Multi-Center Experience with Intravascular Lithotripsy for Treatment of Severe Calcification during TCAR for High-Risk Patients.

OBJECTIVES: Transcarotid artery revascularization (TCAR) offers a safe alternative to carotid endarterectomy (CEA), but severe calcification is currently considered a contraindication in carotid artery stenting. This study aims to describe the safety and effectiveness of TCAR with intravascular lithotripsy (IVL) in patients with traditionally prohibitive calcific disease. METHODS: All consecutive patients who underwent TCAR+IVL from 2018-2022 at nine institutions were identified. IVL was combined with pre-dilatation angioplasty to treat calcified vessels before stent deployment. The primary outcome was a new ipsilateral stroke within 30 days. Secondary outcomes included any new ipsilateral neurologic event (stroke/TIA) at 30 days, technical success, and <30% residual stenosis. RESULTS: Fifty-eight patients (62% Male, mean age 78±6.6 years) underwent TCAR+IVL, with 22 (38%) for symptomatic disease. Fifty-seven patients (98%) met high-risk anatomical or physiologic criteria for CEA. Forty-seven patients had severely calcific lesions. Fourteen patients (30%) had isolated eccentric plaque, 20 patients (43%) had isolated circumferential plaque, and 13 had eccentric and circumferential calcification (27%). Mean procedure and flow reversal times were 87±27 and 25±14 minutes. The median number of lithotripsy pulses per case was 90 (range 30-330), and mean contrast usage was 29 mL. No patients had EEG changes or new deficits observed intraoperatively. Technical success was achieved in 100% of cases, with 98% having <30% residual stenosis on completion angiography. One patient had an in-hospital post-procedural stroke (1.72%). Four patients total had any new ipsilateral neurologic event (stroke/TIA) within 30 days for an overall rate of 6.8%. One TIA and one stroke occurred during the index hospitalization, and two TIAs occurred after discharge. Preoperative mean stenosis in patients with any post-operative neurologic event was 93% (versus 86% in non-stroke/TIA patients, p=.32), and chronic renal insufficiency was higher in patients who had a new neurologic event (75% vs. 17%, p=.005). No differences were observed in calcium, procedural, or patient characteristics between the two groups. The mean follow-up was 132 days (range 19-520). Three stents developed recurrent stenosis (5%) on follow-up duplex; the remainder were patent without issue. There were no reported interventions for recurrent stenosis during the study period. CONCLUSIONS: IVL sufficiently remodels calcified carotid arteries to facilitate TCAR effectively in patients with traditionally prohibitive calcific disease. One patient (1.7%) suffered a stroke within 30 days, though four patients (6.8%) sustained any new neurological event (stroke/TIA). These results raise concerns about the risks of TCAR + IVL and whether it is an appropriate strategy for patients who could potentially undergo CEA.

The sac evolution imaging follow-up after endovascular aortic repair: An international expert opinion-based Delphi consensus study.

OBJECTIVE: Management of follow-up protocols after endovascular aortic repair (EVAR) varies significantly between centers and is not standardized according to sac regression. By designing an international expert-based Delphi consensus, the study aimed to create recommendations on follow-up after EVAR according to sac evolution. METHODS: Eight facilitators created appropriate statements regarding the study topic that were voted, using a 4-point Likert scale, by a selected panel of international experts using a three-round modified Delphi consensus process. Based on the experts' responses, only those statements reaching a grade A (full agreement ≥75%) or B (overall agreement ≥80% and full disagreement <5%) were included in the final document. RESULTS: One-hundred and seventy-four participants were included in the final analysis, and each voted the initial 29 statements related to the definition of sac regression (Q1-Q9), EVAR follow-up (Q10-Q14), and the assessment and role of sac regression during follow-up (Q15-Q29). At the end of the process, 2 statements (6.9%) were rejected, 9 statements (31%) received a grade B consensus strength, and 18 (62.1%) reached a grade A consensus strength. Of 27 final statements, 15 (55.6%) were classified as grade I, whereas 12 (44.4%) were classified as grade II. Experts agreed that sac regression should be considered an important indicator of EVAR success and always be assessed during follow-up after EVAR. CONCLUSIONS: Based on the elevated strength and high consistency of this international expert-based Delphi consensus, most of the statements might guide the current clinical management of follow-up after EVAR according to the sac regression. Future studies are needed to clarify debated issues.

Using Machine Learning to Predict Outcomes of Patients with Blunt Traumatic Aortic Injuries.

