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.

Comparison of Recent Practice Guidelines for the Management of Patients With Asymptomatic Carotid Stenosis.

Despite the publication of several national/international guidelines, the optimal management of patients with asymptomatic carotid stenosis (AsxCS) remains controversial. This article compares 3 recently released guidelines (the 2020 German-Austrian, the 2021 European Stroke Organization [ESO], and the 2021 Society for Vascular Surgery [SVS] guidelines) vs the 2017 European Society for Vascular Surgery (ESVS) guidelines regarding the optimal management of AsxCS patients.The 2017 ESVS guidelines defined specific imaging/clinical parameters that may identify patient subgroups at high future stroke risk and recommended that carotid endarterectomy (CEA) should or carotid artery stenting (CAS) may be considered for these individuals. The 2020 German-Austrian guidelines provided similar recommendations with the 2017 ESVS Guidelines. The 2021 ESO Guidelines also recommended CEA for AsxCS patients at high risk for stroke on best medical treatment (BMT), but recommended against routine use of CAS in these patients. Finally, the SVS guidelines provided a strong recommendation for CEA+BMT vs BMT alone for low-surgical risk patients with >70% AsxCS. Thus, the ESVS, German-Austrian, and ESO guidelines concurred that all AsxCS patients should receive risk factor modification and BMT, but CEA should or CAS may also be considered for certain AsxCS patient subgroups at high risk for future ipsilateral ischemic stroke.

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.

Learning curve and proficiency metrics for transcarotid artery revascularization.

BACKGROUND: When introduced to a new procedure, physicians improve their performance and reduce their procedural adverse event rates rapidly during the initial cases and then improvement slows, signaling that proficiency has been achieved. Determining when they have acquired proficiency has important implications for procedural innovation, education, credentialing, and patient safety. We analyzed the worldwide experience with transcarotid artery revascularization (TCAR), a hybrid approach to carotid revascularization, to identify the (1) procedural performance measures associated with clinical and technical adverse events; (2) target levels of performance measures that minimize adverse event rates; and (3) number of TCAR cases needed to achieve the target levels for the performance measures. METHODS: The patient, lesion, and physician characteristics were collected for each TCAR procedure performed by each physician worldwide in an international quality assurance database. Four procedural performance measures were recorded for each procedure: flow-reversal time, fluoroscopy time, contrast volume, and total skin-to-skin time. Composite clinical adverse events (ie, transient ischemic attack, stroke, myocardial infarction, death) and composite technical adverse events (ie, aborted procedure, conversion to surgery, bleeding, dissection, cranial nerve injury, device failure), occurring within 24 hours were also recorded. Correlations between each performance measure and the clinical and technical adverse event rates were computed. The inflection points in the performance measures were identified at which no further improvements occurred in the adverse event rates. Finally, the minimum number of TCAR cases required to achieve the target performance measure levels was computed. RESULTS: A total of 18,240 procedures performed by 1273 physicians were analyzed. Of the 18,240 patients, 34.9% were women and 62.5% were asymptomatic. The flow-reversal time correlated with clinical adverse events adjusted for age, sex, and symptomatic status (R2 = 0.91; P < .0001) and adjusted technical adverse events (R2 = 0.86; P < .0001). The skin-to-skin time correlated with adjusted technical adverse events (R2 = 0.92; P < .0001). A reduction in flow-reversal times to <13.1 minutes and the skin-to-skin time to <81 minutes did not translate into further improvements in the adverse event rates. A minimum of 26 TCAR cases was required to achieve the target flow-reversal time, and a minimum of 15 cases was required to achieve the target skin-to-skin time. CONCLUSIONS: The flow-reversal time and skin-to-skin time are appropriate performance measures for establishing the level of expertise of physicians as they acquire skills to perform TCAR. A target time of ≤13.1 minutes for flow-reversal and 81 minutes for skin-to-skin time minimized the adverse event rates. Familiarity with the steps involved in performing TCAR was achieved after ≥15 cases, and minimizing clinical adverse events occurred after ≥26 cases.

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.

Evaluating the optimal training paradigm for transcarotid artery revascularization based on worldwide experience.

