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.

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.

Impact of thoracic endovascular aortic repair timing on outcomes after uncomplicated type B aortic dissection in the Society for Vascular Surgery Vascular Quality Initiative postapproval project for dissection.

OBJECTIVE: The timing of thoracic endovascular aortic repair (TEVAR) after the onset of uncomplicated acute type B aortic dissection (uTBAD) remains controversial. The objective of this study was to evaluate the Society for Vascular Surgery Vascular Quality Initiative (VQI) postapproval study (VQI PAS) data for the impact of TEVAR timing for uTBAD on early and late outcomes, including mortality, procedural complications, and long-term reintervention. METHODS: The VQI PAS used for this analysis includes a total of 606 patients. Patients with uTBAD (defined as those without rupture or malperfusion) exclusive of cases categorized as emergent (N = 206) were divided into groups defined by the Society for Vascular Surgery/Society of Thoracic Surgeons reporting guidelines based on the timing of treatment after the onset of dissection: within 24 hours (N = 8), 1 to 14 days (N = 121), and 15 to 90 days (N = 77). Univariate and multivariable analysis were used to determine differences between timing groups for postoperative mortality, in-hospital complications, and reintervention. RESULTS: Demographics and comorbid conditions were very similar across the 3 TEVAR timing groups. Notable differences included a higher prevalence of baseline elevated creatinine (>1.8 mg/dL)/chronic end-stage renal disease and designation as "urgent" in the <24-hour group, as well as a higher rate of preoperative ß-blocker therapy in the 1- to 14-day group. Postoperative stroke, congestive heart failure, and renal ischemia were more common in the <24-hour group without an increase in mortality. Unadjusted 30-day mortality across groups was lowest in the early TEVAR group (0%, 3.3%, and 5.2%; P = .68), as was 1-year mortality (0%, 8.3%, and 18.2%; P = .06), although not statistically different at any time point. Reintervention out to 3 years was not different between the groups. Multivariable analysis demonstrated the need for a postoperative therapeutic lumbar drain to be the only a predictive risk factor for mortality (hazard ratio = 7.595, 95% confidence interval: 1.730-33.337, P = .007). When further subdivided into patients treated 1 to 7 days or 8 to 14 days after dissection, findings were similar. CONCLUSIONS: Patients with uTBAD treated within 24 hours were unusual (N = 8), too small for valid statistical comparison, and likely represent a high-risk subgroup, which is manifested in a higher risk of complications. Although there was a trend toward improved survival in the acute (1- to 14-day) phase, outcomes did not differ compared with the subacute (15- to 90-day) phase with relation to early mortality, postoperative complications, or 1-year survival. These data suggest that the proper selection of patients for early TEVAR can result in equivalent survival and early outcomes.

Retrograde type A dissection in the Vascular Quality Initiative thoracic endovascular aortic repair for dissection postapproval project.

