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.

Preliminary experience with the Endurant II short form stent-graft system.

BACKGROUND: The aim of this study was to evaluate our preliminary experience with the use of the Endurant II short form (IIs) stent-graft in the treatment of abdominal aortic aneurysms (AAAs). METHODS: Between November 2014 and November 2015, 79 patients were consecutively treated with the Endurant IIs stent-graft at three European vascular centers. Early (30-day) results in terms of technical success, limb occlusion, major morbidity, and mortality were analyzed. Estimated 1-year outcomes in terms of survival, freedom from type I endoleak, freedom from limb occlusion, and freedom from any device-related reinterventions were assessed with Kaplan-Meyer method. Factors affecting 1-year freedom from type I endoleak were analyzed by log-rank test and by Cox regression test for multivariate analysis. RESULTS: Intraoperative technical success was achieved in all cases. Thirty-day mortality was 1.3% (one death due to cardiac failure). Early type I endoleak was detected in three patients (3.8%). During the follow-up (mean duration 6.7 months; range 1-14), two type I endoleaks resolved spontaneously. No limb occlusions or aneurysm-related reinterventions were recorded. Estimated survival, freedom from type I endoleak, freedom from limb occlusions, and freedom from any device-related reinterventions rates at 1 year were 96%, 96.6%, 100%, and 100%, respectively. Adoption of chimney technique significantly affected 1-year freedom from type I endoleak (P≤0.001). CONCLUSIONS: Preliminary use of the new Endurant IIs stent-graft is safe and effective in endovascular repair of AAAs (EVAR) without early limb occlusions. Further studies with larger population sizes and longer follow-up are needed to evaluate mid- and long-term results.

Directional Atherectomy With Antirestenotic Therapy vs Drug-Coated Balloon Angioplasty Alone for Common Femoral Artery Atherosclerotic Disease.

PURPOSE: To report an experience using directional atherectomy (DA) with antirestenotic therapy (DAART) in the form of drug-coated balloon (DCB) angioplasty vs DCB angioplasty alone in common femoral artery (CFA) occlusive lesions. METHODS: A retrospective review was conducted of 47 consecutive patients (mean age 71 years; 26 men) treated between October 2011 and July 2016 using either DCB angioplasty alone (n=26) or DAART (n=21) for CFA lesions. The majority of patients had lifestyle-limiting claudication (14 DCB and 15 DAART). Mean lesion length (39±14 mm DCB and 34±16 mm DAART) and vessel calcification (17/26 DCB and 11/21 DAART) were comparable between the groups. There were 4 chronic total occlusions, all in the DAART group. The main outcome measure was primary patency. Key secondary outcomes were technical success, secondary patency, and freedom from clinically-driven target lesion revascularization (TLR). RESULTS: Technical success rates were 89% following DCB angioplasty and 95% for DAART (p=0.41). The 88% 12-month primary patency and 89% freedom from TLR for DAART were higher than the 68% and 75% estimates following DCB angioplasty alone, but neither difference was statistically significant. However, the secondary patency estimate at 12 months was significantly higher in the DAART group (100% vs 81% for DCB, p=0.03). Bailout stenting (1 DCB vs 1 DAART), vessel perforation (1 DCB vs 0 DAART), access site complications (4 DCB vs 3 DAART), and distal embolization (0 DCB vs 1 DAART) were comparable, whereas DCB angioplasty had more non-flow-limiting dissections (8 vs 1 for DAART, p=0.02). CONCLUSION: Preparation of the atherosclerotic CFA with directional atherectomy was not associated with statistically significantly higher primary patency or freedom from TLR compared to DCB angioplasty alone at 12 months. Nonetheless, both modalities had promising outcomes in a primarily surgically treated vascular territory.

Initial Experience With the 6-F and 8-F Indigo Thrombectomy System for Acute Renovisceral Occlusive Events.

