An international, multispecialty, expert-based Delphi Consensus document on controversial issues in the management of patients with asymptomatic and symptomatic carotid stenosis.

OBJECTIVE: Despite the publication of various national/international guidelines, several questions concerning the management of patients with asymptomatic (AsxCS) and symptomatic (SxCS) carotid stenosis remain unanswered. The aim of this international, multi-specialty, expert-based Delphi Consensus document was to address these issues to help clinicians make decisions when guidelines are unclear. METHODS: Fourteen controversial topics were identified. A three-round Delphi Consensus process was performed including 61 experts. The aim of Round 1 was to investigate the differing views and opinions regarding these unresolved topics. In Round 2, clarifications were asked from each participant. In Round 3, the questionnaire was resent to all participants for their final vote. Consensus was reached when ≥75% of experts agreed on a specific response. RESULTS: Most experts agreed that: (1) the current periprocedural/in-hospital stroke/death thresholds for performing a carotid intervention should be lowered from 6% to 4% in patients with SxCS and from 3% to 2% in patients with AsxCS; (2) the time threshold for a patient being considered "recently symptomatic" should be reduced from the current definition of "6 months" to 3 months or less; (3) 80% to 99% AsxCS carries a higher risk of stroke compared with 60% to 79% AsxCS; (4) factors beyond the grade of stenosis and symptoms should be added to the indications for revascularization in AsxCS patients (eg, plaque features of vulnerability and silent infarctions on brain computed tomography scans); and (5) shunting should be used selectively, rather than always or never. Consensus could not be reached on the remaining topics due to conflicting, inadequate, or controversial evidence. CONCLUSIONS: The present international, multi-specialty expert-based Delphi Consensus document attempted to provide responses to several unanswered/unresolved issues. However, consensus could not be achieved on some topics, highlighting areas requiring future research.

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.

Balloon dilation strategy does not affect outcomes for transcarotid artery revascularization in prospective trials.

OBJECTIVES: Strategies of balloon dilation during transfemoral carotid artery stenting include prestent dilation only (PRE), post-stent dilation only (POST), or both predilation and postdilation (PRE+POST). Concerns over higher neurological risk have been raised with POST and PRE+POST during transfemoral carotid artery stenting. Whether these concerns are applicable to transcarotid artery revascularization (TCAR), which uses proximal clamping and cerebral blood flow reversal during stent deployment and balloon angioplasty remains unknown. Our aim is to analyze outcomes of PRE, POST, or PRE+POST balloon dilation strategies during TCAR. METHODS: We analyzed the prospectively collected data from the ROADSTER1 (pivotal), ROADSTER2 (US Food and Drug Administration indicated postmarket), and ROADSTER Extended Access TCAR trials. All trial patients had a high risk anatomic or clinical factors for carotid endarterectomy and were included, unless they did not undergo stent deployment or balloon dilation. For trial inclusion, asymptomatic patients had a carotid stenosis of more than 80%, and symptomatic patients had stenosis of more than 50%. Primary outcome measures were stroke, death, and myocardial infarction (MI) at 30 days. Data were statistically analyzed with χ2, analysis of variance, and multivariable analysis, as appropriate. RESULTS: There were 851 patients (566 male) who underwent dilation by PRE (n = 216), POST (n = 249), or PRE+POST (n = 386). Patients had carotid stenosis of greater than 70% (n = 828, 97%), and 207 (24%) were symptomatic. Flow reversal times were longer in the PRE+POST group (PRE 10.2 minutes, POST 9.8 minutes, and PRE+POST 13.3 minutes; P < .001). The 30-day stroke rate for the whole cohort was 1.9%, mortality was 0.5%, and MI rate was 0.94%. Stroke rates for the PRE cohort (1.9%), POST cohort (2.0%), and PRE+POST cohort (1.8%; P = .98) were similar. Also, death rates at 30 days, and composite stroke, death, and MI rates were similar in the three cohorts. No significant differences in adverse outcomes were noted among the various dilation strategies for both symptomatic and asymptomatic patients. CONCLUSIONS: Based on these prospective trial data, there is no difference in neurological complications owing to balloon dilation strategy during TCAR. The balloon dilation technique best suited to the patient's specific lesion morphology should be used. Further studies are needed to evaluate the relationship of these dilation strategies to long-term outcomes, including stent patency, restenosis, and reintervention.

Optimal Management of Asymptomatic Carotid Stenosis in 2021: The Jury is Still Out. An International, Multispecialty, Expert Review and Position Statement.

