Twelve-month end point results from the evaluation of the Zilver Vena venous stent in the treatment of symptomatic iliofemoral venous outflow obstruction (VIVO clinical study).

BACKGROUND: In the present study, we evaluated the safety and effectiveness of the Zilver Vena venous stent in the treatment of patients with symptomatic iliofemoral outflow obstruction. METHODS: The VIVO clinical study was a prospective, nonrandomized, multicenter study that enrolled patients with symptomatic obstruction of one iliofemoral venous segment. Included were patients with Clinical, Etiological, Anatomical, Pathophysiological (CEAP) clinical classification of ≥3 or a Venous Clinical Severity Score (VCSS) pain score of ≥2. All patients received a self-expanding venous stent (Zilver Vena venous stent; Cook Ireland Ltd, Limerick, Ireland). The primary safety end point was 30-day freedom from major adverse events. The primary effectiveness end point was the 12-month rate of primary quantitative patency by venography as determined by the core laboratory. The secondary end point was the change in the VCSS from baseline to 1 and 12 months. Additional measures included freedom from clinically driven reintervention; change in the CEAP C classification, Venous Disability Score (VDS), and Chronic Venous Disease Quality of Life Questionnaire (CIVIQ) scores from baseline to 12 months; and stent durability measures. RESULTS: Between December 2013 and October 2016, 243 patients (70% female; mean age, 53 ± 15 years; 67.5% with current or previous deep vein thrombosis) were enrolled at 30 institutions. Iliac vein compression by the iliac artery (n = 191; 78.6%) was the primary indication for stent placement. The mean lesion length was 98.6 ± 69.8 mm. The 30-day freedom from major adverse events rate was 96.7%, greater than the literature-defined performance goal of 87% (95% confidence interval [CI], 93.5%-98.6%; P < .0001). The 12-month primary quantitative patency rate was 89.9%, greater than the literature-defined performance goal of 76% (95% CI, 85.1%-93.4%; P < .0001). The change in the VCSS from baseline was -3.0 (95% CI, -3.5 to -2.6; P < .0001) at 1 month and -4.2 (95% CI, -4.7 to -3.7; P < .0001) at 12 months, demonstrating clinical improvement. Similarly, significantly (P < .0001) fewer symptoms over time (from preprocedure through 12 months) were measured using the clinical measures of VDS, CEAP C classification, and CIVIQ. The 12-month rate of freedom from clinically driven reintervention was 95.8% ± 1.3%. Through 12 months, no stent fractures and one clinical migration (Clinical Events Committee adjudicated the latter as technique-related due to device undersizing at placement) had occurred. CONCLUSIONS: The 12-month results of the VIVO study have demonstrated the safety and effectiveness of the Zilver Vena venous stent for the treatment of symptomatic iliofemoral venous outflow obstruction, including clinical symptom improvement compared with baseline.

Using the Evaluating Devices Using Claims and RegisTry Data (EDUCATe) Plan within the Vascular Implant Surveillance and Interventional Outcomes Network (VISION) to Analyze the Long-Term Outcomes following Endovascular Aortic Aneurysm Repair.

BACKGROUND: Implanted devices undergo clinical trials to assess their safety and effectiveness. However, pivotal device trials are limited in their follow-up while postmarket surveillance may incompletely capture late failure. Linking clinical trials to Medicare claims can address these limitations. This study matched patients from investigational device exemption (IDE) clinical trials for endovascular aortic aneurysm repair (EVAR) to Medicare claims-based registry data to compare long-term device outcomes between the 2 sources. METHODS: Patient-level data from 2 industry-sponsored IDE trials of EVAR devices was provided by a single industry partner. Trial data were matched at the patient level to data from the Vascular Implant Surveillance and Interventional Outcomes Network (VISION), a registry that is a part of the Society for Vascular Surgery Patient Safety Organization. The primary outcomes analyzed were survival and freedom from aneurysm-related reintervention. RESULTS: Of 159 clinical trial patients, 134 were eligible for claims-based matching and 115 (85.5%) were successfully matched to VISION registry data. For the matched cohort, the Kaplan-Meier estimated survival was 94.8% at 1 year, 82.6% at 3 years, and 68.1% at 5 years. Estimates for freedom from reintervention were 90% at 1 year, 82.4% at 3 years, and 78.1% at 5 years. The estimates for survival were nearly identical between the clinical trial data and that found in the VISION data (log-rank P = 0.89). Freedom from reintervention was similar between the groups, with IDE trial reported freedom from reintervention of 87.3% and 73.3%, compared to VISION of 92.6% and 83% at 1 and 5 years, respectively (log-rank P = 0.13). CONCLUSIONS: Clinical trial patients who undergo EVAR can be successfully matched to claims-based registry data to improve long-term device surveillance and outcomes reporting. Claims-based results agreed well with IDE trial results for patients through 5 years, supporting the accuracy of claims-based data for longer-term surveillance. Linking clinical trial and claims-based registry data can lead to robust device monitoring.

