Predicting the Safety and Effectiveness of Inferior Vena Cava Filters (PRESERVE): Outcomes at 12 months.

OBJECTIVE: To determine the safety and effectiveness of vena cava filters (VCFs). METHODS: A total of 1429 participants (62.7 ± 14.7 years old; 762 [53.3% male]) consented to enroll in this prospective, nonrandomized study at 54 sites in the United States between October 10, 2015, and March 31, 2019. They were evaluated at baseline and at 3, 6, 12, 18, and 24 months following VCF implantation. Participants whose VCFs were removed were followed for 1 month after retrieval. Follow-up was performed at 3, 12, and 24 months. Predetermined composite primary safety (freedom from perioperative serious adverse events [AEs] and from clinically significant perforation, VCF embolization, caval thrombotic occlusion, and/or new deep vein thrombosis [DVT] within 12-months) and effectiveness (composite comprising procedural and technical success and freedom from new symptomatic pulmonary embolism [PE] confirmed by imaging at 12-months in situ or 1 month postretrieval) end points were assessed. RESULTS: VCFs were implanted in 1421 patients. Of these, 1019 (71.7%) had current DVT and/or PE. Anticoagulation therapy was contraindicated or had failed in 1159 (81.6%). One hundred twenty-six (8.9%) VCFs were prophylactic. Mean and median follow-up for the entire population and for those whose VCFs were not removed was 243.5 ± 243.3 days and 138 days and 332.6 ± 290 days and 235 days, respectively. VCFs were removed from 632 (44.5%) patients at a mean of 101.5 ± 72.2 days and median 86.3 days following implantation. The primary safety end point and primary effectiveness end point were both achieved. Procedural AEs were uncommon and usually minor, but one patient died during attempted VCF removal. Excluding strut perforation greater than 5 mm, which was demonstrated on 31 of 201 (15.4%) patients' computed tomography scans available to the core laboratory, and of which only 3 (0.2%) were deemed clinically significant by the site investigators, VCF-related AEs were rare (7 of 1421, 0.5%). Postfilter, venous thromboembolic events (none fatal) occurred in 93 patients (6.5%), including DVT (80 events in 74 patients [5.2%]), PE (23 events in 23 patients [1.6%]), and/or caval thrombotic occlusions (15 events in 15 patients [1.1%]). No PE occurred in patients following prophylactic placement. CONCLUSIONS: Implantation of VCFs in patients with venous thromboembolism was associated with few AEs and with a low incidence of clinically significant PEs.

Evaluating the Role of Major Lower Extremity Amputation in Nonagenarians.

OBJECTIVE: Elderly patients with critical limb ischemia are an especially frail and vulnerable group of patients. There is little literature investigating outcomes and resource utilization in nonagenarians undergoing major lower extremity amputation (MLEA). This study aims to elucidate the outcomes of this unique set of patients for whom amputation may often be considered a "palliative" intervention. METHODS: Analyzing over 16,000 records from the Vascular Quality Initiative (VQI) database, we collected demographic, operative, and postoperative data on all patients who underwent an MLEA. We performed univariate analysis comparing nonagenarians to younger patients examining both short-term and long-term outcomes. Multimodel inference was used to analyze the effect of age on clinically meaningful outcomes: mortality and long-term living disposition. RESULTS: With 392 nonagenarians and 16,349 patients under the age of 90, we found nonagenarians were less comorbid and less likely to have a prior bypass or amputation. Despite experiencing lower rates of reoperation and individual postoperative complications, nonagenarians suffered higher long-term mortality (46% vs. 22%, P < 0.0005) and were more likely to be living in a facility at follow-up (34% vs. 15%, P < 0.0005). Incorporating important demographic and clinical factors, multimodel inference demonstrated that, the nonagenarian age group was a critical predictor of nonhome living status (Akaike Importance weight 0.99). CONCLUSIONS: Although nonagenarians were less comorbid than their younger counterparts and suffered fewer perioperative complications, MLEA leads to a poorer outcome with significant mortality and a higher likelihood of residing in a facility at long-term follow-up. These findings underscore the importance of frank goals of care discussions in nonagenarians considering major amputation.

Understanding who benefits from endovascular aortic repair in those deemed unfit for open repair.