BACKGROUND: Transcarotid artery revascularization (TCAR) is a new hybrid approach to carotid artery revascularization. Proctored training on live cases is an effort-, time-, and resource-intensive approach to learning new procedures. We analyzed the worldwide experience with TCAR to develop objective performance metrics for the procedure and compared the effectiveness of training physicians using cadavers or synthetic models to that of traditional in-person training on live cases. METHODS: Physicians underwent one of three mandatory training programs: (1) in-person proctoring on live TCAR procedures, (2) supervised training on human cadavers, and (3) supervised training on synthetic models. The training details and information from all subsequent independently performed TCAR procedures were recorded. The composite clinical adverse events (ie, transient ischemic attack, stroke, myocardial infarction, death) and composite technical adverse events (ie, aborted procedure, conversion to surgery, bleeding, dissection, cranial nerve injury, or device failure, occurring within 24 hours were recorded). Four procedural proficiency measures were recorded: procedure time, flow-reversal time, fluoroscopy time, and contrast volume. We compared the adverse event rates between the procedures performed by physicians after undergoing the three training modes and tested whether the proficiency measures achieved during TCAR after training on cadavers and synthetic models were noninferior to proctored training. RESULTS: From March 3, 2009 to May 7, 2020, 1160 physicians had undergone proctored (19.1%), cadaver-based (27.4%), and synthetic model-based (53.5%) TCAR training and had subsequently performed 17,283 TCAR procedures. The proctored physicians had treated younger patients and more patients with asymptomatic carotid stenosis and had had more prior experience with transfemoral carotid stenting. The overall 24-hour composite clinical and technical adverse event rates, adjusted for age, sex, and symptomatic status, were 1.0% (95% confidence interval, 0.8%-1.3%) and 6.0% (95% confidence interval, 5.4%-6.6%), respectively, and did not differ significantly by training mode. The proficiency measures of cadaver-trained and synthetic model-trained physicians were not inferior to those for the proctored physicians. CONCLUSIONS: We have presented key objective proficiency metrics for performing TCAR and an analytic framework to assess adequate training for the procedure. Training on cadavers or synthetic models achieved clinical outcomes, technical outcomes, and proficiency measures for subsequently performed TCAR procedures similar to those achieved with training using traditional proctoring on live cases.

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.

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.

Analysis of the ROADSTER pivotal and extended-access cohorts shows excellent 1-year durability of transcarotid stenting with dynamic flow reversal.

OBJECTIVE: We report the 1-year outcomes of the Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure (ROADSTER) multicenter trial. This trial introduced a novel transcarotid neuroprotection system (NPS), the ENROUTE transcarotid NPS (Silk Road Medical Inc, Sunnyvale, Calif). Postoperative results demonstrated that the use of the ENROUTE transcarotid NPS is safe and effective. The aim of this study was to evaluate the safety of transcarotid artery revascularization (TCAR) and to present the 1-year outcomes. METHODS: This study is a prospective, single-arm clinical trial. Current enrollment occurs in 14 centers. Primary end points were incidence rates of ipsilateral stroke at 1 year after TCAR. Occurrence of stroke was ascertained by an independent Clinical Events Committee. Patients with anatomic or medical high-risk factors for carotid endarterectomy (CEA) were eligible to be enrolled in the ROADSTER trial. RESULTS: Overall, 165 patients were included in the long-term follow-up (112 of 141 patients from the pivotal phase and 53 of 78 patients from the extended access). Mean age was 73.9 years (range, 42.1-91.3 years). Patients aged 75 years and older were 43.3% of the cohort. The majority of patients were white (92.7%) and male (75.2%). Most patients were asymptomatic (79.9%). Anatomic risk factors were distributed as follows: contralateral carotid artery occlusion (11.0%), tandem stenosis of >70% (1.8%), high cervical carotid artery stenosis (25.0%), restenosis after CEA (25.6%), bilateral stenosis requiring treatment (4.3%), and hostile neck (14.6%). Medical high-risk criteria included two-vessel coronary artery disease (14.0%) and severe left ventricular dysfunction with ejection fraction <30% (1.8%). In general, 43.3% of patients had at least one anatomic high-risk factor, whereas 29.9% of patients had medical high-risk factors. Both subsets of factors were present simultaneously in 26.8% of the cohort. At 1-year follow-up, ipsilateral stroke incidence rate was 0.6%, and seven patients (4.2%) died. None of the deaths were neurologic in origin. CONCLUSIONS: TCAR with dynamic flow reversal had previously shown favorable 30-day perioperative outcomes. This excellent performance seems to extend to 1 year after TCAR as illustrated in this analysis. The promising results from the ROADSTER trial likely stem from the novel cerebral protection provided through the ENROUTE transcarotid NPS in comparison to distal embolic protection devices as well as the transcarotid approach's circumventing diseased aortic arch manipulation and minimizing embolization. TCAR offers a safe and durable revascularization option for patients who are deemed to be at high risk for CEA.