Michel J. Bosiers

Anatomical suitability of the T-branch stent-graft in patients with thoracoabdominal aortic aneurysms treated using custom-made multibranched endografts.

Purpose To assess the anatomical suitability of the new off-the-shelf multibranched endograft (t-branch) in patients with thoracoabdominal aortic aneurysms (TAAA) previously treated by means of custom-made multibranched endografts. Methods Clinical and radiological data of 43 consecutive patients (34 men; mean age 72 years) with Crawford types I (n=1), II (n=16), III (n=18), or IV (n=8) TAAAs treated with custom-made multibranched endografts between June 2008 and February 2013 were retrospectively reviewed. Primary anatomical suitability of the t-branch device was assessed using 3-dimensional computed tomographic angiograms. Assisted suitability referred to the ability to use adjuvant procedures to eliminate anatomical obstacles that did not hinder the custom-made devices. Results Among the study group, 21 (49%) patients were suitable for treatment using the t-branch device. Another 6 (14%) would have been suitable with the assistance of additional maneuvers, such as thoracic endografting with (n=3) or without (n=3) left carotid–subclavian bypass. Sixteen (37%) patients violated the eligibility criteria due to a distance >56 cm between the celiac trunk and the most caudal renal artery (9, 60%), insufficient diameter (<25 mm) at the level of the visceral arteries (5, 33%), upward orientation of a renal artery (3, 20%), inadequate (>40 mm) proximal landing zone (2, 13%), and a distance <67 mm between the most caudal renal artery and aortic bifurcation (1, 7%). Conclusion The t-branch stent-graft system would have been primarily suitable for implantation in half of the patients. With additional maneuvers, the assisted suitability reached 63%. Further optimization and refinement of the device will probably lead to a shift toward off-the-shelf multibranched stent-graft exclusion of TAAAs.

Early Experience With the First Commercially Available Off-the-Shelf Multibranched Endograft (t-Branch) in the Treatment of Thoracoabdominal Aortic Aneurysms

Purpose: To assess the feasibility and safety of the first commercially available off-the-shelf multibranched endograft for total endovascular repair of thoracoabdominal aortic aneurysms (TAAA). Methods: Between November 2012 and May 2013, 15 patients (10 men; mean age 70 years) with TAAA underwent implantation of the Zenith t-Branch device, which received European marketing approval in late 2012. Three patients presented with symptomatic TAAAs, and 2 patients had a chronic Stanford type B dissection with false lumen expansion. In a retrospective review of the prospectively collected data, the primary endpoint was 30-day mortality from any cause; the primary outcome measure was technical success. Secondary endpoints were postoperative complications, including renal failure requiring dialysis, organ ischemia, and spinal cord ischemia. Radiological outcomes, such as any type of endoleak, further aneurysm expansion, and branch occlusion, were also assessed. Results: Technical success was 100%, with all target vessels connected and patent. There was no renal function deterioration or organ ischemia. Paraplegia was observed in one patient despite cerebrospinal fluid drainage and monitoring. Four patients suffered from transient paraparesis, which was completely resolved before discharge. There was no in-hospital or 30-day mortality. After a mean follow-up of 5 months, no patient has died, and there has been no branch occlusion or type I/III endoleaks. Conclusion: Use of the off-the-shelf t-Branch device in the treatment of TAAAs is feasible and safe, with encouraging early clinical and radiological outcomes. Long-term results are necessary to evaluate the applicability and performance of this endograft in the urgent setting.

The CLEAR-ROAD study: evaluation of a new dual layer micromesh stent system for the carotid artery.

AIMS The aim of this study was to evaluate the 30-day clinical outcome of treatment using the Roadsaver carotid stent in non-consecutive subjects at high risk for carotid endarterectomy requiring revascularisation. METHODS AND RESULTS The CLEAR-ROAD study is a prospective, multinational, single-arm, physician-initiated study planned to include 100 patients in nine centres in Belgium, Italy and Germany. The primary endpoint was the 30-day rate of major adverse events (MAE), defined as the cumulative incidence of any death, stroke or myocardial infarction (MI). The use of embolic protection devices (EPDs) was not mandatory; 31.0% of the patients were symptomatic and in 58.0% of the patients EPDs were used. Technical success was achieved in all cases. The 30-day MAE rate was 2.1% (one patient experienced MI followed by death; another patient experienced a stroke within the first 30 days after procedure). While no statistical analysis could be performed, subgroup data suggested that there were no notable differences in the 30-day MAE rate between symptomatic and asymptomatic patients, or between EPD use. CONCLUSIONS The 30-day clinical outcome of 100 patients treated with a dual layer micromesh carotid stent (Roadsaver) shows promising results. The Roadsaver stent is a safe and effective device for endovascular treatment of subjects at high risk for carotid endarterectomy.

Outcomes of a novel technique of endovascular repair of aneurysmal internal iliac arteries using iliac branch devices

OBJECTIVE To present midterm outcomes of a novel technique of endovascular repair of aneurysmal internal iliac arteries (AIIAs) using iliac branch devices (IBDs). METHODS Between January 2005 and August 2012, 129 patients with aneurysms involving the iliac bifurcation underwent placement of IBDs. In particular, between April 2010 and August 2012, 16 consecutive patients with aortoiliac or solitary iliac aneurysms and coexisting AIIAs were treated with the novel suggested strategy. The follow-up included physical examination and computed tomography (CT) angiography postoperatively, duplex scan at 3 months, CT scan at 6 months, and then CT scan annually. RESULTS The technical success rate was 100%. The primary patency rate for the overall 21 internal iliac branches (five patients with bilateral aneurysms) was 95.3%. The overall assisted patency was 100%. No patient had evidence of type I/III endoleak during the follow-up of 2 years. Two patients showed type II endoleaks originating from the abdominal aneurysm sac and are under radiological surveillance. CONCLUSIONS Our 2-year experience with the described novel approach showed its safety and feasibility, expanding the applicability of IBDs also in case of coexisting AIIAs. Long-term results and an increased number of treated patients with this technique are needed.