BACKGROUND: Retrograde dissection (RD) can be a serious complication after thoracic endovascular aortic repair (TEVAR), with retrograde type A dissection (RTAD) particularly life-threatening. Prior studies have suggested that treatment timing, anatomic characteristics, device selection, and procedural conduct of TEVAR performed for type B aortic dissection could mitigate the occurrence of RD. The Vascular Quality Initiative TEVAR for Dissection Registry is an ongoing project meant to satisfy Food and Drug Administration requirements for postmarket approval surveillance of the Gore conformable TAG thoracic endoprosthesis (W.L. Gore & Associates, Flagstaff, Ariz), Medtronic Valiant thoracic stent graft (Medtronic, Santa Rosa, Calif), and Cook Medical dissection devices (Cook Medical, Bloomington, Ind) and provides a unique source of evaluation for RTAD in a prospectively collected real-world registry. METHODS: A total of 588 consecutive patients at 49 institutions had undergone TEVAR for acute (<30 days; n = 336) and chronic (≥30 days; n = 252) type B aortic dissection were included. The occurrence of RD as reported by the participating centers and de-identified source documents were reviewed and confirmed independently by two of us (A.W.B. and G.W.). The demographics, procedural and device data, and anatomic considerations were evaluated, and the devices were grouped in a de-identified manner as Gore, Medtronic, and other. RESULTS: The mean follow-up was 889 days (median, 658 days), and 408 patients had completed follow-up data available for >1 year. A total of 19 patients with RD (3.2%) were identified, 9 of whom had been treated for acute and 10 for chronic dissection, a 2.7% and 4.0% incidence, respectively (P = .48, acute vs chronic). Of the 19 RD cases, 15 were RTAD, 6 after treatment of acute and 9 after treatment of chronic dissection, a 1.8% and 3.6% incidence, respectively (P = .19, acute vs chronic). Five cases of RD had occurred intraoperatively (four of which were RTAD). The median time to RD and RTAD was 62 and 69 days, respectively (range, 0 to 1600 days). Of the 15 patients with RTAD, 12 had undergone surgical repair and 2 had not undergone repair; the treatment of one was unknown. The overall mortality was 33.3% (5 of 15). The factors associated with RTAD included more extensive dissection (mean, 5.6 zones without RTAD vs 8.5 zones with RTAD; P = .001), female sex (28.3% female without RTAD vs 53.3% with RTAD; P = .04), and non-White race (62.7% White without RTAD vs 33.3% White with RTAD; P = .05). Mean oversizing was not significantly different for those without RTAD compared with that for those with RTAD (14.0% vs 14.2%; P = .92). The device type was anonymized in this project; however, we found no significant differences between the Gore, Medtronic, and all other devices. CONCLUSIONS: The rate of RD in the present real-world postapproval project was consistent with that from previously reported studies, including highly controlled pivotal studies. Device type was not predictive of RD, and the newly identified risk factors for RTAD include more extensive dissection and a trend toward a greater risk for female sex and non-White race.

Five-year outcomes of endovascular repair of complicated acute type B aortic dissections.

OBJECTIVE: Thoracic endovascular aortic repair is the standard of care for acute complicated type B aortic dissections, but long-term single-device outcomes are limited. METHODS: Fifty patients were treated with the Valiant Captivia thoracic stent graft (Medtronic Inc, Santa Rosa, Calif) for acute complicated type B aortic dissections in this prospective, nonrandomized Dissection Trial. All-cause mortality, secondary procedures, and serious adverse events were assessed, and a core lab evaluated images for aortic remodeling. RESULTS: Compliance for both clinical and imaging follow-up was 78% (18 out of 23) for the available patients at 5 years. Notable baseline characteristics were 86% of patients (43 out of 50) had malperfusion, 20% (10 out of 50) had ruptures, and 94% (46 out of 49) had DeBakey class IIIB dissections. The 5-year freedom from dissection-related mortality, secondary procedures related to the dissection, and endoleaks was 83%, 86%, and 85%, respectively. After 5 years, 89% of patients (16 out of 18) had a completely thrombosed false lumen in the stented segment of the aorta and the true lumen diameter over the length of stent graft was stable or increased for 94% of patients (16 out of 17) while the false lumen diameter was stable or decreased in 77% (13 out of 17) after 5 years. CONCLUSIONS: In the Dissection Trial, patients experienced positive and sustained measures of aortic remodeling. Survival outcomes, need for secondary procedures, and adverse event rates were consistent with previous thoracic endovascular aortic repair studies. Although limitations exist with the follow-up compliance, the Valiant Captivia thoracic stent graft system was effective in the long-term management of acute complicated type B aortic dissections in this patient population with a challenging condition.

Five-Year Outcomes From the United States Pivotal Trial of Valiant Captivia Stent Graft for Blunt Aortic Injury.