Long-Term Effectiveness of a Drug-Eluting Stent for Femoropopliteal In-Stent Restenosis: Subanalysis of the Zilver PTX Japan Post-Market Surveillance Study.

PURPOSE: To present a subgroup analysis of patients from a large real-world study evaluating the safety and effectiveness of the Zilver PTX drug-eluting stent (DES) for treating femoropopliteal in-stent restenosis (ISR). MATERIALS AND METHODS: This study examined patients enrolled in the Zilver PTX Japan Post-Market Surveillance Study (ClinicalTrials.gov identifier NCT02254837), a prospective, multicenter registry of 904 symptomatic patients with 1082 femoropopliteal lesions treated with the DES at 95 institutions in Japan. Five-year outcomes, including mortality, stent radiography, freedom from target lesion revascularization (TLR), and clinical benefit, were evaluated for 177 patients (mean age 74.2±8.3 years; 118 men) with 204 ISR lesions treated with the Zilver DES. Over half of the patients (108, 61.0%) were diabetic. Mean lesion length was 17.8±10.4 cm, and a third (72, 35.3%) were total occlusions. Outcome measures were all-cause mortality, thrombosis, freedom from TLR, and clinical benefit, defined as freedom from persistent or deteriorating ischemic symptoms. RESULTS: No device-related or procedure-related deaths or paclitaxel-related adverse events were reported. All-cause mortality was 25.1% at 5 years. Stent fracture was observed in 5 stents through 5 years. The 5-year rate of freedom from clinically-driven TLR was 73.4%, and the rate of clinical benefit was 63.6%. Improvement in Rutherford category and ankle-brachial index was sustained through 5 years. CONCLUSION: The safety and effectiveness of the Zilver PTX stent for the treatment of femoropopliteal ISR lesions demonstrated that this device provides a favorable treatment option in this difficult-to-treat subgroup.

Final results from a postmarket registry of an iliac leg graft with a continuous, spiral nitinol stent.

OBJECTIVE: To evaluate clinical outcomes from a postmarket registry of the Zenith Spiral-Z abdominal aortic aneurysm iliac leg graft with a continuous, spiral nitinol stent that was designed for improved conformability, kink, and migration resistance. METHODS: This prospective, multicenter registry was designed to evaluate physician-reported outcomes of the Spiral-Z leg graft in up to 600 patients who underwent endovascular repair of abdominal aortic or aortoiliac aneurysms at up to 30 investigative sites in the United States and Canada. Study outcomes were focused on iliac limb occlusion, limb-related reintervention, limb-related endoleak, component separation, and device integrity. Short-term data were collected during an interval of 1 to 6 months, with longer term data collected at 12 months. RESULTS: Between March 2012 and March 2015, 599 patients (mean age 74 ± 8 years; 87% male; 26% with aortoiliac aneurysm) were treated, with Spiral-Z iliac leg grafts placed in 564 left iliac arteries and 559 right iliac arteries. The mean iliac inner diameters (both left and right) were 9 ± 3 mm; moderate/severe occlusive disease, calcification, and vessel tortuosity were present in 14%, 25%, and 36% and 15%, 25%, and 34% of the left and right iliac arteries, respectively. Iliac artery adjunctive procedures (iliac artery angioplasty and/or stent placement) were performed intraoperatively in 112 patients (19%; bilateral in 52 patients). Mortality within 30 days was 1.7% (10/599); cumulative mortality at 1 year was 6.2% (37/599). There were no aortic ruptures and only one open conversion (0.2%). Limb occlusions occurred in 11 of 599 patients (2%; 3 within 30 days and 8 after 30 days, all unilateral, none had received procedural iliac artery adjuncts at implantation); of these, 7 patients underwent reinterventions. Other limb-related reinterventions were performed on eight patients for nonocclusive kink, compression, or thrombus (six within 30 days and three after 30 days). In total, 13 patients (2%) underwent 15 limb-related reinterventions (7 for occlusions and 8 for nonocclusive causes). In one patient, a distal type I endoleak and device migration (>10 mm) involving a right iliac leg was noted at the 12-month follow-up visit. No other limb-related endoleak, migration, component separation, or stent fracture was reported during a mean follow-up of 11 ± 6 months. CONCLUSIONS: The Spiral-Z leg graft demonstrated excellent patency and required infrequent limb-related reinterventions in routine clinical care in a postmarket registry.

