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.

Intravascular Iliac Artery Lithotripsy to Facilitate Aortic Endograft Delivery: Midterm Results of a Dual-Center Experience.

PURPOSE: To assess the feasibility and safety of intravascular lithotripsy (IVL) for enabling transfemoral abdominal (EVAR), thoracic (TEVAR), and thoracoabdominal (BEVAR) endovascular aneurysm repair in patients with narrow and calcified iliac arteries. MATERIALS AND METHODS: Consecutive patients treated with IVL for severe calcified and narrowed iliac access before EVAR, TEVAR, or BEVAR between November 2020 and June 2022 were retrospectively evaluated. All anatomical iliac characteristics were acquired by multi-planar reconstruction of preoperative computed tomography angiography (CTA). The hostility of the vascular accesses was classified based on Peripheral Arterial Calcium Scoring System (PACSS) and calcified access severity score (CASS), a new score considering both anatomical (calcium grade and length, minimum lumen diameter [MLD], and tortuosity index) and aortic stent-graft (SG/MLD index) parameters. Primary endpoint was technical success defined as successful aortic endograft delivery and deployment without iliac rupture. Freedom from complications and primary patency were additionally analyzed. RESULTS: Twenty-eight iliac axes were treated with IVL (8 bilateral) in 20 patients (mean age 74.5±6.7 years) with a mean follow-up of 26.5±6.2 (range 17-36) months. Ten patients underwent EVAR: 3 TEVAR, and 7 BEVAR procedures. In 14 patients (70%), aneurysm disease was associated with symptomatic aorto-iliac occlusive disease (AIOD), with Rutherford class III to IV. The PACSS was grade IV in 89% of the cases and the CASS (mean 14±2) was grade III to IV in all cases. The stent-graft (SG) outer diameter (5.60±1.65 mm) was significantly larger by 50% than MLD (3.96±1.20 mm), with an SG/MLD index of 1.50±0.51 (p<0.001). Technical success was 100%. No dissection, rupture, or distal embolization occurred. One (3.4%) bail-out stenting was necessary as endoconduit after IVL treatment. One month CTA showed that postoperative luminal gain increased by 93% (p<0.001). An improvement of 2 Rutherford classes occurred in all AIOD patients with a primary patency of 100% at last follow-up. CONCLUSIONS: This study shows the safety and feasibility of IVL as a valuable option to treat narrow and calcified iliac arteries to facilitate endograft delivery. Further studies will be useful to confirm these results. CLINICAL IMPACT: In this article, the use of intravascular iliac artery lithotripsy to facilitate aortic endograft delivery is explored. The presence of iliac severe calcifications still represents a contraindication for aortic endovascular repair. Intravascular lithotripsy increases the feasibility and safety of endovascular aortic procedures, facilitating endograft delivery and reducing the risk of iliac rupture and/or dissections by improving vessel compliance and luminal gain. This novel vessel preparation could be an alternative to "paving and cracking" and/or iliac conduits. This study describes a new score to classify the severity of iliac calcifications, considering anatomical parameters and the profile of aortic endografts delivery system.

Indication and Outcome of Late Open Conversion after Abdominal Endovascular Aortic Repair.

