Endovascular Repair of Thoracoabdominal Aortic Aneurysm in High-Surgical Risk Patients: Fenestrated and Branched Endografts.

To report early and mid-term results of endovascular repair of thoracoabdominal aortic aneurysms (TAAAs) by using Cook Zenith fenestrated/branched endografts (FB-EVAR) in high surgical risk patients unfit for open repair (OR). Between January 2012 and April 2015, all the patients with TAAA, considered at high surgical risk for OR and treated by Cook Zenith FB-EVAR, were prospectively enrolled. Patients were studied using a thoracoabdominal computer tomography angiography (CTA) and dedicated software for advanced vessels analysis. Follow-up was performed by duplex ultrasound (DU), contrast-enhanced DU, and/or CTA. Early end points were the following: technical success (TS), spinal cord ischemia (SCI), and 30-day morbidity/mortality. Follow-up end points were the following: survival, TAAA-related mortality, target visceral vessels (TVV) patency, type I/III endoleaks, and freedom from reinterventions (FFRs). Thirty patients (male 77%, mean age 73 ± 7 years, American Society of Anesthesiologists 3/4 60%/40%) affected by TAAA type I (4%), II (21%), III (57%), and IV (18%) were enrolled. The mean aneurysm diameter was 66 ± 14 mm. The overall number of TVV was 107 (3.5 ± 0.9 vessels/patients). Custom-made and off-the-shelf endografts were used in 22 (73%) and 8 (23%) cases, respectively. The procedure was performed in multiple steps in 23 cases (77%). There were not intraoperative mortality and type I-III endoleaks, and the TVV patency was 97% (104/107). TS was 87%.There were 2 irreversible paraplegias (6.6%) and 1 reversible paraparesis (3.4%). Postoperative cardiac and pulmonary complications occurred in 2 (6.6%) and 2 (6.6%) patients, respectively. Renal function worsening (≥30% of the baseline level) was detected in 4 cases (13%). The 30-day mortality was 6.6%. Survival at 6, 12, and 24 months was 90%, 85%, and 68%, respectively. There was no TAAA-related mortality. The TVV patency at 3, 6, and 24 months was 95%, 90%, and 90%, respectively, and there were no type I-III endoleaks. FFRs at 6, 12, and 24 months was 88%. The endovascular repair of TAAA by using Cook Zenith fenestrated/branched endografts is feasible with acceptable technical and clinical results at early to mid-term results in patients at high surgical risk unfit for OR.

Gallitto E ，Gargiulo M ，Freyrie A ，Massoni CB ，Pini R ，Mascoli C ，Faggioli G ，Ancetti S ，Stella A ... -  《-》

Off-the-shelf multibranched endograft for urgent endovascular repair of thoracoabdominal aortic aneurysms.

The aim of this paper was to report early and midterm results of endovascular repair of urgent thoracoabdominal aortic aneurysms (TAAAs) by the off-the-shelf multibranched Zenith t-Branch endograft (Cook Medical, Bloomington, Ind). Between January 2014 and April 2016, all patients with urgent TAAAs (asymptomatic with diameter >8 cm, symptomatic, or ruptured TAAAs) and aortoiliac anatomic feasibility underwent endovascular repair by t-Branch and were prospectively enrolled. Clinical, morphologic, intraoperative, and postoperative data were recorded. Follow-up was performed by duplex ultrasound, contrast-enhanced duplex ultrasound, and computed tomography angiography. Early end points were technical success (absence of type I or type III endoleak, loss of target visceral vessels [TVVs], conversion to open repair, or 24-hour mortality), spinal cord ischemia, and 30-day mortality. Follow-up end points were survival, TVV patency, type I or type III endoleaks, and freedom from reintervention. Seventeen patients (male, 71%; age, 73 ± 6 years; American Society of Anesthesiologists class 3/4, 60%/40%) affected by type II (47%), III (29%), and IV (24%) TAAAs were enrolled. The indications for t-Branch were as follows: contained TAAA rupture, four (24%); symptomatic TAAA (pain or peripheral embolism), four (24%); and TAAA diameter ≥8 cm, nine (52%). The mean TAAA diameter was 80 ± 19 mm, with 63 TVVs. Fifteen patients (87%) needed adjunctive intraoperative procedures: 14 proximal thoracic endografts (thoracic endovascular aortic repair), 1 left carotid-subclavian bypass, 2 endovascular hypogastric branches, and 2 surgical iliac conduits. In four cases (24%), a significant malorientation (≥60 degrees) of the main body occurred during t-Branch deployment. Technical success was achieved in 14 cases (82%), with technical failures consisting of the loss of three renal arteries (TVV patency, 95%). Spinal cord ischemia occurred in one case (6%) with temporary paraparesis. The 30-day mortality was 6% (one patient with ruptured type II TAAA died on postoperative day 7 of respiratory failure). Renal function worsening occurred in four patients (25%), with one case requiring permanent hemodialysis. The mean follow-up was 11 ± 9 months. Survival at 1 month, 6 months, and 12 months was 94%, 82%, 82%, respectively. No TAAA-related mortality and TVV occlusion occurred in the follow-up. One type III endoleak was detected at 3 months and successfully treated. Freedom from reintervention at 1 month, 6 months, and 12 months was 88%, 82%, and 82%, respectively. The off-the-shelf multibranched endograft is a safe and effective therapeutic option for urgent total endovascular TAAA repair for which a custom-made endograft is not obtainable in due time. However, the complex anatomy of these aneurysms needs a number of adjunctive and complex intraoperative procedures to achieve a durable repair.

