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 ... -  《-》

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 ... -  《-》

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

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. 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. 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. 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.

Silingardi R ，Gennai S ，Leone N ，Gargiulo M ，Faggioli G ，Cao P ，Verzini F ，Ippoliti A ，Tusini N ，Ricci C ，Antonello M ，Chiesa R ，Marone EM ，Mangialardi N ，Speziale F ，Veraldi GF ，Bonardelli S ，Marcheselli L ，Italian mbEVAR study group ... -  《-》

Proximal Aortic Coverage and Clinical Results of the Endovascular Repair of Juxta-/Para-renal and Type IV Thoracoabdominal Aneurysm with Custom-made Fenestrated Endografts.

Juxta-renal (JAAA)/para-renal (PAAA) and type IV-thoracoabdominal (TAAA) aneurysms can be repaired by custom-made fenestrated endografts (CM-FEVAR). Differently from open repair, a relatively long segment of healthy proximal aorta needs to be covered to achieve a durable sealing, and this may be considered a disadvantage of the endovascular approach. We aimed to quantify the additional proximal aortic coverage in JAAAs, PAAAs, and type-IV TAAAs treated with CM-FEVAR and to evaluate its impact on early/follow-up clinical outcomes. Between 2006 and 2018, preoperative, intraoperative, and postoperative data of JAAAs, PAAAs, and type-IV TAAAs submitted to CM-FEVAR were collected. The length of proximal healthy aortic coverage was evaluated on the preoperative endograft planning as the distance between the top of the CM-FEVAR endograft and the hypothetical level of aortic cross-clamping in case of open repair (type-IV TAAA-above the celiac trunk; PAAA-above the superior mesenteric artery; JAAA-above the lowest renal artery). Spinal cord ischemia (SCI), bowel ischemia (BI), renal function worsening (RFW) (estimated glomerular filtration rate reduction > 25% of the baseline level - RFW), and mortality were assessed at 30-day. Survival, target visceral vessel (TVV) patency, and freedom from reinterventions (FFRs) were assessed during follow-up by Kaplan-Meier analysis R2. One hundred forty-seven cases were submitted to CM-FEVAR, for 72 (49%) JAAAs, 46 (31%) PAAAs, and 29 (20%) type IV-TAAAs, with 1(4-3%), 2 (28-19%), 3 (48-33%), and 4 (67-45%) fenestrations. JAAAs required a fenestration + bridging stent graft for the superior mesenteric artery and celiac trunk, in 46(64%) and 24(33%) cases, respectively. Nineteen (41%) PAAAs required a fenestration + bridging stent graft for the celiac trunk. The mean proximal additional aortic coverage was 48 ± 2 mm with no differences among JAAAs (52 ± 1 mm), PAAAs (42 ± 2 mm), and type IV-TAAAs (50 ± 2 mm) (P.09). Technical success, defined as correct endograft deployment, with TVV patency, absence of type I-III endoleaks, iliac leg stenosis/occlusions, open surgical conversion, and 24-hour mortality, was achieved in 98% of cases. Failures occurred for 1 type-III endoleak (type-IV TAAA) and 2 renal artery losses (PAAA and type IV-TAAA). The only case of SCI (0.7%) occurred in a type-IV TAAA where the proximal healthy aortic coverage was 80 mm. One BI was caused by acute thrombosis of the bridging stent graft for the superior mesenteric artery at 24 hours in 1 type IV-TAAA (0.7%). Thirty-five patients (24%) suffered postoperative RFW and required hemodialysis in 1 (0.7%) JAAA with severe preoperative chronic renal failure. There was no difference of proximal additional aortic coverage between patients with (49 ± 29 mm) and without (48 ± 23 mm) RFW (P.2). The 30-day mortality was 1.4%. The mean follow-up was 37 ± 2 months with no cases of aneurysm-related late mortality. Survival was 94%, 89%, and 75% at 1, 2, and 5 years, respectively. TVV patency was 97%, 97%, and 93% at 1, 2, and 5 years, respectively. FFR was 98%, 95%, and 87% at 1, 2, and 5 years, respectively. Custom-made FEVAR requires a mean proximal additional aortic coverage of 48 ± 2 mm above the level of hypothetical aortic cross-clamping in case of open repair. This aspect should be considered for CM-FEVAR indication in JAAAs, PAAAs, and type-IV TAAAs; nevertheless, it does not appear to be associated with negative early and follow-up clinical sequelae.

Gallitto E ，Faggioli G ，Pini R ，Logiacco A ，Mascoli C ，Fenelli C ，Abualhin M ，Gargiulo M ... -  《-》

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 ... -  《-》