Upper extremity versus lower extremity for secondary access during transcatheter aortic valve implantation: rationale and design of the randomised TAVI XS trial.

BACKGROUND: During transcatheter aortic valve implantation (TAVI), secondary access is required for angiographic guidance and temporary pacing. The most commonly used secondary access sites are the femoral artery (angiographic guidance) and the femoral vein (temporary pacing). An upper extremity approach using the radial artery and an upper arm vein instead of the lower extremity approach using the femoral artery and femoral vein may reduce clinically relevant secondary access site-related bleeding complications, but robust evidence is lacking. TRIAL DESIGN: The TAVI XS trial is a multicentre, randomised, open-label clinical trial with blinded evaluation of endpoints. A total of 238 patients undergoing transfemoral TAVI will be included. The primary endpoint is the incidence of clinically relevant bleeding (i.e. Bleeding Academic Research Consortium (BARC) type 2, 3 or 5 bleeding) of the randomised secondary access site (either diagnostic or pacemaker access, or both) within 30 days after TAVI. Secondary endpoints include time to mobilisation after TAVI, duration of hospitalisation, any BARC type 2, 3 or 5 bleeding, and early safety at 30 days according to Valve Academic Research Consortium­3 criteria. CONCLUSION: The TAVI XS trial is the first randomised trial comparing an upper extremity approach to a lower extremity approach with regard to clinically relevant secondary access site-related bleeding complications. The results of this trial will provide important insights into the safety and efficacy of an upper extremity approach in patients undergoing transfemoral TAVI.

Thoracic Stent Graft Numerical Models To Virtually Simulate Thoracic Endovascular Aortic Repair: A Scoping Review.

OBJECTIVE: Pre-procedural planning of thoracic endovascular aortic repair (TEVAR) may implement computational adjuncts to predict technical and clinical outcomes. The aim of this scoping review was to explore the currently available TEVAR procedure and stent graft modelling options. DATA SOURCES: PubMed (MEDLINE), Scopus, and Web of Science were systematically searched (English language, up to 9 December 2022) for studies presenting a virtual thoracic stent graft model or TEVAR simulation. REVIEW METHODS: The Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews (PRISMA-ScR) was followed. Qualitative and quantitative data were extracted, compared, grouped, and described. Quality assessment was performed using a 16 item rating rubric. RESULTS: Fourteen studies were included. Among the currently available in silico simulations of TEVAR, severe heterogeneity exists in study characteristics, methodological details, and evaluated outcomes. Ten studies (71.4%) were published during the last five years. Eleven studies (78.6%) included heterogeneous clinical data to reconstruct patient specific aortic anatomy and disease (e.g., type B aortic dissection, thoracic aortic aneurysm) from computed tomography angiography imaging. Three studies (21.4%) constructed idealised aortic models with literature input. The applied numerical methods consisted of computational fluid dynamics analysing aortic haemodynamics in three studies (21.4%) and finite element analysis analysing structural mechanics in the others (78.6%), including or excluding aortic wall mechanical properties. The thoracic stent graft was modelled as two separate components (e.g., graft, nitinol) in 10 studies (71.4%), as a one component homogenised approximation (n = 3, 21.4%), or including nitinol rings only (n = 1, 7.1%). Other simulation components included the catheter for virtual TEVAR deployment and numerous outcomes (e.g., Von Mises stresses, stent graft apposition, drag forces) were evaluated. CONCLUSION: This scoping review identified 14 severely heterogeneous TEVAR simulation models, mostly of intermediate quality. The review concludes there is a need for continuous collaborative efforts to improve the homogeneity, credibility, and reliability of TEVAR simulations.

Long Term Health Related Quality of Life After Acute Type B Aortic Dissection: a Cross Sectional Survey Study.