Gallitto E ，Gargiulo M ，Freyrie A ，Pini R ，Mascoli C ，Ancetti S ，Faggioli G ，Stella A ... -  《-》

Prospective, nonrandomized study to evaluate endovascular repair of pararenal and thoracoabdominal aortic aneurysms using fenestrated-branched endografts based on supraceliac sealing zones.

To investigate outcomes of manufactured fenestrated and branched endovascular aortic repair (F-BEVAR) endografts based on supraceliac sealing zones to treat pararenal aortic aneurysms and thoracoabdominal aortic aneurysms (TAAAs). A total of 127 patients (91 male; mean age, 75 ± 10 years old) were enrolled in a prospective, nonrandomized single-center study using manufactured F-BEVAR (November 2013-March 2015). Stent design was based on supraceliac sealing zone in all patients with ≥ four vessels in 111 (89%). Follow-up included clinical examination, laboratory studies, duplex ultrasound, and computed tomography imaging at discharge, 1 month, 6 months, and yearly. End points adjudicated by independent clinical event committee included mortality, major adverse events (any mortality, myocardial infarction, stroke, paraplegia, acute kidney injury, respiratory failure, bowel ischemia, blood loss >1 L), freedom from reintervention, and branch-related instability (occlusion, stenosis, endoleak or disconnection requiring reintervention), target vessel patency, sac aneurysm enlargement, and aneurysm rupture. There were 47 pararenal, 42 type IV, and 38 type I-III TAAAs with mean diameter of 59 ± 17 mm. A total of 496 renal-mesenteric arteries were incorporated by 352 fenestrations, 125 directional branches, and 19 celiac scallops, with a mean of 3.9 ± 0.5 vessels per patient. Technical success of target vessel incorporation was 99.6% (n = 493/496). There were no 30-day or in-hospital deaths, dialysis, ruptures or conversions to open surgical repair. Major adverse events occurred in 27 patients (21%). Paraplegia occurred in two patients (one type IV, one type II TAAAs). Follow-up was >30 days in all patients, >6 months in 79, and >12 months in 34. No patients were lost to follow-up. After a mean follow-up of 9.2 ± 7 months, 23 patients (18%) had reinterventions (15 aortic, 8 nonaortic), 4 renal artery stents were occluded, five patients had type Ia or III endoleaks, and none had aneurysm sac enlargement. Primary and secondary target vessel patency was 96% ± 1% and 98% ± 0.7% at 1 year. Freedom from any branch instability and any reintervention was 93% ± 2% and 93% ± 2% at 1 year, respectively. Patient survival was 96% ± 2% at 1 year for the entire cohort. Endovascular repair of pararenal aortic aneurysms and TAAAs, using manufactured F-BEVAR with supraceliac sealing zones, is safe and efficacious. Long-term follow-up is needed to assess the impact of four-vessel designs on device-related complications and progression of aortic disease.

Oderich GS ，Ribeiro M ，Hofer J ，Wigham J ，Cha S ，Chini J ，Macedo TA ，Gloviczki P ... -  《-》

Fenestrated and branched endovascular aneurysm repair outcomes for type II and III thoracoabdominal aortic aneurysms.