One-year follow-up after total endovascular repair of a contained-ruptured thoracoabdominal aortic aneurysm with the sandwich technique

We report the case of a 68-year-old woman who was referred to our clinic due to a contained-ruptured type III thoracoabdominal aortic aneurysm 9 cm in diameter. The patient was not a candidate for an open repair because of her comorbid conditions, including dialysis, heart insufficiency requiring pacemaker support, chronic obstructive pulmonary disease, coronary artery disease, and previous abdominal aortic repair. Owing to her hemodynamic instability, we performed a totally endovascular repair with off-the-shelf devices by means of the sandwich technique. An intraoperative gutters-associated endoleak occurred but resolved after 2 months. The 1-year follow-up confirmed the safety of the technique, showing aneurysm shrinkage, absence of any endoleak, and patent visceral vessels.

Directional Atherectomy With Antirestenotic Therapy vs Drug-Coated Balloon Angioplasty Alone for Isolated Popliteal Artery Lesions

Purpose: To report a single-center study comparing drug-coated balloon (DCB) angioplasty vs directional atherectomy with antirestenotic therapy (DAART) for isolated lesions of the popliteal artery. Methods: Seventy-two patients were treated with either DCB angioplasty alone (n=31) or with DAART (n=41) for isolated popliteal artery stenotic disease between October 2009 and December 2015. The majority of patients presented with lifestyle-limiting claudication (74% vs 86%, respectively). Vessel calcification (29% vs 29%, respectively), mean lesion length (47 vs 42 mm, respectively), and number of runoff vessels were comparable between the groups. The primary outcome measure was primary patency; secondary outcomes were technical success (<30% residual stenosis or bailout stenting), secondary patency, and freedom from clinically driven target lesion revascularization (TLR). Results: The technical success rate following DCB was 84% vs 93% (p=0.24) after DAART. The 12-month primary patency rate was significantly higher in the DAART group (65% vs 82%; hazard ratio 2.64, 95% confidence interval 1.09 to 6.37, p=0.021), while freedom from TLR did not differ between the 2 treatment strategies (82% vs 94%, p=0.072). Secondary patency at 12 months was identical for both groups (96% vs 96%). Although not statistically significant, bailout stenting was more common after DCB angioplasty (16% vs 5% for DAART, p=0.13) and aneurysmal degeneration of the popliteal artery was seen more often after DAART (7% vs 0% for DCB alone, p=0.25). Popliteal artery injury was observed in 2 patients treated using DAART (5% vs 0% for DCB alone, p=0.5), whereas distal embolization rates were comparable between the groups (3% for DCB alone vs 5% for DAART, p=0.99). Conclusion: In this study, the use of DAART was associated with a higher primary patency rate compared with DCB angioplasty for isolated popliteal lesions. Nonetheless, both treatment options were associated with excellent 12-month secondary patency. Aneurysmal degeneration of the popliteal artery and increased bailout stenting could compromise the outcomes of DAART and DCB, respectively.

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.

Incidence and prognostic factors related to major adverse cerebrovascular events in patients with complex aortic diseases treated by the chimney technique

Objective: Endovascular aneurysm repair (EVAR) with the chimney technique (ch‐EVAR) has been used for the treatment of aortic aneurysms as an alternative approach to fenestrated endografting or open repair. Nonetheless, the need for an upper extremity arterial access may contribute to a higher risk for periprocedural cerebrovascular events. This study reports on the perioperative cerebral and major adverse cardiac and cerebrovascular events (MACCE) after ch‐EVAR. Methods: The PERICLES registry (PERformance of the chImney technique for the treatment of Complex aortic pathoLogiES) is an international, retrospective multicenter study evaluating the performance of ch‐EVAR for the treatment of complex aortic pathologies. For the purpose of the current analysis, 425 patients treated by ch‐EVAR between 2008 and 2014 were included. The primary outcome of this analysis was the incidence of procedure related cerebrovascular events defined as transient ischemic attack or stroke. The secondary end point was in‐hospital MACCE, including acute coronary syndrome, stroke, and death of any cause. Results: The incidence of clinical relevant cerebrovascular events was 1.9% (8/425). A postoperative transient ischemic attack was observed in four patients (0.95%) and a stroke in additional four (0.95%). Three patients died during the hospital stay secondary to sequelae from postoperative stroke. A prior history of stroke/transient ischemic attack, atrial fibrillation, previous carotid revascularization, or known carotid artery disease did not significantly increase the risk for adverse neurologic events. The overall MACCE rate amounted to 8.5% (36/425). Logistic regression analysis revealed that the use of bilateral upper extremity access (odds ratio [OR], 2.79; 95% confidence interval [CI], 1.04‐7.45]), aneurysm rupture (OR, 5.33; 95% CI, 1.74‐16.33), and a prolonged operation time (>290 minutes; OR, 1.005; 95% CI, 1.001‐1.008) were associated with a significantly increased risk for MACCE. Conclusions: This analysis demonstrates that ch‐EVAR is associated with a relatively low rate of cerebrovascular events. However, a postoperative stroke is associated with increased mortality. Ruptured aneurysms, bilateral upper extremity access as in case of multiple chimney graft placement, and longer operative times were identified as independent risk factors for MACCE.