Post hoc analysis of the SuperB and Zilverpass trials for treatment of long and complex superficial femoral artery lesions.

OBJECTIVE: In two randomized controlled trials, the outcomes of endovascular treatment of complex femoropopliteal arterial lesions were compared with bypass surgery and considered a valid alternative treatment. The aim of this study was to compare both endovascular treatment options with the hypothesis that implantation of heparin-bonded self-expanding covered stents (Viabahn [SECS]) or drug-eluting stents (ZilverPTX [DES]) are related to similar clinical outcomes at 1-year follow-up. METHODS: In a post-hoc analysis, the SuperB trial and Zilverpass databases were merged. Patients in the endovascular treatment arms were included, and data was analyzed in an intention-to-treat (ITT) and a per-protocol (PP) fashion. Data included baseline and lesion characteristics, procedural details, and follow-up data. The primary endpoint of this study was primary patency at 1-year follow-up. The secondary endpoints were secondary patency, target lesion revascularization (TLR), limb loss, and all-cause mortality. RESULTS: A total of 176 patients were included; 63 in the SECS arm and 113 in the DES arm. Through 1-year follow-up, there were no significant differences in primary patency (ITT: 63.4% vs 71.1%: P = .183 and PP: 60.8% vs 71.1%; P = .100). Secondary patency rates were not significantly different in the ITT analysis (86.5% vs 95.1%; P = .054), but in the PP analysis, there was a significant difference in favor of the DES group (SECS, 85.6% vs DES, 95.1%; P = .038). There was no significant difference in freedom from TLR between groups (79.6% vs 77.0%; P = .481). No major amputations were performed in the SECS group, and two were performed in the DES group (1.8%). Survival rate was 98.2% in the SECS group, and 91.3% in the DES group after 1-year follow-up (P = .106). Based on diagnosis (intermittent claudication vs chronic limb-threatening ischemia) no differences between patients with intermittent claudication and chronic limb-threatening ischemia were observed in primary patency, secondary patency and freedom from TLR. CONCLUSIONS: Treatment of complex femoropopliteal arterial disease with the heparin-bonded Viabahn endoprosthesis and the Zilver PTX drug-eluting stent are related to similar primary and secondary patency, and TLR rates at 1 year, except for secondary patency in the PP analysis. This study further supports the endovascular treatment of long complex lesions in the femoropopliteal artery.

ZILVERPASS Study: ZILVER PTX Stent versus Prosthetic Above-the-Knee Bypass Surgery in Femoropopliteal Lesions, 5-year Results.

PURPOSE: To report the 60-month safety and effectiveness results of a multicenter, prospective, randomized controlled trial comparing the ZILVER PTX paclitaxel-eluting stent to prosthetic above-the-knee bypass for the treatment of symptomatic TransAtlantic Inter-Society Consensus (TASC) C and D femoropopliteal lesions. MATERIALS AND METHODS: Patients were enrolled between October 2013 and July 2017. One of the secondary outcomes was primary patency at 60 months, defined as no evidence of binary restenosis or occlusion within the target lesion or bypass graft based on a duplex ultrasound peak systolic velocity ratio < 2.4 and no clinically-driven target lesion revascularization (TLR) in endovascular cases or reintervention to restore flow in the bypass at 60 months. Survival rates after 5 years were also analyzed. RESULTS: 220 patients (mean age 68.6 ± 10.5 years; 159 men) were included and randomized to ZILVER PTX (n = 113, 51.40%) or BYPASS group (n = 107, 48.60%). The 60-month primary patency rate was 49.3% for the ZILVER PTX group versus 40.7% for the bypass group (p = 0.6915). Freedom from TLR was 63.8% for the ZILVER PTX group versus 52.8% for the bypass group (p = 0.2637). At 5 years, no significant difference in survival rate could be seen between the ZILVER PTX and the bypass group (69.1% vs. 71% respectively, p = 0.5503). CONCLUSION: Even at 5 years, non-inferior safety and effectiveness results of the ZILVER PTX could be seen. These findings confirmed that the use of ZILVER PTX stents can be considered as a valid alternative for bypass surgery when treating long and complex femoropopliteal lesions.

ZILVERPASS Study: ZILVER PTX Stent vs. Bypass Surgery in Femoropopliteal Lesions, 3 year results and economic analysis.

