolton perspective.

BACKGROUND: In the light of current evidence, endovascular repair of aortic arch pathologies with custom-made devices should be considered a valid alternative to decrease operative mortality and morbidity associated with open or hybrid repair. Today, two double inner branch devices are available on market. We report our single-center experience with Bolton double branch stent graft in the treatment of aortic arch disease. METHODS: Between 2013 and 2016, 15 high-risk patients with arch pathology were treated in our center with a custom-made branched device. Six of these received a Cook arch branched stent graft. Nine were treated with Bolton device. Among these, 2 with single branch model were excluded leaving a subgroup of 7 patients object of this study. RESULTS: Out of the 7 male patients (mean age 76, range 70-85) included in the study, 2 died in-hospital after stroke and retrograde dissection, respectively. No other death, major complication or secondary intervention was recorded at a mean follow-up of 24 (min-max 6-53) months, neither any aneurysmal diameter evolution nor branch related complications. CONCLUSIONS: Despite the small sample size, our results are in line with the early-published experiences about this technique. Endovascular repair of aortic arch disease with custom-made branched devices should always be considered to give high-risk patients a chance of repair.

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.

Secondary Procedures Following Iliac Branch Device Treatment of Aneurysms Involving the Iliac Bifurcation: The pELVIS Registry.

PURPOSE: To evaluate the incidence and reasons for secondary procedures in patients treated with iliac branch devices (IBDs) for isolated iliac aneurysm or aortoiliac aneurysms involving the iliac bifurcation. METHODS: Between January 2005 and December 2015, 575 surgical-high-risk patients (mean age 72.0±8.4 years; 558 men) with isolated iliac aneurysms (n=79) or aortoiliac aneurysms involving the iliac bifurcation (n=496) were treated with placement of 650 ZBIS or Gore IBDs (75 bilateral) in 6 European centers. The primary outcome was procedure-related reinterventions for occlusion or high-grade (>70%) stenosis of the bridging device, occlusion of the ipsilateral common or external iliac artery (EIA), type I/III endoleak, rupture, or infection following IBD implantation. Clinical and radiological data were analyzed based on preset definitions of comorbidities, aneurysm morphology, intraoperative variables, and follow-up strategies. RESULTS: Nine (1.6%) reinterventions were performed within 30 days for occlusion or endoleak. Among 10 (1.5%) occluded EIAs ipsilateral to a deployed IBD, 6 underwent a reintervention with additional stent placement after thrombolysis (n=4) or a femorofemoral or iliofemoral crossover bypass (n=2). Three of 14 patients with early type I endoleak had a reintervention for an insufficient proximal sealing zone (stent-grafts in 2 common iliac arteries and 1 bifurcated endograft). Mean clinical and radiological follow-up were 32.6±9.9 and 29.8±21.1 months, respectively. Forty-two (7.3%) patients underwent reinterventions in the follow-up period. The overall postoperative reintervention rate was 8.9%. Both external and common iliac segments occluded in 30 (4.6%) IBDs; 2 patients had a crossover bypass and 14 were treated with endovascular techniques. In the other 14 patients, no specific treatment was performed. Seven (1.2%) patients with isolated EIA occlusion were treated during follow-up. Nineteen of the overall 28 patients with type I endoleak underwent endovascular repair. The other 9 were under radiological surveillance due to less significant (<5 mm) sac increase. No reintervention was performed to recanalize 11 (1.6%) occluded internal iliac arteries. CONCLUSION: Midterm experience with placement of IBDs is associated with a low incidence of secondary procedures due to type I endoleaks and occlusions. The main reasons for reinterventions seem to be short proximal sealing zone and poor conformability of the ZBIS device in elongated EIAs.

Fourteen-year outcomes of abdominal aortic endovascular repair with the Zenith stent graft.