Paclitaxel-Coated Zilver PTX Drug-Eluting Stent Treatment Does Not Result in Increased Long-Term All-Cause Mortality Compared to Uncoated Devices.

PURPOSE: Patient-level data from two large studies of the Zilver PTX drug-eluting stent (DES) with long-term follow-up and concurrent non-drug comparator groups were analyzed to determine whether there was an increased mortality risk due to paclitaxel. METHODS: Data from the Zilver PTX randomized controlled trial (RCT) and Zilver PTX and bare metal stent (BMS) Japan post-market surveillance studies were analyzed. Five-year follow-up is complete in both DES studies; follow-up for the BMS study was limited to 3 years and is complete. Kaplan-Meier analyses assessed mortality. A Cox proportional hazards model identified significant factors related to mortality. RESULTS: In the RCT, there were 336 patients treated with the DES and 143 patients treated with percutaneous transluminal angioplasty (PTA) or BMS. In Japan, there were 904 DES patients and 190 BMS patients. There was no difference in all-cause mortality for the DES compared to PTA/BMS in the RCT (19.1% DES versus 17.1% PTA/BMS through 5 years, p = 0.60) or Japan (15.8% DES versus 15.3% BMS through 3 years, p = 0.89). Cox proportional hazard models revealed that age, tissue loss, and congestive heart failure were significantly associated with mortality in the RCT, and critical limb ischemia, age, renal failure, and gender were significantly associated with mortality in Japan (all p < 0.05). Neither treatment with Zilver PTX (p = 0.46 RCT, p = 0.49 Japan) nor paclitaxel dose (p = 0.86 RCT, p = 0.07 Japan) was associated with mortality. CONCLUSION: Analyses of the Zilver PTX patient-level data demonstrated no increase in long-term all-cause mortality. LEVEL OF EVIDENCE: Zilver PTX RCT: Level 1, randomized controlled trial; Japan PMS studies: Level 3, post-market surveillance study.

Thoracic endovascular aortic repair with stent grafts alone or with a composite device design in patients with acute type B aortic dissection in the setting of malperfusion.

