Revascularization for claudication: Changing the natural history of a benign disease!

OBJECTIVE: The benign natural history of intermittent claudication was first documented in 1960 and has been reconfirmed in several subsequent studies. Excellent outcomes in patients with intermittent claudication can be achieved with exercise therapy and optimal medical management. Professional society guidelines have clearly stated that revascularization procedures should be performed only in patients with incapacitating claudication who have failed conservative therapy. Despite these guidelines, revascularization procedures, primarily percutaneous interventions, have been increasingly utilized in patients with claudication. Many of these patients are not even offered an attempt at medical therapy, and those who are often do not undergo a full course of treatment. Many studies document significant reintervention rates following revascularization, which are associated with increased rates of acute and chronic limb ischemia that may result in significant rates of amputation. The objectives of this study were to compare outcomes of conservative therapy to those seen in patients undergoing revascularization procedures and to determine the impact of revascularization on the natural history of claudication. METHODS: Google Scholar and PubMed were searched for manuscripts on the conservative management of claudication and for those reporting outcomes following revascularization for claudication. RESULTS: Despite early improvement in claudication symptoms following revascularization, multiple studies have demonstrated that long-term outcomes following revascularization are often no better than those obtained with conservative therapy. High reintervention rates (up to 43% for tibial atherectomies) result in high rates of both acute and chronic limb ischemia as compared with those patients undergoing medical therapy. In addition, amputation rates as high as 11% on long-term follow-up are seen in patients undergoing early revascularization. These patients also have a higher incidence of adverse cardiovascular events such as myocardial infarctions compared with patients treated medically. CONCLUSIONS: Revascularization procedures negatively impact the natural history of claudication often resulting in multiple interventions, an increase in the incidence of acute and chronic limb ischemia, and an increased risk of amputation. Accordingly, informed consent requires that all patients undergoing early revascularization must be appraised of the potential negative impact of revascularization on the natural history of claudication.

Indications for a "Surgery-First" Approach for the Treatment of Lower Extremity Arterial Disease.

BACKGROUND: In recent years, there has been a tendency toward an "endovascular-first" approach for the treatment for femoropopliteal arterial disease. The purpose of this study is to determine if there are patients that are better served with an initial femoropopliteal bypass (FPB) rather than an endovascular attempt at revascularization. METHODS: A retrospective analysis of all patients undergoing FPB between June 2006 - December 2014 was performed. Our primary endpoint was primary graft patency, defined as patent using ultrasound or angiography without secondary intervention. Patients with <1-year follow-up were excluded. Univariate analysis of factors significant for 5-year patency was performed using χ2 tests for binary variables. A binary logistic regression analysis incorporating all factors identified as significant by univariate analysis was used to identify independent risk factors for 5-year patency. Event-free graft survival was evaluated using Kaplan-Meier models. RESULTS: We identified 241 patients undergoing FPB on 272 limbs. FPB indication was disabling claudication in 95 limbs, chronic limb-threatening ischemia (CLTI) in 148, and popliteal aneurysm in 29. In total, 134 FPB were saphenous vein grafts (SVG), 126 were prosthetic grafts, 8 were arm vein grafts, and 4 were cadaveric/xenografts. There were 97 bypasses with primary patency at 5 or more years of follow-up. Grafts patent at 5 years by Kaplan-Meier analysis were more likely to have been performed for claudication or popliteal aneurysm (63% 5-year patency) as compared with CLTI (38%, P < 0.001). Statistically significant predictors (using log rank test) of patency over time were use of SVG (P = 0.015), surgical indication of claudication or popliteal aneurysm (P < 0.001), Caucasian race (P = 0.019) and no history of COPD (P = 0.026). Multivariable regression analysis confirmed these 4 factors as significant independent predictors of 5-year patency. Of note, there was no statistical correlation between FPB configuration (above or below knee anastomosis, in-situ versus reversed saphenous vein) and 5-year patency. There were 40 FPBs in Caucasian patients without a history of COPD receiving SVG for claudication or popliteal aneurysm that had a 92% estimated 5-year patency by Kaplan-Meier survival analysis. CONCLUSIONS: Long-term primary patency that was substantial enough to consider open surgery as a first intervention was demonstrated in Caucasian patients without COPD, having good quality saphenous vein, and who underwent FPB for claudication or popliteal artery aneurysm.