OBJECTIVES: The recommendations of international guidelines for the management of asymptomatic carotid stenosis (ACS) often vary considerably and extend from a conservative approach with risk factor modification and best medical treatment (BMT) alone, to a more aggressive approach with a carotid intervention plus BMT. The aim of the current multispecialty position statement is to reconcile the conflicting views on the topic. MATERIALS AND METHODS: A literature review was performed with a focus on data from recent studies. RESULTS: Several clinical and imaging high-risk features have been identified that are associated with an increased long-term ipsilateral ischemic stroke risk in patients with ACS. Such high-risk clinical/imaging features include intraplaque hemorrhage, impaired cerebrovascular reserve, carotid plaque echolucency/ulceration/ neovascularization, a lipid-rich necrotic core, a thin or ruptured fibrous cap, silent brain infarction, a contralateral transient ischemic attack/stroke episode, male patients < 75 years and microembolic signals on transcranial Doppler. There is growing evidence that 80-99% ACS indicate a higher stroke risk than 50-79% stenoses. CONCLUSIONS: Although aggressive risk factor control and BMT should be implemented in all ACS patients, several high-risk features that may increase the risk of a future cerebrovascular event are now documented. Consequently, some guidelines recommend a prophylactic carotid intervention in high-risk patients to prevent future cerebrovascular events. Until the results of the much-anticipated randomized controlled trials emerge, the jury is still out regarding the optimal management of ACS patients.

The long-term fate of renal and visceral vessel reconstruction after open thoracoabdominal aortic aneurysm repair.

OBJECTIVES: In the ever-advancing era of endovascular thoracoabdominal aneurysm (TAAA) repair, understanding long-term patency of renovisceral reconstructions after open TAAA repair provides important benchmarks. METHODS: Institutional open TAAA repair patient data were queried. Patients dying during index admission or with incomplete operative detail were excluded. Visceral and renal reconstructions were categorized as bypass, incorporation into a proximal or distal beveled aortic anastomosis, inclusion button, Carrel patch, or hybrid stent along with endarterectomy/stent adjuncts. Axial imaging or angiography determined long-term patency. Vessel event was defined as new occlusion or reintervention after repair. Overall time-to-event analysis was performed as well as separate analyses for each vessel (celiac, superior mesenteric artery [SMA], right renal, left renal) by reconstruction type utilizing Kaplan-Meier methods. Log-rank testing was employed to compare reconstructive strategies. RESULTS: Over 28 years, 604 repairs (type I, 106 [18%]; type II, 73 [12%]; type III, 195 [32%]; and type IV, 230 [38%]) were identified. Follow-up (median, 500 days) was available in 410/570 (72%) celiac, 406/573 (71%) SMA, 379/532 (71.2%) right renal, and 370/515 (72%) left renal reconstructions. There were five celiac, one SMA, eight right renal, and 10 left renal events. No type of reconstruction or adjunct was significantly associated with event. Overall 5-year patency of all renal/visceral reconstructions was 94% (95% confidence interval, 90%-96%). Estimated 5-year patency of the celiac, SMA, left renal, and right renal were similar, and were 99%, 100%, 97%, and 96%, respectively (P = .09). CONCLUSIONS: Visceral and renal long-term patency after open TAAA repair is excellent regardless of reconstructive technique. No differences are appreciated even when target vessel disease is addressed at the time of reconstruction. These findings continue to substantiate the effective long-term durability of open TAAA repair and are particularly germane to the ongoing evolution of endovascular strategies.

Society for Vascular Surgery (SVS) and Society of Thoracic Surgeons (STS) reporting standards for type B aortic dissections.

This Society for Vascular Surgery/Society of Thoracic Surgeons (SVS/STS) document illustrates and defines the overall nomenclature associated with type B aortic dissection. The contents describe a new classification system for practical use and reporting that includes the aortic arch. Chronicity of aortic dissection is also defined along with nomenclature in patients with prior aortic repair and other aortic pathologic processes, such as intramural hematoma and penetrating atherosclerotic ulcer. Complicated vs uncomplicated dissections are clearly defined with a new high-risk grouping that will undoubtedly grow in reporting and controversy. Follow-up criteria are also discussed with nomenclature for false lumen status in addition to measurement criteria and definitions of aortic remodeling. Overall, the document provides a facile framework of language that will allow more granular discussions and reporting of aortic dissection in the future.

CT-Derived Pretreatment Thoracic Sarcopenia Is Associated with Late Mortality after Thoracic Endovascular Aortic Repair.