OBJECTIVE: The objective of this study was to compare short-term outcomes in patients who underwent thoracic endovascular aortic repair (TEVAR) with stent grafts alone or with a composite device design (stent graft plus bare-metal aortic stent) for acute type B aortic dissection in the setting of malperfusion. METHODS: This retrospective analysis included patients with acute (≤14 days of symptom onset) complicated type B dissection in the setting of malperfusion who were treated with stent grafts alone (TEVAR cohort) at two European institutions vs those who underwent TEVAR with a composite device design (Cook Medical, Bloomington, Ind) in the investigational STABLE I feasibility study and STABLE II pivotal study (STABLE cohort). Preoperative characteristics and 30-day outcomes (including mortality, malperfusion-related mortality, morbidity, and secondary interventions) were compared between the two groups. RESULTS: The TEVAR cohort (41 patients; mean age, 58.8 ± 12.7 years; 78.0% male) and the STABLE cohort (84 patients; mean age, 57.8 ± 11.7 years; 71.4% male) were largely similar in preoperative medical characteristics, with more STABLE patients presenting with a history of hypertension (79.8% vs 58.5%; P = .018). The TEVAR and STABLE groups had similar lengths of dissection (451.8 ± 112.7 mm vs 411.8 ± 116.4 mm; P = .10) and similar proximal and distal extent of dissection. At presentation, the two groups exhibited comparable organ system involvement in malperfusion: renal (53.7% TEVAR, 57.1% STABLE), gastrointestinal (41.5% TEVAR, 44.0% STABLE), lower extremities (34.1% TEVAR, 52.4% STABLE), and spinal cord (9.8% TEVAR, 2.4% STABLE). The 30-day rate of all-cause mortality was 17.1% (7/41) in the TEVAR group and 8.3% (7/84) in the STABLE group (P = .22). The 30-day rate of malperfusion-related mortality (deaths from bowel/mesenteric ischemia or multiple organ failure) was 12% (5/41) in the TEVAR group and 2.4% (2/84) in the STABLE group (P = .038). The 30-day morbidity, for the TEVAR and STABLE groups, respectively, included bowel ischemia (9.8% [4/41] vs 2.4% [2/84]; P = .09), renal failure requiring dialysis (7.3% [3/41] vs 9.5% [8/84]; P > .99), paraplegia or paraparesis (4.9% [2/41] vs 3.6% [3/84]; P = .66), and stroke (2.4% [1/41] vs 10.7% [9/84]; P = .16). The occurrence of 30-day secondary intervention was similar in the TEVAR and STABLE groups (7.3% [3/41] vs 7.1% [6/84]; P > .99). True lumen expansion in the abdominal aorta was significantly greater in the STABLE group. CONCLUSIONS: In patients with acute type B aortic dissection in the setting of branch vessel malperfusion, the use of a composite device with proximal stent grafts and distal bare aortic stent appeared to result in lower malperfusion-related mortality than the use of stent grafts alone. The 30-day rates of morbidity and secondary interventions were similar between the groups.

Risk factors for positive margins after wide local excision of cutaneous squamous cell carcinoma.

BACKGROUND AND OBJECTIVES: The standard treatment for cutaneous squamous cell carcinoma (cSCC) is wide local excision (WLE). Incomplete tumor excision is associated with increased recurrence rates and mortality risk. Risk factors for positive margins after WLE of cSCC has been examined in only a few studies. We sought to assess the influence of several clinicopathological factors on margin status in the largest cSCC population to date. METHODS: We performed a retrospective review of records at two skin cancer clinics identifying patients with biopsy-proven cSCC who underwent WLE. We mined clinicopathological information for eligible subjects including age, gender, lesion location, immunosuppression, previous treatment, lesion size, biopsy type, tumor subtype, tumor thickness, degree of differentiation, ulceration and perineural invasion. RESULTS: A total of 1468 patients were eligible and 117 (8%) had positive margins after WLE. Older age at diagnosis (p = .011), lesion location on the head and neck (p < .001), previous treatment (p < .001), increased lesion diameter (p < .001), invasive subtype (p = .020) or increased tumor thickness (p < .001) were statistically significant risk factors for positive surgical margins. CONCLUSIONS: Our results present an opportunity to stratify cSCC patients into low- or high-risk for incomplete tumor clearance after WLE based on several clinicopathological factors. These findings should educate and inform the dermatologic surgeon's choice of primary management of cSCC.

Long-Term Effectiveness of the Zilver PTX Drug-Eluting Stent for Femoropopliteal Peripheral Artery Disease in Patients with No Patent Tibial Runoff Vessels-Results from the Zilver PTX Japan Post-Market Surveillance Study.