Incidence of venous thromboembolism in patients with sickle cell disease undergoing noncardiovascular surgery.

OBJECTIVE: Patients with sickle cell disease (SCD) will have a baseline hypercoagulable state and an increased risk of venous thromboembolism (VTE). Few data are available regarding the efficacy of standard prophylaxis in preventing VTE after noncardiovascular surgery for patients with SCD. Our objective was to investigate the incidence of VTE in patients with SCD who had undergone noncardiovascular surgery. METHODS: We performed a retrospective medical record review of 352 patients with SCD who had undergone noncardiovascular surgery from August 2009 to August 2019 at Beaumont Hospitals. An equal number of control patients without SCD were propensity matched for age, sex, race, body mass index, and specific surgery. The data collected included demographics, comorbidities, VTE prophylaxis used, occurrence of deep vein thrombosis (DVT) and pulmonary embolism (PE), hospital length of stay, and 30-day mortality. RESULTS: We found no differences in age, race, sex, ethnicity, operative time, or hospital length of stay between the SCD and propensity-matched control patients. DVT prophylaxis was used more frequently for the SCD patients than for the controls (96.0% vs 88.6%; P < .001). Four SCD patients (1.1%) had developed DVT vs five control patients (1.4%; P > .999). One patient in each group had developed PE (0.3%; P > .999). No difference was found in 30-day mortality between the SCD group and the control group (1 [0.3%] vs 3 [0.9%]; P = .312). Of those with a diagnosis of VTE ≤30 days postoperatively, no differences were present in age, sex, race, BMI, or procedure type. DVT had been diagnosed significantly later in the SCD patients than in the controls (median, postoperative day 12 vs 5; P = .014). None of the five SCD patients with VTE was a smoker compared with four of the six non-SCD patients with VTE, who were current or former tobacco users (P = .061). All the patients who had developed VTE had received DVT prophylaxis at surgery. CONCLUSIONS: We found no differences in the perioperative rates of DVT, PE, or mortality between the SCD patients and matched control patients after noncardiovascular surgery. Vigilant attention to routine VTE prophylaxis seemed to effectively reduce the VTE risk for these hypercoagulable patients. SCD patients might need VTE prophylaxis for a longer period postoperatively compared with those without SCD.

Intramural hematoma of the thoracic aorta: A single-institution, 12-year experience.

OBJECTIVE: The natural history and management of intramural hematoma (IMH) has varied significantly worldwide. From the present retrospective analysis of our institutional database, we have reported the long-term results from medical and surgical management of types A and B IMH. METHODS: Computed tomography reports completed at our tertiary care hospital from July 2007 to July 2020 were used to identify patients with IMH with a thickness of ≥7 mm. Those with IMH directly related to trauma, previous aortic surgery, penetrating atheromatous ulcer, dissection flap, or an iatrogenic source and those who had never received any treatment of IMH at presentation were excluded. RESULTS: A total of 54 patients with IMH had met the inclusion and exclusion criteria. Of the 54 patients, 24 had presented with Stanford type A. Of these 24 patients, 10 had initially undergone surgery and 14 had initially received medical treatment. Two patients in the medical group had subsequently undergone surgery. In addition, 30 patients had presented with type B IMH and had initially received medical treatment, with 3 eventually requiring surgical intervention. In-hospital survival was 90% for type A IMH treated surgically, 93% for type A IMH treated medically, and 97% for type B IMH treated medically. At the last follow-up imaging study of the medically treated patients, 36% of those with type A IMH and 31% of those with type B IMH had experienced complete resolution of IMH at 3.7 and 31.5 months respectively, without surgical intervention. The development of an aortic aneurysm at the site of a previous IMH had occurred in 18% (2 of 11) and 12% (3 of 26) of the type A medical and type B medical cohorts. The overall rate of aortic aneurysm formation in the region of IMH or in another segment was 50%. No difference was found in long-term survival between the three cohorts at a mean follow-up of 22.8 months. CONCLUSIONS: A role appears to exist for medical treatment with anti-impulse therapy for appropriately selected patients with type A IMH. These patients must be followed up closely clinically and radiographically for signs of deterioration in the short- and long-term phases of their care. They can achieve long-term survival similar to that of surgically treated type A IMH and medically treated type B IMH patients using this algorithm. However, they might require late surgical intervention, especially for aneurysmal disease.