OBJECTIVE: Acute type B aortic dissection (ATBD) is a rare yet serious cardiovascular event that potentially has an impact on health related quality of life (HRQoL). However, long term follow up data on this topic are scarce. This study aimed to review the long term HRQoL among patients treated for ATBD. METHODS: In this multicentre, cross sectional survey study, consecutive treated patients with ATBD between 2007 and 2017 in four referral centres in the Netherlands were retrospectively included and baseline data were collected. Between 2019 and 2021 the 36 Item Short Form Survey (SF-36) was sent to all surviving patients (n = 263) and was compared with validated SF-36 scores in the Dutch general population stratified by age and sex. RESULTS: In total, 144 of 263 surviving patients completed the SF-36 (response rate 55%). Median (IQR) age was 68 (61, 76) years at completion of the questionnaire, and 40% (n = 58) were female. Initial treatment was medical in 55% (n = 79), endovascular in 41% (n = 59), and surgical in 4% (n = 6) of ATBD patients. Median follow up time was 6.1 (range 1.7-13.9; IQR 4.0, 9.0) years. Compared with the general population, patients scored significantly worse on six of eight SF-36 subdomains, particularly physical domains. Apart from bodily pain, there were no substantial differences in HRQoL between male and female ATBD patients. Compared with sex matched normative data, females scored significantly worse on five of eight subdomains, whereas males scored significantly lower on six subdomains. Younger patients aged 41-60 years seemed more severely impaired in HRQoL compared with the age matched general population. Treatment strategy did not influence HRQoL outcomes. Follow up time was associated with better Physical and Mental Component Summary scores. CONCLUSION: Long term HRQoL was impaired in ATBD patients compared with the Dutch general population, especially regarding physical status. This warrants more attention for HRQoL during clinical follow up. Rehabilitation programmes including exercise and physical support might improve HRQoL and increase patients' health understanding.

Mid-term outcomes of the use of endoanchors during thoracic endovascular aortic repair in multicentre analysis.

OBJECTIVE: To describe mid-term outcomes of the use of EndoAnchors as an adjunct for arch and thoracic endovascular aortic repair (TEVAR). METHODS: A retrospective multicentre series from nine centres using the Heli-FX EndoAnchor System (Medtronic Inc, Minneapolis, USA) at TEVAR over May 2014-May 2019 is presented. The study is registered at ClinicalTrials.gov with number NCT04100499. The primary outcome was freedom from Type I endoleak at EndoAnchors deployments; secondary outcomes included evaluation of aortic wall penetration (AWP) at first computed tomography scan, EndoAnchor-related issues and mortality. RESULTS: 54 high-risk patients (35 males/19 females, age 73 ± 11 years) with arch, thoracic and thoracoabdominal aneurysmal disease (3 chronic post-dissection and one patch pseudoaneurysm), with a mean neck length 19.7 ± 6.6 mm that were treated with multiple hybrid and endovascular techniques were included. A total of 329 EndoAnchors were used with a mean of 6.1 ± 2.5 per patient. Overall adequate AWP was 86%, whereas arch (Ishimaru's zones 0-2) deployments achieved 80.6% when compared to 87.3% in descending thoracic aorta (dTA); although there was no statistical significance. Freedom from type I endoleaks was 88% at 2 year follow-up, due to 4 type IA endoleaks, two of them successfully treated, one with conservative treatment due to complexity of repair and remaining patient died 1 year later due to endograft infection. There were reported five EndoAnchor-related issues; four losses and one renal stent-graft was crushed due to catheter deflection solved with balloon reinflation. None of the losses had clinical significance. Overall mortality is described for 7 (9.5%) patients, one of them aneurysm-related. CONCLUSIONS: The adjunctive use of EndoAnchors in TEVAR and complex TEVAR procedures achieved acceptable outcomes at midterm in a high-risk series with hostile seal zones. Still, they should be still judiciously used as there is lack of data to suggest a more liberal use; therefore, the landing zone should not be compromised in favour of their use.

Transcatheter closure of postsurgical aortic pseudoaneurysms guided by three-dimensional image reconstruction: a single-centre experience.