BACKGROUND: To report the 3-year safety and effectiveness results of a multicenter, prospective, randomized controlled trial comparing the ZILVER PTX paclitaxel-eluting stent to surgical bypass and to conduct a health economic analysis up to 3-year follow-up of the two treatment modalities. METHODS: This is a study in symptomatic TransAtlantic Inter-Society Consensus (TASC) C and D femoropopliteal lesions comparing endovascular ZILVER PTX stenting vs. surgical bypass surgery using a prosthetic graft (ClinicalTrials.gov identifier NCT01952457). Between October 2013 and July 2017, 220 patients (mean age 68.6±10.5 years; 159 men) were enrolled and randomized to the ZILVER PTX treatment group (113, 51.40%) or the bypass treatment group (107, 48.60%). One of the secondary outcomes was primary patency at 3-year, defined as no evidence of binary restenosis or occlusion within the target lesion or bypass graft based on a duplex ultrasound peak systolic velocity ratio <2.4 and no clinically-driven target lesion revascularization (TLR) in endovascular cases or reintervention to restore flow in the bypass. An economic analysis was conducted to analyze the cost differences between ZILVER PTX and bypass, which shows the perspective of the public authority/organization that pays for healthcare in the two countries (payor), Germany and USA. RESULTS: The 3-year primary patency rate was 53.30% (95% CI 61.40% to 45.20%) for the ZILVER PTX group vs. 58.20% (95% CI 67.10% to 49.30%) for the bypass arm (P=0.9721). Freedom from TLR at 3-year was 62.80% (95% CI 72.60% to 53%) for the ZILVER PTX group vs. 65.30% (95% CI 75.40% to 55.20%) for the bypass group (P=0.635). There was also no significant difference (P=0.358) in survival rate at 3-year between the ZILVER PTX group 78.50%, (95% CI to 87.70% to 69.30%) and the bypass group 87.40% (95% CI 97.6% to 77.2%). None of the deaths was categorized as related to the procedure or device. The economic analysis, taking into account procedural-, hospitalization- and reintervention costs, showed a clear cost-benefit for Zilver PTX in both investigated countries up to 3-year follow-up: Germany (Bypass €9446 per patient versus ZILVER PTX €5755) and USA (Bypass $26,373 per patient versus ZILVER PTX $19,186). CONCLUSIONS: The non-inferior safety and effectiveness results of the ZILVER PTX stent were associated with lower costs for the payer and confirmed that ZILVER PTX stent treatment can be considered as a valid alternative for bypass surgery in long and complex femoropopliteal lesions.

Intravascular lithotripsy: a powerful tool to treat peripheral artery calcifications.

Calcification represent one the most important predictors of treatment failure of endovascular therapy for peripheral arterial disease, since it restricts wall expansion and acts as a barrier for drug uptake. It also increases complications after PTA like dissection, perforation, and embolization with poor outcomes. Intravascular lithotripsy (IVL) is a novel approach for the treatment of vascular calcifications with the goal to optimize outcome in patients with PAD and heavy calcifications. This review gives an overview of the currently published articles regarding the use of IVL within the vascular field. In conclusion, IVL is a safe and effective approach in the treatment of highly calcified arteries with excellent results and low rates of related complications, such as embolization, dissection, and perforation. However, it seems to require adjunctive therapies to enhance long-term patency as well as an adequate sizing (1.1:1 ratio). Its use to facilitate access of large-bore devices seems to be valuable by changing vessel compliance and achieving luminal gain. Further studies are nonetheless mandatory.

Performance of the Gore VBX Balloon Expandable Endoprosthesis as Bridging Stent-Graft in Branched Endovascular Aortic Repair for Thoracoabdominal Aneurysms.

PURPOSE: Bridging stent stability is crucial for efficacy and safety of branched aortic endovascular repair (bEVAR) of thoracoabdominal aortic aneurysms (TAAAs). In this study, we assess the performance of the new Viabahn Balloon-Expandable endoprosthesis (VBX) in bEVAR. Based on our learning curve we give recommendations for a safe and effective use of the device. MATERIALS AND METHODS: We prospectively collected the data of patients with TAAAs undergoing bEVAR between December 2017 and December 2019. All patients with implantation of at least 1 VBX stent-graft as bridging stent were included in our single-center analysis. Demographic, comorbidity, and computed tomography angiography (CTA) data of 112 patients were retrospectively evaluated. Primary endpoint was a composite of branch-related technical success and freedom from target vessel instability. Secondary endpoints were clinical and ongoing clinical success. RESULTS: Primary endpoint: technical success was achieved in all patients (100%) with a freedom from target vessel instability of 96.3% after a median follow-up of 18 months. Overall mortality was 13.4% (n=15) and 13 patients underwent secondary interventions, 12 of them are still alive and 1 suffered from aneurysm sac expansion, consequently an ongoing clinical success of 75.9% was reached. After modification of the implantation technique during the course of the study by selecting longer stent lengths after accurate estimation of vessel curvature and expected adaptation of the flexible endoskeleton to the specific anatomical conditions, no type Ic endoleaks were observed in the last 70 cases. CONCLUSIONS: The VBX stent-graft can be safely used as bridging stent for branched thoracoabdominal repair. However, learning curve should be considered to avoid type Ic endoleak and edge stenosis. Based on this experience longer landing zones and 2-step deployment of VBX are useful for successful bridging also of challenging target vessels.