PURPOSE: To examine the safety and effectiveness of the new large-bore Indigo thrombectomy catheters to treat patients with acute renovisceral occlusion without the need of thrombolytic agents. METHODS: Between November 2015 and 2016, 7 consecutive patients (mean age 65±5 years; 5 men) with acute renovisceral artery occlusion were treated with the new large-bore (6-F and 8-F) vacuum-assisted thrombectomy catheters. The occluded vessels were 6 renal arteries and 3 superior mesenteric arteries (SMAs); 5 of the 9 thromboses were in bridging stent-grafts associated with branched endografts. Mean lesion length was 63±36 mm. For the SMA and all bridging stent-grafts, 8-F catheters are routinely used through a brachial access, whereas 6-F aspiration catheters were used in native renal arteries. Technical success was defined as restoration of antegrade blood flow without the need of lysis or alternative thrombectomy/revascularization strategies. Safety endpoints were any in-hospital major adverse events. Pre- and postoperative hemoglobin and hematocrit levels were compared. RESULTS: Technical success was 100% with no major adverse events or fatal bleeding. The mean amount of aspirated blood was 219±97 mL. The mean hemoglobin and hematocrit values were 13.1±2.1 g/dL and 39%±6% prior to and 11.6±2.2 g/dL (p=0.001) and 34%±6% (p<0.0001) directly after the intervention, respectively. CONCLUSION: The first assessment of the new large-bore Indigo thrombectomy catheters showed them to be an effective and safe lysis-free frontline therapy for acute renovisceral artery occlusion in a small cohort of patients. New users should be fully aware of the potential blood loss during aspiration.

Anatomical Suitability of the Zenith Off-the-Shelf (p-Branch) Endograft in Juxtarenal Aortic Aneurysms Previously Treated Using the Chimney Technique.

PURPOSE: To examine the suitability of the Zenith off-the-shelf (p-branch) endograft in patients with juxta- or pararenal abdominal aortic aneurysms (J/PRAA) previously treated with endovascular aneurysm repair incorporating the chimney technique (chEVAR). METHODS: Between January 2012 and December 2014, high-resolution computed tomography angiograms and clinical data from 50 patients (mean age 79 years; 45 men) with J/PRAAs treated with chEVAR were retrospectively reviewed. Primary anatomical suitability was evaluated according to the Investigational Device Exemption protocol for the Zenith p-branch endograft in a dedicated 3-dimensional vascular workstation. Secondary suitability was defined as any additional intervention needed to overcome adverse anatomical conditions at the access vessels. The Zenith p-branch endograft is available in 2 configurations (A and B), with the main difference being the distance between the superior mesenteric artery (SMA) and the renal fenestrations. RESULTS: The p-branch endograft showed a primary suitability of 54% (n=27). Each configuration was suitable in 18 (36%) patients. Main anatomical limitations were the clock position of the left renal artery (LRA; n=7, 14%), the distance between the SMA and LRA (A: n=16, 32%; B: n=16, 32%), and significantly narrowed or calcified iliac arteries. If additional interventions at the access vessels were employed, a secondary suitability of 64% (n=32) could be achieved. CONCLUSION: In this specific group of patients treated with chEVAR, the Zenith p-branch system would be suitable in about half of the patients, which could be raised to two-thirds with ancillary access vessel procedures. A prospective clinical study is warranted to evaluate these results.

Postmarket Clinical Experience with the INCRAFT AAA Stent Graft System for Challenging Access Routes.