BACKGROUND: Frailty, characterized by physiologic depletion, predicts postoperative morbidity and mortality in vascular surgery patients. CT-derived sarcopenia is a valuable method for objectively staging frailty preoperatively. PURPOSE: With prior analyses primarily measuring psoas cross-sectional area on CT, we compared a method of measuring thoracic sarcopenia to existing techniques of lumbar sarcopenia and assessed the association with long-term survival and outcomes post-Thoracic Endovascular Aortic Repair (TEVAR). METHODS: Prospectively collected data of 217 patients undergoing TEVAR from 2009 to 2012 were reviewed. Thoracic sarcopenia was quantified by measuring total area of the rectus abdominis, latissimus dorsi, intercostal, erector spinae, and external and internal oblique muscles at the T12 vertebral level. Total psoas area at the L3 was used to measure lumbar sarcopenia. RESULTS: 200 patients had preoperative imaging enabling measurements of thoracic sarcopenia, 186 of these patients were also assessed for lumbar sarcopenia. Thoracic sarcopenic patients were older, had lower body mass indices, were more commonly female, and most commonly being treated for aneurysms. Thoracic sarcopenic patients had significantly higher rates of congestive heart failure, hypertension, prior vascular intervention, and TEVAR-related adverse events. Thoracic sarcopenia was associated with significantly higher mortality at 2 and 5 years post-TEVAR (2-year mortality: 19% vs 8%, P = 0.02; 5-year mortality: 31% vs 18%, P = 0.03). Lumbar sarcopenia was not associated with increased mortality at any time point. Patients whose muscle mass degraded over 48-month follow-up did not experience significantly higher rates of adverse events. CONCLUSIONS: CT-derived thoracic sarcopenia, but not lumbar sarcopenia, is significantly associated with 5-year mortality post-TEVAR.

Five-year results from the Study of Thoracic Aortic Type B Dissection Using Endoluminal Repair (STABLE I) study of endovascular treatment of complicated type B aortic dissection using a composite device design.

OBJECTIVE: We report the final 5-year results from the Study of Thoracic Aortic Type B Dissection Using Endoluminal Repair (STABLE I) study, a prospective, single-arm, multicenter study of the Zenith Dissection Endovascular System (William Cook Europe, Aps, Bjaeverskov, Denmark), a pathology-specific device comprising a proximal stent graft with barbs and a distal bare stainless steel stent for the treatment of patients with complicated type B aortic dissection. METHODS: The study prospectively enrolled 86 patients (mean age, 59 years; 73% male) at sites in the United States, Europe, and Australia from 2007 to 2012. Treatment occurred during the acute phase (≤14 days after symptom onset) in 55 patients and during the nonacute phase (>14 days; all treated ≤90 days) in 31 patients. Five-year clinical and imaging follow-up was available for 88.5% of eligible patients. RESULTS: The 30-day all-cause mortality rate was 5.5% (3 of 55) for acute and 3.2% (1 of 31) for nonacute patients (P > .99). The 5-year freedom from all-cause mortality was 79.9% ± 6.2% for acute and 70.1% ± 8.4% for nonacute patients (log-rank test, P = .40). The 5-year freedom from dissection-related mortality (including deaths of indeterminate relatedness to dissection repair) was 83.9% ± 5.9% for acute and 90.1% ± 5.9% for nonacute patients (log-rank test, P = .55). Complete false lumen thrombosis in the thoracic aorta increased over time and was observed in 74.1% of acute and in 58.8% of nonacute patients at 5 years. From preprocedure through 5 years, there was an overall increase in true lumen diameter and a concomitant decrease in false lumen diameter in both acute and nonacute patients at the level of the largest diameter in both the thoracic and abdominal aortas. At 5 years, 65.5% of acute and 81.3% of nonacute patients exhibited a stable or shrinking transaortic diameter in the thoracic aorta, and 48.3% of acute and 76.5% of nonacute patients had a stable or shrinking transaortic diameter in the abdominal aorta. Freedom from secondary intervention at 5 years was 65.5% ± 7.5% for acute and 71.2% ± 9.0% for nonacute patients (log-rank test, P = .71). CONCLUSIONS: Endovascular repair of complicated type B aortic dissection with a composite device design demonstrated low all-cause mortality at 30 days, as well as low dissection-related mortality throughout follow-up. Overall, the acute and nonacute cohorts appeared to respond similarly to treatment involving use of the stent-graft and bare metal stent, demonstrating similar clinical outcomes and favorable improvement in aortic remodeling in the thoracic and abdominal aortas.

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.

Durability of open surgical repair of type I-III thoracoabdominal aortic aneurysm.