Predictors of mortality in nonagenarians undergoing abdominal aortic aneurysm repair: Analysis of the National Surgical Quality Improvement Program dataset.

BACKGROUND: The present study used the American College of Surgeons National Surgical Quality Improvement Program dataset to identify the predictors of 30-day mortality for nonagenarians undergoing endovascular aortic aneurysm repair (EVAR) or open surgical repair (OSR). METHODS: Patients aged >90 years who had undergone abdominal aortic aneurysm repair from 2005 to 2017 were identified using procedure codes. Those with operative times <15 minutes were excluded. The demographics, preoperative comorbidities, and postoperative complications of those who had died by 30 days were compared with those of the patients alive at 30 days. RESULTS: A total of 1356 nonagenarians met the criteria: 1229 (90.6%) had undergone EVAR and 127 (9.4%) had undergone OSR. The overall 30-day mortality was 10.4%. The patients who had died within 30 days were significantly more likely to have undergone OSR than EVAR (40.9% vs 7.2%; P < .001). They also had a greater incidence of dependent functional status (22.0% for those who had died vs 8.1% for those alive at 30 days; P < .001), American Society of Anesthesiology (ASA) classification of ≥4 (81.2% vs 18.8%; P < .001), perioperative blood transfusion (59.6% vs 20.3%; P < .001), postoperative pneumonia (12.1% vs 2.9%; P = .001), mechanical ventilation >48 hours (22.7% vs 2.6%; P < .001), and acute renal failure (12.1% vs 0.5%; P < .001). The EVAR group had a 30-day mortality rate of 2.6% in 1008 elective cases and 28.6% in 221 emergent cases. The OSR group had a 30-day mortality rate of 19.1% in 47 elective cases and 53.7% in 80 emergent cases. In the EVAR cohort, the 30-day mortality group had had a significantly greater incidence of dependent functional status (17% for those who had died vs 8% for those alive at 30 days; P = .004), ASA classification of ≥4 (76.4% vs 40.3%; P < .001), perioperative blood transfusion (57% vs 19%; P < .001), emergency surgery (71% vs 14%; P < .001), and longer operative times (150 vs 128 minutes; P = .001). CONCLUSIONS: Nonagenarians had an incrementally increased, but acceptable, risk of 30-day mortality with EVAR in elective and emergent cases compared with that reported for octogenarians and cohorts of patients not selected for age. We found greater mortality for patients with dependent status, a higher ASA classification, emergent repair, and OSR. These preoperative risk factors could help identify the best surgical candidates. Given these results, consideration for EVAR or OSR might be reasonable for highly selected patients, especially for elective patients with a larger abdominal aortic aneurysm diameter for whom the risk of rupture is higher.

Long-term outcomes and interventions of postoperative type 1a endoleak following elective endovascular aortic aneurysm repair.