BACKGROUND: Endovascular aortic repair (EVAR) has become the standard of care for patients with infrarenal aortic aneurysms over the last 2 decades. Endograft technology and treatment of complications like endoleaks, graft migration, or graft occlusion developed over time. However, sometimes open surgical conversion maybe required. Our aim was to analyze the indications, the technical aspects and outcomes in patients who underwent open conversion after EVAR with different types and generations of endografts. METHODS: This retrospective single-center study reviewed all patients who underwent EVAR from 2004 to 2020. Open surgical conversions >1 month post EVAR were identified. Conversions for graft infection were excluded. Indications for conversion and operative technique were analyzed. Primary endpoint of the study was 30-day mortality. Secondary endpoints were re-interventions and follow-up mortality. RESULTS: During 2004 and 2020, 443 consecutive EVARs were performed, and 28 patients required open surgical conversion, with an additional 3 referred from other hospitals (N = 31). The median age was 75 (range 58-93); 94% were male. Conversion was performed after a median time of 55 months (range 16-209). Twenty patients underwent elective and 11 emergency conversion. Indications for open conversion were graft migration, respectively, disease progression with endoleak type Ia and/or Ib in 52% (16/31) and sac expansion due to endoleak type II in 26% (8/31). Of the 31 patients, 17 (55%) had at least one previous endovascular re-intervention. All patients met the device-specific instructions for use for each implanted endograft. In-hospital intervention rate was 16% (5/31). Thirty-day mortality rate was 3% (1/31) with one patient died due to multiorgan failure after rupture with complete endograft replacement. Five patients (16%) died during follow-up. Mid-term follow-up was 47.5 months (range 24-203) with estimated cumulative survival rates of 97%, 89%, and 84%, at 1, 3, and 5 years, respectively. CONCLUSIONS: Late open conversion remains a valuable treatment option and can be performed safely in elective and emergency setting with a low early mortality. Lifelong surveillance and prompt intervention when necessary are essential in ensuring optimal outcomes after EVAR and preventing the need for emergent conversions.

Two-year target vessel-related outcomes following use of off-the-shelf branched endografts for the treatment of thoracoabdominal aortic aneurysms.

OBJECTIVE: The aim of this study was to assess clinical outcomes and target vessel patency through 2 years following thoracoabdominal aortic aneurysms (TAAA) repair with the off-the-shelf Zenith t-Branch Thoracoabdominal Endovascular Graft (William Cook Europe). METHODS: This post-market observational study was conducted at three European sites with ambispective enrollment from 2012 to 2017. Patients underwent endovascular TAAA repair with the t-Branch graft and bridging stent grafts (BSGs) for the celiac (CA), superior mesenteric (SMA), left renal (LRA), and/or right renal (RRA) arteries. Follow-up was through 2 years, per sites' standard of care. Procedural and 1-year results were reported previously. RESULTS: Eighty patients (mean age, 71.0±7.4 years; 70.0% men) were enrolled; six patients had symptomatic TAAAs, and 15 patients had contained ruptures. Technical success was achieved in 98.8% of patients (79/80). Median follow-up was 22.2 months (interquartile range, 9.2-25.1 months). At 24 months, Kaplan-Meier (KM) freedom from all-cause and aneurysm-related mortality were 78.5% and 98.6%, respectively. Beyond 12 months, 38 adverse events occurred in 20 patients, including two aortic ruptures (one study aneurysm and one non-study aneurysm) and six deaths (none aneurysm-related, as reported by the site). Compared with postprocedure, maximum aneurysm diameter decreased (>5 mm) in 84.6% (44/52), remained unchanged in 3.8% (2/52), and increased (>5 mm) in 11.5% (6/52) of patients with imaging follow-up after 12 months. No conversions to open repair, and no t-Branch graft or other endograft component migration or integrity issues were reported. No loss of patency was reported in the t-Branch or iliac limb grafts throughout the study. Throughout study duration, four patients had five imaging-reported BSG compressions, none of which required secondary intervention. KM freedom from secondary intervention was 76.3% at 24 months. Fourteen target vessel-related secondary interventions were performed, primarily consisting of stent placement for endoleak, stenosis, or occlusion. KM freedom from loss of primary patency was 94.8%, 100%, 91.3%, and 89.3% for the CA, SMA, LRA, and RRA, respectively, at 24 months. KM freedom from loss of secondary patency in the CA, SMA, LRA, and RRA were 96.3%, 100%, 98.2%, and 98.3% at 24 months, respectively. A total of 298 vessels were targeted, of which 12 were occluded over the study period. CONCLUSIONS: Primary and secondary target vessel patency rates through 2 years demonstrated durable repair with the t-Branch graft in patients treated for symptomatic or asymptomatic thoracoabdominal aortic aneurysms.