Thoracoabdominal aortic aneurysm (TAAA) repair remains a challenging clinical pathology. Endovascular technology, in particular the evolution of fenestrated and branched (F/B) endografts used in endovascular aneurysm repair (EVAR) has provided a less invasive method of treating these complex aneurysms. This study evaluated the technical and clinical outcomes of F/B-EVAR for extensive type II and III TAAA. Data from 354 high-risk patients enrolled in a physician-sponsored investigational device exemption trial (2004-2013) undergoing F/B-EVAR for type II and III TAAA were evaluated. Technical success, perioperative clinical outcomes, and midterm outcomes (36 months) for branch patency, reintervention, aneurysm-related death, and all-cause mortality were analyzed. Data are presented as mean ± standard deviation and were assessed using Kaplan-Meier, univariate, and multivariate analysis. F/B-EVARs incorporating 1305 fenestration/branches were implanted with 96% of target vessels successfully stented. Completion aortography showed 2.8% patients had a type I or III endoleak. Procedure duration (6.0 ± 1.7 vs 5.5 ± 1.6 hours; P < .01) and hospital stay (13.1 ± 10.1 vs 10.2 ± 7.4 days; P < .01) were longer for type II TAAA. Perioperative mortality was greater in type II repairs (7.0% vs 3.5%; P < .001). Permanent spinal cord ischemia occurred in 4% and renal failure requiring hemodialysis occurred in 2.8% of patients. Twenty-seven branches (7.6%) required reintervention for stenosis or occlusion; and celiac artery, superior mesenteric artery, and renal artery secondary patency at 36 months was 96% (95% confidence interval [CI], 0.93-0.99), 98% (95% CI, 0.97-1.0), and 98% (95% CI, 0.96-1.0), respectively. Eighty endoleak repairs were performed in 67 patients, including 55 branch-related endoleaks, 4 type Ia, 5 type Ib, and 15 type II endoleaks. At 36 months, freedom from aneurysm-related death was 91% (95% CI, 0.88-0.95), and freedom from all-cause mortality was 57% (95% CI, 0.50-0.63). The treatment of type II TAAA (P < .01), age (P < .01), and chronic obstructive pulmonary disease (P < .05) negatively affected survival. F/B-EVAR is a robust treatment option for patients at increased risk for conventional repair of extensive TAAAs. Technical success and branch patency are excellent, but some patients will require reintervention for branch-related endoleak. Aneurysm extent portends a higher risk of perioperative and long-term morbidity and mortality. Additional efforts are needed to improve outcomes and understand the utility of this treatment option in the general TAAA population.

Eagleton MJ ，Follansbee M ，Wolski K ，Mastracci T ，Kuramochi Y ... -  《-》

Impact of previous open aortic repair on the outcome of thoracoabdominal fenestrated and branched endografts.

Thoracoabdominal aortic aneurysms (TAAAs) after previous aortic open surgical repair (OSR) are challenging clinical scenarios. Redo-OSR is technically demanding, and standard endovascular repair is unavailable due to visceral vessel involvement. Fenestrated and branched endografts (FB-EVAR) are effective options to treat TAAAs in high surgical risk patients but dedicated studies on the FB-EVAR outcomes in patients with TAAAs with previous OSR are not available. The aim of the study was to evaluate the impact of previous OSR on TAAAs FB-EVAR outcomes. Between 2010 and 2016, all TAAAs undergoing FB-EVAR were prospectively evaluated, retrospectively categorized in two groups, and then compared: group A-primary TAAAs and group B-TAAAs after previous OSR (abdominal, thoracic, or thoracoabdominal aneurysm). Early end points were technical success (absence of type I-III endoleak, target visceral vessel loss, conversion to OSR, intraoperative mortality), spinal cord ischemia (SCI), and 30-day mortality. Follow-up end points were survival, target visceral vessel patency, and freedom from reinterventions. Sixty-two patients (male: 74%; age: 72 ± 7 years) with 1 (1%) extent I, 14 (23%) extent II, 24 (39%) extent III, and 23 (37%) extent IV TAAA underwent FB-EVAR. The mean TAAA diameter and total target visceral vessels were 65 ± 13 mm and 226, respectively. Ninety branches and 136 fenestrations were planned. Thirty cases (48%) were clustered in group A and 32 (52%) in group B. Patients in group A and group B had similar preoperative clinical and morphologic characteristics, except for female sex (group A: 40% vs group B: 13%; P = .02). Technical success was 92% (group A: 90% vs group B: 94%; P = .6), SCI 5% (group A: 10% vs group B: 0%; P = .1) and 30-day mortality 5% (group A: 10% vs group B: 0%; P = .1). The mean follow-up was 17 ± 11 months with a total survival of 86%, 80%, and 60% at 6, 12, and 24 months, respectively and no differences in the two groups (group A: 83%, 83%, and 67% vs group B: 88%, 78%, and 55% respectively; P = .96). There was no late TAAA-related mortality. Target visceral vessel patency was 91%, 91%, and 91% at 6, 12, and 24 months, respectively (group A: 87%, 87%, and 87% vs group B: 95%, 95%, and 95%; P = .25). Freedom from reinterventions was 90%, 87%, and 87%, at 6, 12, and 24 months, respectively, and it was significantly lower in group A compared with group B (group A: 83%, 76%, and 76% vs group B: 96%, 96%, and 96% respectively; P = .002). Previous open surgery repair does not significantly affect the early outcomes of FB-EVAR in TAAA, with encouraging results in terms of technical success, SCI, mortality, and lower reinterventions rate at midterm follow-up.

Gallitto E ，Faggioli G ，Mascoli C ，Pini R ，Ancetti S ，Vacirca A ，Stella A ，Gargiulo M ... -  《-》