OBJECTIVE: Long-term results of abdominal aortic aneurysm (AAA) endovascular repair are affected by graft design renewals that tend to improve the performance of older generation prostheses but usually reset the follow-up times to zero. The present study investigated the long-term outcomes of endovascular AAA repair (EVAR) using the Zenith graft, still in use without major modification, in a single center experience. METHODS: Between 2000 and 2011, 610 patients underwent elective EVAR using the Zenith endograft (Cook Inc, Bloomington, Ind) and represent the study group. Primary outcomes were overall survival, freedom from AAA rupture, and freedom from AAA-related death. Secondary outcomes included freedom from late (>30 days) reintervention, freedom from late (>30 days) conversion to open repair, freedom from aneurysm sac enlargement >5.0 mm and freedom from EVAR failure, defined as a composite of AAA-related death, AAA rupture, AAA growth >5 mm, and any reintervention. RESULTS: Mean age was 73.2 years. Mean aneurysm diameter was 55.3 mm. There were five perioperative deaths (0.8%) and three intraoperative conversions. At a mean follow-up of 99.2 (range, 0-175) months, seven AAA ruptures occurred, all fatal except one. Overall survival was 92.8% ± 1.1% at 1 year, 70.1% ± 1.9% at 5 years, 37.8% ± 2.9% at 10 years, and 24 ± 4% at 14 years. Freedom from AAA-rupture was 99.8% ± 0.02 at 1 year (one case), 99.4% ± 0.04 at 5 years (three cases), and 98.1% ± 0.07 at 10 and 14 years. Freedom from late reintervention and conversion was 98% ± 0.6 at 1 year, 87.7% ± 1.5 at 5 years, 75.7% ± 3.2 at 10 years, and 69.9% ± 5.2 at 14 years. Freedom from aneurysm sac growth >5.0 mm was 99.8% at 1 year, 96.6% ± 0.7 at 5 years, 81.0% ± 3.4 at 10 years, and 74.1% ± 5.8% at 14 years. EVAR failure occurred in 132 (21.6%) patients at 14 years. At multivariate analysis, independent predictors of EVAR failure resulted type I and III endoleak (hazard ratio [HR], 6.7; 95% confidence interval [CI], 4.6- 9.7; P < .001], type II endoleak (HR, 2.3; 95% CI, 1.6-3.4; P < .001), and American Society of Anesthesiologists grade 4 (HR, 1.6; 95% CI, 1.0-2.6; P = .034). CONCLUSIONS: EVAR with Zenith graft represents a safe and durable repair. Risk of rupture and aneurysm-related death is low, whereas overall long-term survival remains poor. Novel endograft models should be tested and evaluated considering that one-fourth of the operated patients will still be alive after 14 years.

Impact on outcome of different types of carotid stent: results from the European Registry of Carotid Artery Stenting.

AIMS: Conflicting data exist on the impact on outcome of the use of different stent types during carotid artery stenting (CAS). The aim of this study was to evaluate clinical outcomes according to different carotid stent design among the population of the European Registry of Carotid Artery Stenting (ERCAS). METHODS AND RESULTS: The present study was conducted in 1,604 patients who underwent neuroprotected CAS in ERCAS. All types of commercially available carotid stent were used. Open-cell design stents were classified according to free cell area into <7.5 mm2 or >7.5 mm2. A total of 713 closed-cell, 456 hybrid-cell, 238 <7.5 mm2 open-cell, and 197 >7.5 mm2 open-cell stents were implanted. Overall, the 30-day stroke and death rate was 1.37%. At 30 days, 19 strokes occurred (1.18%): eight in the group of patients treated with a closed-cell (1.12%), two in those with a hybrid-cell (0.44%), three in those with a <7.5 mm2 open-cell (1.26%), and six in those treated with a >7.5 mm2 open-cell stent (3.05%) (p=0.045). CONCLUSIONS: Data of the present study suggest that, in the setting of neuroprotected CAS performed in high-volume centres by properly trained operators, the use of an open-cell design stent with a free cell area >7.5 mm2 may be associated with an increased 30-day stroke risk.

A propensity-matched comparison for endovascular and open repair of thoracoabdominal aortic aneurysms.