BACKGROUND: The INCRAFT system is a new device that has become available in Europe in September 2014 after the announcement of the 2-year results of the INNOVATION trial. However, no data in the "real-world" practice exist. Herein, we report our early series of consecutive patients treated with the INCRAFT after its launch on the market. METHODS: Prospectively collected data of patients enrolled in the INNOVATION trial (group IT) and consecutive patients from CE Mark approval to April 2015 (group CM) were retrospectively evaluated and compared. Main outcomes were any device- or procedure-related major adverse event (MAE) within 30 days and survival and reinterventions during follow-up. RESULTS: Seventeen patients were included in group IT (median follow-up [95% CI]; 60.4 months [55-63]), and 24 patients were in group CM (12.5 [6.6-13.5]). The patients' comorbidities were comparable between the groups. The average diameter of aortic bifurcation and the bilateral external iliac arteries was significantly smaller in group CM. Adjunctive interventions for iliac artery disease were performed in 8 patients (33%) in group CM, whereas no adjunctive was required in group IT. MAEs within 30 days were not significantly different between 2 groups. Survival and reintervention rates were also equivalent after a median follow-up of 13 months. CONCLUSIONS: Compared to our patients recruited for the INNOVATION trial, the patients after CE Mark approval had significantly more challenging access routes reflecting the difficulties of "real-world" conditions. Despite frequent adjunctive procedures in group CM, the early performance of the endograft was encouraging so far. Long-term surveillance of those patients remains mandatory.

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.

Results of primary stent therapy for femoropopliteal peripheral arterial disease at 7 years.

OBJECTIVE: Primary stenting is a well-established treatment option for femoropopliteal arterial disease. However, there is a paucity of data concerning the performance of this modality at ≥5 years. This study evaluated the long-term clinical and radiologic outcomes of primary stent therapy in patients with femoropopliteal arterial disease. METHODS: A prospective data collection and analysis was conducted in patients undergoing primary stent placement in femoropopliteal lesions between September 2006 and September 2007. The EverFlex (Medtronic/Covidien, Plymouth, Minn) bare-metal stent was used. The primary outcome of this study was the primary patency rate. Secondary outcomes were secondary patency rate, amputation-free-survival (AFS), and freedom from target lesion revascularization (TLR). A Cox regression analysis identified risk factors for the primary and the secondary measure outcomes. RESULTS: Included were 89 patients (102 stents). The prevalence of critical limb ischemia was 34% (n = 30). The initial angiography revealed a TransAtlantic Inter-Society Consensus for the Management of Peripheral Arterial Disease C/D lesion in 31 patients (35%). Occlusions were present in 49 patients (55%), and the mean lesion length was 116 ± 33 mm. Popliteal artery disease was present in 39 treated limbs (35%). The primary patency rate at 1, 3, 5, and 7 years was 73%, 64%, 47%, and 33% respectively. At 7 years, secondary patency rate was 67%, freedom from TLR was 47%, and the AFS was 73%. Cox regression analysis revealed a decreased AFS among diabetic patients (hazard ratio [HR], 2.6; 95% confidence interval [CI], 1.08-6.28; P = .03), whereas secondary endovascular interventions showed a protective effect for AFS (HR, 0.14; 95% CI, 0.03-0.65; P = .01). Popliteal artery disease was identified as independent risk factor for secondary interventions (HR, 2.07; 95% CI, 1.05-4.06; P = .04) and TLR (HR, 1.99; 95% CI, 1.03-3.83; P = .04). Critical limb ischemia was associated with an increased incidence of surgical conversion owing to endovascular treatment failure (HR, 5.46; 95% CI, 2.44-12.17; P < .001). CONCLUSIONS: This study found primary stenting was associated with acceptable clinical and radiologic long-term outcomes. Diabetes was associated with poor AFS, and popliteal artery involvement correlated with an increased need for reinterventions. AFS was better among patients undergoing secondary procedures.

Efficacy and Safety of Transbrachial Access for Iliac Endovascular Interventions.