BACKGROUND: The Clinical PeRformancE of the Valiant Thoracic Stent Graft with Capitvia Delivery System for the EndovaSCUlar treatment of Blunt Thoracic Aortic Injuries (RESCUE) study evaluating thoracic endovascular repair using the Valiant Captivia endograft for blunt thoracic aortic injury reported promising 30-day outcomes. We now describe 5 years of follow-up of this cohort. METHODS: Fifty patients (mean age 40.7 ± 17.4 years, 76% male, mean injury severity score 38 ± 14.4) were treated for blunt thoracic aortic injury (2010 to 2012) with this endograft. Seventy percent (n = 35) of blunt thoracic aortic injury extent was grade III or higher. Extent of arch repair required full (40%) or partial (18%) left subclavian artery coverage. At 5 years, clinical and imaging compliance was 90.3% (28 of 31) and 67.7% (21 of 31), respectively. RESULTS: Thirty-day mortality was 8%. Three additional patients died of non-device-related causes (respiratory failure, infection, metastatic cancer) through 5-year follow-up, yielding a Kaplan-Meier survival of 85.2% through 5 years. Neither stroke nor spinal cord ischemia was observed at 5 years. Two type II endoleaks seen at 30 days resolved spontaneously, and no additional endoleaks were described in the study cohort through 5 years. No secondary endovascular procedures or conversion to open surgery were reported through 5 years. Four subjects underwent left subclavian revascularization for symptomatic indications. Finally, complete exclusion of the traumatic injury was maintained with no incidences of stent graft kinking, fracture, loss of patency, or migration through 5 years in all patients. CONCLUSIONS: This multicenter clinical trial describes excellent 5-year outcomes and durable exclusion of blunt thoracic aortic injury using a novel stent graft system. Thoracic endovascular repair with this endograft appears to be a safe and effective treatment option for patients with blunt thoracic aortic injury.

Predicting the Safety and Effectiveness of Inferior Vena Cava Filters Study: Design of a unique safety and effectiveness study of inferior vena cava filters in clinical practice.

BACKGROUND: Death from venous thromboembolism remains a significant cause of death worldwide. Although anticoagulation is the cornerstone of treatment in patients at risk for venous thromboembolism, inferior vena cava (IVC) filter use has increased exponentially over the last decade driven predominantly by the prophylactic use in patients at risk for venous thromboembolism despite limited evidence supporting this practice. The Predicting the Safety and Effectiveness of Inferior Vena Cava Filters (PRESERVE) Study is being implemented by the Society for Vascular Surgery, Society of Interventional Radiology, U.S. Food and Drug Administration, and several IVC filter manufactures to better understand the safety, effectiveness, and current patterns of real-world use of IVC filters. METHODS: The PRESERVE Study includes IVC filters from seven manufacturers: ALN (ALN ± hook), Argon (Option Elite), B. Braun (LP, Vena Tech Convertible), CR Bard (Denali), Cook (Gunther Tulip), Cordis (OptEase, TrapEase), and Philips Volcano (Crux). The indications for filter placement, filter brand, complications, stability, frequency and success of retrieval, and clinical effectiveness of each filter will be recorded. Approximately 2100 patients (300 for each filter brand included in the study) are intended to be enrolled at 60 U.S. centers. RESULTS: Men and women age 18 years or older requiring IVC filters for prevention of venous thromboembolism will be included in the study if no contrast allergy is present and they are willing to commit to the prescribed study follow-up. Participants will be evaluated at discharge, 3, 6, 12, 18, and 24 months after filter placement and/or 1 month after retrieval, which ever occurs first. Intravascular ultrasound examination or venography will be done before and after IVC filter placement, with abdominal plain film at 3 months, and contrast enhanced computed tomography scans at 12 and 24 months to evaluate filter stability. The primary safety end point is a composite of clinical end points, including freedom from perforation, embolization, thrombosis, recurrent DVT, and defined serious adverse events. Secondary end points include mechanical stability and procedure related complications at 3 months, major adverse events at 6, 12, 18, and 24 months, and filter tilt of more than 15° at any point. CONCLUSIONS: The PRESERVE Study represents the largest prospective study ever undertaken to investigate real-world outcomes with contemporary use of IVC filters. The investigators await results with the hope that it can improve patient care.

Thirty-day outcomes from the Society for Vascular Surgery Vascular Quality Initiative thoracic endovascular aortic repair for type B dissection project.