OBJECTIVE: The aim of this study was to investigate outcomes of patients treated with endovascular repair (ER) with the use of fenestrated and branched stent grafts or open surgery (OS) for thoracoabdominal aortic aneurysm (TAAA) in a current series of patients. METHODS: All TAAA patients undergoing repair at three centers between January 2007 and December 2014 were included in a prospective database. Patients were stratified according to treatment by ER or OS, and outcomes were compared using propensity score matching (1:1). Covariates included age, sex, aneurysm extent, hypertension, coronary disease, chronic pulmonary disease, diabetes, and renal function. The primary end points were mortality and paraplegia. Secondary end points included any spinal cord ischemia (SCI), renal and respiratory insufficiency, and a composite of these complications or death at 30 days. All-cause survival and freedom from reintervention were compared in the two groups. RESULTS: Of 341 patients, 84 (25%) underwent ER and 257 underwent OS (75%). After propensity score matching (65 patients per group), no significant differences were observed in rates of 30-day mortality (7.7% in ER and 6.2% in OS; P = 1) and paraplegia (9.2% and 10.8%; P = 1). Any SCI, renal insufficiency, and respiratory insufficiency were 12.3% and 20% (P = .34), 9.2% and 12.3% (P = .78), and 0% and 12.3% (P = .006) in ER and OS, respectively. The incidence of the composite end point was significantly lower in ER patients (18.5% in ER vs 36.0% in OS; P =.03). According to Kaplan-Meier estimates, all-cause survival at 24 months was 82.8% in ER and 84.9% in OS, with rates unchanged at 42 months (P = .9). Rates of freedom from reintervention were 91.0% vs 89.7% at 24 months and 80.0% vs 79.9% at 42 months in ER vs OS, respectively (P = .3). CONCLUSIONS: A propensity score analysis in patients with TAAA undergoing repair suggests an early benefit from ER compared with OS with regard to the composite end point because of reduced 30-day respiratory complications. No significant differences were found in SCI and renal insufficiency at 30 days and in survival and reintervention rates at midterm.

The Gore Global Registry for Endovascular Aortic Treatment: Objectives and Design.

BACKGROUND: The Global Registry for Endovascular Aortic Treatment (GREAT) is a prospective observational multicenter cohort registry that was initiated in November 2011. The aim of the GREAT is to collect contemporary real-world data on the performance of all Gore aortic endografts in the treatment of multiple aortic pathologies. The primary and secondary objectives, design, and future directions of the GREAT are described. METHODS: The GREAT aims to enroll 5000 consecutive patients with Gore thoracic and abdominal aortic endografts from multiple centers throughout the world. The GREAT has broad inclusion criteria with minimal exclusion criteria to reflect real-world practice such as including off-label use, nonstandard indications and devices deployed outside instruction for use. Follow-up will extend to 10 years providing major insights into the long-term durability and behavior of Gore aortic endografts. Primary end points include the incidence and timing of (1) endoleak of any type, (2) endograft migration and/or stent fracture, (3) endograft explantation, and (4) aortic rupture. Secondary end points include the following: (1) incidence of serious device events by pathology, (2) incidence of serious device events by aortic segment (ascending aorta, arch of aorta, descending thoracic aorta, abdominal aorta), (3) long-term survival by pathology, and (4) aorta-related mortality by pathology. RESULTS: As of June 2015, 2960 patients have been enrolled into the GREAT from 78 centers in Europe, the United States, Australia, New Zealand, and Brazil. The majority of patients and centers are from Europe and the United States. Completion of enrollment is anticipated to be in 2017 with interim results planned to be published during enrollment and on follow-up. CONCLUSIONS: Upon completion, the GREAT will be among the largest clinical registry to date of abdominal and thoracic aortic devices manufactured by a single sponsor. It will provide valuable real-world data on the use and durability of Gore aortic endografts in the treatment of a variety of aortic pathologies and devices deployed within and outside instruction for use.

Results of aberrant right subclavian artery aneurysm repair.