BACKGROUND: Postsurgical thoracic aortic pseudoaneurysms (PTAPs) are a potentially lethal complication after cardiac or aortic surgery. Surgical management can pose a challenge with high in-hospital mortality rates. Transcatheter closure is a less-invasive alternative treatment option for selected patients, although current experience is limited. AIMS: We aimed to evaluate procedural and imaging outcomes of our first 11 cases of transcatheter PTAP closure with the use of closure devices. METHODS: Patients with a high operative risk who underwent transcatheter PTAP closure at our centre from 2019 to 2021 were retrospectively included. Suitability was evaluated on preprocedural computed tomography (CT) scans and three-dimensional (3D) reconstructions. All procedures were performed in the catheterisation laboratory. Intraprocedural aortography and postprocedural CT scans with 3D reconstructions were used to evaluate PTAP occlusion. RESULTS: Eleven consecutive patients with a high operative risk and a history of cardiac/aortic surgery who underwent transcatheter PTAP closure were included. PTAPs were predominantly located at the proximal or distal anastomosis of a supracoronary ascending aortic vascular graft or Bentall prosthesis (82%). Implanted closure devices included Amplatzer Valvular Plug III (82%), Amplatzer septal occluder (9%) and Occlutech atrial septal defect occluder (9%). No periprocedural complications occurred. After device deployment, residual flow was absent on aortography in 64% and minimal residual flow was present in 36% of patients. Subtotal or total occlusion of the PTAP on follow-up CT ranged between 45% and 73%. CONCLUSIONS: Although subtotal or total occlusion of the PTAP was found at follow-up in only 45-73% of cases, transcatheter PTAP closure guided by preprocedural 3D reconstructions can offer a valuable minimally invasive primary treatment option for patients who otherwise would face a high-risk reoperation.

Long-term patency of surgical left subclavian artery revascularization.

OBJECTIVE: Little is known regarding the long-term patency rates of surgical left subclavian artery (LSA) revascularization, especially when performed concomitant to thoracic endovascular aortic repair and without arterial occlusive disease. Our aim is to contribute to the existing evidence by reporting the patency rates at mid- and long-term follow-up after surgical LSA revascularization. METHODS: This observational, retrospective, single-center cohort study included 90 eligible patients who underwent a left common carotid artery to LSA bypass (72%) or transposition (28%) from December 31, 2017 to January 1, 2000. Data regarding demographics, medical history, intraoperative characteristics, and outcomes regarding bypass graft or transposition patency, severe stenosis, or occlusion were assessed at discharge, 3 months, 1 year, and maximum follow-up using consecutive follow-up computed tomography scans. RESULTS: In our predominantly male (74%) cohort with a mean age of 66 years (standard deviation, ±12 years), LSA revascularization was mostly performed concomitant to or adjacent to thoracic endovascular aneurysm repair procedures (98%) with the primary indication for surgery being degenerative or saccular aneurysmatic aortic disease (50%), subacute or acute type B aortic dissection (17%), post-dissection aortic aneurysm (16%), type B intramural hematoma (6%), and other indications (11%). Ninety-seven percent of our left common carotid artery to LSA bypasses were performed using a central, supraclavicular approach, and the other 3% were performed using an infraclavicular approach to the LSA. Median diameter of the bypass was 6 mm (range, 6-12 mm). We found two occlusions at 7.7 and 12.9 months follow-up and four severe stenoses at 21.2, 35.4, 38.3, and 46.7 months follow-up, respectively. Estimated freedom from occlusion was 97% ± 2% and freedom from severe stenosis was 90% ± 4% at both midterm (5 years) and long-term (10 years) follow-up, with a median follow-up duration of 42.2 months for occlusion (25th-75th percentile, 15.4-67.4 months) and 41.9 months (25th-75th percentile, 15.4-67.4 months) for severe stenosis. CONCLUSIONS: Open surgical LSA revascularization may be considered the gold standard to preserve antegrade LSA flow in the context of debranching for thoracic endovascular aneurysm repair or open surgical aortic arch repair, with excellent patency rates at mid-term and long-term follow-up.