One-Year Results From the SURPASS Observational Registry of the CTAG Stent-Graft With the Active Control System.

Purpose: To report the outcomes from the observational SURPASS registry, which was created to assess the performance of the Conformable TAG (CTAG) stent-graft with the Active Control System (ACS) in patients undergoing thoracic endovascular aortic repair (TEVAR) in a real-world setting. Materials and Methods: The SURPASS registry (ClinicalTrials.gov; identifier NCT03286400) was an observational, prospective, single-arm, post-market, international study that enrolled patients undergoing TEVAR using the CTAG with ACS for both acute and chronic thoracic aortic disease between October 2017 and July 2018. The CTAG with ACS features 2-stage deployment of the stent-graft and an optional angulation mechanism that modifies only the proximal end of the stent-graft. During the observation period, 127 patients (mean age 67.1±12.1 years, range 27-86; 92 men) were enrolled and treated for an array of aortic pathologies, including chronic and acute lesions and 4 ruptured descending thoracic aneurysms. The primary outcome of this study was technical success; secondary outcomes were clinical success and major adverse events at 30 days and 12 months. The numbers of 2-stage device deployments and applications of the angulation mechanism were recorded, along with the reasons for use. Results: Technical success of the TEVAR was 97.6% owing to unintentional partial coverage of supra-aortic branches in 3 cases (the vessels were patent on imaging). The stent-graft was repositioned at its intermediate diameter in 79 patients (62.2%), and the angulation feature was applied in 64 cases (50.4%), mainly to improve proximal wall apposition and orthogonality in the aorta. The desired effect was achieved in 60 cases (93.8%). There was no device compression, bird-beak configuration, fracture, or graft occlusion. The 30-day and 12-month clinical success rates were 97.6% and 92.9%, respectively. There were 3 aorta-related deaths at 30 days and a further 3 at 12 months. Fatalities were due to a retrograde type A dissection (0.8%), paraplegia, bowel ischemia, sepsis in the setting of a mycotic aneurysm, aneurysm rupture post aortoesophageal fistula, and multiorgan dysfunction syndrome. Three endoleaks (2 type Ia and 1 type III) required reintervention. Conclusion: In the SURPASS registry, the use of the CTAG device with ACS showed promising outcomes despite the challenging pathologies. The new delivery system enables a controlled staged delivery with in situ adjustments during positioning, facilitating the treatment of complex aortic disease.

Longer bridging stent-grafts in iliac branch endografting does not worsen outcome and expands its applicability, even in concomitant diseased hypogastric arteries.

BACKGROUND: The iliac side branch device (IBD) is a valid method for the treatment of abdominal aorto-iliac aneurysms. However there is still a lack of evidence regarding the optimal length of the bridging stent graft (BSG) since aneurysmal degeneration of the hypogastric artery (HA) is an exclusion criterion. The aim of this study was to analyse the impact of longer BSG compared to the widely used 38mm stent-grafts in terms of reintervention rate and primary patency. METHODS: We retrospectively analyzed our prospectively collected database of all patients who underwent an endovascular aneurysm repair using an IBD in our center between April 2005 and May 2015. The used BSGs were divided into 2 groups. In group A, the BSG was ≤38 mm, and group B>38 mm. The primary endpoint was BSG-related events, including stenosis, occlusion or endoleak. Secondary endpoints were technical success, primary patency and 30-day mortality. RESULTS: Two hundred sixty IBDs were implanted in 215 consecutive patients. Ninetyseven (37%) in group A and 163 (63%) in group B. The technical success rate was 100%. The 30-day mortality was 1% (N.=1) and 1.2% (N.=2) respectively for group A and B (P=0.8). The freedom from BSG-related events amounted to 84% at 60 months for the total cohort. The comparison between the two groups shows no significant difference, while a slight favorable trend for group B (75% vs. 91% at 60 months, P=0.081) was observed. No differences were found as to primary patency (96% and 99% at 60 months respectively for group A and B, P=0.237). CONCLUSIONS: The use of longer stent-grafts (>38 mm) seems not to affect the performance of BSG even in the long run, expanding the indication for IBD also for aneurysms of the hypogastric artery.