OBJECTIVE: The objective of this multicenter registry was to review current treatments and late results of repair of aneurysm of aberrant right subclavian artery (AARSA). METHODS: All consecutive AARSA repairs from 2006 to 2013 in seven centers were reviewed. End points were 30-day and late mortality, reintervention rate, and AARSA-related death. RESULTS: Twenty-one AARSA repairs were included (57% men; mean age, 67 years); 3 ruptures (14%) required emergent treatment; 12 (57%) were symptomatic for dysphagia (33%), dysphonia (24%), or pain (19%). Eight cases (38%) presented with thoracic aortic aneurysm, two with intramural hematoma, and one with acute type B aortic dissection. Mean AARSA diameter was 4.2 cm; a single bicarotid common trunk was present in 38% of cases. The majority of patients underwent hybrid intervention (n = 15; 71%) consisting of single (n = 2) or bilateral (n = 12) subclavian to carotid transposition or bypass or ascending aorta to subclavian bypass (n = 1) plus thoracic endovascular aortic repair (TEVAR); 19% of cases underwent open repair and 9% simple TEVAR with AARSA overstenting. Perioperative death occurred in two patients (9%): in one case after TEVAR in ruptured AARSA, requiring secondary sternotomy and aortic banding; and in an elective case due to multiorgan failure after a hybrid procedure. Median follow-up was 30 (interquartile range, 15-46) months. The Kaplan-Meier estimate of survival at 36 months was 90% (standard error, 0.64). Late AARSA-related death in one case was due to AARSA-esophageal fistula presenting with continuing backflow from distal AARSA and previous TEVAR. At computed tomography controls, one type I endoleak and one type II endoleak were detected; the latter required reintervention by aneurysm wrapping and ligature of collaterals. AARSA-related death was more frequent after TEVAR, a procedure reserved for ruptures, compared with elective open or hybrid repair. CONCLUSIONS: Hybrid repair is the preferred therapeutic option for patients presenting with AARSA. Midterm results show high rates of clinical success with low risk of reintervention. Simple endografting presents high risk of related death; these findings underline the importance of achieving complete sealing to avoid treatment failures.

Aorto-bronchial and aorto-pulmonary fistulation after thoracic endovascular aortic repair: an analysis from the European Registry of Endovascular Aortic Repair Complications.

OBJECTIVES: To learn upon incidence, underlying mechanisms and effectiveness of treatment strategies in patients with central airway and pulmonary parenchymal aorto-bronchial fistulation after thoracic endovascular aortic repair (TEVAR). METHODS: Analysis of an international multicentre registry (European Registry of Endovascular Aortic Repair Complications) between 2001 and 2012 with a total caseload of 4680 TEVAR procedures (14 centres). RESULTS: Twenty-six patients with a median age of 70 years (interquartile range: 60-77) (35% female) were identified. The incidence of either central airway (aorto-bronchial) or pulmonary parenchymal (aorto-pulmonary) fistulation (ABPF) in the entire cohort after TEVAR in the study period was 0.56% (central airway 58%, peripheral parenchymal 42%). Atherosclerotic aneurysm formation was the leading indication for TEVAR in 15 patients (58%). The incidence of primary endoleaks after initial TEVAR was n = 10 (38%), of these 80% were either type I or type III endoleaks. Fourteen patients (54%) developed central left bronchial tree lesions, 11 patients (42%) pulmonary parenchymal lesions and 1 patient (4%) developed a tracheal lesion. The recognized mechanism of ABPF was external compression of the bronchial tree in 13 patients (50%), the majority being due to endoleak formation, further ischaemia due to extensive coverage of bronchial feeding arteries in 3 patients (12%). Inflammation and graft erosion accounted for 4 patients (30%) each. Cumulative survival during the entire study period was 39%. Among deaths, 71% were attributed to ABPF. There was no difference in survival in patients having either central airway or pulmonary parenchymal ABPF (33 vs 45%, log-rank P = 0.55). Survival with a radical surgical approach was significantly better when compared with any other treatment strategy in terms of overall survival (63 vs 32% and 63 vs 21% at 1 and 2 years, respectively), as well as in terms of fistula-related survival (63 vs 43% and 63 vs 43% at 1 and 2 years, respectively). CONCLUSIONS: ABPF is a rare but highly lethal complication after TEVAR. The leading mechanism behind ABPF seems to be a continuing external compression of either the bronchial tree or left upper lobe parenchyma. In this setting, persisting or newly developing endoleak formation seems to play a crucial role. Prognosis does not differ in patients with central airway or pulmonary parenchymal fistulation. Radical bronchial or pulmonary parenchymal repair in combination with stent graft removal and aortic reconstruction seems to be the most durable treatment strategy.