INTRODUCTION: The optimal management of blunt thoracic aortic injury (BTAI) remains controversial, with experienced centers offering therapy ranging from medical management to TEVAR. We investigated the utility of a machine learning (ML) algorithm to develop a prognostic model of risk factors on mortality in patients with BTAI. METHODS: The Aortic Trauma Foundation registry was utilized to examine demographics, injury characteristics, management and outcomes of patients with BTAI. A STREAMLINE (A Simple, Transparent, End-To-End Automated Machine Learning Pipeline Facilitating Data Analysis and Algorithm Comparison) model as well as logistic regression (LR) analysis with imputation using chained equations was developed and compared. RESULTS: From a total of 1018 patients in the registry, 702 patients were included in the final analysis. Of the 258 (37%) patients who were medically managed, 44 (17%) died during admission, 14 (5.4%) of which were aortic related deaths. 444 (63%) patients underwent TEVAR and 343 of which underwent TEVAR within 24 hours of admission. Amongst TEVAR patients, 39 (8.8%) patients died and 7 (1.6%) had aortic related deaths. (Table 1) Comparison of the STREAMLINE and LR model showed no significant difference in ROC curves and high AUCs of 0.869 (95% CI, 0.813 - 0.925) and 0.840 (95% CI, 0.779 - 0.900) respectively in predicting in-hospital mortality. Unexpectedly, however, the variables prioritized in each model differed between models (Figure 1A-B). The top three variables identified from the LR model were similar to that from existing literature. The STREAMLINE model, however, prioritized location of the injury along the lesser curve, age and aortic injury grade (Figure 1A). CONCLUSIONS: Machine learning provides insight on prioritization of variables not typically identified in standard multivariable logistic regression. Further investigation and validation in other aortic injury cohorts are needed to delineate the utility of ML models. LEVEL OF EVIDENCE: Level IIIStudy TypeOriginal research (prognostic/epidemiological).

Initial Outcomes of the Gore TAG Thoracic Branch Endoprosthesis for Endovascular Repair of Blunt Thoracic Aortic Injury.

BACKGROUND: Endovascular repair of blunt thoracic aortic injury (BTAI) has dramatically reduced the morbidity and mortality of intervention. Injuries requiring zone 2 coverage of the aorta traditionally require left subclavian artery (LSA) sacrifice or open revascularization. Furthermore, these injuries are associated with an increased risk of in-hospital mortality and long-term morbidity. Here we report 1-year outcomes of total endovascular repair of BTAI with the GORE® TAG® Thoracic Branch Endoprosthesis for LSA preservation. METHODS: Across 34 investigative sites, 9 patients with BTAI requiring LSA coverage were enrolled in a nonrandomized, prospective study of a single-branched aortic endograft. The thoracic branch endoprosthesis device allows for graft placement proximal to the LSA and incorporates a single side branch for LSA perfusion. RESULTS: This initial cohort included 8 male and 1 female patient with a median age of 43 (22, 76) and 12 months of follow-up. Five total years of follow-up are planned. All participants had grade 3 BTAI. All procedures took place between 2018 and 2019. The median injury severity score was 2 (0, 66). The median procedure time was 109 min (78, 162). All aortic injuries were repaired under general anesthesia and with heparinization. A spinal drain was used in one patient. Post-deployment balloon angioplasty was conducted in one case at the distal landing zone. There was one asymptomatic LSA branch occlusion 6 months after repair. It was attributed to the purposeful proximal deployment of the branch stent to accommodate an early vertebral takeoff. The occlusion did not require revascularization. There were no strokes, mortalities, or aortic adverse events (migration, endoleak, native aortic expansion, dissection, or thrombosis) through 12 months of follow-up. CONCLUSIONS: Initial cohort outcomes suggest that endovascular repair of zone 2 BTAI is feasible and has favorable outcomes using the thoracic branch device with LSA preservation. Additional cases and longer-term follow-up are required for a definitive assessment of the device's safety and durability in traumatic aortic injuries.

Development and Validation of a Risk Prediction Tool for In-hospital Mortality After Thoracic Endovascular Repair in Patients with Blunt Thoracic Aortic Injury Using the Aortic Trauma Foundation Registry.