INTRODUCTION: Patients with abdominal aortic aneurysms (AAAs) who are deemed unacceptable candidates for open repair (UNFIT) pose a clinical challenge. The EVAR2 Trial randomized UNFIT patients to endovascular aortic repair (EVAR) vs no intervention from 1999 to 2003, concluding that survival was not improved by EVAR. However, outcomes after EVAR over the last 2 decades have dramatically changed. Thus, the purpose of this study was to evaluate outcomes after EVAR in UNFIT patients using more contemporary data and to determine which subsets of UNFIT patients may potentially benefit from EVAR. METHODS: The Vascular Quality Initiative database (2003-2020) was used to identify elective EVARs for AAAs. Patients were categorized as UNFIT or suitable (SUITABLE) for open repair by the operative surgeon. Predicted 1-year mortality of untreated AAAs was calculated via a modified Gagne Index adjusted for AAA size. The primary outcome for the study was 30-day mortality. Secondary outcomes included perioperative major adverse cardiac events (a composite of clinically significant arrhythmia, congestive heart failure, and myocardial infarction), length of stay, and 1-year mortality. RESULTS: A total of 31,471 patients met study criteria with 27,036 (85.9%) deemed SUITABLE and 4435 (14.1%) UNFIT. UNFIT patients were more likely to experience a perioperative major adverse cardiac event (5.1% vs 2.2%, P < .001) and had longer lengths of stay (1 day [interquartile range, 1-3 days] vs 1 day [interquartile range, 1-2 days], P < .001). The 30-day mortality was significantly higher for UNFIT patients (0.8% vs 0.4%, P < .001). UNFIT patients had worse 1-year survival compared with SUITABLE patients. However, UNFIT and SUITABLE patients had significantly improved actual 1-year mortality with EVAR compared with predicted 1-year mortality without EVAR: 9.5% vs 15.6% (P < .001) and 4.0% vs 11.7% (P < .001), respectively. The mortality benefit after EVAR in UNFIT patients was primarily restricted to those with smaller Gagne Indices and larger aneurysm diameters. Patients deemed unsuitable for open repair due to frailty or multiple reasons had significantly higher 30-day mortality rates after EVAR when compared with SUITABLE patients (1.3% vs 1.6% vs 0.4%, P < .001). Those deemed unsuitable for open repair due to frailty or multiple reasons had worse 1-year cumulative survival compared with all other UNFIT patients. CONCLUSIONS: Despite being high risk with higher perioperative morbidity and mortality, UNFIT patients have lower actual 1-year mortality with EVAR than predicted 1-year mortality without EVAR. However, this potential benefit is reserved to those with small Gagne Indices, larger AAA diameters, and lack of frailty.

Defining the threshold surgeon volume associated with improved patient outcomes for carotid endarterectomy.

OBJECTIVE: The outcomes for common vascular operations, such as carotid endarterectomy (CEA), are associated with surgeon volume. However, the number of operations associated with an improved stroke or death rate for CEA is not known. The objective of the current study was to define the annual surgeon volume of CEAs that is associated with a lower risk of stroke or death rate. METHODS: The Nationwide Inpatient Sample was analyzed to identify patients undergoing CEA between 2003 and 2009. Annual surgeon volume was correlated with a composite end point of in-hospital stroke or death. Mixed linear regression analyses were conducted to determine if annual surgeon volume of CEAs is independent predictor of the composite outcome. Receiver operating characteristic curves were constructed from the regression models and used to calculate the Youden Index, which defined the optimal cutoff point of annual surgeon volume of CEAs in predicting in-hospital stroke and death. This cutoff point was further assessed using Chi square analyses to determine whether incremental increases in the annual volume of CEAs were associated with a lower in-hospital stroke or death rate. RESULTS: A total of 104,918 CEA cases with surgeon identifiers were included in the analysis. The crude in-hospital stroke or death rate for CEA was 1.26 %. As expected, the stroke or death rate after CEA was higher for symptomatic patients, compared to asymptomatic patients (6.46 % vs 0.72%; P < .0001). For symptomatic patients, the relationship between surgeon volume and the composite end point was not significant (P = .435). In contrast, there was a strong relationship between surgeon volume and outcomes for asymptomatic patients undergoing CEA with a stroke/death rate of 1.66%, 0.91%, and 0.65% for low-, moderate-, and high-volume surgeons (P < .0001). Multivariate analysis identified age, African-American race, Charlson Comorbidity Index, and surgeon volume as independent predictors of stroke/death after CEA for asymptomatic carotid stenosis. For asymptomatic patients, the optimal cutoff number of CEAs to predict stroke/death rate was 19.4 CEAs per year (sensitivity = 74.9%, specificity = 72.6%, Youden index = 0.475). Analyses of outcomes at different cutoff points of surgeon volume revealed that the rate of crude complications and the adjusted probability of stroke or death was higher with case numbers less than 20 CEAs per year and lower with case numbers of 20 CEA or higher per year. Cutoff points above 20 cases were year did not yield a stroke/death rate that was significantly lower than the stroke/death rate at 20 CEAs per year, which confirmed the cutoff point of 20 CEAs per year. Only 16% of surgeons in the database achieved the threshold of 20 CEAs per year. CONCLUSIONS: Higher surgeon volume is associated with improved outcomes for CEAs performed in patients with asymptomatic carotid disease, but not for symptomatic carotid disease. For asymptomatic carotid disease, the probability of stroke or death was no longer reduced significantly at cutoff points of 20 or more CEAs per year. There are a number of other variables that may impact the clinical outcomes for CEA, so it is premature at this time to restrict privileges based on surgeon volume criteria.

Outcomes after Open Lower Extremity Revascularization in Patients with Critical Limb Ischemia.