Interdisciplinary expert consensus on management of type B intramural haematoma and penetrating aortic ulcer.

An expert panel on the treatment of type B intramural haematoma (IMH) and penetrating atherosclerotic ulcer (PAU) consisting of cardiologists, cardiothoracic surgeons, vascular surgeons and interventional radiologists reviewed the literature to develop treatment algorithms using a consensus method. Data from 46 studies considered relevant were retrieved for a total of 1386 patients consisting of 925 with IMH, and 461 with PAU. The weighted mean 30-day mortality from IMH was 3.9%, 3-year aortic event-related mortality with medical treatment 5.4%, open surgery 23.2% and endovascular therapy 7.1%. In patients with PAU early and 3-year aortic event-mortality rates with open surgery were 15.9 and 25.0%, respectively, and with TEVAR were 7.2 and 10.4%, respectively. According to panel consensus statements, haemodynamic instability, persistent pain, signs of impending rupture and progressive periaortic haemorrhage in two successive imaging studies require immediate surgical or endovascular treatment. In the absence of these complications, medical treatment is warranted, with imaging control at 7 days, 3 and 6 months and annually thereafter. In the chronic phase, aortic diameter >55 mm or a yearly increase ≥ 5 mm should be considered indications for open surgery or thoracic endovascular treatment, with the latter being preferred. In complicated type B aortic PAU and IMH, endovascular repair is the best treatment option in the presence of suitable anatomy.

Contemporary comparison of aortic arch repair by endovascular and open surgical reconstructions.

OBJECTIVE: This study analyzed total aortic arch reconstruction in a contemporary comparison of current open and endovascular repair. METHODS: Endovascular (group 1) and open arch procedures (group 2) performed during 2007 to 2013 were entered in a prospective database and retrospectively analyzed. Endovascular repair (proximal landing zones 0-1), with or without a hybrid adjunct, was selected for patients with a high comorbidity profile and fit anatomy. Operations involving coverage of left subclavian artery only (zone 2 proximal landing: n = 41) and open hemiarch replacement (n = 434) were excluded. Early and midterm mortality and major complications were assessed. RESULTS: Overall, 100 (78 men; mean age, 68 years) consecutive procedures were analyzed: 29 patients in group 2 and 71 in group 1. Seven group 1 patients were treated with branched or chimney stent graft, and 64 with partial or total debranching and straight stent graft. The 29 patients in group 2 were younger (mean age, 61.9 vs 70.3; P = .005), more frequently females (48.2% vs 11.3; P < .001) with less cardiac (6.9% vs 38.2%; P = .001), hypertensive (58.5% vs 88.4%; P = .002), and peripheral artery (0% vs 16.2%; P = .031) disease. At 30 days, there were six deaths in group 1 and four in group 2 (8.5% vs 13.8%; odds ratio, 1.7; 95% confidence interval, 0.45-6.66; P = .47), and four strokes in group 1 and one in group 2 (odds ratio, 0.59; 95% confidence interval, 0.06-5.59; P = 1). Spinal cord ischemia occurred in two group 1 patients and in no group 2 patients. Three retrograde dissections (1 fatal) were detected in group 1. During a mean follow-up of 26.2 months, two type I endoleaks and three reinterventions were recorded in group 1 (all for persistent endoleak), and one reintervention was performed in group 2. According to Kaplan Meier estimates, survival at 4 years was 79.8% in group 1 and 69.8% in group 2 (P = .62), and freedom from late reintervention was 94.6% and 95.5%, respectively (P = .82). CONCLUSIONS: Despite the older age and a higher comorbidity profile in patients with challenging aortic arch disease suitable and selected for endovascular arch repair, no significant differences were detected in perioperative and 4-year outcomes compared with the younger patients undergoing open arch total repair. An endovascular approach might also be a valid alternative to open surgery in average-risk patients with aortic arch diseases requiring 0 to 1 landing zones, when morphologically feasible. However, larger concurrent comparison and longer follow-up are needed to confirm this hypothesis.

Abdominal aortic endografting beyond the trials: a 15-year single-center experience comparing newer to older generation stent-grafts.