PURPOSE: To evaluate 2-year results of the Zilver PTX (Cook Medical, Bloomington, Indiana) drug-eluting stent (DES) for femoropopliteal peripheral artery disease (PAD) in patients with no continuous patent infrapopliteal runoff arteries compared with patients with ≥ 1 continuous patent runoff vessels. MATERIALS AND METHODS: A retrospective analysis of patients with femoropopliteal PAD enrolled in the Zilver PTX Post-Market Surveillance Study in Japan was performed. There were no exclusion criteria. Outcomes, including freedom from target lesion revascularization (TLR), patency, and clinical benefit, for the no-runoff group (n = 54) were compared with the runoff group (n = 846). RESULTS: The 2 groups were similar in terms of demographics, lesion characteristics, and comorbidities (P > .05). There was a higher incidence of critical limb ischemia in the no-runoff group compared with the runoff group (44.8% vs 19.7%; P < .01). There were 3 amputations (5.6%) in the no-runoff group versus 7 amputations (0.8%) in the runoff group (P = .02). At 2 years, freedom from TLR rates were 81.3% versus 83.8% (P = .87), patency rates were 68.4% versus 70.7% (P = .95), and clinical benefit rates were 73.7% versus 80.0% (P = .16) in the no-runoff versus runoff group, respectively. CONCLUSIONS: Results in patients with no continuous patent tibial runoff were favorable through 2 years and similar to results for patients with ≥ 1 continuous patent runoff vessels, indicating that the Zilver PTX DES may be a valid treatment option for patients with these difficult-to-treat lesions.

Impact of Chronic Renal Failure on Safety and Effectiveness of Paclitaxel-Eluting Stents for Femoropopliteal Artery Disease: Subgroup Analysis from Zilver PTX Post-Market Surveillance Study in Japan.

PURPOSE: Favorable long-term outcomes of the Zilver PTX drug-eluting stent (DES) in femoropopliteal lesions have been demonstrated. Chronic renal failure (CRF) has been shown to be a risk factor for restenosis and decreased limb salvage. The results of the DES in patients with CRF have not previously been reported. This study compares the results with the DES in patients with CRF and those without CRF. METHODS: This retrospective analysis from the Zilver PTX Japan Post-Market Surveillance Study included 321 patients with CRF and 584 patients without CRF. Outcomes included freedom from target lesion revascularization (TLR) and patency. RESULTS: Of the patients included in this subgroup analysis, 2-year data were available for 209 patients in the CRF group and 453 patients in the non-CRF group. The two groups were similar in terms of lesion length and the frequency of in-stent restenosis. Critical limb ischemia, severe calcification, and diabetes were more common in patients with CRF, whereas total occlusion was more common in patients without CRF. Freedom from TLR rates were 81.4 versus 84.9% (p = 0.24), and patency rates were 70.7 versus 70.3% (p = 0.95) in patients with and without CRF at 2 years, respectively. CONCLUSION: This is the first comparative study of the DES in femoropopliteal artery lesions in patients with and without CRF. These results indicate that the DES placed in femoropopliteal artery lesions of CRF patients is safe and effective with similar patency and TLR rates to patients without CRF. LEVEL OF EVIDENCE: Level 3, Post-Market Surveillance Study.

Chronic hernia repair in a rat model using small intestinal submucosa.

BACKGROUND. Small intestinal submucosa (SIS) body wall defect repair in preclinical studies results in host tissue that resembles original host tissue histologically and has adequate strength to maintain repair integrity. However, these studies have been performed using acute hernia models that may not represent healing in a naturally occurring hernia. METHODS. Fifty-four male Sprague-Dawley rats were divided into nine groups (n = 6) and fascia/muscle/peritoneal abdominal wall defects were created. One control group had no surgery. Four surgery groups had defects repaired immediately by (1) fascia suture apposition, (2) polypropylene mesh (PPM) peritoneal onlay, (3) SIS inlay, or (4) SIS peritoneal onlay. After defect creation, chronic hernias matured for 28 days, and then were similarly repaired. Follow-up after hernia repair for all groups was 28 days. Gross evaluation for hernia recurrence, infection, and adhesions was followed by histopathology and tensile testing of the repair. RESULTS. There were no recurrent hernias or infection. Adhesions covered all implants. Histopathologic findings of inflammation and fibrosis were similar between all groups. There were no significant differences in tensile strength between SIS and PPM healing/incorporation or between acute and chronic hernia groups. Normal body wall was stronger than all repairs. Fascia closure in chronic hernias was stronger than acute fascia closure (p < .01). CONCLUSIONS. We found no significant differences between SIS and PPM healing/incorporation as determined by gross and histopathology and tensile strength testing. The study suggests that preclinical testing of abdominal body wall reconstruction in the rat may be adequately performed in acute studies.