BACKGROUND: For decades, open intervention was the treatment of choice in patients requiring lower extremity revascularization. In the endovascular era, however, open and endovascular revascularization are options. The implications of prior revascularization on the outcomes for subsequent revascularization are not known. In the present study, we evaluated 30-day outcomes after open lower extremity revascularization for critical limb ischemia (CLI) in those who had previous interventions. METHODS: The 2012-2017 open lower extremity bypass Participant User Data Files from the National Surgical Quality Improvement Program were used to identify a cohort of patients with CLI. Patients whose operation was considered emergent were excluded from the analysis. Patients were stratified on whether they had a previous open or endovascular intervention or undergoing a primary revascularization. The primary outcome measure was 30-day major adverse limb events (MALEs). Secondary outcomes included major adverse cardiac events (MACEs) and wound complications. RESULTS: A total of 12,668 patients met study criteria with 59.6% (n = 7,549) undergoing a primary open revascularization, 22.4% (n = 2,839) having a prior endovascular intervention, and 18.0% (n = 2,280) having a prior open revascularization. There were notable differences in the baseline characteristics between the 3 groups. In addition, there were differences in the reason for intervention (rest pain versus tissue loss), type of revascularization, and type of conduit used between the 3 groups. After adjustment, a prior open revascularization was significantly associated with 30-day MALE when compared with a primary revascularization (adjusted odds ratio, 1.69; 95% confidence interval, 1.47-1.94; P < 0.001) and prior endovascular intervention (adjusted odds ratio, 1.76; 95% confidence interval, 1.46-2.12; P < 0.001). There were no differences in outcomes between primary revascularization and prior endovascular patients. There were no differences between MACEs or wound complications between the 3 groups. CONCLUSIONS: A prior endovascular intervention does not seem to accrue any additional short-term risk when compared with primary revascularization, suggesting an endovascular-first approach may be a safe strategy in patients with CLI. However, a prior open intervention is significantly associated with 30-day MALE in patients undergoing redo open revascularization, which may be related to the rapid decline in patients once they have exhausted their best open revascularization option.

Attrition rates in integrated vascular and cardiothoracic surgery residency and fellowship programs.

BACKGROUND: Attrition in surgical programs remains a significant problem resulting in trainee dissatisfaction and wasted time and educational dollars. Attrition rates in general surgery training programs approximate 5% per year (30% cumulative). Attrition rates in cardiovascular surgery training for the traditional vascular surgery fellowship (VSF), the vascular surgery residency (VSR), and the corresponding programs in cardiothoracic surgery have yet to be described, although they are assumed to be similar to those associated with general surgery training. METHODS: A retrospective review of the Association of American Medical Colleges Annual Physician Specialty Data Book was performed. Data from consecutive academic years 2007-2008 to 2013-2014 were analyzed. The number of total residents, the number who did not complete their training, and those who successfully completed the program were recorded. Attrition rates were then calculated for VSF, VSR, general surgery residency (GSR), cardiothoracic surgery fellowship (CTF), and cardiothoracic surgery integrated residency (CTR). RESULTS: Annually, between 2007-2008 and 2013-2014, there were zero to two vascular surgery residents who failed to complete the program (0%-5.9%). In the last 4 years of the study, whereas the absolute number of residents who failed to complete the program remained constant at 1 or 2 per year, the attrition rate decreased to 1 of 171 trainees (0.6%) in 2013-2014 as the total number of programs (and numbers of vascular surgery residents) significantly increased. During the same 7-year period, the number of vascular surgery fellows who did not complete their training ranged from one to six annually (0.4%-2.5%). Compared with the VSF, the VSR data show a relatively low and constant rate of attrition. In contrast, the number of general surgery residents who did not complete their program during the study period varied from 255 to 388 residents annually (3.3%-5.2%). During its first 3 years of inception, the CTR program had an attrition rate of 0%, and it was not until 2012-2013 that trainees failed to complete the program, resulting in an annual attrition rate of 1.2% to 3.2% from that point on. The annual attrition rate of CTF training programs ranged from 7 to 15 fellows (2.9%-6.8%) during the study period. CONCLUSIONS: The inception of VSR and CTR programs dramatically changed the paradigms for training in these highly specialized surgical fields. Comparisons of attrition rates between these two programs and the traditional VSF and CTR as well as GSR suggests lesser rates of attrition in the integrated programs. These data may prove reassuring to VSR and CTR program directors, whose significantly smaller programs are more vulnerable to the loss of even a single trainee than general surgery training programs are. In addition, the VSF program has stable and lower attrition rates compared with the CTF and GSR programs.

Aggressive Phenotype of Intravascular Lymphoma Relative to Other Malignant Intraabdominal Tumors Requiring Vascular Reconstruction.