PURPOSE: To evaluate the use of a brachial artery access for endovascular treatment of iliac artery disease. METHODS: A retrospective review was conducted of 201 patients (mean age 73 years; 147 men) treated via a brachial artery access for iliac artery stenosis. The majority (n=141, 70%) presented with lifestyle-limiting claudication (Rutherford category 3), whereas the incidence of critical limb ischemia (Rutherford categories 4-6) was 30% (n=70). Diagnostic angiography revealed a TransAtlantic Inter-Society Consensus II (TASC) C/D lesion in 114 (57%) patients. The primary outcome was technical success achieved exclusively with a brachial artery access. Secondary outcomes were secondary technical success (adjunctive transfemoral access), access site complications, and stroke/transient ischemic attack (TIA). RESULTS: In 17 (8%) patients, lesion crossing was unsuccessful, while an adjunctive transfemoral approach was necessary to restore iliac vessel patency in 23 (11%) cases. Thus, the primary and secondary technical success rates were 81% and 92%, respectively. Local hematomas (9, 4%) dominated the access site complications, followed by pseudoaneurysms (8, 4%), late brachial artery bleeding (4, 2%), brachial artery occlusion (2, 1%), and puncture site infection (2, 1%). No transient or permanent median nerve dysfunction was observed. The stroke/TIA rate was 2% (n=4). A single patient died due to acute coronary syndrome (0.5% mortality). TASC II class (p=0.58), sex (p=0.66), and target vessel (p>0.3 for all locations) had no effect on technical success. Female gender unfavorably influenced the incidence of access site complications (hazard ratio 6.7, 95% confidence interval 2.7 to 15, p<0.001), but sheath size did not (p=0.22). CONCLUSION: Brachial artery access enables endovascular treatment of iliac artery disease in the majority of patients, although an adjunctive transfemoral access may be required. However, the high incidences of access site complications and cerebral events remain a significant limitation of the transbrachial approach.

Validation of the Wound, Ischemia, foot Infection (WIfI) classification system in nondiabetic patients treated by endovascular means for critical limb ischemia.

BACKGROUND: The Society for Vascular Surgery Lower Extremity Guidelines Committee developed the Wound, Ischemia, foot Infection (WIfI) a classification system to predict the amputation risk in patients with critical limb ischemia (CLI). A number of published studies have already evaluated its prognostic value. However, most of the included patients were diabetic, and the validation was done independent of the revascularization procedure. This single-center study evaluated the prognostic value of WIfI stages in nondiabetic patients treated by endovascular means. METHODS: A retrospective analysis was performed of prospectively collected data of nondiabetic patients treated by endovascular means between January 2013 and September 2014. All patients were classified according to their wound status, ischemia index, and extent of foot infection to four classes: very low risk, low risk, moderate risk, and high risk. Comorbidities and vascular lesions for each group were analyzed. The prognostic value of WIfI was analyzed based on the amputation-free survival, overall survival rate, and freedom from amputation at 12 months. RESULTS: Data from 302 CLI patients treated in the study period were reviewed. A total of 219 patients (73%) underwent an endovascular intervention, and among them, 126 nondiabetic patients (58%) were enrolled in this study. Most patients were classified as low risk (33%), and the prevalence of very low-risk, moderate-risk, and very high-risk patients was 23%, 23%, and 21%, respectively. The modified Edifoligide for the Prevention of Infrainguinal Vein Graft Failure (PREVENT III) score was statistically significantly higher in the high-risk group (5.2 ± 2.4) than in the very low-risk, low-risk, and moderate-risk groups (4.3 ± 2.5, 3.5 ± 2.3, 4.5 ± 2.2, respectively; P = .048). One major amputation (1%) was performed during the hospital stay in a high-risk patient. Mean follow-up was 14 ± 8 months. The amputation-free survival at 12 months was 87%, 81%, 81%, and 62%, in the very low-risk, low-risk, moderate risk, and very high-risk groups, respectively (P = .106). The difference was statistically significant between the very low-risk and high-risk groups (hazard ratio, 3.4; 95% confidence interval, 1.1-10.3; P = .029). A similar trend was also observed for 1-year survival between the very low-risk and the high-risk groups (87%, 84%, 81%, 65%; P = .166). The amputation rate during the follow-up time was 0%, 2% (n = 6), 3% (n = 5), and 12% (n = 9) for the very low-risk, low-risk, moderate-risk, and very high-risk groups, respectively (P = .033). CONCLUSIONS: The WIfI classification system predicted the amputation risk and survival in this highly selected group of nondiabetic CLI patients treated by endovascular means, with a statistically significant difference between very low-risk and high-risk patients already at 1 year.