Early and midterm results from a postmarket observational study of Zenith t-Branch thoracoabdominal endovascular graft.

OBJECTIVE: We have reported the short-term outcomes regarding the safety of the off-the-shelf Zenith t-Branch multibranched thoracoabdominal stent-graft (William Cook Europe ApS, Bjaeverskov, Denmark) in a postmarket, multicenter study. METHODS: Patients who had been treated with the t-Branch device from September 2012 to November 2017 at three European centers were either prospectively or retrospectively enrolled in the present study. Device implantation and postprocedural follow-up were performed according to the standard of care at each center. The primary objectives of the present study were to assess the procedure-related mortality and morbidity at 30 days and 1 year and to assess the presence of endoleaks, device integrity, and stent-graft and branch vessel patency. RESULTS: A total of 80 patients were included in the present study (mean age, 71.0 ± 7.4 years; 70.0% male). Most (n = 77) had been treated for thoracoabdominal aortic aneurysms (TAAAs) and the rest for dissection (n = 3). Most TAAAs were stable (72.7%; 56 of 77). The remaining TAAAs were symptomatic (7.8%; 6 of 77) or had a contained rupture (19.5%; 15 of 77). The t-Branch device was successfully deployed in 79 patients. In one patient, the delivery system of the device could not be advanced through the iliac artery. Within 30 days, one patient had died (1.3%). At 1 year, seven patients had died (8.8%), and no aortic rupture or conversion to open surgery had been reported. The 30-day neurologic events included stroke in three patients (3.8%), paraplegia in one (1.3%), and paraparesis in six patients (7.5%). Secondary interventions were required in nine patients (11.3%) during follow-up. Postoperative endoleaks were observed in 37 of 72 patients (51.4%), including type II endoleak in 30, type Ia in 4, and type III endoleak in 6 patients. At 1 year, endoleaks had been reported in 20 patients (16 with type II and 4 with type III). The t-Branch main body graft patency was 100% throughout the 1-year follow-up period. At 30 days after the procedure, all celiac and superior mesenteric artery branches were patent and one left renal and one right renal branch were occluded. At 1 year, occlusion had developed in three bridging stent-grafts for the celiac artery, one for the left renal artery, and two for the right renal artery. CONCLUSIONS: The t-Branch device appears safe, with good 30-day and 1-year mortality and morbidity in the present study, including both stable and symptomatic cases.

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.

Effectiveness of Intra-Arterial Aneurysm Sac Embolization for Type Ia Endoleak after Endovascular Aneurysm Repair.

PURPOSE: To evaluate the effectiveness and durability of intra-arterial aneurysm sac embolization for the treatment of type Ia endoleak after endovascular aneurysm repair (EVAR). MATERIALS AND METHODS: From February 2011 to December 2016, 22 patients underwent embolization of a type Ia endoleak after EVAR. Four patients (18%) were treated during the index EVAR and 18 (82%) in follow-up. Five patients (23%) were treated urgently and 17 (77%) electively. The embolization was performed with the use of liquid embolic agent, coils, and/or plugs. Adjunctive neck procedures were performed in 55% (n = 12) of the patients. The primary endpoint of this study was freedom from sac enlargement. Key secondary endpoints were technical success and freedom from endoleak-related reinterventions. RESULTS: Technical success was 100%. The 30-day mortality was 5% (n = 1; acute coronary syndrome). At a mean follow-up of 15.4 months (range 0.1-65.4) the freedom from sac enlargement rate was 76% (16 out of 21). Reintervention-free survival rates at 6, 12, and 24 months were 80%, 68% and 68%, respectively. CONCLUSIONS: In patients with persistent type Ia endoleak the embolization of the aneurysm sac with or without adjunctive neck procedures can be safely performed, leading to acceptable clinical and radiologic outcomes.

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.

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.

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.

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.

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.

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.

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.

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.