Surgical versus endovascular revascularization of subclavian artery arteriosclerotic disease.

BACKGROUND: Endovascular treatment offers an alternative, less invasive approach to open repair for subclavian artery atherosclerotic disease (SAAD). However, only few studies compared the outcomes of both strategies in the long run. This study reports on the performance of endovascular and surgical revascularization for SAAD. METHODS: A retrospective review was conducted on patients treated for SAAD at two institutions between January 1998 and December 2015. Primary outcome of this study was the composite endpoint of reintervention-free survival (RFS) defined as time to reintervention and/or death from any cause. Secondary endpoints included primary patency (PPR) and secondary patency (SPR) rates as well as overall survival and time to reintervention. RESULTS: Surgical treatment was the preferred treatment option in 27 (25%) patients, while 83 (75%) patients underwent primary stent therapy. The median follow-up was 87 months (interquartile range [IQR]: 38 to 151) in the surgical group and 27 (IQR: 12 to 59) in the endovascular (P=0.0001). Severe arterial wall calcification was more commonly observed in the surgical arm (P<0.0001), while mild and moderate calcification in the endovascular (P=0.0004 and P=0.014). Vessel occlusion was more frequent among patients treated surgically (100% vs. 34%, P<0.0001). At 98 months RFS was significantly higher after surgical treatment (95% vs. 54%, HR: 8.4, 95% CI: 3.9 to 18.1, P=0.0002). Although overall survival did not differ significantly between the two groups (HR: 4.28, 95% CI: 0.86 to 21.22, P=0.093), open repair was associated with reduced reintervention rate (HR: 12.04, 95% CI: 4.98 to 29.12, P=0.001). The PPR at 98 months following surgical and endovascular therapy amounted to 96% and 65% (HR: 12.87, 95% CI: 5.44 to 30.44, P=0.0008) respectively. No significant difference was observed regarding the SPR between the two groups (100% vs. 95%, P=0.090). CONCLUSIONS: Surgical treatment was associated in this cohort with increased patency and a significant reduction of reinterventions compared to the endovascular approach.

Balloon Angioplasty Versus Bailout Stenting for Isolated Chronic Total Occlusions in the Popliteal Artery.

AIMS:: Stenting of the popliteal artery (PA) is generally considered inappropriate due to the high mechanical stress and bending of the artery during knee flexion. Nevertheless, vessel recoil remains problematic following angioplasty procedure for chronic total occlusions (CTOs) and adjunctive stenting may be required. The purpose of this study is to compare balloon angioplasty alone versus bailout stenting for isolated CTO of the PA. MATERIALS AND METHODS:: Between March 2012 and October 2016, 43 patients were treated with percutaneous transluminal angioplasty with balloon alone (PTA, n = 16) or bailout stenting percutaneous transluminal angioplasty and stenting (PTAS, n = 27) for de novo CTO of PA. There was no statistically significant difference between both groups with regard to patient demographics and lesions characteristics (calcification severity and lesion length). The median lesion lengths were 67 mm (39.5-78.5) in the PTA group and 94 mm (50-114) in the PTAS group ( p = 0.14). The primary outcome measure was primary patency; secondary outcomes were technical success, primary assisted patency, major amputation, and increased Rutherford classification. RESULTS:: Technical success rate was 37% and 96.3% in the PTA and PTAS groups, respectively. There was no statistical difference in 12-month primary patency rate (65.8% versus 58.7%; p = 0.15) and primary assisted patency at 12 months (75.2 versus 69.2; p = 0.47) between the 2 groups. Freedom from target lesion revascularization at 12 months was not significantly different, with 85.7% and 81.6% ( p = 0.2) in the PTA and PTAS groups, respectively. One amputation occurred in the PTA group. CONCLUSION:: This small cohort suggests that stenting as a bailout procedure in CTO of the PA provides similar results to successful balloon angioplasty. Stenting should only be performed after suboptimal balloon angioplasty with vessel recoil. Due to the large lost to follow-up, strong evidence of a therapy over the other cannot be formulated. Larger studies with longer and stronger follow-up are needed to confirm those results.