OBJECTIVE: The purpose of the Society for Vascular Surgery Vascular Quality Initiative thoracic endovascular aortic repair (TEVAR) for dissection project is to assess the effectiveness of TEVAR for type B dissection by evaluation in a prospective quality improvement registry. Here we describe the project cohort and 30-day outcomes of TEVAR for both acute dissection (AD) and chronic dissection (CD) patients and focus specifically on outcomes of uncomplicated AD patients based on timing of treatment. METHODS: Summary statistics were performed comparing patients with AD (<30 days) and patients with CD. Both groups were further divided into those with complicated (ie, malperfusion or rupture) or uncomplicated presentation. Further subdivision of the uncomplicated AD patients into treatment at ≤48 hours, >48 hours to <7 days, ≥7 days to ≤14 days, and >14 days to <30 days was performed. Kaplan-Meier analysis was performed for 30-day survival and freedom from reintervention. RESULTS: Data for 397 patients (204 AD patients and 193 CD patients) were collected from 40 institutions. Overall, AD patients were younger than CD patients (58.8 vs 62.2 years; P = .003). Technical success, including coverage of the primary entry tear, was 98.0% for AD patients and 99.0% for CD patients, with a trend toward a higher 30-day mortality in AD patients (AD, 9.3%; CD, 5.2%; P = .126). Any degree of procedure-related spinal cord ischemia occurred in 4.4% of AD patients vs 2.1% of CD patients (P = .261), with a deficit at discharge in 3.4% of AD patients vs 0.5% of CD patients (P = .068). Disabling stroke occurred in 2.5% of AD patients vs 1.6% of CD patients (P = .725); retrograde type A dissection occurred in 1.1% of AD patients vs 2.6% of CD patients (P = .412). There was a trend toward a lower freedom from reintervention in AD patients (90.7% vs 94.8%; P = .13). In uncomplicated AD patients, rapid aortic expansion was more common in the treatment groups of ≥7 days to ≤14 days and >14 days to <30 days compared with those treated within 7 days of dissection (P = .042). The uncomplicated AD cohorts based on timing of treatment were otherwise similar in demographics and presentation, with no significant differences in 30-day mortality or serious complications, such as spinal cord ischemia, stroke, or retrograde type A dissection. The 30-day reintervention rate for uncomplicated AD patients was 5.8%, with no apparent differences in reintervention rates according to timing of treatment of initial TEVAR. CONCLUSIONS: As expected, AD patients demonstrated a trend toward a higher 30-day mortality and lower freedom from reintervention compared with CD patients. Mortality at 30 days after TEVAR for uncomplicated AD was 5.8%, and there were no clear patterns in mortality or reintervention based on timing of treatment. Further study and evaluation at longer follow-up are needed to determine the impact of timing of intervention in uncomplicated AD patients.

In Vivo Assessment of Ascending and Arch Aortic Compliance.

BACKGROUND: Dynamic compliance (Cd) of the adult thoracic ascending and arch aorta has had limited in vivo evaluation in patients with aortic disease. This study evaluates aortic compliance using intravascular ultrasound (IVUS) across a range of thoracic aortic diseases. METHODS: Seventy-nine patients undergoing thoracic aortic endovascular procedures had Cd measurements of the ascending aorta proximal to the origin of the brachiocephalic trunk and distal to the origin of the left common carotid artery using IVUS before endograft deployment. Cd was calculated for each segment using the following equation, Cd = ΔD/(D • ΔP) where ΔD = change in aortic diameter, D = diameter in diastole, and ΔP = pulse pressure. RESULTS: Mean Cd of the ascending aorta in all patients (18.4%/mm Hg) and aortic arch (16.5 %/100 mm Hg) did not differ significantly. Compliance was significantly lower in patients being treated for thoracic aortic aneurysm and penetrating ulcer than in patients with traumatic rupture, acute and chronic dissection (P = 0.009). Compliance was significantly higher in patients with aortic transection compared with thoracic aneurysm or penetrating ulcer (P = 0.001). Compliance decreased with age by 0.44 ± 0.06 (P = 0.001) per year in the ascending aorta and 0.41 ± 0.05 (P = 0.001) per year in the aortic arch. Compliance did not increase with diameter when adjusted for age (P = 0.65). Compliance measured in the ascending aorta in 7 patients after descending thoracic aortic endograft repair decreased to 12.6%/100 mm Hg, although not significant (P = 0.18). CONCLUSIONS: Ascending and aortic arch compliance is significantly higher than reported for peripheral vessels. Thoracic aortic compliance decreases with age and is not related to aortic diameter. The results of the present study are important when considering the development of endoprosthesis devices and long-term effects on the thoracic aorta.

Results of the VALOR II trial of the Medtronic Valiant Thoracic Stent Graft.