OBJECTIVE: This study evaluated the incidence and long-term outcomes of postoperative type 1a endoleak (PT1a) following endovascular aortic aneurysm repair (EVAR). METHODS: A retrospective review of consecutive aortoiliac EVARs performed at a single institution from June 2006 to June 2012 was conducted. Patients with PT1a were identified by postoperative imaging and compared with those who did not develop a PT1a. Late outcomes were also studied of a subset of patients with PT1a who had persistent intraoperative type 1a endoleak (iT1a) on completion angiogram during EVAR that had resolved on initial follow-up imaging. RESULTS: Three hundred eighty-nine patients underwent EVAR with median follow-up of 87 months (interquartile range, 64-111 months). The incidence of PT1a was 8.2% (n = 32) with a median follow-up of 74 months (interquartile range, 52-138 months). Compared with the total cohort, those who developed PT1a were statistically more likely to be female (32% vs 17%; P = .03) and have a higher all-cause mortality (71% vs 40%; P < .01) and aneurysm-related mortality (15.6% vs 1.7%; P < .01). Median time to presentation was 52 months. Of the 32 patients with PT1a, five (15.6%) presented with aortic rupture, of which three underwent extension cuff placement, one had open graft explant, and one declined intervention. Six patients in total (18.7%) declined intervention; five of these died of nonaneurysmal causes and one remains alive. Of the 26 patients with PT1a who had intervention, 21 (80.7%) showed resolution of PT1a, and five (19.2%) had recurrence. For patients with recurrent PT1a, two had resulting aneurysm-related mortality, two endoleaks resolved after relining with an endograft, and one patient declined intervention but remains alive. Patients with PT1a who had intervention with resolution showed no significant difference in median survival estimates (140.0 months) compared with the remaining EVAR cohort (120.0 months; P = .80). Within the PT1a cohort, 6 (18.7%) had also experienced iT1a with a mean time to presentation of the late PT1a of 45 months. iT1a was associated with a significantly increased likelihood of developing a PT1a (P < .01) and decreased median survival (P < .01), but there was no known aneurysm-related mortality. CONCLUSIONS: Development of PT1a following elective EVAR is associated with increased all-cause and aneurysm-related mortality and presents an average of 52 months postoperatively. This underscores the importance of long-term surveillance. Patients with PT1a who had a successful intervention showed no significant difference in median survival. Those with iT1a had a higher risk for PT1a compared with the EVAR cohort overall and had decreased median survival, without increased aneurysm-related mortality.

Importance of diversity, equity, and inclusion in the community practice setting.

Vascular surgeons of all backgrounds play an important role in providing high quality vascular surgical care in their communities. In America, with our diverse population and communities, patients presenting with vascular disease are very common and could pattern the community demographic. Often faced with the challenges of community hospital politics and demand, the vascular surgical workforce has continued to be active members in their communities, focusing on their strengths to lead vascular surgery healthcare in an environment of high patient demand. Having a varied vascular surgery workforce provides all patients afflicted by vascular disease a comfortable opportunity for compassionate and empathic vascular care. This is a significant strength of vascular care when diversity, equity, and inclusion are supported by the leadership.

Screening Chest Computed Tomography is Indicated in All Patients with Abdominal Aortic Aneurysm.

BACKGROUND: This study quantifies the prevalence of thoracic aortic aneurysm (TAA) in patients with known abdominal aortic aneurysm (AAA). METHODS: A retrospective review of patients with a diagnosis of AAA from January 2007 to December 2017 within Beaumont Health was undertaken. Radiology reports of abdominal ultrasound, computed tomography (CT), and magnetic resonance imaging were reviewed to identify patients with AAA. Of these, patients with a chest CT scan performed within 180 days before or after abdominal imaging were reviewed for diagnosis of TAA. AAA was defined as aortic diameter ≥30 mm, and TAA was defined as aortic diameter ≥40 mm. RESULTS: The cohort included 218 patients with a chest CT scan performed within 180 days of initial diagnosis of AAA. The mean age at diagnosis of AAA was 74 years; 82 (37.6%) were women. There were no differences between men and women in the prevalence of diabetes mellitus, hypertension, hyperlipidemia, chronic obstructive pulmonary disease, tobacco use, and family history of aortic aneurysm. Forty concomitant AAAs and TAAs were detected, for an overall prevalence of 18.3%, with no significant difference between men and women (15% vs. 24%, P = 0.07). Women were diagnosed with AAA at an older age than men (76 vs. 73 years, P = 0.01) and had lower body mass index (23 vs. 26, P = 0.01), smaller maximum AAA diameter (36.5 vs. 40 mm, P = 0.03), and larger TAA (47 vs. 41 mm, P = 0.01). TAAs were classified by location: 47.5% (19/40), ascending; 32.5% (13/40), descending; and 20% (8/40), ascending and descending. Six patients had thoracoabdominal aortic aneurysms: 2 patients with extent II, 2 with extent III, and 2 with extent V. These patients were included in the overall analysis; excluding them resulted in a rate of concomitant AAA/TAA of 16%. No significant differences were noted in comorbidities or AAA size between the TAA/AAA and AAA only groups. CONCLUSIONS: TAAs appear to occur concomitantly with AAAs with significant frequency. Women appear to have larger TAA diameter than men, despite smaller sized AAA at diagnosis. These data support creating guidelines for obtaining a screening chest CT scan in all patients diagnosed with an AAA.