Initial Single-Center Experience With the Knickerbocker Technique During Thoracic Endovascular Aortic Repair to Block Retrograde False Lumen Flow in Patients With Type B Aortic Dissection.

OBJECTIVE: Effectiveness of thoracic endovascular aortic repair in type B aortic dissection is impaired by persistent retrograde false lumen flow via distal re-entry tears. Controlled, stentgraft-assisted balloon dilatation of the true lumen at its lower end, or Knickerbocker technique, may block retrograde false lumen flow and consequently improve effectiveness by inducing immediate thrombosis along the entire descending thoracic aorta. MATERIALS AND METHODS: A single-center retrospective analysis was performed for all consecutive patients with aortic dissection treated with the Knickerbocker technique to block retrograde false lumen flow. RESULTS: Eleven patients were included for analysis. Intraoperative control angiography showed successful occlusion of the false lumen at the level of balloon dilatation in 9 out of 11 patients (82%). There was one perioperative mortality (9%), due to stroke. There were 2 early reinterventions, due to retroperitoneal bleeding and due to chyle leakage in the neck after left subclavian artery bypass. Median clinical follow-up duration was 6 (interquartile range [IQR] 2-11] months. There were 2 deaths during follow-up, one at 2 months after TEVAR from unknown cause of death, and one after 11 months due to rupture of an ascending aortic pseudoaneurysm. The Knickerbocker technique led to positive aortic remodeling. At 3 months follow-up, 100% of patients showed complete false lumen thrombosis in the thoracic aorta proximal to the level of balloon dilatation, with decreasing false lumen diameters (100%) and stable (44%) or decreasing (56%) total aortic diameters. In most patients, the false lumen distal to the stentgraft (i.e. at visceral level) remained patent (11% false lumen thrombosis rate), leading to ≥2 mm dilatation at this level (78% of patients) and in the infrarenal abdominal aorta (56% of patients) at 3 months postoperatively. No distal stent-graft-induced new entry tears were noticed during follow-up. CONCLUSION: The Knickerbocker technique is feasible and effective, leading to positive aortic remodeling of the aorta covered by stentgraft in all of a small cohort of patients. CLINICAL IMPACT: Persistent, retrograde false lumen perfusion from distal re-entries following thoracic endovascular aortic repair (TEVAR) for Stanford type B aortic dissection, may lead to progressive, aneurysmal dilatation. Controlled, stent graft-assisted balloon dilatation of the true lumen in the distal descending aorta (i.e. Knickerbocker technique) during TEVAR effectively excludes the false lumen from persistent flow resulting in positive aortic remodeling in our small cohort of patients, and hence potentially eliminates the risk of late post-dissection aneurysm formation in the descending thoracic aorta.

Endovascular Repair of Complicated Type B Aortic Intramural Haematoma: A Single Centre Long Term Experience.

OBJECTIVE: To evaluate the efficacy of thoracic endovascular aortic repair (TEVAR) in the treatment of patients with complicated type B aortic intramural haematoma (IMH). METHODS: A retrospective observational study of patients treated between January 2002 and December 2017 was performed. Complicated type B IMH was defined as persistent pain, rapid dilatation, presence of ulcer-like projections (ULPs), haemothorax, and other signs of (impending) rupture. Thirty day results and long term follow up outcomes were reported. RESULTS: Thirty-nine patients were included for analysis (mean age 68 ± 8 years, 36% male). The thirty day mortality rate was 5%, stroke rate 10%, and re-intervention rate 3%. The median follow up duration was 49 months (25th - 75th percentile: 2 - 96 months). At 10 years, estimated freedom from all cause mortality was 66 ± 9%. During follow up, nine re-interventions were performed, leading to a 10 year estimated freedom from re-intervention rate of 72 ± 8%. Estimated freedom from aortic growth at 10 years was 85 ± 9%. CONCLUSION: Complicated type B IMH can be treated effectively by TEVAR, thus preventing death from aortic rupture. However, severe early post-operative complications, most importantly stroke, are of concern. Long term outcomes are excellent, although re-interventions are not uncommon, either for progression of proximal or distal aortic disease or due to stent graft related complications.