OBJECTIVE: Early outcomes and late mortality after open repair of extent I to III thoracoabdominal aortic aneurysms (TAAAs) are described, but late graft and aortic events are seldom detailed. This study investigated long-term aortic and graft outcomes as these data are increasingly important as endovascular repair matures. METHODS: During 28 years, 516 patients underwent repair (type I, n = 177 [34%]; type II, n = 100 [20%]; type III, n = 239 [46%]). Patients were monitored for late events. Late aortic events were defined as native aortic disease leading to death or further intervention. Planned secondary procedures were excluded. Graft complications included anastomotic aneurysm, graft infection, and branch occlusions. Variables were assessed for association with end points using log-rank methods and Cox proportional hazards regression. Time-to-event analysis was performed using Kaplan-Meier methods. RESULTS: In-hospital death occurred in 40 patients (8%), leaving 476 for surveillance. Mean age was 69.8 ± 10.5 years. Mean follow-up was 4.9 ± 4.6 years. Repair conduct included distal aortic perfusion and motor evoked potential monitoring (n = 169 [35.5%]), clamp and sew (n = 307 [64.5%]), and selectively applied in-line mesenteric shunting (n = 172 [36.1%]). At the time of repair, 117 patients (24.6%) had 122 synchronous, noncontiguous aortic aneurysms. There were 98 late aortic and graft events in 89 patients (18.7%); 62 aortic-related events occurred in 56 patients (12%; elective repair, n = 47; emergent repair, n = 14; type A dissection, n = 1) at a mean of 4.4 ± 4.2 years after repair. Variables independently predictive of an aortic event were aortic clamp time (hazard ratio [HR], 1.02/min; P = .001), type III extent (HR, 2.5; P = .008), and expansion of retained aorta (HR, 10.4; P < .0005). There were 33 patients (7%) who experienced 36 graft-related events (anastomotic aneurysm, n = 14 [3% of cohort; aortic, n = 7; visceral patch, n = 6; side graft, n = 1]; graft infection, n = 12; renovisceral occlusion/repair, n = 9 [1.9%; side-arm graft, n = 8; native, n = 1]; and anastomotic stricture, n = 1) occurring at 4.7 ± 4.5 years. Variables predictive of graft-related complication were type II extent (HR, 3.4; P = .002) and distal aortic perfusion and motor evoked potential monitoring (HR, 3.6; P = .02). Freedom from aortic- or graft-related event was 80% at 5 years. Freedom from any aortic or graft reintervention was 84% at 5 years. Aortic-related mortality after discharge was 2.7% and estimated to be 3.1% at 5 years. Overall survival was 67% and 44% at 5 and 10 years, respectively. CONCLUSIONS: After type I-III TAAA repair, late aortic and graft-related events occur in 19% of patients. Native aortic disease sequelae are more common than graft complication. Aortic events are predicted by complex operation and degree of remaining aorta. Extensive reconstruction drives graft-related events. Ultimately, reintervention is rare and aorta-related mortality low. These findings verify durability of extensive TAAA repair, serving as benchmarks for endovascular repair.

Durability of open surgical repair of type IV thoracoabdominal aortic aneurysm.

OBJECTIVE: Perioperative outcomes and late mortality after open type IV thoracoabdominal aortic aneurysm (TAAA) repair are known, yet risk of late graft and subsequent aortic events is infrequently described. Such data are increasingly important as endovascular repair becomes an option and are the subject of this study. METHODS: During a 27-year interval, 233 patients underwent open surgical repair of type IV TAAA. Surviving patients were monitored for late aortic or graft-related events. Late aortic events were defined as native aortic disease unrelated to the prior reconstruction leading to death or further intervention. Graft-related complications included anastomotic aneurysm, graft infection, and branch occlusion. Variables were assessed for association with study end points using univariate log-rank methods and Cox proportional hazards regression. Time-to-event analysis was performed using Kaplan-Meier techniques. RESULTS: In-hospital mortality occurred in 7 patients (3%), leaving 226 available for surveillance. Mean age was 72 ± 9 years; 50 patients (21%) had 52 synchronous, noncontiguous aortic aneurysms at time of repair (n = 11 ascending aorta/arch; n = 41 descending thoracic aorta). Mean follow-up was 4.3 ± 3.7 years (median, 3.5 years; interquartile range, 5 years). Aortic events (n = 19 [8%]) included elective aortic repair (n = 15), emergent repair (n = 2), and atheroembolic embolization (n = 2) at a mean of 2.6 ± 2.2 years after type IV TAAA repair. There were 17 patients (8%) who experienced graft-related events (renovisceral occlusion [n = 10; 4% of cohort], anastomotic aneurysm repair [n = 5], graft infection [n = 1], and graft-caval fistula [n = 1]) occurring at 1.7 ± 1.9 years after repair. Variables independently predictive of an aortic event were initial rupture (hazard ratio, 5.6; P = .02) and native aortic expansion during surveillance (hazard ratio, 3.9; P = .04). No independent predictors of graft-related complication were identified. Freedom from an aortic or graft-related event was 93% at 1 year and 66% at 5 years. Freedom from graft or aortic reintervention was 86% at 5 years. Aortic-related mortality in follow-up was 2% and estimated to be 5% at 5 years after type IV TAAA repair. Overall survival was 92% and 66% at 1 year and 5 years, respectively. CONCLUSIONS: After open type IV TAAA repair, late aortic and graft-related events are uncommon. Native aortic disease sequelae and graft complications occur with equal frequency and with similar temporal relation to repair. Need for reintervention is infrequent, and aortic-related mortality is low. These findings verify durability of open type IV TAAA repair and serve as long-term comparative results for endovascular repair.

Predictors of late aortic intervention in patients with medically treated type B aortic dissection.