BACKGROUND: The objective of our present effort was to use an international blunt thoracic aortic injury (BTAI) registry to create a prediction model identifying important preoperative and intraoperative factors associated with postoperative mortality, and to develop and validate a simple risk prediction tool that could assist with patient selection and risk stratification in this patient population. METHODS: For the purpose of the present study, all patients undergoing thoracic endovascular aortic repair (TEVAR) for BTAI and registered in the Aortic Trauma Foundation (ATF) database from January 2016 as of June 2022 were identified. Patients undergoing medical management or open repair were excluded. The primary outcome was binary in-hospital all-cause mortality. Two predictive models were generated: a preoperative model (i.e. only including variables before TEVAR or intention-to-treat) and a full model (i.e. also including variables after TEVAR or per-protocol). RESULTS: Out of a total of 944 cases included in the ATF registry until June 2022, 448 underwent TEVAR and were included in the study population. TEVAR for BTAI was associated with an 8.5% in-hospital all-cause mortality in the ATF dataset. These study subjects were subsequently divided using 3:1 random sampling in a derivation cohort (336; 75.0%) and a validation cohort (112; 25.0%). The median age was 38 years, and the majority of patients were male (350; 78%). A total of 38 variables were included in the final analysis. Of these, 17 variables were considered in the preoperative model, 9 variables were integrated in the full model, and 12 variables were excluded owing to either extremely low variance or strong correlation with other variables. The calibration graphs showed how both models from the ATF dataset tended to underestimate risk, mainly in intermediate-risk cases. The discriminative capacity was moderate in all models; the best performing model was the full model from the ATF dataset, as evident from both the Receiver Operating Characteristic curve (Area Under the Curve 0.84; 95% CI 0.74-0.91) and from the density graph. CONCLUSIONS: In this study, we developed and validated a contemporary risk prediction model, which incorporates several preoperative and postoperative variables and is strongly predictive of early mortality. While this model can reasonably predict in-hospital all-cause mortality, thereby assisting physicians with risk-stratification as well as inform patients and their caregivers, its intrinsic limitations must be taken into account and it should only be considered an adjunctive tool that may complement clinical judgment and shared decision-making.

2022 ACC/AHA guideline for the diagnosis and management of aortic disease: A report of the American Heart Association/American College of Cardiology Joint Committee on Clinical Practice Guidelines.

AIM: The "2022 ACC/AHA Guideline for the Diagnosis and Management of Aortic Disease" provides recommendations to guide clinicians in the diagnosis, genetic evaluation and family screening, medical therapy, endovascular and surgical treatment, and long-term surveillance of patients with aortic disease across its multiple clinical presentation subsets (ie, asymptomatic, stable symptomatic, and acute aortic syndromes). METHODS: A comprehensive literature search was conducted from January 2021 to April 2021, encompassing studies, reviews, and other evidence conducted on human subjects that were published in English from PubMed, EMBASE, the Cochrane Library, CINHL Complete, and other selected databases relevant to this guideline. Additional relevant studies, published through June 2022 during the guideline writing process, were also considered by the writing committee, where appropriate. STRUCTURE: Recommendations from previously published AHA/ACC guidelines on thoracic aortic disease, peripheral artery disease, and bicuspid aortic valve disease have been updated with new evidence to guide clinicians. In addition, new recommendations addressing comprehensive care for patients with aortic disease have been developed. There is added emphasis on the role of shared decision making, especially in the management of patients with aortic disease both before and during pregnancy. The is also an increased emphasis on the importance of institutional interventional volume and multidisciplinary aortic team expertise in the care of patients with aortic disease.

Initial experience with a modified "candy-plug" technique for false lumen embolization in chronic type B aortic dissection.

Background: Persistent distal false lumen (FL) perfusion after thoracic endovascular aortic repair (TEVAR) for type B aortic dissection (TBAD) can lead to aneurysmal degeneration and an increased risk of rupture. We have presented our initial experience using a modified "candy-plug" (CP) technique for FL embolization. Methods: From February 2021 to July 2022, we treated six patients using the modified CP technique. All the patients had undergone prior or simultaneous TEVAR for chronic TBAD with persistent FL perfusion and aneurysm expansion. Bilateral common femoral artery access was obtained, and intravascular ultrasound was used to confirm wire access in the true lumen (TL) and FL. A conformable TAG device (W.L. Gore & Associates, Flagstaff, AZ) was used in four cases and an Excluder aortic cuff (W.L. Gore & Associates) in two cases. The device was modified by placing a constraining "napkin-ring" suture through the middle segment of the device. Femoral sheaths were placed in the TL and FL. A standard TL TEVAR extension was performed at the level of the celiac artery (zone 5). Next, the CP device was advanced and deployed in the FL, distally aligning it with the TL device. An appropriately sized Amplatzer II plug (Abbot Vascular, Santa Clara, CA) was then deployed in the constrained segment of the modified stent graft. Completion angiography was performed to confirm successful FL embolization. Results: Technical success was defined as successful deployment of the CP device in the FL. The technical success rate was 100% (six of six patients). Clinical success was defined as the cessation of aneurysm growth on follow-up computed tomography angiography. No 30-day mortality, myocardial infarction, stroke, spinal cord ischemia, access site complications, or aortic-related reinterventions occurred. Surveillance imaging at a mean follow-up of 10 months confirmed clinical success (stable aneurysm size or shrinkage) for all five patients with follow-up data available. Conclusions: The modified CP embolization technique is a promising solution for persistent distal FL perfusion after TEVAR for TBAD. Further investigation is required to determine the long-term durability of this technique as an adjunct to TEVAR to promote aortic remodeling.

Cover with caution: Management of the Left Subclavian Artery in TEVAR for trauma.