BACKGROUND: Safe resection of intraabdominal and retroperitoneal malignancies with a goal of negative margins may require vascular surgical assistance with grafting of the aorta and/or vena cava. The current report reviews malignancies associated with major vascular reconstructions at a single tertiary referral center. METHODS: Adults with abdominal or retroperitoneal tumors involving the aorta, vena cava, or iliac arteries that underwent reconstruction with vascular grafts at the University of Michigan from 2010 to 2016 were reviewed retrospectively. The initial presentation, surgical management, and outcomes were analyzed. RESULTS: Twelve patients with tumors involving the abdominal aorta, vena cava, or iliac arteries underwent major vascular reconstruction in this seven-year study period. Tumor pathology included solid tumors (leiomyosarcoma [n = 7], germ cell tumor [n = 3], and intravascular lymphoma [n = 2]). Surgical treatment included grafting of the vena cava (n = 6), aorta (n = 3), iliac artery (n = 4), or both the aorta and vena cava (n = 1). Patients with intravascular lymphoma were identified incidentally during treatment of abdominal aortic aneurysm or on pathological analysis of thromboembolism from an aortic source. Other patients had planned resection. Follow-up ranged from 9 to 86 months (median: 28.9). There were no graft occlusions. Tumor metastasized or recurred in patients with sarcoma (n = 2; 28.6%), germ cell tumor (n = 1; 33.3%), and intravascular lymphoma (n = 2; 100%). Both patients with lymphoma had multiple anastomotic or tumor-embolic pseudoaneurysms for <14 months after vascular reconstruction. Both lymphoma patients died during follow-up. CONCLUSIONS: This single-center review suggests that sarcoma and germ cell tumors may be safely resected in conjunction with major vascular reconstruction in carefully selected patients. In comparison, intravascular lymphoma identified incidentally at the time of aortic reconstruction resulted in a more malignant course with pseudoaneurysm formation of anastomoses or native vessels, cancer recurrence, and 100% mortality. Aneurysm contents and emboli should be carefully reviewed perioperatively by pathologists.

A survey of vascular specialists' practice patterns of inferior vena cava filter placement and retrieval.

OBJECTIVES: The placement of inferior vena cava filters (IVCF) continues to rise. Vascular specialists adopt different practices based on local expertise. This study was performed to assess the attitudes of vascular specialists towards the placement and retrieval of IVCF. METHODS: An online survey of 28 questions related to practice patterns regarding IVCF was administered to 1429 vascular specialists. Vascular specialists were categorized as low volume if they place less than three IVCF per month and high volume if they place at least three IVCF per month. The responses of high volume and low volume were compared using two-sample t-tests and Chi-square tests. RESULTS: A total of 259 vascular specialists completed the survey (18% response rate). There were 191 vascular surgeons (74%) and 68 interventional radiologists (26%). The majority of responders were in academic practice (67%) and worked in tertiary care centers (73%). The retrievable IVCF of choice was Celect (27%) followed by Denali (20%). Forty-two percent used a temporary IVCF and left it in situ instead of using a permanent IVCF. Eighty-two percent preferred placing the tip of the IVCF at or just below the lowest renal vein. Thirty-one percent obtained a venous duplex of the lower extremities prior to retrieval while 24% did not do any imaging. There were 132 (51%) low volume vascular specialists and 127 (49%) high volume vascular specialists. Compared to low volume vascular specialists, significantly more high volume vascular specialists reported procedural times of less than 30 min for IVCF retrieval (57% vs. 42%, P = 0.026). There was a trend for high volume to have fewer unsuccessful attempts at IVCF retrieval but that did not reach statistical significance ( P = .061). High volume were more likely to have attempted multiple times to retrieve an IVCF (66% vs. 33%, P < .001), and to have used bronchoscopy forceps (32% vs. 14%, P = .001) or a laser sheath (14% vs. 2%, P < .001) for IVCF retrieval. In general, vascular specialists were not comfortable using bronchoscopy forceps (65%) or a laser sheath (82%) for IVCF retrieval. CONCLUSIONS: This study underscores significant variability in vascular specialists practice patterns regarding IVCF. More studies and societal guidelines are needed to define best practices.

Radiation brain dose to vascular surgeons during fluoroscopically guided interventions is not effectively reduced by wearing lead equivalent surgical caps.

OBJECTIVE: Radiation to the interventionalist's brain during fluoroscopically guided interventions (FGIs) may increase the incidence of cerebral neoplasms. Lead equivalent surgical caps claim to reduce radiation brain doses by 50% to 95%. We sought to determine the efficacy of the RADPAD (Worldwide Innovations & Technologies, Lenexa, Kan) No Brainer surgical cap (0.06 mm lead equivalent at 90 kVp) in reducing radiation dose to the surgeon's and trainee's head during FGIs and to a phantom to determine relative brain dose reductions. METHODS: Optically stimulated, luminescent nanoDot detectors (Landauer, Glenwood, Ill) inside and outside of the cap at the left temporal position were used to measure cap attenuation during FGIs. To check relative brain doses, nanoDot detectors were placed in 15 positions within an anthropomorphic head phantom (ATOM model 701; CIRS, Norfolk, Va). The phantom was positioned to represent a primary operator performing femoral access. Fluorography was performed on a plastic scatter phantom at 80 kVp for an exposure of 5 Gy reference air kerma with or without the hat. For each brain location, the percentage dose reduction with the hat was calculated. Means and standard errors were calculated using a pooled linear mixed model with repeated measurements. Anatomically similar locations were combined into five groups: upper brain, upper skull, midbrain, eyes, and left temporal position. RESULTS: This was a prospective, single-center study that included 29 endovascular aortic aneurysm procedures. The average procedure reference air kerma was 2.6 Gy. The hat attenuation at the temporal position for the attending physician and fellow was 60% ± 20% and 33% ± 36%, respectively. The equivalent phantom measurements demonstrated an attenuation of 71% ± 2.0% (P < .0001). In the interior phantom locations, attenuation was statistically significant for the skull (6% ± 1.4%) and upper brain (7.2% ± 1.0%; P < .0001) but not for the middle brain (1.4% ± 1.0%; P = .15) or the eyes (-1.5% ± 1.4%; P = .28). CONCLUSIONS: The No Brainer surgical cap attenuates direct X rays at the superficial temporal location; however, the majority of radiation to an interventionalist's brain originates from scatter radiation from angles not shadowed by the cap as demonstrated by the trivial percentage brain dose reductions measured in the phantom. Radiation protective caps have minimal clinical relevance.