BACKGROUND: The 1-year results of endovascular exclusion of degenerative descending thoracic aortic aneurysms (DTA) with the Valiant Thoracic Stent Graft (Medtronic Vascular, Santa Rosa, Calif) have been previously reported. With long-term follow-up now complete, the 5-year results are reported. METHODS: The VALOR II trial (Evaluation of the Clinical Performance of the Valiant Thoracic Stent Graft System in the Treatment of Descending Thoracic Aneurysms of Degenerative Etiology in Subjects Who Are Candidates for Endovascular Repair) was a prospective, nonrandomized trial of the Valiant Thoracic Stent Graft system in patients with degenerative DTA. The trial involved 24 sites in the United States and enrolled patients between December 2006 and September 2009. Standard follow-up included physical examination, computed tomography, and chest radiography through 5 years. RESULTS: The study enrolled 160 patients. The average age was 72.2 years (range, 36-85 years), 95 (59%) were men, 150 (94%) had hypertension, and 26 (16%) had renal insufficiency. There were 50 patients (31%) who presented with symptoms; back pain was the most common (34 [68%]). The average aneurysm diameter was 57 mm (range, 32-96 mm). There were 103 patients (64%) with a fusiform aneurysm and 57 (36%) with a saccular aneurysm or penetrating ulcer. Two or more devices were implanted in 126 patients (79%), and the maximum number of grafts implanted was four. There were 54 deaths during the study. The 5-year actuarial survival was 64%. There were eight aneurysm-related deaths (5 deaths ≤30 days of implant), and the 5-year freedom from aneurysm-related death was 95%. There was one conversion to open repair at 36 months. Eleven patients underwent 13 secondary procedures (9 for endoleak, 3 for aneurysm expansion, and 1 rupture). Follow-up imaging was available at 5 years for 56 patients. The average aortic diameter decreased >5 mm in 27 patients (48%), increased >5 mm in 6 patients (11%), and remained unchanged in 23 (41%). CONCLUSIONS: The VALOR II 5-year results demonstrate that the reintervention and aneurysm-related death rates are low. The Valiant Thoracic Stent Graft is an effective treatment of degenerative DTA.

Innovative postmarket device evaluation using a quality registry to monitor thoracic endovascular aortic repair in the treatment of aortic dissection.

OBJECTIVE: United States Food and Drug Administration (FDA)-mandated postapproval studies have long been a mainstay of the continued evaluation of high-risk medical devices after initial marketing approval; however, these studies often present challenges related to patient/physician recruitment and retention. Retrospective single-center studies also do not fully represent the spectrum of real-world performance nor are they likely to have a sufficiently large enough sample size to detect important signals. In recent years, The FDA Center for Devices and Radiological Health has been promoting the development and use of patient registries to advance infrastructure and methodologies for medical device investigation. The FDA 2012 document, "Strengthening the National System for Medical Device Post-market Surveillance," highlighted registries as a core foundational infrastructure when linked to other complementary data sources, including embedded unique device identification. The Vascular Quality Initiative (VQI) thoracic endovascular aortic repair for type B aortic dissection project is an innovative method of using quality improvement registries to meet the needs of device evaluation after market approval. Here we report the organization and background of this project and highlight the innovation facilitated by collaboration of physicians, the FDA, and device manufacturers. METHODS: This effort used an existing national network of VQI participants to capture patients undergoing thoracic endovascular aortic repair for acute type B aortic dissection within a registry that aligns with standard practice and existing quality efforts. The VQI captures detailed patient, device, and procedural data for consecutive eligible cases under the auspices of a Patient Safety Organization (PSO). Patients were divided into a 5-year follow-up group (200 acute; 200 chronic dissections) and a 1-year follow-up group (100 acute; 100 chronic). The 5-year cohort required additional imaging details, and the 1-year group required standard VQI registry data entry. RESULTS: The sample size of patients in each of the 5-year acute and chronic dissection arms was achieved ≤24 months of project initiation, and data capture for the 1-year follow-up group is also nearly complete. Data completeness and follow-up has been excellent, and the two FDA-approved devices for dissection are equally represented. CONCLUSIONS: Although the completeness of long-term follow-up is yet to be determined, the rapidity of data collection supports the use of this construct for device assessment after market approval. The alignment of this effort with routine clinical practice and ongoing quality improvement initiatives is critical and has required minimal additional effort by practitioners, thus facilitating patient inclusion. Importantly, the success and development of this unique project has helped inform FDA strategy for future device evaluation after market approval.