Analgesic effect of bupivacaine eluting porcine small intestinal submucosa (SIS) in ferrets undergoing acute abdominal hernia defect surgery.

BACKGROUND: Porcine small intestinal submucosa (SIS) is used as a biological implant for abdominal wall hernia repair to facilitate wound healing and augment local tissue strength. This prospective, randomized, blinded study evaluated local pain control provided by bupivacaine adsorbed to SIS for repair of acutely created abdominal wall full thickness muscle/fascial defects in ferrets. MATERIALS AND METHODS: Eighteen healthy ferrets were randomly and equally assigned to three groups: (1) SIS with bupivacaine subjected to surgery, (2) SIS with no bupivacaine subjected to surgery, and (3) anesthesia only control group. Ferrets in groups 1 and 2 were anesthetized with butorphanol and sevoflurane for the surgery. Control ferrets were anesthetized in the same fashion for the same duration without surgery. Behavior and pain were evaluated in all ferrets by behavioral observation, algometer, and palpometer measurements, and heart and respiratory rates each obtained before surgery and at various intervals for 96 h after surgery. When pain reached a predetermined threshold, buprenorphine was used as a rescue analgesic. The serum and combined tissue concentrations of bupivacaine were analyzed. RESULTS: Overall, the palpometer testing was better tolerated in the bupivacaine treated SIS group than by the untreated SIS group (P = 0.04). There was an observed physiologically significant difference in algometer and other palpometer readings as well as heart and respiratory rates. All ferrets in the untreated SIS group were rescued while 33% of the SIS-bupivacaine groups were rescued (P < 0.01). Peak serum concentrations of bupivacaine were in the range of 0.7 µg/mL with tissue level below detection levels and no clinical signs of toxicity were observed. CONCLUSIONS: Bupivacaine adsorbed to SIS provided some degree of pain relief over 2-4 days with no clinical adverse effects observed in the ferrets.

Aneurysmal iliac arteries do not portend future iliac aneurysmal enlargement after endovascular aneurysm repair for abdominal aortic aneurysm.

OBJECTIVES: The purpose of this study was to examine the fate of aneurysmal iliac arteries managed during endovascular aneurysm repair (EVAR) for abdominal aortic aneurysm (AAA). METHODS: We analyzed data from the Cook Zenith trial. Follow-up was at 1 month, 6 months, 12 months, and then annually for 5 years. Patients were evaluated according to the largest iliac artery diameter: group A (≥ 20 mm) and group B (< 20 mm). These groups were further subdivided based on iliac artery growth ≥ 5 mm during follow-up. The Fisher exact test and χ(2) test were used. RESULTS: Of 736 patients treated, 671 had a follow-up examination (group A = 274). In group A, 220 (80%) were treated with flared limbs in the common iliac artery. Group A did not demonstrate increased iliac growth as compared to group B. Furthermore, both groups had a similar percentage of patients that experienced iliac artery expansion of 32.1% and 31.5%, respectively. Extension to the external iliac artery did not affect growth (P = .4). No difference was noted in the need for secondary interventions between groups. However, group A patients that did not experience growth were more likely to develop a distal type I endoleak than group B patients who did not develop growth (P = .03). There was no difference in serious adverse events (SAEs) between groups (P = .51). However, patients that developed iliac artery growth in either group were less likely to have an SAE compared to patients who did not experience growth (P = .035). There was no difference in the mean percent oversizing of the iliac limbs between groups A and B. However, the mean percent oversizing in groups A and B that had iliac artery growth was significantly higher than in those that demonstrated no growth (P < .01). CONCLUSION: Aneurysmal iliac arteries managed by flared limbs or external iliac extensions at the time of EVAR for AAA do not demonstrate future iliac growth, increased rate of secondary interventions, or SAEs compared to patients with normal iliac arteries. This suggests that aneurysmal iliac arteries can be safely treated with appropriately sized limbs landed in the common or external iliac artery.