Continued Ultrasound Surveillance Required after Hand Ischemia Associated with Trauma in Children.

BACKGROUND: Hand ischemia following trauma in children is rare, and the natural history after upper extremity arterial bypass in children is unknown. We hypothesize children with brachial artery repair are at long-term risk of developing aneurysmal degeneration or thrombosis, thus necessitating annual duplex ultrasonography and physical examination. METHODS: A retrospective review of children who had brachial artery repair (bypass or vein patch) for hand ischemia secondary to trauma at a level I trauma pediatric hospital was performed. Telephone interviews were conducted to assess the presence of arm/hand symptoms (pain, weakness, fatigue, sensory function, limb length discrepancy). RESULTS: Between 2003 and 2016, 16 children (12 males), mean age 8 years (3-13 years) underwent brachial artery repair (12 bypass with vein, 4 vein patch). Mechanism of injury included 11 supracondylar fractures and 5 lacerations. All patients were seen at 2 weeks with a duplex ultrasound. Thirteen patients were lost to follow-up. The 3 patients with follow-up had patent bypasses, but one patient 6 years out from the repair had aneurysmal degeneration of the vein graft. Seven patients were never seen again. Phone interviews were conducted for the remaining 6 patients and 2 complained of arm fatigue and intermittent hand pain. Only one patient reported that the pediatrician checked pulses in the affected extremity. CONCLUSIONS: Eighty percentage of children had no further follow-up after the postoperative visit. Asymptomatic aneurysmal degeneration of the vein graft was noted 6 years following repair in one patient, and 2 patients had unevaluated hand complaints. These patients are at risk for late complications and are unlikely to return for routine follow-up. The importance of graft surveillance must be more clearly emphasized at time of initial surgery.

Pancreaticoduodenal and Gastroduodenal Artery Aneurysms Associated with Celiac Artery Occlusive Disease.

BACKGROUND: The purpose of this study is to better define the clinical relevance of aneurysms affecting collateral vessels in patients with celiac artery (CA) occlusive disease. METHODS: True pancreaticoduodenal artery (PDA) and gastroduodenal artery (GDA) aneurysms associated with CA stenoses or occlusions reported from 1970 to 2010 in the English literature and similar cases treated at the University of Michigan were reviewed. Clinical presentations and differing treatment modalities were documented and analyzed. RESULTS: One hundred twenty-five patients having CA occlusive disease exhibited true arterial aneurysms affecting the PDA (105 patients), GDA (10 patients), or both PDA and GDA and their branches (10 patients). Aneurysm size averaged 2.1 cm. Included were 110 patients culled from the literature and 15 treated by the authors. The mean age of patients in this series was 59 years and there was no gender predilection. Aneurysms were asymptomatic in 26%. Abdominal pain affected 54% of the patients, including all who experienced rupture. Rupture occurred in 48 patients of whom 15 were hemodynamically unstable, including 6 who died. Surgical interventions included endovascular embolization (39), aneurysmectomy alone (25), and aneurysmectomy with arterial reconstruction (20). Salutary outcomes occurred in 91% of the cases. Open surgical procedures have remained constant, but were equaled by endovascular interventions in 1996, with the latter having increased 3-fold in the past 15 years. CONCLUSIONS: PDA and GDA aneurysms associated with CA occlusive disease carry a high risk of nonfatal rupture, warranting early treatment. Endovascular and open interventions may be successfully undertaken with minimal risks in treating these uncommon aneurysms.

Renal Salvage with Renal Artery Stenting Improves Long-term Survival.

BACKGROUND: The Cardiovascular Outcomes in Renal Atherosclerotic Lesions (CORAL) Trial cast doubt on the benefits of renal artery stenting (RAS). However, the outcomes for patients with chronic kidney disease (CKD) were not analyzed separately in the CORAL Trial. We hypothesized that patients who experienced a significant improvement in renal function after RAS would have improved long-term survival, compared with patients whose renal function was not improved by stenting. METHODS: This single-center retrospective study included 60 patients with stage 3 or worse CKD and renal artery occlusive disease who were treated with RAS for renal salvage. Patients were categorized as "responders" or "nonresponders" based on postoperative changes in estimated glomerular filtration rate (eGFR) after RAS. "Responders" were those patients with an improvement of at least 20% in eGFR over baseline; all others were categorized as "nonresponders." Survival was analyzed using the Kaplan-Meier method. Cox proportional hazards regression was used to identify predictors of long-term survival. RESULTS: The median age of the cohort was 66 years (interquartile range [IQR], 60-73). Median preoperative eGFR was 34 mL/min/1.73 m2 (IQR, 24-45). At late follow-up (median 35 months, IQR, 22-97 months), 16 of 60 patients (26.7%) were categorized as "responders" with a median increase in postoperative eGFR of 40% (IQR, 21-67). Long-term survival was superior for responders, compared with nonresponders (P = 0.046 by log-rank test). Cox proportional hazards regression identified improved renal function after RAS as the only significant predictor of increased long-term survival (hazard ratio = 0.235, 95% confidence interval = 0.075-0.733; P = 0.0126 for improved versus worsened renal function after RAS). CONCLUSIONS: Successful salvage of renal function by RAS is associated with improved long-term survival. These data provide an important counter argument to the prior negative clinical trials that found no benefit to RAS.