Feasibility of endovascular repair of ascending aortic pathologies as part of an FDA-approved physician-sponsored investigational device exemption.

OBJECTIVE: Endovascular treatment of ascending aortic lesions has been reported, but to date, no FDA-approved studies have been conducted to define feasibility and the use of endografts in this particular location or to analyze the critical factors involved. METHODS: Patients were consented for entry into an FDA-approved physician-sponsored investigational device exemption study to investigate the outcome of those with ascending aortic pathologies. These patients were suitable according to the instructions for use for endovascular repair with a Valiant Captivia (Medtronic, Inc, Minneapolis, Minn) thoracic stent graft, a device designed specifically for deployment in the ascending aorta. All patients had sequential gated-cardiac computed tomography scans, with data being entered into the VQI Complex TEVAR software (West Lebanon, NH). All procedures were performed in a hybrid room, with the capability to convert to an open repair to ensure maximal patient protection. The first five patients constituted the feasibility study, with continued enrollment based on initial results and submission of an annual report to the FDA. RESULTS: Thirty-nine patients were screened, and six patients were entered into the physician-sponsored investigational device exemption study. Although there was no early mortality, there was one late death. All patients had sequential computed tomographies and cardiac echocardiograms with no evidence of migration, one type 1a endoleak, one postoperative stroke, and regression of the aortic lesions in the excluded aortic segment. CONCLUSIONS: In this feasibility study, the preliminary evaluation of endovascular treatment for ascending aortic pathologies demonstrates uniform accuracy of deployment and secure fixation up to 17.5 months of follow-up. There is positive remodeling of the excluded aortic segments similar to surveillance studies involving the descending aorta.

General Anesthesia Is Not Necessary for Hemodialysis Access Surgery.

Chronic kidney disease has been identified as a risk factor for mortality after procedures under general anesthesia (GA). However, a recent study showed that 85 per cent of arteriovenous fistulas in the United States are performed under GA. Our aim was to demonstrate that GA can be avoided in patients with chronic kidney disease and end-stage renal disease by using local anesthesia (LA) with monitored anesthesia care or brachial plexus block (BPB) during hemodialysis access surgery. A retrospective review was performed at a single institution. Outcome measures included need for conversion to GA, major perioperative complications, and 30-day mortality. Four hundred and fourteen access procedures were performed by seven vascular surgeons between 2011 and 2014. Arteriovenous fistulas were placed in 379 (92%), arteriovenous grafts were placed in 31 (7%), and four (1%) received unsuccessful extremity exploration. Anesthetic approach was LA in 344 (83%) and BPB in 64 (15%). GA was initially induced in three (0.7%) and three (0.7%) additional patients required conversion to GA from LA. There were no cardiopulmonary events or perioperative deaths. Of the 32 patients who received an arteriovenous graft, only three (10%) required GA. In conclusion, LA and BPB are safe and conversion to GA is rare. GA should be avoided in hemodialysis access surgery.

Comparison of Neurocognitive Outcomes after Carotid Endarterectomy and Carotid Artery Stenting.

Cognitive and emotional outcomes after carotid endarterectomy (CEA) and carotid artery stenting with embolic protection device (CAS + EPD) are not clear. Patients were entered prospectively into a United States Food and Drug Administration-approved single-center physician-sponsored investigational device exemption between 2004 and 2010 and received either CEA or CAS + EPD. Patients underwent cognitive testing preprocedure and at 6, 12, and 60 months postprocedure. Cognitive domains assessed included attention, memory, executive, motor function, visual spatial functioning, language, and processing speed. Beck Depression and anxiety scales were also compared. There were a total of 38 patients that met conventional indications for carotid surgery (symptomatic with ≥50% stenosis or asymptomatic with ≥70% stenosis)-12 patients underwent CEA, whereas 26 patients underwent CAS + EPD. Both CEA and CAS + EPD patients showed postprocedure improvement in memory and executive function. No differences were seen at follow-up in regards to emotional dysfunction (depression and anxiety), attention, visual spatial functioning, language, motor function, and processing speed. Only two patients underwent neuropsychiatric testing at 60 months-these CAS + EPD patients showed sustained improvement in memory, visual spatial, and executive functions. In conclusion, cognitive and emotional outcomes were similar between CEA and CAS + EPD patients.