Guidelines for hospital privileges in vascular surgery and endovascular interventions: Recommendations of the Society for Vascular Surgery.

The Hospital Privileges Practice Guideline Writing Group of the Society for Vascular Surgery is making the following five recommendations concerning guidelines for hospital privileges for vascular surgery and endovascular therapy. Advanced endovascular procedures are currently entrenched in the everyday practice of specialized vascular interventionalists, including vascular surgeons, but open vascular surgery remains uniquely essential to the specialty. First, we endorse the Residency Review Committee for Surgery recommendations regarding open and endovascular cases during vascular residency and fellowship training. Second, applicants for new hospital privileges wishing to perform vascular surgery should have completed an Accreditation Council for Graduate Medical Education-accredited vascular surgery residency or fellowship or American Osteopathic Association-accredited training program before 2020 and should obtain American Board of Surgery certification in vascular surgery or American Osteopathic Association certification within 7 years of completion of their training. Third, we recommend that applicants for renewal of hospital privileges in vascular surgery include physicians who are board certified in vascular surgery, general surgery, or cardiothoracic surgery. These physicians with an established practice in vascular surgery should participate in Maintenance of Certification programs as established by the American Board of Surgery and maintain their respective board certification. Fourth, we provide recommendations concerning guidelines for endovascular procedures for vascular surgeons and other vascular interventionalists who are applying for new or renewed hospital privileges. All physicians performing open or endovascular procedures should track outcomes using nationally validated registries, ideally by the Vascular Quality Initiative. Fifth, we endorse the Intersocietal Accreditation Commission recommendations for noninvasive vascular laboratory interpretations and examinations to become a Registered Physician in Vascular Interpretation, which is included in the requirements for board eligibility in vascular surgery, but recommend that only physicians with demonstrated clinical experience in the diagnosis and management of vascular disease be allowed to interpret these studies.

Aneurysmal Degeneration in Patients with Type B Aortic Dissection.

BACKGROUND: The optimal management of type B aortic dissection (TBAD) remains controversial in the era of endovascular therapies. This study reports the outcomes and complication rates of different treatment paradigms for TBAD. METHODS: A retrospective review was undertaken of all patients with TBAD from June 2006 to June 2012. Demographics, hospital course, and follow-up visits were analyzed. Patients who underwent surgical interventions were compared to those with medical therapy. Survival rates and predictors of outcome were determined using the Kaplan-Meier method with Cox proportional hazards. RESULTS: Of 261 consecutive patients who were hospitalized during this period with a confirmed thoracic dissection, 134 (51%) had TBAD. Sixty-two (46%) were women, and the mean age was 66.4 ± 14.9. Median follow-up was 22.4 (0, 184) months. Thirty-five patients underwent surgical intervention with 20 thoracic endovascular aortic repair (TEVAR) and open surgery in 15. The overall 30-day mortality was 7%, and cumulative survival rates at 1, 3, and 5 years were 85% (95% confidence interval [CI], 79-91), 68% (95% CI, 59-78), and 57% (95% CI, 47-69) with no difference between medical versus surgical groups (P = 0.8) and TEVAR versus open surgery group (P = 1.0). Sixty-six (50%) patients developed aneurysmal expansion, which required surgical intervention in 26 (hazard ratios [HR], 0.99; P = 0.96). Malperfusion and rupture only occurred in 5 (HR, 1.57; P = 0.54) and 5 (HR, 3.64; P = 0.01) patients, respectively. Multivariate analysis for overall survival found renal insufficiency (HR, 2.6; P = 0.004) and age (HR, 1.06; P < 0.0001) and rupture (HR 3.3, P = 0.04) were independent predictors of mortality. Intramural hematoma was not a significant predictor of survival (HR, 0.49; P = 0.11). CONCLUSIONS: Medical therapy remains the mainstay of treating TBAD with low morbidity. Surgical interventions are indicated in selected patients with malperfusion or aneurysmal expansion with comparable survival rates.