Safety and effectiveness of total percutaneous access for fenestrated endovascular aortic aneurysm repair.

BACKGROUND: Percutaneous femoral vascular access is frequently used for aortic endovascular procedures, with a local access complication rate of 5% to 16%. Fenestrated endovascular aneurysm repair (FEVAR) has recently emerged as a new technique for the repair of short-neck and juxtarenal abdominal aortic aneurysms. The safety and effectiveness of percutaneous access for FEVAR has not been established to date. METHODS: Since United States Food and Drug Administration approval of the Zenith fenestrated aortic endograft (Cook Medical, Bloomington, Ind), 94 patients (60 Zenith fenestrated, 6 p-Branch, and 28 custom-made devices) have undergone FEVAR. Percutaneous access was performed using the "preclose" technique with the Perclose Proglide device (Abbott Vascular, Redwood City, Calif). Open access was performed when severely disease or calcified femoral arteries prevented percutaneous access. Patient-based analysis was performed assessing outcomes for the access site used for the larger profile sheath of the main device. RESULTS: Percutaneous access was used in 90 patients (177 common femoral arteries) and open access in four (11 common femoral arteries). Arm access was used in 41 patients (44%). The median sheath size was 20F (interquartile range [IQR], 20F-22F). Median operative time was 207 minutes (IQR, 160-270 minutes), with a median blood loss of 500 mL (IQR, 300-700 mL). The percutaneous access success rate was 92%. No preoperative factors predicted technical failure. No 30-day deaths occurred. Patients with failed percutaneous closure and who required conversion to open repair had higher estimated median blood loss of 800 (IQR, 600-1200) vs 500 (IQR, 300-600) mL (P = .01) and a longer median time to start ambulation of 4 (IQR, 2-7) vs 2 (IQR, 1-3) days (P = .03). Patients undergoing percutaneous closure had lower median blood loss (500 mL; IQR, 300-600 mL) than patients who underwent open surgical access (800 mL; IQR, 750-800 mL). Postoperative complications related to vascular access occurred in 11 patients (12%). CONCLUSIONS: Percutaneous femoral access is a safe and effective alternative to open access for FEVAR. Operative blood loss and longer time to ambulation are significantly increased after failed percutaneous closure.

The natural history of type II endoleaks after endovascular aneurysm repair for ruptured abdominal aortic aneurysm.

OBJECTIVE: The natural history of type II endoleak (T2EL) after endovascular aneurysm repair (EVAR) for ruptured abdominal aortic aneurysm (rAAA) remains elusive; as such, treatment guidelines are ill defined. The purpose of this study was to better delineate the natural history of T2EL after EVAR for rAAA in an effort to determine the need for reintervention and optimal surveillance. METHODS: A retrospective record review was conducted of all patients undergoing EVAR for rAAA in two large tertiary care academic vascular centers. Patient demographics, comorbidities, anatomic variables, and operative details were analyzed. Primary outcomes included the presence of T2EL, reintervention, delayed rupture, and aneurysm-related death. RESULTS: EVAR was used to treat rAAA in 56 patients between 2000 and 2013. Mean follow-up of this cohort was 634 days. Completion arteriogram demonstrated T2ELs in 12 patients (21%), and an additional four T2ELs (7%) were found by postoperative computed tomography angiogram that were not identified on the completion angiogram. Body mass index was the only statistically significant variable associated with the development of T2EL (P = .03). Preoperative warfarin use, aortic thrombus burden, and device type did not correlate with T2EL development. Iliolumbar vessels supplied 75% (n = 12) of T2ELs. Of the 14 patients with T2ELs who underwent serial imaging postoperatively, six (43%) sealed spontaneously. Five patients (36%) underwent reintervention for T2EL by way of coil embolization-four in which treatment was initiated by attending preference. One patient was treated for ongoing anemia in the immediate postoperative period. There was no sac expansion, delayed rupture, or graft explantation. CONCLUSIONS: T2ELs after EVAR for rAAA are common and appear to be associated with a benign natural history if left untreated. Although many will spontaneously seal early in the postoperative period, those that remain patent do not appear to increase the risk for sac expansion or delayed rupture or affect patient survival. As such, a conservative approach to treatment of T2ELs in rAAA may be warranted.

Gender and perioperative outcomes after fenestrated endovascular repair using custom-made and off-the-shelf devices.