Management and Outcome of Prosthetic Vascular Graft Infections: A Single Center Experience.

BACKGROUND: Prosthetic vascular graft infection (PVGI) remains a severe and challenging complication in vascular surgery with high morbidity and mortality rates. Incidence has been reported between 1% and 6%. The aim of this study was to report our experience in terms of general and surgical management as well as outcome, over 15 years. METHODS: A retrospective consecutive study was conducted of all patients treated in our department for PVGI between January 2000 and December 2015. We analyzed all data relative to primary operation, duration interval between initial surgery and infections signs, infection site, type of microorganism involved, and surgical treatment modality, as well as evaluation of short- and long-term results. RESULTS: Sixty-two patients were admitted for PVGI. Primary revascularization procedures consisted of a peripheral bypass in 42 (68%) patients and an aortic bypass in the remaining 20 (32%) patients. Median interval between primary procedure and reintervention was 3 months (interquartile range 17 [IQR 17]) in the peripheral group and 48 months (IQR 70.5) in the aortic group. Complete excision of the prosthetic graft was carried out in 85% of the cases. Thirty-day mortality was 0% and 9.5% in the aortic and peripheral group, respectively. The overall survival rate was 62.3% at 2-years, 46.4% in the aortic group, and 69.7% in the peripheral group. CONCLUSIONS: Prosthetic vascular graft infection needs a multidisciplinary management with appropriate antibiotherapy, radical removal of the infected graft, and in situ reconstruction. This strategy gives satisfactory results in terms of mortality, morbidity, patency rates, and infection control.

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.

Outcome of a drug-eluting stent in longer below-the-knee lesions in patients with critical limb ischemia.

BACKGROUND: The superiority of drug eluting stents versus bare metal stents or balloon angioplasty in the treatment of patients with critical limb ischemia and infrapopliteal lesions has been established. However, only shorter lesions were evaluated. This study was designed to evaluate the immediate and long-term (up to 12 months) outcome of the Xience Prime™ Everolimus-Eluting Coronary Stent System (Abbott Vascular) in a controlled, prospective, multi-center investigation for long lesions up to 10 cm. METHODS: All patients with critical limb ischemia and long infrapopliteal lesions between 30 and 100 mm, who met the inclusion criteria, were included in this study. The primary endpoint was primary patency at 12 months, defined as absence of restenosis (≥50% stenosis) or occlusion based on quantitative analysis of contrast angiography. RESULTS: Between August 2011 and October 2013, 60 patients were enrolled in this study with a mean lesion length of 47.40±25.06 mm (range 2-100 mm). The primary patency rate at 12 months was 75.4%. Freedom from target lesion revascularization was 84.9%. The amputation rate was rare (94.4% freedom from amputation). At the 12-month follow-up time point, a total of 36 out of 42 (85.7%) patients improved in their Rutherford classification by at least 1 class. CONCLUSIONS: The use of everolimus-eluting stents in longer infrapopliteal lesions in the treatment of critical limb ischemia is safe and effective with a comparable primary patency, freedom from target lesion revascularization and amputation free survival as in short lesions.

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.

Computer-aided endovascular aortic repair using fully automated two- and three-dimensional fusion imaging.

OBJECTIVE: To assess the usability of a fully automated fusion imaging engine prototype, matching preinterventional computed tomography with intraoperative fluoroscopic angiography during endovascular aortic repair. METHODS: From June 2014 to February 2015, all patients treated electively for abdominal and thoracoabdominal aneurysms were enrolled prospectively. Before each procedure, preoperative planning was performed with a fully automated fusion engine prototype based on computed tomography angiography, creating a mesh model of the aorta. In a second step, this three-dimensional dataset was registered with the two-dimensional intraoperative fluoroscopy. The main outcome measure was the applicability of the fully automated fusion engine. Secondary outcomes were freedom from failure of automatic segmentation or of the automatic registration as well as accuracy of the mesh model, measuring deviations from intraoperative angiography in millimeters, if applicable. RESULTS: Twenty-five patients were enrolled in this study. The fusion imaging engine could be used in successfully 92% of the cases (n = 23). Freedom from failure of automatic segmentation was 44% (n = 11). The freedom from failure of the automatic registration was 76% (n = 19), the median error of the automatic registration process was 0 mm (interquartile range, 0-5 mm). CONCLUSIONS: The fully automated fusion imaging engine was found to be applicable in most cases, albeit in several cases a fully automated data processing was not possible, requiring manual intervention. The accuracy of the automatic registration yielded excellent results and promises a useful and simple to use technology.