Differential outcomes of carotid stenting and endarterectomy performed exclusively by vascular surgeons in the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST).

OBJECTIVE: Outcomes in the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) did not differ between carotid artery stenting (CAS) and carotid endarterectomy (CEA) for the composite primary end point of stroke, myocardial infarction (MI), or death during the periprocedural period or ipsilateral stroke within 4 years. Rigorous credentialing and training of interventionists, including vascular surgeons, were required for the randomization phase of CREST. Because the lead-in phase of CREST had suggested higher perioperative risks after CAS performed by vascular surgeons, the purpose of this analysis was to examine differences in outcomes after randomization between CAS and CEA performed by vascular surgeons. METHODS: CREST is a prospective randomized controlled trial with blinded end point adjudication. Vascular surgeons performed 237 (21%) of the CAS procedures and 765 (65%) of the CEA procedures among 2320 patients who received their assigned treatment. Proportional hazards analyses were used to estimate the relative efficacy of CAS vs CEA for the composite primary end point and also for stroke and death. RESULTS: Among 2502 randomized patients, 1321 (53%) were symptomatic and 1181 (47%) were asymptomatic. For procedures performed exclusively by vascular surgeons, the primary end point did not differ between CAS and CEA at 4-year follow-up (6.2% vs 5.6%, respectively; hazard ratio [HR], 1.30; 95% confidence interval [CI], 0.70-2.41; P = .41) In this subgroup, the periprocedural stroke and death rates were higher after CAS than CEA for symptomatic patients (6.1% vs 1.3%; P = .01). Asymptomatic patients also had slightly higher stroke and death rates after CAS (2.6% vs 1.1%; P = .20), although this difference did not reach statistical significance. Conversely, cranial nerve injuries (0.0% vs 5.0%; P < .001) were less frequent after CAS than CEA. The MI rates were slightly lower after CAS (1.3% vs 2.6%; P = .24). In performing CAS, vascular surgeons had outcomes for the periprocedural primary end point comparable to the outcomes of all interventionists (HR, 0.99; 95% CI, 0.50-2.00) after adjusting for age, sex, and symptomatic status. Vascular surgeons also had similar results after CEA for the periprocedural primary end point compared with other surgeons (HR, 0.73; 95% CI, 0.42-1.27). CONCLUSIONS: When performed by surgeons, CAS and CEA have similar net outcomes, although the periprocedural risks vary (lower stroke with CEA and lower MI with CAS). These data suggest that appropriately trained vascular surgeons may safely offer both CEA and CAS for the prevention of stroke. The remarkably low stroke and death rates after CEA performed by vascular surgeons in CREST, particularly among symptomatic patients, represent the best outcomes ever reported after carotid interventions from a randomized controlled trial. ClinicalTrials.gov identifier: NCT0000473.

Legal implications of pushing the endovascular envelope.

Endovascular technology continues to improve for the treatment of vascular disease. However, application of these technologies without first obtaining proper informed consent may result in medical malpractice litigation. Similarly, use of these technologies without proper government and/or hospital approval may result in both criminal and/or civil liability. Care must be taken when pushing the envelope of endovascular interventions.

Good Samaritan statutes: a malpractice defense for "doing the right thing".