BACKGROUND: The role of gender on perioperative outcomes after fenestrated endovascular aortic aneurysm repair (FEVAR) has not been established. The aim of this study is to determine the effect of gender on perioperative outcomes after FEVAR for complex abdominal aortic aneurysms using premanufactured devices. METHODS: During a 2-year period, 79 patients (63 men [80%] and 16 women [20%]) underwent FEVAR using Zenith Fenestrated AAA Endovascular Grafts, investigational Zenith pivot branch (p-branch) devices and fenestrated custom-made devices. A single-institutional study was performed to evaluate postoperative outcomes after FEVAR. The χ2, Fisher's, and nonparametric tests were used for bivariate analysis. Logistic regression was used for multivariate analysis. RESULTS: Median age was 73 years (interquartile range [IQR], 68-79 years). The median number of fenestrations was three. There was no difference in aneurysm anatomic location, size, or number of fenestrations between patients in either group. Women were more likely to undergo endoconduits at the access site before the target procedure (19% vs 2%; P = .02). The overall postoperative complication rate was similar among females and males (31% vs 33%; P > .5). However, women experienced longer times in the intensive care unit (median, 3 days [IQR, 2-5] vs 2 [IQR, 1-3]; P = .05) and longer duration of hospital stay (median, 4.5 days [IQR, 3-6.5] vs 3 [IQR, 2-4]; P < .01). Similarly, the rate of reinterventions was higher among women, 25% vs 5% (P = .02). For renal adverse events, there was a trend for a higher rate of renal function deterioration based in creatinine levels among women, when compared with men (18% vs 5%; P = .09). Multivariate analysis showed that female gender was associated with a 8-fold increased risk of renal function deterioration (odds ratio, 8.1; 95% confidence interval, 6.1-10.8). Female gender was also identified as in independent factor for reinterventions at 30 days (odds ratio, 7.4; 95% confidence interval, 6.7-8.1). CONCLUSIONS: FEVAR is a safe and effective procedure for patients at high and standard risk for open repair who are not eligible for standard EVAR. Women are at greater risk for more severe renal function deterioration, early reinterventions and longer durations of hospital and intensive care unit stay.

New image-processing and noise-reduction software reduces radiation dose during complex endovascular procedures.

BACKGROUND: A new proprietary image-processing system known as AlluraClarity, developed by Philips Healthcare (Best, The Netherlands) for radiation-based interventional procedures, claims to lower radiation dose while preserving image quality using noise-reduction algorithms. This study determined whether the surgeon and patient radiation dose during complex endovascular procedures (CEPs) is decreased after the implementation of this new operating system. METHODS: Radiation dose to operators, procedure type, reference air kerma, kerma area product, and patient body mass index were recorded during CEPs on two Philips Allura FD 20 fluoroscopy systems with and without Clarity. Operator dose during CEPs was measured using optically stimulable, luminescent nanoDot (Landauer Inc, Glenwood, Ill) detectors placed outside the lead apron at the left upper chest position. nanoDots were read using a microStar ii (Landauer Inc) medical dosimetry system. For the CEPs in the Clarity group, the radiation dose to surgeons was also measured by the DoseAware (Philips Healthcare) personal dosimetry system. Side-by-side measurements of DoseAware and nanoDots allowed for cross-calibration between systems. Operator effective dose was determined using a modified Niklason algorithm. To control for patient size and case complexity, the average fluoroscopy dose rate and the dose per radiographic frame were adjusted for body mass index differences and then compared between the groups with and without Clarity by procedure. Additional factors, for example, physician practice patterns, that may have affected operator dose were inferred by comparing the ratio of the operator dose to procedural kerma area product with and without Clarity. A one-sided Wilcoxon rank sum test was used to compare groups for radiation doses, reference air kermas, and operating practices for each procedure type. RESULTS: The analysis included 234 CEPs; 95 performed without Clarity and 139 with Clarity. Practice patterns of operators during procedures with and without Clarity were not significantly different. For all cases, procedure radiation dose to the patient and the primary and assistant operators were significantly decreased in the Clarity group by 60% compared with the non-Clarity group. By procedure type, fluorography dose rates decreased from 44% for fenestrated endovascular repair and up to 70% with lower extremity interventions. Fluoroscopy dose rates also significantly decreased, from about 37% to 47%, depending on procedure type. CONCLUSIONS: The AlluraClarity system reduces the patient and primary operator's radiation dose by more than half during CEPs. This feature appears to be an effective tool in lowering the radiation dose while maintaining image quality.

Severely regurgitant left ventricle to ascending aorta conduit in a failing fontan patient treated with a vascular endograft and melody transcatheter pulmonary valve via hybrid approach.

A 28-year-old male with single ventricular heart disease status post Fontan palliation and subsequent placement of left ventricle to ascending aorta (LV-AAo) valved conduit developed ascites and edema. Diagnostic catheterization revealed elevated ventricular end diastolic pressures (EDP) secondary to severe LV-AAo conduit regurgitation. Given the unique anatomy, surgical access via the right axillary artery provided optimal route for transcatheter valve implantation within the conduit. The procedure resulted in significant hemodynamic improvement with no complications. © 2016 Wiley Periodicals, Inc.

Open Mesenteric Interventions Are Equally Safe as Endovascular Interventions and Offer Better Midterm Patency for Chronic Mesenteric Ischemia.