Intermediate results of a United States multicenter trial of fenestrated endograft repair for juxtarenal abdominal aortic aneurysms.

OBJECTIVE: This article reports the intermediate-term (24-month) outcomes of a prospective multicenter trial designed to evaluate the Zenith Fenestrated AAA Endovascular Graft (Cook Medical, Bloomington, Ind) for treating juxtarenal abdominal aortic aneurysms with short proximal necks. The study goals were to evaluate the safety and preliminary effectiveness of the device and refine patient selection criteria. METHODS: Five centers in the United States enrolled 30 patients with juxtarenal aortic aneurysms with >or=50-mm diameter and short proximal necks. Devices were custom-designed for each patient based on measurements from reconstructed computed tomography (CT) data. Follow-up studies included physical examinations, laboratory studies, CT imaging, mesenteric-renal duplex ultrasound imaging, and abdominal flat plate radiographs at hospital discharge, at 1, 6, and 12 months, and yearly thereafter up to 5 years. RESULTS: During a 1-year period, 30 patients (80% men; mean age, 75 years) with a mean aneurysm size of 61.4 mm were enrolled. In these 30 patients, 77 visceral vessels were accommodated by fenestrations located within the sealing segment of the grafts. The most common design accommodated two renal arteries and the superior mesenteric artery (66.7%). All prostheses were implanted successfully. No visceral arteries were lost. Of the 30 patients treated, 27 were available for 12-month follow-up and 23 were available for 24-month follow-up. No aneurysm-related deaths, aneurysm ruptures, or conversions were observed through 24 months of follow-up. No type I or type III endoleaks were observed. Type II endoleaks were noted in six (26.1%) at 12 months and four (20.0%) at 24 months. No patients had aneurysm growth >5 mm. Aneurysm size decreased in 16 of 23 (69.6%) and was stable in the remaining patients at 24 months. Eight patients experienced a renal event (4 renal artery stenoses, 2 renal artery occlusions, and 2 renal infarcts). Five underwent secondary interventions. No renal failure developed requiring dialysis. CONCLUSIONS: The intermediate-term (24-month) results of the 30 patients in this multicenter study are concordant with previous single-center studies and support the concept that placement of fenestrated endovascular grafts is safe and effective at centers with experience in endovascular repair and renal/mesenteric stent placement.

Invasive rodent eradication on islands.

Invasive mammals are the greatest threat to island biodiversity and invasive rodents are likely responsible for the greatest number of extinctions and ecosystem changes. Techniques for eradicating rodents from islands were developed over 2 decades ago. Since that time there has been a significant development and application of this conservation tool. We reviewed the literature on invasive rodent eradications to assess its current state and identify actions to make it more effective. Worldwide, 332 successful rodent eradications have been undertaken; we identified 35 failed eradications and 20 campaigns of unknown result. Invasive rodents have been eradicated from 284 islands (47,628 ha). With the exception of two small islands, rodenticides were used in all eradication campaigns. Brodifacoum was used in 71% of campaigns and 91% of the total area treated. The most frequent rodenticide distribution methods (from most to least) are bait stations, hand broadcasting, and aerial broadcasting. Nevertheless, campaigns using aerial broadcast made up 76% of the total area treated. Mortality of native vertebrates due to nontarget poisoning has been documented, but affected species quickly recover to pre-eradication population levels or higher. A variety of methods have been developed to mitigate nontarget impacts, and applied research can further aid in minimizing impacts. Land managers should routinely remove invasive rodents from islands <100 ha that lack vertebrates susceptible to nontarget poisoning. For larger islands and those that require nontarget mitigation, expert consultation and greater planning effort are needed. With the exception of house mice (Mus musculus), island size may no longer be the limiting factor for rodent eradications; rather, social acceptance and funding may be the main challenges. To be successful, large-scale rodent campaigns should be integrated with programs to improve the livelihoods of residents, island biosecurity, and reinvasion response programs.