BACKGROUND: Patients with medically managed type B aortic dissection (TBAD) have a high incidence of aorta-related complications over time. Whereas early thoracic endovascular aortic repair (TEVAR) to seal the entry tear can promote aortic remodeling and prevent late aneurysm formation, there are sparse data as to which patients will benefit from such therapy. The goal of this study was to identify clinical and anatomic factors that are associated with the need for subsequent aortic intervention in patients who present with uncomplicated TBAD. These factors could guide the selection of patients who will benefit from TEVAR in the subacute phase. METHODS: Patients who presented with acute uncomplicated TBAD and were initially managed medically from January 2000 to December 2013 were included in the study. Timing of intervention was stratified into early (within 180 days of initial presentation) and late (181 days and later) cohorts. All patients had follow-up axial imaging studies. These imaging studies were reviewed for anatomic criteria in a retrospective fashion. Predictors of aortic intervention were determined using Cox regression analyses. RESULTS: There were 254 patients (65% men) with medically managed acute TBAD. The average age at presentation was 66.3 years, and 82.5% had a history of hypertension. Mean follow-up was 6.8 years (range, 0.1-13.6 years). There were a total of 97 (38%) patients who required an aortic intervention during follow-up; 30 (12%) patients required an early intervention, and 67 (26%) were treated during late follow-up (100% for aneurysmal degeneration). Predictors of late aortic intervention included entry tear >10 mm (odds ratio [OR], 2.1; 95% confidence interval [CI], 1.5-3.8; P = .03), total aortic diameter >40 mm at time of presentation (OR, 2.2; 95% CI, 1.8-4.3; P = .02), false lumen diameter >20 mm (OR, 1.8; 95% CI, 1.3-4.7; P = .03), and increase in total aortic diameter >5 mm between serial imaging studies (OR, 2.3; 95% CI, 1.3-3.5; P = .02). Complete thrombosis of the false lumen was protective against late operative intervention (OR, 0.22; 95% CI, 0.11-0.48; P < .01). CONCLUSIONS: Nearly 40% of patients who present with an uncomplicated TBAD will ultimately require an aortic intervention. All of the late interventions were performed for aneurysmal degeneration. A variety of readily available anatomic features can predict the need for eventual operative intervention in TBAD; accordingly, these parameters can guide the desirability of early TEVAR.

Thoracic endovascular aortic repair migration and aortic elongation differentiated using dual reference point analysis.

OBJECTIVE: We evaluated images of patients undergoing a thoracic endovascular aortic repair procedure using two reference points as a means for differentiating stent graft migration from aortic elongation. Conventional standards define migration of a stent graft as an absolute change in the distance from the distal graft ring to a distal landmark ≥10 mm compared with a baseline measurement. Aortic elongation occurs over time in both healthy individuals and patients with aortic disease. Aortic elongation in patients with stent grafts may result in increased distal thoracic aortic lengths over time. False-positive stent graft migration would be defined when these patients meet the standard definition for migration, even if the stent has not moved in relation to the elongating aorta. METHODS: This retrospective study evaluated the aortic length of 23 patients treated with the conformable GORE TAG thoracic endoprosthesis (W. L. Gore & Associates, Flagstaff, Ariz) in three clinical trials (dissection, traumatic injury, and aneurysm). Patients who met the standard definition for migration were selected. A standardized protocol was used to measure aortic centerline lengths, including the innominate artery (IA) to the most distal device ring, the IA to the celiac artery (CA), and the distal ring to the CA. Baseline lengths obtained from the first postoperative image were compared with length measurements obtained from the first interval at which they met the standard definition for migration. The conventional standards for migration using a single reference point were compared with the use of dual reference points. RESULTS: Of the 23 patients with endograft changes, 20 were deemed to have aortic elongation rather than true migration. The remaining three patients were deemed to have migration on the basis of the IA to distal ring position compared with the IA to CA length change. The IA to CA interval length change was markedly greater in those with elongation compared with migration (23.8 ± 8.4 mm vs -3.5 ± 5.4 mm, respectively; P < .05). The distal ring to CA interval length change was greater in patients showing elongation rather than migration (18.5 ± 6.6 mm vs -9.8 ± 5.4 mm, respectively; P < .05). The distance between the IA and distal ring was similar for elongation and migration. CONCLUSIONS: These results highlight the dynamic changes that can occur in the aorta as a natural consequence of age. Employing two landmarks can account for these changes and proves to be an important factor, among others, in the differentiation of aortic elongation from true stent graft migration.

Use of extracorporeal bypass is associated with improved outcomes in open thoracic and thoracoabdominal aortic aneurysm repair.

