Systematic review and meta-analysis of published studies on endovascular repair of thoracoabdominal aortic aneurysms with the t-Branch off-the-shelf multibranched endograft.

Endovascular treatment of thoracoabdominal aortic aneurysms is becoming increasingly popular in clinical practice, mainly because of its reduced perioperative mortality and morbidity. However, the custom-made stent graft platform that companies offer requires detailed preoperative planning and production time that can take up to 12 weeks. This may delay surgery in elective patients and is not an option for urgent or emergent cases. To surpass this limitation, the t-Branch (Cook Medical, Bloomington, Ind) was launched in 2012 in Europe as the first off-the-shelf standardized multibranched endograft for the endovascular treatment of thoracoabdominal aneurysms. Our aim was to systematically evaluate all published experience with this commercially available off-the-shelf thoracoabdominal stent graft. We performed a systematic inquiry of the medical databases to identify all published studies that reported on the outcomes of patients treated with the t-Branch stent graft and then conducted a qualitative synthesis and meta-analysis of the results. The main end points studied were technical success, mortality, major stroke, spinal cord ischemia, primary branch patency, and renal insufficiency during the first 30 days along with midterm mortality and reintervention rate. We estimated pooled proportions and 95% confidence intervals (CIs). We identified seven retrospective studies published between 2014 and 2018, with a total of 197 patients (mean age, 72.3 ± 7 years; 70% male). Among 165 patients, 45% were symptomatic and 19% were treated for a ruptured aortic aneurysm. In 197 patients, pooled technical success was 92.75% (95% CI, 83.9%-98.7%), and in 10% of the cases, an early endoleak was detected (95% CI, 0%-43.7%). Early mortality was 5.8% (95% CI, 2.5%-10%), and major stroke was observed in 4% of the patients (95% CI, 0.96%-8.40%). The rate of spinal cord ischemia was 12.2% (95% CI, 4.1%-23.2%), with the rate of permanent paraplegia at 1.3% (95% CI, 0%-8.7%). Acute renal failure was 18.7% (95% CI, 9.1%-30.4%), whereas primary branch patency was calculated at 98.2% (95% CI, 96.7%-99.2%). Mean follow-up was 15 ± 7 months. During this time, midterm mortality (after 30 days) was 6.9% (95% CI, 2.44%-12.8%) and pooled reintervention rate was 5.7% (95% CI, 1.70%-11.4%). This pooled analysis indicated good technical success rate after t-Branch endograft implantation, with acceptable mortality and neurologic complications despite a high rate of urgent procedures. Thoracoabdominal endovascular repair with the t-Branch endograft is a feasible and safe therapeutic option for elective and urgent patients.

Konstantinou N ，Antonopoulos CN ，Jerkku T ，Banafsche R ，Kölbel T ，Fiorucci B ，Tsilimparis N ... -  《-》

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 ... -  《-》

Early Outcomes of the t-Branch Off-the-Shelf Multibranched Stent-Graft in Urgent Thoracoabdominal Aortic Aneurysm Repair.

Spanos K ，Kölbel T ，Theodorakopoulou M ，Heidemann F ，Rohlffs F ，Debus ES ，Tsilimparis N ... -  《-》

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 ... -  《-》

Early outcomes of the t-Branch off-the-shelf multi-branched stent graft in 542 patients for elective and urgent aortic pathologies: A retrospective observational study.

The t-Branch, a standardized off-the-shelf multi-branched stent graft has been used for the treatment of elective and urgent cases in aortic disease. The aim of this study was to assess the early outcomes in terms of technical success, mortality, and morbidity in >500 patients being treated with the t-Branch device. A two-center retrospective observational study was undertaken including patients treated using the t-Branch (Cook Medical, Bloomington, IN) in elective or urgent settings for complex abdominal aortic aneurysm and thoraco-abdominal aortic aneurysm between 2014 and 2019 (early experience 2014-2016; late experience 2017-2019). Primary endpoints were technical success and early (30-day) mortality, and secondary endpoints were early morbidity, endoleak, and target vessel patency rates. Multivariable regression models were used to determine the independent association of risk factors with (1) mortality and (2) spinal cord ischemia. A total of 542 patients (mean age, 70.5 ± 8.5 years; 388 men [72%]; mean aneurysm diameter, 7.5 ± 2.5 cm) were included (63% elective; 90% thoraco-abdominal aortic aneurysm). The technical success rate was 97% (526/542) (elective, 96.7% [328/339] vs urgent, 97.6% [208/213]). The total 30-day mortality rate was 12.3% (8.5% in elective, 15% in symptomatic, and 30% in contained rupture). After multivariate regression analysis, the mortality rate was associated with older age (odds ratio [OR], 1.07; 95% confidence interval [CI], 1.03-1.11; P < .001) and with lower baseline glomerular filtration rate (OR, 0.98; 95% CI, 0.98-0.99; P < .001). In elective cases, the mortality rate was associated with a history of coronary artery disease (OR, 0.26; 95% CI, 0.09-0.73; P < .011) and higher body mass index (OR, 0.87; 95% CI, 0.77-0.98; P < .027). In urgent cases, the mortality rate was associated with older age, (OR, 1.07; 95% CI, 1.02-1.13; P < .010) and lower baseline glomerular filtration rate (OR, 0.97; 95% CI, 0.95-0.99; P < .001). The spinal cord ischemia rate was 10.5% (6.5% temporary, 4% permanent) and was associated with the early study period (OR, 2.01; 95% CI, 1.03-3.89; P < .038). The renal impairment rate was 13%, the stroke rate was 2.5%, and the myocardial infarction rate was 1.8%, whereas the access complications rate was 7.7%. On early computed tomography angiography, the primary patency rate for the right renal artery was 99.6%, for the left renal artery was 100%, for the superior mesenteric artery was 99.4%, and for the coeliac trunk was 99.8%. The endoleak I and III rates were 2.7% (15/542) and 2.7% (15/542), respectively. Elective and urgent use of the t-Branch multi-branched off-the shelf stent graft showed high technical success and early target vessel patency rates. Early mortality and morbidity rates were acceptable.

Kölbel T ，Spanos K ，Jama K ，Behrendt CA ，Panuccio G ，Eleshra A ，Rohlffs F ，Jakimowicz T ... -  《-》