Outcomes of Thoracic Endovascular Aortic Repair in Acute Type B Aortic Dissection: Results From the Valiant United States Investigational Device Exemption Study.

BACKGROUND: Acute type B aortic dissection complicated by malperfusion or rupture carries a risk of death. We report 30-day and 12-month results of endovascular treatment with the Valiant Captivia Thoracic Stent Graft (Medtronic, Santa Rosa, CA) in patients with acute, complicated type B aortic dissection. METHODS: The Medtronic DISSECTION Trial is a prospective, nonrandomized, United States Food and Drug Administration-regulated, pivotal trial that enrolled patients at 16 United States sites between June 2010 and May 2012. Follow-up examinations were at 1, 6, and 12 months, and annually through 5 years. RESULTS: Fifty patients were enrolled. Mean age was 57 years (range, 18 to 83 years). Rupture was present in 20% and malperfusion in 86%. Mean time from symptom onset to procedure was 4.7 days (range, 0 to 23 days). Successful deployment and coverage of the primary entry tear was achieved in all patients. Two patients (4%) underwent open repair 5 and 56 days postprocedure for retrograde aortic dissections. Thirty-day mortality was 8% (4 of 50) and 12-month mortality was 15% (7 of 48). Spinal ischemia was 6%. Serious adverse events occurred in 23 of 49 patients within 12 months. Four patients underwent secondary endovascular procedures. Through 12 months, true lumen diameter in the stented region remained stable or increased in 93.1% (27 of 29) of patients. False lumen diameter remained stable or decreased in 22 patients and was partially or completely thrombosed in 91% (30 of 33). CONCLUSIONS: The initial results of the Valiant Thoracic Stent Graft in the treatment of acute type B aortic dissection are encouraging, but longer-term outcomes are needed.

Contemporary results of carotid endarterectomy in "normal-risk" patients from the Society for Vascular Surgery Vascular Registry.

OBJECTIVE: Acceptable complication rates after carotid endarterectomy (CEA) are drawn from decades-old data. The recent Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) demonstrated improved stroke and mortality outcomes after CEA compared with carotid artery stenting, with 30-day periprocedural CEA stroke rates of 3.2% and 1.4% for symptomatic (SX) and asymptomatic (ASX) patients, respectively. It is unclear whether these target rates can be attained in "normal-risk" (NR) patients experienced outside of the trial. This study was done to determine the contemporary results of CEA from a broader selection of NR patients. METHODS: The Society for Vascular Surgery (SVS) Vascular Registry was examined to determine in-hospital and 30-day event rates for NR, SX, and ASX patients undergoing CEA. NR was defined as patients without anatomic or physiologic risk factors as defined by SVS Carotid Practice Guidelines. Raw data and risk-adjusted rates of death, stroke, and myocardial infarction (MI) were compared between the ASX and SX cohorts. RESULTS: There were 3977 patients (1456 SX, 2521 ASX) available for comparison. The SX group consisted of more men (61.7% vs 57.0%; P = .0045) but reflected a lower proportion of white patients (91.3% vs 94.4%; P = .0002), with lower prevalence of coronary artery disease (P < .0001), prior MI (P < .0001), peripheral vascular disease (P = .0017), and hypertension (P = .029), although New York Heart Association grade >3 congestive heart failure was equally present in both groups (P = .30). Baseline stenosis >80% on duplex imaging was less prevalent among SX patients (54.2% vs 67.8%; P < .0001). Perioperative stroke rates were higher for SX patients in the hospital (2.8% vs 0.8%; P < .0001) and at 30 days (3.4% vs 1.0%; P < .0001), which contributed to the higher composite death, stroke, and MI rates in the hospital (3.6% vs 1.8; P = .0003) and at 30 days (4.5% vs 2.2%; P < .0001) observed in SX patients. After risk adjustment, the rate of stroke/death was greater among SX patients in the hospital (odds ratio, 2.05; 95% confidence interval, 1.18-3.58) although not at 30 days (odds ratio, 1.36; 95% confidence interval, 0.85-2.17). No in-hospital or 30-day differences were observed for death or MI by symptom status. CONCLUSIONS: The SVS Vascular Registry results for CEA in NR patients are similar by symptom status to those reported for CREST and may serve as a benchmark for comparing results of alternative therapies for treatment of carotid stenosis in NR patients outside of monitored clinical trials. The contemporary perioperative risk of stroke after CEA in NR patients continues to be higher for SX than for ASX patients.