Combined Directional Atherectomy and Drug-Eluting Balloon Angioplasty for Isolated Popliteal Artery Lesions in Patients With Peripheral Artery Disease.

PURPOSE: To evaluate the midterm results of combined directional atherectomy (DA) and drug-eluting balloon (DEB) angioplasty for atherosclerotic lesions of the popliteal artery. METHODS: In a single-arm, prospective study, 21 patients (mean age 63±16 years; 16 men) with isolated popliteal artery lesions were enrolled and underwent treatment with combined DA and DEB angioplasty under filter protection between October 2009 and February 2014. The majority (18, 86%) presented with lifestyle-limiting intermittent claudication and 3 with critical limb ischemia. Fifteen (71%) target sites were de novo lesions; 4 were occlusions. The main outcome was primary patency; secondary outcomes were technical success, secondary patency, and early and midterm morbidity and mortality. RESULTS: The TurboHawk atherectomy device was used in 15 (71%) patients and the SilverHawk peripheral plaque excision system in the remaining 6 patients. The In.Pact Admiral/Pacific DEB was used in the majority of cases (15, 71%). The technical success rate was 90% (n=19). One flow-limiting dissection was treated with bailout stenting. Complications included a perforation of the popliteal artery and 2 puncture site hematomas; there was no distal embolic event. The mean follow-up was 18±12 months. Two restenoses were retreated successfully. Kaplan-Meier estimates of primary patency at 12 and 18 months were 95% and 90%, respectively; the secondary patency was 100%. One (5%) patient died in follow-up. None of the patients had an amputation. CONCLUSION: In this prospective single-arm study, the combined therapy of DA and DEB angioplasty for popliteal artery lesions showed promising midterm performance. The combination of DA and DEB may, in highly selected patients, overcome the challenges presented by the mobility of the knee joint.

Cryopreserved human allografts (homografts) for the management of graft infections in the ascending aortic position extending to the arch.

OBJECTIVES: The management of infected Dacron grafts in the ascending aortic position involving the aortic arch and aortic root remains a technical challenge. Total replacement of the infected graft material with cryopreserved homografts appears to be an effective treatment strategy for these patients. METHODS: Seventeen consecutive patients were operated on for infection of their ascending aortic graft where the aortic arch was also involved 26 ± 33 months after initial surgery, in 70%, for type A aortic dissection (12 acute aortic dissection type A and 1 chronic aortic dissection type A). The aortic root was additionally affected in 14 patients. Computed tomography and echocardiography follow-up was performed in all patients. RESULTS: Hospital mortality was 24% (n = 4). Cardiopulmonary bypass and aortic cross-clamp times were 288 ± 128 and 165 ± 78 min, respectively. In 14 patients, the aortic root was replaced. Hypothermic circulatory arrest was necessary in all patients (41 ± 25 min) with additional cold selective antegrade cerebral perfusion in 14 (41 ± 30 min). During follow-up, 1 patient died due to a cerebral haemorrhage at 3 months and another at 4 years, of pulmonary embolism. Two patients were successfully reoperated on for degeneration of the aortic valve at 16 and 94 months; 1 patient had an early degeneration of the homograft and needed re-replacement with a homograft. In 2 other patients, a stent graft had to be placed to cover the distal anastomosis between the homograft and native aorta. In all others, recent follow-up revealed no degeneration of the implanted homografts. CONCLUSIONS: Surgery for infected Dacron grafts in the ascending aortic position with involvement of the arch can be performed with an acceptable perioperative mortality. In case of degeneration of the valve, reoperations can be performed with good results in experienced hands. Therefore, we consider the concept of complete explantation of all infected material and replacement with homografts a successful treatment strategy. Nevertheless, close follow-up of the patients is mandatory so as not to miss any degeneration or reinfection of the implanted grafts.