BACKGROUND: Elective Thoracic Endovascular Aortic Repair (TEVAR) with left subclavian artery coverage (LSA-C) without revascularization is associated with increased rates of ischemic stroke. In patients with blunt thoracic aortic injury (BTAI) requiring TEVAR, LSA-C is frequently required in over one-third of patients. This study aimed to evaluate outcomes of TEVAR in BTAI patients with and without LSA-C. METHODS: The largest existing international multicenter prospective registry of BTAI, developed and implemented by the Aortic Trauma Foundation, was utilized to evaluate all BTAI patients undergoing TEVAR from March 2016 to January 2021. Patients with uncovered left subclavian artery (LSA-U) were compared with patients who had left subclavian artery coverage with (LSA-R) and without (LSA-NR) revascularization. RESULTS: Of the 364 patients with BTAI who underwent TEVAR, 97 (26.6%) underwent LSA-C without revascularization, 10 (2.7%) underwent LSA-C with revascularization (LSA-R). Late and all ischemic strokes were more common in LSA-NR patients than LSA-U patients ( p = 0.006, p = 0.0007). There was no difference in rate of early, late, or overall incidence of paralysis/paraplegia between LSA-NR and LSA-U. When compiled as composite central nervous system ischemic sequelae, there was an increased rate in early, late, and overall events in LSA-NR compared with LSA-U ( p = 0.04, p = 0.01, p = 0.001). CONCLUSION: While prior studies have suggested the relative safety of LSA-C in BTAI, preliminary multicenter prospective data suggests there is a significant increase in ischemic events when the left subclavian artery is covered and not revascularized. Additional prospective study and more highly powered analysis is necessary. LEVEL OF EVIDENCE: Therapeutic/Care Management; Level III.

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.

Endovascular treatment of complicated versus uncomplicated acute type B aortic dissection.

OBJECTIVE: The study objective was to analyze the outcomes of thoracic endovascular aortic repair performed for complicated and uncomplicated acute type B aortic dissections. METHODS: Patients from WL Gore's Global Registry for Endovascular Aortic Treatment who underwent thoracic endovascular aortic repair for acute type B aortic dissections were included, and data were retrospectively analyzed. RESULTS: Of 5014 patients enrolled in the Global Registry for Endovascular Aortic Treatment, 172 underwent thoracic endovascular aortic repair for acute type B aortic dissections. Of these repairs, 102 were for complicated acute type B aortic dissections and 70 were for uncomplicated acute type B aortic dissections. There were 46 (45.1%) procedures related to aortic branch vessels versus 15 (21.4%) in complicated type B aortic dissections and uncomplicated type B aortic dissections (P = .002). The mean length of stay was 14.3 ± 10.6 days (median, 11; range, 2-75) versus 9.8 ± 7.9 days (median, 8; range, 0-42) in those with complicated type B aortic dissections versus those with uncomplicated acute type B aortic dissections (P < .001). Thirty-day mortality was not different between groups (complicated type B aortic dissections 2.9% vs uncomplicated acute type B aortic dissections 1.4%, P = .647), as well as aortic complications (8.8% vs 5.7%, P = .449). Aortic event-free survival was 62.9% ± 37.1% versus 70.6% ± 29.3% at 3 years (P = .696). CONCLUSIONS: In the Global Registry for Endovascular Aortic Treatment, thoracic endovascular aortic repair results for complicated type B aortic dissections versus uncomplicated acute type B aortic dissections showed that 30-day mortality and perioperative complications were equally low for both. The midterm outcome was positive. These data confirm that thoracic endovascular aortic repair as the first-line strategy for treating complicated type B dissections is associated with a low risk of complications. Further studies with longer follow-up are necessary to define the role of thoracic endovascular aortic repair in uncomplicated acute type B dissections compared with medical therapy. However, in the absence of level A evidence from randomized trials, results of the uncomplicated acute type B aortic dissection patient cohort treated with thoracic endovascular aortic repair from registries are important to understand the related risk and benefit.

Surgical and endovascular treatment of late postcoarctation repair aortic aneurysms: Results from an international multicenter study.