BACKGROUND: Endovascular (EV) techniques are being advocated as the preferred method for mesenteric interventions because of their safety profile. However, midterm and long-term results are thought to be inferior to open interventions. We sought to compare our institutional experience with treatment of acute and chronic mesenteric ischemia (AMI and CMI, respectively) using EV and open techniques. METHODS: The medical records of open and EV mesenteric procedures performed at a single center were queried from 2002 to 2012. Demographic, perioperative, and follow-up data were extracted and analyzed. RESULTS: Thirty-eight patients underwent EV mesenteric interventions, whereas 77 patients underwent open revascularization. The demographic and perioperative characteristics for patients were similar. Most EV procedures (89.2%) comprised stenting, whereas open procedures included 25 (32.1%) antegrade bypasses, 38 (48.7%) retrograde bypasses, 8 (10.3%) thromboembolectomies, and 7 (9%) transaortic endarterectomies. Postoperative complications, overall 30-day morbidity and mortality were not significantly different in the open and EV groups for AMI or CMI. Thirty-day mortality in AMI (n = 34) was 38.2% (EV: 45.5% vs. open: 34.8%; P = nonsignificant). There was no mortality in either group for CMI patients. Mean follow-up was much longer for the open procedures (34.9 vs. 12.7 months, P = 0.004). Primary and secondary patency rates were better for open revascularization for CMI patients. CONCLUSIONS: Open revascularizations are equally safe as EV interventions for AMI and CMI. Patency of open revascularization for CMI is better than EV procedures at midterm follow-up.

Predictors of compliance with surveillance after endovascular aneurysm repair and comparative survival outcomes.

OBJECTIVE: Although imaging surveillance is mandatory for all patients after endovascular aneurysm repair (EVAR), many patients are not compliant with follow-up. We sought to determine predictors of compliance with EVAR surveillance and to examine how compliance with current surveillance protocols correlates with survival. METHODS: We analyzed 188 patients who underwent EVAR at our institution for infrarenal abdominal aortic aneurysms (AAAs) between 2001 and 2011. The primary end point was compliance with post-EVAR surveillance recommendations. Univariate analysis included patient demographics and socioeconomic information, AAA characteristics, EVAR hospital course variables, late complications and secondary interventions, length of follow-up, smoking status, family history of AAA, driving distances, primary care providers, and medical comorbidities. Mortality was determined by the Social Security Death Index. Multinomial logistic regressions were fit to identify independent predictors of compliance. Survival plots were generated with the Kaplan-Meier method and compared with the log-rank test. Univariate and multivariate Cox regression analysis was used to determine effect of compliance on survival after adjusting for confounders. RESULTS: Of 188 patients, 89 (47.3%) were 100% compliant with follow-up visits and imaging, 21 (11.1%) were moderately compliant by missing appointments, and 78 (41.4%) were lost to follow-up completely. Overall median age was 74 years, and 81.9% of patients were male. Late complications occurred in 77 patients (40.9%), secondary interventions were performed in 32 patients (17%), and 5-year mortality was 21.2%. Mean follow-up interval was >40 months for 100% compliant and moderately compliant patients and <20 months for those lost to follow-up (P < .0001). In adjusted analysis, late complications (odds ratio [OR], 2.71; 95% confidence interval [CI], 1.32-5.55; P = .007), absence of social work consultation (OR, 2.43; 95% CI, 1.12-5.27; P = .024), and family history of AAA (OR, 2.67; 95% CI, 1.06-6.75; P = .037) were associated with 100% compliance, whereas shorter driving distances (P = .051) and shorter hospital stay (P = .056) approached significance. Transient ischemic attack or stroke (OR, 3.59; 95% CI, 1.18-10.91; P = .024) was the only variable independently associated with moderate compliance. Compared with patients lost to follow-up, 100% compliant patients had worse survival (log-rank test, P = .033), whereas moderately compliant patients' survival was not significantly different (log-rank test, P = .149). In adjusted Cox regression analysis, 100% compliant patients had decreased survival duration (rate ratio, 2.67; 95% CI, 1.18-6.06; P = .018) compared with those lost to follow-up. CONCLUSIONS: Follow-up surveillance is incomplete for more than half of patients who undergo EVAR at our institution, and patient compliance can be predicted by covariates mentioned before. Compliance with current surveillance regimens does not confer a survival benefit. Further research individualizing surveillance protocols based on risk level of late complications and noncompliance and prospective studies examining resulting survival benefits of compliance are warranted.

Incidental discovery of a chronically thrombosed abdominal aortic aneurysm: case report and literature review.

Chronic spontaneously thrombosed abdominal aortic aneurysms (AAAs) are rare. We present a patient with a completely thrombosed abdominal aortic aneurysm found incidentally on imaging for evaluation of unrelated abdominal pain. The patient was asymptomatic with regards to the aneurysm due to extensive collateralization of the intercostal and lumbar arteries to the bilateral hypogastric and internal mammary arteries to the common femoral arteries bilaterally. Follow-up imaging after 10 months showed no aneurysmal change. Further study is needed regarding indications for elective repair, medical therapy, and surveillance modality and schedule for patients with chronically occluded AAAs as these patients are at risk for aneurysm rupture and thrombus propagation.