Vascular surgeons are often called emergently to help treat bleeding patients. These cases may involve unexpected intraoperative bleeding, bleeding in the pregnant patient, or bleeding in patients in the emergency room. In many instances, the vascular surgeon is not "on call" and therefore has no legal duty to assist in the care of these patients. Unfortunately, because many of these types of cases result in litigation, some vascular surgeons refuse to respond to a call for help. Simply, it is important that vascular surgeons "do the right thing" and answer these requests for assistance. The legal system recognizes the need to protect physicians who appropriately respond and, therefore, Good Samaritan statutes were adopted.

Reviewing medical malpractice cases for a plaintiff's attorney: heresy or responsibility.

Many physicians refuse to provide an expert review of a medical malpractice case for a plaintiff's attorney. They consider it to be "sleeping with the enemy". However, one method of avoiding frivolous suits is for reputable vascular surgeons to provide an honest and thorough review of the care provided to a patient by another vascular surgeon. This article discusses the importance and some guidelines for providing these reviews.

Secure fixation following EVAR with the Powerlink XL System in wide aortic necks: results of a prospective, multicenter trial.

PURPOSE: Endovascular stent graft repair of abdominal aortic aneurysms (AAA) with the Endologix Powerlink System (Endologix, Inc, Irvine, Calif) has been shown to be a safe and effective alternative to open surgery in patients having an aortic neck diameter of up to 26 mm. We assessed the safety and effectiveness of AAA repair in patients with wide aortic necks (up to 32 mm in diameter) using the Powerlink XL System. METHODS: Between September 2005 and June 2008, a prospective, multicenter, pivotal US Food and Drug Administration trial of the Powerlink XL System for endovascular aneurysm repair was conducted at 13 centers. Using a sizing algorithm based on computed tomography scan (CT)-based measurements, a total of 78 patients (N = 60 [pivotal trial]; N = 18 [continued access]) presenting with AAA and an infrarenal aortic neck up to 32 mm in diameter received a bifurcated stent graft via anatomical fixation at the aortoiliac bifurcation and proximal sealing with a Powerlink XL infrarenal proximal extension stent graft. Postoperatively, results were assessed with contrast-enhanced CT scans and abdominal x-rays at one, six, and 12 months, with continued annual follow-up to five years. RESULTS: Predominantly male (91%), patients presented at a mean age of 73 +/- 8.6 years with mean maximum aortic neck and AAA diameters of 31 +/- 1.9 mm (range, 25 to 32 mm) and 5.7 +/- 1.0 cm (range, 4.3 to 10 cm), respectively. Challenging infrarenal aortic neck anatomy, defined as the presence of severe thrombus and/or reverse taper, was present in 85% of patients. Technical success was achieved in 98.7% of patients, with one patient requiring femoral-femoral bypass intraoperatively. Aneurysm exclusion was achieved in 100% of patients over a mean procedure time of 129 +/- 66 minutes. Patients were discharged at a mean of 2.2 days postoperatively. At the one-month CT scan, the independent core lab identified a Type II endoleak in 13 patients, distal Type I and Type II endoleak in one patient, and unknown endoleak in three patients. At 30 days, there were no deaths, conversions, ruptures, or migrations. Through one year follow-up, Type II endoleak predominated (9/10 patients with endoleak), with one proximal Type I and no Type III, IV, or unknown endoleak; no conversions, ruptures, or migrations have been observed. The one-year all-cause mortality rate was 6.4%, with 100% freedom from aneurysm-related mortality. Secondary procedures were performed within one year in five patients (6.4%) for treatment of proximal Type I endoleak (n = 2), proximal Type I/Type II endoleak (n = 1), and distal Type I endoleak (n = 2). Reduced or stable aneurysm sac diameter at one year is observed in 96% of patients. CONCLUSIONS: The combination of an anatomically-fixed Powerlink bifurcated stent graft and a Powerlink XL infrarenal proximal extension appears safe and effectively excludes aneurysms in patients with wide aortic necks. These results suggest that fixation at the aortic bifurcation can provide secure fixation for patients with large diameter diseased proximal aortic necks.