OBJECTIVE: The formation of postaortic coarctation aneurysms (pCoAA) is well-described in the literature and carries a significant risk of rupture and death. Treatment strategies include open surgical, hybrid, and endovascular repair, depending on the clinical presentation, risk assessment, and anatomy. The aim of this study was to report the early and midterm results of open surgical and endovascular repair of pCoAA. METHODS: This is an international multicenter retrospective study including patients who underwent open surgical or endovascular repair for pCoAA between 2000 and 2021 at 14 highly specialized academic cardiovascular centers. The preoperative, intraoperative, and postoperative data were recorded and analyzed. RESULTS: A total of 74 patients (46 male; median age, 44 years; interquartile range [IQR], 35-53 years) underwent pCoAA repair. All patients had previously undergone surgical repair of aortic coarctation at a median age of 11 years for the index procedure (IQR, 7-17 years). The most common first surgical correction was synthetic patch aortoplasty in 48 patients, followed by graft interposition in 11. The median pCoAA diameter was 54 mm (IQR, 44-63 mm). The median time from the aortic coarctation repair to the pCoAA diagnosis was 33 years (IQR, 25-40 years). A total of 33 patients had symptoms at presentation, including thoracic or back pain in 8 patients. Open surgical repair was performed in 28 patients, including four frozen elephant trunk procedures and one Bentall. The remaining 46 patients underwent endovascular repair of the pCoAA. Two in-hospital deaths were observed (one frozen elephant trunk and one endovascular). After a median follow-up of 50 months (IQR, 14-127 months), there were a total of seven reinterventions. CONCLUSIONS: This international multicenter study demonstrates that patients with pCoAA can be safely treated with either open surgical or endovascular interventions. Because the median time between the coarctation repair and the aneurysm formation was more than 30 years, life-long surveillance of these patients is warranted.

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.

Risk calculator predicts 30-day mortality after thoracic endovascular aortic repair for intact descending thoracic aortic aneurysms in the Vascular Quality Initiative.

OBJECTIVE: Thoracic endovascular aortic repair (TEVAR) for descending thoracic aortic aneurysm (DTAA) is associated with high perioperative survival, although mortality is a possible outcome. However, no risk score has been developed to predict mortality after TEVAR for intact DTAA to aid in risk discussion and preoperative patient selection. Our objective was to use a multi-institutional database to develop a 30-day mortality risk calculator for TEVAR after DTAA repair. METHODS: The Vascular Quality Initiative database was queried for patients treated with TEVAR for intact DTAA between August 2014 and August 2020. Univariable and multivariable analyses aided in developing a 30-day mortality risk score. Internal validation was done with K-fold cross-validation and calibration curve analysis. RESULTS: Of 2141 patients included in the analysis, 90 (4.2%) died within 30 days after the procedure. Clinically relevant variables identified to be independently associated with 30-day mortality and therefore used to derive the predictive model included age 75 years or greater (odds ratio [OR], 2.27; 95% confidence interval [CI], 1.50-3.44; P < .001), coronary artery disease (OR, 1.60; 95% CI, 1.03-2.47; P = .036), American Society of Anesthesiologists class IV/V (OR, 2.39; 95% CI, 1.39-4.10; P = .002), urgent vs elective procedure (OR, 3.47; 95% CI, 1.90-6.33; P < .001), emergent vs elective procedure (OR, 5.27; 95% CI, 2.36-11.75; P < .001), prior carotid revascularization (OR, 3.24; 95% CI, 1.64-6.39; P = .001), and proximal landing zone <3 (OR, 2.51; 95% CI, 1.65-3.81; P < .001). The model showed an area under the receiver operating characteristic curve of 0.75. Internal validation demonstrated a bias-corrected area under the receiver operating characteristic curve of 0.73 (95% CI, 0.66-0.79) and a calibration slope of 1.00 with a corresponding intercept of 0.00. CONCLUSIONS: This study provides a novel clinically relevant risk prediction model to estimate 30-day mortality risk after TEVAR for DTAA. The TEVAR Mortality Risk Calculator provides useful prognostic information to guide patient selection and facilitate preoperative discussions and shared decision making. An easily accessible online version of the TEVAR Mortality Risk Score is available to facilitate ease of use.

Outcomes and practice patterns of medical management of blunt thoracic aortic injury from the Aortic Trauma Foundation global registry.

OBJECTIVE: Blunt thoracic aortic injury (BTAI) is the second leading cause of death from blunt trauma. In the present study, we aimed to determine the outcomes of medical management (MM) for BTAI. We hypothesized from the results of several previously reported studies, that patients with a minimal aortic injury (BTAI grades 1 and 2) could safely be treated with definitive MM alone. METHODS: The Aortic Trauma Foundation international prospective multicenter registry was used to examine the demographics, injury characteristics, management, and outcomes of patients with BTAI. We analyzed a subset of patients for whom MM was initiated as definitive therapy. RESULTS: From November 2016 to April 2020, 432 patients (median age, 41 years; 76% male; median injury severity score, 34) with BTAI (Society for Vascular Surgery grade 1, 23.6%; grade 2, 14.4%; grade 3, 51.2%; grade 4, 10.9%) were evaluated. Of the 432 patients, 245 (57%) had received MM in the initial period and 114 (26.4%) had received MM as the planned definitive therapy (grade 1, 59.6%; grade 2, 23.7%; grade 3, 15.8%; grade 4, 0.9%). The most common mechanism of BTAI was a motor vehicle collision (60.4%). Hypotension was present on arrival in 74 patients (17.2%). Continuous titratable infusion of antihypertensive medication was used for 49.1%, followed by intermittent bolus administration (29.8%), with beta-blockers (74.6%) the most common agent used. Treatments were targeted to a goal systolic blood pressure for 83.3%, most often to a target goal systolic blood pressure <120 mm Hg (66.3%). The MM goals based on blood pressure control were attained in 64.0% (73 of 114). Twelve patients (10.5%; grade 1, 1; grade 2, 0; grade 3, 10; grade 4, 1) had required subsequent intervention after MM. Eleven patients (9.6%) had undergone thoracic endovascular aortic repair and one (0.9%) had required open repair for a grade 4 injury. The overall in-hospital mortality for patients selected for definitive MM was 7.9%. No aortic-related deaths had occurred in the patients receiving definitive MM. CONCLUSIONS: Approximately one in four patients with BTAI will receive MM as definitive therapy. The variation in the pharmacologic therapies used is considerable. MM for patients with minimal aortic injury (BTAI grades 1 and 2) is safe and effective, with a low overall intervention rate and no aortic-related deaths. These findings support the use of definitive MM for grade 2 BTAI.