One-year results of thoracic endovascular aortic repair for blunt thoracic aortic injury (RESCUE trial).

OBJECTIVE: One-year outcomes of the RESCUE trial (endovascular aortic repair using Valiant Captivia for blunt thoracic aortic injury) are reported. METHODS: RESCUE is a prospective, nonrandomized, multicenter trial. Fifty patients with blunt thoracic aortic injury were enrolled between April 2010 and January 2012. One-year outcomes included secondary procedures, device-, procedure-, and/or aorta-related adverse events, and all-cause mortality. RESULTS: Mean patient age was 40.7 ± 17.4 years; 76% of patients were male. Fifty-two thoracic stent grafts were implanted within a median of 1 day of injury. Seventy percent (35 of 50) of aortic injuries were grade III or higher, including 1 free rupture. The mean Injury Severity Score was 37.6 ± 14.3. Vascular access, device delivery, and deployment were successful in all patients. The left subclavian artery was completely covered in 40% (20 of 50) and partially covered in 18% of patients (9 of 50). There were no strokes or spinal cord injuries. Median procedure time was 90.5 minutes; median hospital stay was 11 days. All-cause mortality within 1 year was 12%. There were no conversions to open repair. Four patients (8%) had subclavian artery revascularization; 1 preoperatively; 3 others postoperatively on days 8, 36, and 103. There were no device-related adverse events. During follow-up, 1 patient (2%) had aortic-related and 9 patients (18%) had procedure-related adverse events. CONCLUSIONS: TEVAR has favorable early midterm outcomes in the treatment of blunt thoracic aortic injury, and remains the treatment modality of choice. Longevity of the stent grafts in this young patient population has yet to be established.

Fatigue and in vivo validation of a peritoneum-lined self-expanding nitinol stent-graft.

PURPOSE: To assess the fatigue and in vivo performance of a new stent-graft incorporating bovine peritoneum lining that is designed for application in peripheral vascular occlusive disease. METHODS: Bovine peritoneum-lined stent-grafts were subjected to accelerated in vitro pulsatile fatigue and axial/torsional fatigue testing designed to simulate 10 years of physiological strain on the devices. At specified times the devices were evaluated for stent fracture, suture failure, or tissue tearing. Seven dogs underwent bilateral common iliac artery (CIA) balloon angioplasty injury with unilateral placement of the peritoneum-lined stent-graft. Angiography and intravascular ultrasound were performed prior to treatment, after treatment, and prior to sacrifice at 30 days. Vessels were perfusion fixed and histologically evaluated at 5 regions: above stent, proximal stent, mid stent, distal stent, and below stent. RESULTS: No evidence of stent, suture, or tissue failure was present during or after pulsatile and axial/torsional fatigue testing. At 30±0.3 days after implantation, all vessels were patent. The average lumen area at explantation across stented vessels was 25.45 mm(2). Lumen areas tended to be reduced above (23.57 mm(2)) and below (24.17 mm(2)) the stent. Lumen areas were consistent across stented regions at explantation (proximal stent 27.80 mm(2), mid stent 25.88 mm(2), and distal stent 25.81 mm(2)). The mean neointimal area in peritoneum-lined stents was 2.02±1.52 mm(2), with a neointima:media ratio of 1.03±0.50. These values were significantly lower in the above and below stent areas than in the stented regions, but there was no difference in either measure within the proximal, mid, or distal stent. CONCLUSION: The custom-designed peritoneum-lined stent-graft is promising for clinical peripheral applications due to its ability to resist relevant long-term physiological stresses and outstanding short-term patency rates in canine implantations.