OBJECTIVE: There is no consensus on the use or benefit of extracorporeal circulation (EC) during aneurysm repair of the descending thoracic aorta (DTA) or thoracoabdominal aorta (TAA). We evaluated the role of EC during DTA or TAA aneurysm repair using U.S. Medicare data. METHODS: Medicare (2004-2007) patients undergoing open repair of nonruptured DTA or TAA aneurysm were identified by International Classification of Diseases, Ninth Revision code. Specific exclusions included ascending aortic or arch repairs, concomitant cardiac procedures, and procedures employing deep hypothermic circulatory arrest. The impact of EC (code 3961) on early and late outcomes was analyzed using univariate analysis and multivariable regression. Survival was assessed using Kaplan-Meier analysis and Cox proportional hazards regression models. RESULTS: There were 4230 patients who had repair of intact DTA or TAA aneurysms, 2433 (57%) of which employed EC. Differences in baseline clinical features of EC and non-EC patients showed that patients undergoing aortic reconstruction with EC were older (73 ± 1 years vs 72 ± 1 years; P = .002), were more likely to be female (53% vs 47%; P < .001), and had more hypertension (56% vs 53%; P = .02); they had less chronic obstructive pulmonary disease (28% vs 34%; P < .0001), peripheral vascular disease (5.7% vs 11.3%; P < .001), and chronic kidney disease (7.7% vs 5.5%; P = .003). The 30-day mortality (9.7% for EC vs 12.2%; P = .02) and any major complication (49% for EC vs 58%; P < .001) were significantly reduced with EC use. EC use was associated with a shorter length of stay (13.5 ± 13 days vs 17.2 ± 18 days; P < .01) and lower total hospital charges ($151,000 ± 140,000 vs $180,000 ± 190,000; P < .01) compared with non-EC patients. EC patients were more likely to be discharged home instead of to an extended care facility (67% vs 56%; P < .01). Multivariable regression modeling to adjust for baseline clinical differences showed EC to independently reduce the risk of operative mortality (odds ratio [OR], 0.80; 95% confidence interval [CI], 0.65-0.97; P = .02), any complication (OR, 0.67; 95% CI, 0.59-0.76; P < .01), pulmonary complications (OR, 0.68; 95% CI, 0.59-0.79; P < .01), and acute renal failure (OR, 0.52; 95% CI, 0.44-0.61; P < .01). Long-term survival was higher (log-rank, P < .01) in EC patients at 1 year (81% ± 0.8% vs 73% ± 1%) and 5 years (67% ± 1% vs 52% ± 1%). Risk-adjusted Cox proportional hazards regression also showed that EC was independently associated with improved long-term survival (hazard ratio, 0.69; 95% CI, 0.63-0.74; P < .01). CONCLUSIONS: Although important clinical variables such as DTA or TAA aneurysm extent and spinal cord ischemic complications cannot be assessed with the Medicare database, EC use during open DTA and TAA aneurysm repair is associated with improved late survival and a significant reduction in operative mortality, morbidity, and procedural costs. These data indicate that EC should be a more widely applied adjunct in open DTA or TAA aneurysm repair.

Aneurysm sac expansion is independently associated with late mortality in patients treated with endovascular aneurysm repair.

BACKGROUND: Patients undergoing endovascular aneurysm repair (EVAR) for abdominal aortic aneurysms can exhibit variations in sac behavior ranging from complete regression to expansion. We evaluated the impact of sac behavior at 1-year follow-up on late survival. METHODS: We used the Vascular Study Group of New England (VSGNE) registry from 2003 to 2011 to identify EVAR patients with 1-year computed tomography follow-up. Aneurysm sac enlargement ≥5 mm (sac expansion) and decrease ≥5 mm (sac regression) were defined per Society for Vascular Surgery guidelines. Predictors of change in sac diameter and impact of sac behavior on long-term mortality were assessed by multivariable methods. RESULTS: Of 2437 patients who underwent EVAR, 1802 (74%) had complete 1-year follow-up data and were included in the study. At 1 year, 162 (9%) experienced sac expansion, 709 (39%) had a stable sac, and 931 (52%) experienced sac regression. Sac expansion was associated with preoperative renal insufficiency (odds ratio [OR], 3.4; 95% confidence interval [CI], 1.5-8.0; P < .01), urgent repair (OR, 2.7; 95% CI, 1.4-5.1; P < .01), hypogastric coverage (OR, 1.7; 95% CI, 1.1-2.7; P = .02), and type I/III (OR, 16.8; 95% CI, 7.3-39.0; P < .001) or type II (OR, 2.9; 95% CI, 2.0-4.3; P < .001) endoleak at follow-up, and sac expansion was inversely associated with smoking (OR, 0.6; 95% CI, 0.4-0.96; P = .03) and baseline aneurysm diameter (OR, 0.7; 95% CI, 0.6-0.9; P < .001). Sac regression (vs expansion or stable sac) was associated with female gender (OR, 1.8; 95% CI, 1.4-2.4; P < .001) and larger baseline aneurysm diameter (OR, 1.4; 95% CI, 1.2-1.5; P < .001) and inversely associated with type I/III (OR, 0.2; 95% CI, 0.1-0.5; P < .01) or type II endoleak at follow-up (OR, 0.2; 95% CI, 0.2-0.3; P < .001). After risk-adjusted Cox regression, sac expansion was independently associated with late mortality (hazard ratio, 1.5; 95% CI, 1.1-2.0; P = .01), even with adjustment for reinterventions and endoleak during follow-up. Sac regression was associated with lower late mortality (hazard ratio, 0.6; 95% CI, 0.5-0.7; P < .001). Long-term survival was lower (log-rank, P < .001) in patients with sac expansion (98% 1-year and 68% 5-year survival) compared with all others (99% 1-year and 83% 5-year survival). CONCLUSIONS: These data suggest that an abdominal aortic aneurysm sac diameter increase of at least 5 mm at 1 year, although infrequent, is independently associated with late mortality regardless of the presence or absence of endoleak and warrants close observation and perhaps early intervention.