Outcomes of thoracic endovascular aortic repair in patients with concomitant blunt thoracic aortic injury and traumatic brain injury from the Aortic Trauma Foundation global registry.

BACKGROUND: Traumatic brain injury (TBI) and blunt thoracic aortic injury (BTAI) are the top two leading causes of death after blunt force trauma. Patients presenting with concomitant BTAI and TBI pose a specific challenge with respect to management strategy, because the optimal hemodynamic parameters are conflicting between the two pathologies. Early thoracic endovascular aortic repair (TEVAR) is often performed, even for minimal aortic injuries, to allow for the higher blood pressure parameters required for TBI management. However, the optimal timing of TEVAR for the treatment of BTAI in patients with concomitant TBI remains an active matter of controversy. METHODS: The Aortic Trauma Foundation international prospective multicenter registry was used to identify all patients who had undergone TEVAR for BTAI in the setting of TBI from 2015 to 2020. The primary outcomes included delayed ischemic or hemorrhagic stroke, in-hospital mortality, and aortic-related mortality. The outcomes were examined among patients who had undergone TEVAR at emergent (<6 vs ≥6 hours) or urgent (<24 vs ≥24 hours) intervals. RESULTS: A total of 100 patients (median age, 43 years; 79% men; median injury severity score, 41) with BTAI (Society for Vascular Surgery BTAI grade 1, 3%; grade 2, 10%; grade 3, 78%; grade 4, 9%) and concomitant TBI who had undergone TEVAR were identified. Emergent repair was performed for 51 patients (51%). Comparing emergent repair (<6 hours) to urgent repair (≥6 hours), no difference was found in delayed cerebral ischemic events (2.0% vs 4.1%; P = .614), in-hospital mortality (15.7% vs 22.4%; P = .389), or aortic-related mortality (2.0% vs 2.0%; P = .996) and no patient had experienced delayed hemorrhagic stroke. Likewise, repairs conducted in an urgent (<24 hours) setting showed no differences compared with those completed in an emergent (≥24 hours) setting regarding delayed ischemic stroke (2.6% vs 4.3%; P = .548), in-hospital mortality (18.2% vs 21.7%; P = .764), or aortic-related mortality (1.3% vs 4.3%; P = .654), and no patient had experienced delayed hemorrhagic stroke. CONCLUSIONS: In contrast to prior retrospective efforts, results from the Aortic Trauma Foundation international prospective multicenter registry have demonstrated that neither emergent nor urgent TEVAR for patients with concomitant BTAI and TBI was associated with delayed stroke, in-hospital mortality, or aortic-related mortality. In these patients, the timing of TEVAR did not have an effect on the outcomes. Therefore, the decision to intervene should be guided by individual patient factors rather than surgical timing.

A preliminary analysis of late structural failures of the Navion stent graft in the treatment of descending thoracic aortic aneurysms.