European Multicenter Registry for the Performance of the Chimney/Snorkel Technique in the Treatment of Aortic Arch Pathologic Conditions.

BACKGROUND: To study the performance of the chimney technique in the treatment of aortic arch pathologic conditions. METHODS: We retrospectively evaluated the clinical and procedural outcome data of patients undergoing endovascular treatment in the aortic arch by use of the chimney technique at four European centers between June 2002 and December 2014. The primary endpoint was technical success. The secondary endpoints were type I endoleak, 30-day mortality, stroke, primary patency of the chimney graft, and freedom from reintervention. RESULTS: Ninety-five patients were included in the study. The underlying pathologic conditions were degenerative aneurysm (n = 45, 47.4%), type B aortic dissection (n = 30, 31.6%), dissecting aneurysm (n = 6, 6.5%), penetrating atherosclerotic ulcer (n = 5, 5.3%), type I endoleak after previous thoracic endovascular aortic repair (n = 6, 6.3%), and aortic embolic disease (n = 3, 3.2%). Twenty-one patients (22%) underwent arch-branch debranching before chimney graft implantation. The majority of patients were treated electively (n = 49, 51.6%). Forty-six patients (48.4%) underwent urgent placement of chimney grafts because of their symptoms (n = 25) or rupture (n = 21). Technical success was 89.5%. The 30-day mortality was 9.5% (9 patients). No aorta-related death was observed. A type Ia endoleak occurred in 10 patients (10.5%) intraoperatively, resolving spontaneously within the first 30 days in 50% of these cases. Major stroke was diagnosed in 2 patients (2%). Primary patency of the chimney grafts was 98%, and 5 patients (5.2%) required a reintervention. CONCLUSIONS: The chimney technique in the aortic arch proved highly and predictably successful, with a low rate of reinterventions.

Custom-made versus off-the-shelf multibranched endografts for endovascular repair of thoracoabdominal aortic aneurysms.

OBJECTIVE: This study compared early outcomes between the custom-made and the new off-the-shelf multibranched endograft (mbEVAR, t-branch; Cook Medical, Bloomington, Ind) for the endovascular repair of thoracoabdominal aortic aneurysms (TAAAs). METHODS: Between January 2010 and January 2013, 46 consecutive patients with TAAAs underwent endovascular aortic repair with mbEVARs. A custom-made device was used in 24 patients (group A, 52%), with Crawford classification type I, 2 (8%); type II, 4 (17%); type III, 9 (38%); and type IV/V, 9 (38%), and the a t-branch endograft was used in 22 patients (group B, 47%), with type II, 9 (41%); type III, 12 (55%); and type IV/V, 1 (4%). The main outcome measure was technical success, defined as successful target revascularization without occlusion of the bridging endografts or type I or III endoleak at the completion angiography. Secondary end points were mortality, unplanned reinterventions, branch occlusion, paraplegia, and persistent (after discharge) paraparesis. RESULTS: Technical success was 100% in both groups. The 30-day mortality was 8% in group A (n = 2) and 0% in group B (P = .51). Survival rates at 6 months were 71% in group A (mean follow-up, 13 ± 11 months) and 94% in group B (mean follow-up, 6 ± 3 months; (P = .04). There was only one procedure-related death caused by cerebral bleeding and herniation in group A. The freedom-from-reintervention rate at 6 months was 100% in group A (mean follow-up, 12 ± 11.5 months) and 90% in group B (mean follow-up, 6 ± 3.9 months; P = .07). No branch occlusions were observed in group A, whereas a branch occlusion occurred in three patients in group B (in all cases the bridging endograft for the renal artery). In two patients, the possible reason for branch occlusion was a thrombophilic disorder, whereas in one patient, the reason remains unknown. Paraplegia was observed in one patient in each group (group A: 4%; group B: 5%; P = .51) and persistent paraparesis in two patients in group A (8%) and in one patient (5%) in group B (P = .94). CONCLUSIONS: The t-branch device, with the unique advantage of direct implantation without any delay for manufacturing, showed 100% technical success and comparable clinical outcomes to the traditional custom-made mbEVARs. Further long-term evaluation remains mandatory.

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.

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.