Severe contralateral carotid stenosis or occlusion does not have an impact on risk of ipsilateral stroke after carotid endarterectomy.

OBJECTIVE: This study evaluates the impact of severe (>70%) contralateral carotid stenosis or occlusion (SCSO) on outcomes after carotid endarterectomy (CEA). METHODS: Clinical data for all patients undergoing CEA at a single center were prospectively gathered and retrospectively reviewed, with the sample population stratified according to the presence of SCSO. Perioperative outcomes of CEA in the presence of SCSO were analyzed using univariate and multivariate methods. RESULTS: During a 17-year study period, 2945 CEAs were performed on 1843 patients, including 736 (25%) patients with SCSO. Patients identified with SCSO had a higher rate of positive intraoperative electroencephalographic changes (30% vs 16%; P < .0001) and use of an intraoperative shunt (40% vs 28%; P < .0001). Univariate analysis identified SCSO as a risk factor for any stroke (2.8% vs 1.5%; P = .02), death (2.2% vs 1.1%; P = .02), and any stroke/death (4.3% vs 2.4%; P < .0079) but not ipsilateral stroke (1.5% vs 1.2%; P = .38). Multivariable regression demonstrated SCSO as an independent predictor of any stroke (odds ratio [OR], 1.8; 95% confidence interval [CI], 1.0-3.3; P = .05) and any stroke/death (OR, 1.7; 95% CI, 1.1-2.7; P = .02), without increasing risk of ipsilateral stroke (OR, 1.3; 95% CI, 0.6-2.7; P = .54). The presence of SCSO was also associated with a higher risk of late mortality (hazard ratio, 1.3; 95% CI, 1.1-1.4; P < .01). CONCLUSIONS: Although the presence of SCSO is a risk factor for any stroke/death with CEA, it does not increase the risk of ipsilateral stroke. These data suggest that increased attention to perioperative medical and hemodynamic management should be especially considered in this cohort of patients as the observed strokes do not occur in the territory at risk from the surgical procedure.

Favorable impact of thoracic endovascular aortic repair on survival of patients with acute uncomplicated type B aortic dissection.

BACKGROUND: In uncomplicated type B aortic dissection (UTBAD), the "gold standard" has been nonoperative treatment with medical therapy, although this has been questioned by studies demonstrating improved outcomes in those treated with thoracic endovascular aortic repair (TEVAR). This study assessed long-term survival after acute UTBAD comparing medical therapy, open repair, and TEVAR. METHODS: The California Office of Statewide Hospital Planning Development database was analyzed from 2000 to 2010 for adult patients with acute UTBAD. Patients with nonemergent admission for aortic dissection, type A dissection, trauma, bowel ischemia, lower extremity ischemia, acidosis, or shock were excluded. The cohort was stratified by treatment type at index admission into medical therapy, open surgical repair, and TEVAR. Multivariable regression and survival analyses were used to evaluate the association of treatment type with long-term overall survival. RESULTS: There were 9165 cases, 95% medical therapy, 2% open repair, and 2.9% TEVAR. The mean age was 66 ± 15 years, with 39% female, 2.4% cocaine users, 18% with congestive heart failure, and 17% with Charlson Comorbidity Index >3. Mean inpatient costs were $57,000 for medical therapy, $200,000 for open repair, and $130,000 for TEVAR (P < .01). Inpatient mortality was 6.5% overall, 6.3% for medical therapy, 14% for open repair, and 7.1% for TEVAR (P < .01). One-year and 5-year survivals were 84% and 60% in medical therapy, 76% and 67% in open repair, and 85% and 76% in TEVAR (log-rank, P < .01). On risk-adjusted multivariable analysis, TEVAR had improved survival compared with medical therapy (hazard ratio, 0.68; 95% confidence interval, 0.6-0.8; P < .01), with no difference between open repair and medical therapy (hazard ratio, 1.0; 95% confidence interval, 0.8-1.3; P < .01). CONCLUSIONS: This statewide study on survival after acute UTBADs shows an independent survival advantage for TEVAR over medical therapy. These data add further evidence for a paradigm shift in acute management of type B dissection in favor of early TEVAR.

Risk factor profile and anatomic features of previously asymptomatic patients presenting with carotid-related stroke.