OBJECTIVE: Patients in the Valiant Evo U.S. and international clinical trials had positive short-term outcomes; however, late structural failures, including type IIIb endoleaks have been recently discovered. Type IIIb endoleaks are serious adverse events because the repressurization of the aneurysm sac increases the risk of rupture. The purpose of the present study was to detail the imaging patterns associated with the structural failures with the aim of increasing awareness of failing graft presentation, early recognition, and prompt treatment. METHODS: The Valiant Evo clinical trial was a prospective, single-arm investigation of a thoracic stent graft system. With the recent late structural failures, sites were requested to submit all available imaging studies to date to allow the core laboratory to assess for structural failures such as type IIIb endoleaks, stent ring fractures, and stent ring enlargement. Of the 100 patients originally enrolled in the trial from 2016 to 2018, the core laboratory assessed the imaging studies performed at ≥1 year for 83 patients. RESULTS: No structural failures of the graft were reported through 1 year of follow-up. At 1 to 4 years, graft structural failures were detected in 11 patients with descending thoracic aortic aneurysms. Of the 11 patients, 5 had a type IIIb endoleak. Four of the five had imaging findings showing stent fractures consistent with the location of the graft seam and one had a type IIIb endoleak attributed to calcium erosion with no stent fracture or ring enlargement. Of the four patients with stent fracture in line with the graft seam, three underwent a relining procedure that successfully excluded the type IIIb endoleak. One of these three patients died 4 days later of suspected thoracic aortic rupture because the distal thoracic endovascular aortic repair extension had been landed in a previously dissected and fragile section of the aorta. The remaining six patients had had stent ring enlargement. One of the six patients had had persistent aneurysm expansion from the time of implantation onward and had died of unknown causes. The remaining five patients have continued to be monitored. CONCLUSIONS: In the present preliminary analysis, the imaging patterns associated with type IIIb endoleaks, stent fractures, and stent ring enlargement appear to be related to the loss of seam integrity or detachment of the stent rings from the surface of the graft material. The imaging patterns we have detailed should be closely monitored using computed tomography angiography surveillance to allow structural failures to be promptly identified and treated.

Clinical trial outcomes and thoracic aortic morphometry after one year with the Valiant Navion stent graft system.

AUTHORS' NOTE: On February 17, 2021, Medtronic Incorporated issued a global voluntary recall of the Valiant Navion Thoracic Stent Graft System (the device under study in the Valiant Evo Global Clinical Program that is the subject of this publication), and instructed physicians to immediately cease use of the Valiant Navion system and return any unused product. Medtronic initiated the recall in response to three clinical trial subjects recently observed with stent fractures, two of whom have confirmed type IIIb endoleaks. The data collection, analysis, and manuscript submission occurred before the notice of this recall, and, specifically, the 100 procedures reviewed for this series were free of events at 1 year related to the reason for this device recall. The authors of this article and the manufacturer were unaware of the recently detected adverse events at the time of the preparation of the manuscript, and the 1-year trial results, and imaging-based analyses described are unchanged. Management of thoracic aortic aneurysms continues to be a challenging problem and outcomes are dependent on patient anatomy. The present publication focuses on the importance of achieving proximal and distal seals and the consideration of the temporal changes of the aortic morphology as a part of the TEVAR planning process. The authors believe there is still scientific merit in disclosing this information, despite the current nonavailability of the Valiant Navion system. OBJECTIVE: The Valiant Navion stent graft system (Medtronic Inc, Santa Rosa, Calif) is a third-generation device with improved conformability. We have reported the 1-year clinical trial outcomes, with a focus on an imaging-based analysis of the aortic morphology. We assessed the effects of graft implantation on the native anatomy and the effects of the 1-year changes in thoracic aorta morphology on the original seal zones of the stent graft. METHODS: A total of 100 subjects were enrolled in a prospective single-arm clinical trial investigating the Valiant Navion stent graft system. An independent core laboratory (Syntactx, New York, NY) assessed the anatomic characteristics and performance outcomes. RESULTS: Through 1 year of follow-up, the freedom from all-cause mortality, aneurysm-related mortality, and secondary procedures was 89.8%, 97.0%, and 94.8% respectively. Of the 100 patients, 5 had undergone a total of six secondary procedures, and 9 patients had developed an endoleak (type Ia and Ib in 1, type Ia in 1, type Ib in 3, and type II in 4 patients) within the first year. After 1 year, 2 of 76 patients (2.6%) had had an increase in their maximum aneurysm diameter of ≥5 mm, 62 (81.6%) had had stable sacs, and 12 (15.8%) had experienced sac shrinkage. Although no deployment failures had occurred, 36 of the 100 proximal (36%) and 31 of the 100 distal (31%) attachment zones were considered short according to our definitions. The stent graft had conformed to the native anatomy at implantation, because the preprocedural thoracic aorta tortuosity (1.45 ± 0.02) had not significantly changed at 1 month after implantation (1.46 ± 0.02). Despite a natural increase in thoracic tortuosity after 1 year (1.49 ± 0.02), wall apposition had been maintained over time, as evidenced by the low endoleak rates. Aortic elongation and dilation had occurred at the proximal end of the graft by an average of 1.2 mm and 1.6 mm, respectively. Aortic remodeling was more pronounced at the distal end, with an average increase of 4.2 mm in length and 2.8 mm in diameter. CONCLUSIONS: The included patients had had positive 1-year outcomes with high freedom from mortality, endoleak development, and secondary procedures. Aortic elongation and dilation were more prevalent at the distal end, emphasizing the importance of distal attachment zone consideration as part of preoperative planning. Because aortic remodeling can be expected to continue over time, additional follow-up and imaging analysis in the trial will be necessary to assess the aortic morphology and its effects on stent graft performance.

Outcomes of intact thoracic endovascular aortic repair in octogenarians.