PURPOSE: To evaluate the late results of endovascular aneurysm repair (EVAR) with the endografts currently in use and compare outcomes to older devices. METHODS: Clinical, demographic, and imaging data on consecutive patients undergoing elective EVAR from January 1997 to December 2011 at a single center were retrieved from an electronic database and reviewed. Newer stent-grafts (NSG) were defined as those introduced after 2004 (second-generation Excluder and Anaconda) or currently in use without modifications (Zenith, Endurant). Of the 1412 consecutive patients (1290 men; mean age 73 years) who underwent elective EVAR in a tertiary university hospital, 882 were treated with NSGs and 530 with older stent-grafts (OSGs). RESULTS: In the NSG group, the abdominal aortic aneurysms (AAA) were larger (55.7 vs. 53.2 mm, p<0.0001) and the patients were older (p<0.0001) and less frequently smokers or had pulmonary disease, while hypertension and diabetes were more frequent (all p<0.0001). Thirty-day mortality was 0.8% in the NSG group vs. 1.1% in the OSG group (p=NS). Follow-up ranged from 1 to 174 months (mean 54.1±42.4); the OSG patients had longer mean follow-up compared to the NSG group (80.2±47.9 vs. 38.4±29.1 months, p<0.0001). All-cause survival rates were comparable in both groups. Freedom from late conversion (96.1% vs. 89.1% at 7 years, p<0.0001) or reintervention (83.6% vs. 74.2% at 7 years, p=0.015) and freedom from AAA diameter growth >5 mm (p=0.022) were higher in the NSG group. In adjusted analyses, the use of a new-generation device was a negative independent predictor of reintervention [hazard ratio (HR) 0.67, 95% confidence interval (CI) 0.49 to 0.93, p=0.015] and aneurysm growth (HR 0.63, 95% CI 0.45 to 0.89, p=0.010). CONCLUSION: Newer-generation endografts can perform substantially better than the older devices. In the long term, incidences of reintervention, conversion, and AAA growth are decreased in patients treated with devices currently in use. However, the need for continuous surveillance is still imperative for all endografts.

Aortic arch debranching and thoracic endovascular repair.

OBJECTIVE: Currently, the best approach to the aortic arch remains unsupported by robust evidence. Most of the available data rely on small sample numbers, heterogeneous settings, and limited follow-up. The objective of this study was to evaluate early and midterm results of arch debranching and endovascular procedures. METHODS: From 2005 through 2013, 104 consecutive patients underwent elective arch treatment with debranching and thoracic endovascular aortic repair. Rates of perioperative (30-day) mortality and neurological complications, and mortality, endoleak, supra-aortic vessel patency, and arch diameter changes at 5 years were analyzed. RESULTS: Patients' mean age was 69.8 years, and 90 were males. Twenty arches were repaired for dissection. Nineteen patients required total debranching for diseases extended to zone 0. In 59, debranching and thoracic endovascular aortic repair procedures were staged. At 30 days, death, stroke, and spinal cord ischemia occurred in six, four, and three patients, respectively. Extension to ascending aorta (zone 0 landing) was the only multivariate independent predictor for perioperative mortality (odds ratio, 9.6; 95% confidence interval, 1.54-59.90; P = .015), but not for stroke. Four retrograde dissections, two fatal, occurred during the perioperative period. At 1, 3, and 5 years, Kaplan-Meier survival rates were 89.0%, 82.8%, and 70.9%, and freedom from persistent endoleak rates were 96.1%, 92.5%, and 88.3%, respectively. Over 5-year follow-up, 34 aneurysms shrank ≥ 5 mm, and four grew. Five reinterventions were required. Two supra-aortic vessel occlusions and no late aorta-related mortalities were recorded. CONCLUSIONS: Despite the perioperative mortality risk, the late outcome of endovascular arch repair presents a low rate of aorta-related deaths and reinterventions and acceptable midterm survival. Furthermore, more than one-third of the aneurysms' diameters decrease over 5 years as a measure of the long-term efficacy of treatment. Retrograde type A dissection remains a major concern in the perioperative period and careful arch approach is required.