OBJECTIVE: Although carotid atherosclerotic-mediated stroke remains a major cause of morbidity and mortality, some have suggested intervention in carotid stenosis should be limited to symptomatic patients given the advances in medical therapy. The present study was conducted to assess the atherosclerotic risk factor profiles, anatomic features, and clinical outcomes of previously asymptomatic patients admitted with stroke of carotid etiology. METHODS: We reviewed the data from 3382 patients admitted to a tertiary referral center with an ischemic stroke during 2005 to 2015. We focused on patients admitted with a radiographically confirmed infarct ipsilateral to a documented carotid artery stenosis ≥50%, with the admitting neurology team adjudicating the stroke etiology as carotid related. Patients were excluded if they had had a previous transient ischemic attack, previous infarct ipsilateral to any carotid lesion, or previous carotid revascularization, intracranial hemorrhage, or malignancy. Patient demographic data, medical treatments before stroke, stroke admission carotid imaging, and stroke treatments and outcomes were assessed. RESULTS: A total of 219 carotid stroke patients (7% of all strokes) were identified, of whom 61% were white and 66% were men, with a mean age of 68 ± 12 years. Hypertension (79%) and smoking (33% current; 29% former) were predominant risk factors. On admission, 50% were receiving antiplatelet therapy (aspirin, n = 92 [41%]; clopidogrel, n = 9 [4%]; dual therapy, n = 11 [5%]) and 55% were receiving lipid-lowering agents (statin, n = 115 [53%]; other, n = 6 [2%]); 77 patients (35%) were receiving both antiplatelet and lipid-lowering therapy. Of the 219 patients, 156 (71%) presented with a moderate or severe stroke (National Institutes of Health stroke scale ≥5 at admission), 54 (25%) received lytic therapy, 96 (43%) presented with an occluded ipsilateral internal carotid artery, and 117 (53%) ultimately underwent carotid revascularization at a median of 4 days. Individuals receiving both antiplatelet and lipid-lowering therapy were significantly less likely to experience a moderate or severe stroke (44% vs 78%; P = .006). CONCLUSIONS: Internal carotid artery occlusion is the culprit lesion in 43% of carotid-related strokes in those without previous symptoms. Previously asymptomatic patients not receiving combined antiplatelet and lipid-lowering medical therapy presenting with carotid-related stroke are significantly more likely to experience a severe, debilitating stroke. However, those receiving appropriate risk-reduction medical therapy are still at risk of carotid-mediated stroke. These results suggest medical therapy alone is unlikely to be sufficient stroke prevention for patients with significant carotid stenosis.

Select early type IA endoleaks after endovascular aneurysm repair will resolve without secondary intervention.

OBJECTIVE: Although it is traditionally considered ominous, the natural history of early proximal attachment site endoleaks (IA) after endovascular aneurysm repair (EVAR) is not well known. Our aim was to identify risk factors for persistent type IA endoleaks and to determine their effect on long-term outcomes after EVAR. METHODS: All patients who underwent infrarenal EVAR at a single institution between 1998 and 2015 were identified. Preoperative axial imaging and intraoperative arteriograms were reviewed, and those patients with a type IA endoleak were further studied. Aneurysm features were characterized by two reviewers and were studied for predictors of persistent endoleaks at the conclusion of the case. Patient records and the Social Security Death Index were used to record 1-year and overall survival. RESULTS: We identified 1484 EVARs, 122 (8%) of which were complicated by a type IA endoleak on arteriography after graft deployment, with a median follow-up of 4 years. The majority of patients underwent additional ballooning of the proximal site (52 [43%]) or placement of an aortic cuff (47 [39%]); 30 patients (25%) received a Palmaz stent, and four patients were treated with coils or anchors. At case end, only 43 (35%) of the type IA endoleaks remained; at 1 month, only 16 endoleaks persisted (13%), and only six persisted at 1 year (6%). In multivariable analysis, the only independent predictor of persistence of type IA endoleak at the conclusion of the case was the presence of extensive neck calcifications (odds ratio [OR], 9.9; 95% confidence interval [CI], 1.4-67.9; P = .02). Thirteen patients (11%) underwent reintervention for type IA endoleaks, with a time frame ranging from 3 days postoperatively to 11 years. There were three patients (2.4%) who experienced aneurysm rupture. Postoperative type IA endoleak was associated with lower survival at 1 year (79% vs 91%; relative risk, 2.5; 95% CI, 1.1-5.4; P = .02), but it did not affect long-term survival (log-rank, P = .45). Both an increase in aneurysm sac size and failure of the endoleak to resolve by case end were independent predictors of a need for reintervention (growth: OR, 8.3; 95% CI, 2.2-31.6; P < .01; persistent endoleak: OR, 7.6; 95% CI, 1.8-31.5; P < .01). A persistent type IA endoleak was not independently associated with an increase in sac size on surveillance imaging (P = .28). CONCLUSIONS: Aneurysm rupture secondary to persistent type IA endoleak is rare, and most will resolve within 1 year. Extensive neck calcification is the only independent predictor of persistent type IA endoleak, and an increase in sac size warrants reintervention. These data suggest that select early persistent type IA endoleaks can be safely observed.