BACKGROUND: Thoracic endovascular aortic repair (TEVAR) is a suitable alternative to open aortic surgery especially for older patients with poor general health and functional status. However, data on the benefit of TEVAR in elderly patients are limited. The aim of this study was to use a large national database to compare the outcomes of TEVAR in octogenarians vs nonoctogenarians in the treatment of thoracic aortic aneurysms and dissection. METHODS: All patients who underwent TEVAR for nonruptured thoracic aneurysms or dissection (zones 1-5) between January 2014 and February 2019 were identified in the Vascular Quality Initiative database. The primary outcome was in-hospital mortality. Secondary outcomes included cardiac adverse events; neurologic events; respiratory complications; new-onset dialysis; leg compartment syndrome; postoperative hematoma in addition to spinal, bowel, arm, and leg emboli/ischemia; and return to the operating room. Outcomes were compared between octogenarians (age ≥80 years) and nonoctogenarians (age <80 years) using univariable and multivariable logistic regression models. RESULTS: A total of 2042 patients were identified, including 390 octogenarians (19.1%). Compared with nonoctogenarians, octogenarians had higher percentages of females (49.5% vs 40.4%; P < .01) and White patients (75.9% vs 68.6%; P < .01) and were more likely to present with thoracic aneurysms (86.2% vs 64.3%; P < .001). They also had larger aortic diameters (maximum diameter, 60.3 ± 15.8 mm vs 53.4 ± 17.4 mm), less proximal disease zones (zone 1, 3.3% vs 5.5%; zone 2, 13.9% vs 24.1%; P < .001) and were more likely to undergo the procedure under local/regional anesthesia (5.4% vs 2.4%; P < .01) compared with patients less than 80 years of age. No association was observed between octogenarians and in-hospital mortality after TEVAR for aneurysms (5.1% vs 3.3%; odds ratio [OR], 1.38; 95% confidence interval [CI], 0.72-2.61; P = .33) or dissection (5.6% vs 4.9%; OR, 0.68; 95% CI, 0.14-3.32; P = .63). However, for thoracic aneurysm repair, octogenarians had a 44% higher adjusted odds of in-hospital complications (27.4% vs 20.7%; OR, 1.44; 95% CI, 1.04-1.98; P = .03) compared with their younger counterparts. In-hospital complications (27.8% vs 26.2%; P = .79; OR, 1.02; 95% CI, 0.50-2.11; P = .95) were similar in octogenarians undergoing endovascular repair for dissections of the thoracic aorta. Octogenarians were also associated with 1.74 times the mortality hazard compared with nonoctogenarians (adjusted hazard ratio, 1.74; 95% CI, 1.18-2.58; P = .01). CONCLUSIONS: TEVAR is an acceptable treatment option for octogenarians who have aortic arch and descending aortic aneurysms or dissections (zones 1-5). However, in case of aneurysms, they might be at a higher risk of in-hospital complications. Octogenarians also had increased hazard of 1-year mortality; however, the exact cause of this mortality could not be deciphered. Our findings suggest that elderly patients should not be denied TEVAR based on age if they are medically and anatomically fit for this procedure.

Do patients with minimal blunt thoracic aortic injury require thoracic endovascular repair?

INTRODUCTION: The optimal management of minimal blunt thoracic aortic injuries (BTAIs) remains controversial, with experienced centers using therapy ranging from medical management (MM) to thoracic endovascular aortic repair (TEVAR). METHODS: The Aortic Trauma Foundation registry was used to examine demographics, injury characteristics, management, and outcomes of patients with BTAI. RESULTS: Two hundred ninety-six patients from 28 international centers were analyzed (mean age, 44.5 years [SD, 18 years]; 76% [225/296] male; mean Injury Severity Score, 34 [SD, 14]). Blunt thoracic aortic injury was classified as Grade I, 22.6% (67/296); Grade II, 17.6% (52/296); Grade III, 47.3% (140/296); and Grade IV, 12.5% (37/296). Overall aortic-related mortality (ARM) was 4.7% (14/296). Among all deaths, 33% (14/42) were ARM. Open repair was required for only 2%, with most undergoing TEVAR (58.4%) or MM (28.0%). Thoracic endovascular repair complications occurred in 3.4% (6/173), most commonly Type 1 endoleak (2.3%; 4/173). Among patients with minimal aortic injury (Grades I and II), 59.7% (71/119) received MM, while 40.3% (48/119) underwent TEVAR. Two patients initially managed with MM required subsequent TEVAR for injury progression during initial hospital stay. No significant difference in ARM between MM and TEVAR was noted for Grades I and II injuries. CONCLUSION: A third of the trauma victims with BTAI succumb to ARM. Thoracic endovascular repair has replaced open repair but remains equivalent in outcomes to MM for minimal injuries. These data support MM of patients with minimal aortic injury. LEVEL OF EVIDENCE: Therapeutic study, level IV.