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.

Preoperative Planning for EndoAnchor Use During Thoracic Endovascular Aortic Repair in the Distal Aortic Arch.

PURPOSE: To describe steps related to intraoperative C-arm orientations that can be taken during preoperative planning of thoracic stent-graft repair to facilitate the deployment of EndoAnchors in the distal aortic arch. TECHNIQUE: Previous experience from transcatheter aortic valve implantation (TAVI) may be helpful in addressing issues with C-arm orientation. In TAVI, preoperative computed tomography (CT) images are routinely obtained to generate a patient-specific curve that represents a virtually complete rotation of the C-arm perpendicular to the annulus. The curve clearly demonstrates that each adjustment in cranial or caudal view needs parallax correction in the left or right anterior oblique direction to remain perpendicular, and vice versa. This experience can be translated to the preoperative planning of EndoAnchor use in the aortic arch. By placing markers along the circumference of the proximal landing zone of the preoperative CT scan, the required C-arm orientations can be determined for each marker. CONCLUSION: Determining the optimal C-arm orientation during preoperative planning will facilitate successful EndoAnchor deployment and may contribute to improved durability of endovascular repair in hostile necks in the aortic arch.

The GORE TAG conformable thoracic stent graft with the new ACTIVE CONTROL deployment system.

OBJECTIVE: The aim of this study was to describe single-center intraoperative details and early outcome of the new GORE TAG conformable stent graft with ACTIVE CONTROL (C-TAG ACTIVE CONTROL; W. L. Gore & Associates, Flagstaff, Ariz). METHODS: Between September 2017 and June 2018, a consecutive 30 patients underwent thoracic endovascular aortic repair with C-TAG ACTIVE CONTROL. This new system provides an intermediate deployment step at 50% and optional angulation control of the proximal part of the stent graft. Indications for thoracic endovascular aortic repair varied widely, including chronic postdissection and degenerative aneurysms, complicated acute dissections, and intramural hematomas, among others, in an elective (63.3%), urgent (13.3%), or emergent (23.3%) setting. The proximal landing zone (LZ) was LZ 2 in 23.3%, LZ 3 in 43.3%, and LZ 4 in 33.3%. Data were collected retrospectively and analyzed for technical and clinical success. RESULTS: In all patients, the stent graft was successfully introduced and deployed at the intended position, with complete exclusion of aortic disease and without intraoperative mortality (primary technical success, 100%). One emergent patient died at 2 days of ongoing septic shock (clinical success at 30 days, 96.6%). Median follow-up was 107 days (range, 33-271 days); late mortality was 3.4% (one patient died of stent graft infection at 40 days). Freedom from type I and type III endoleak at the early follow-up was 100%. No patients required other surgical or endovascular procedures for the primary treated aortic disease. CONCLUSIONS: Our reported initial experience in 30 patients with the C-TAG ACTIVE CONTROL showed excellent early results, with high deployment accuracy and conformability. The additional features of staged deployment and angulation control may be of great help in challenging aortic arch diseases, allowing precise positioning and preventing bird-beak effect.

A New Methodology to Determine Apposition, Dilatation, and Position of Endografts in the Descending Thoracic Aorta After Thoracic Endovascular Aortic Repair.

Purpose: To validate computed tomography angiography (CTA)-applied software to assess apposition, dilatation, and position of endografts in the proximal and distal landing zones after thoracic endovascular aortic repair (TEVAR) of thoracic aortic aneurysm. Materials and Methods: Twenty-two patients (median age 75.5 years; 11 men) with a degenerative descending thoracic aortic aneurysm treated with TEVAR with at least one postoperative CTA were selected from a single center's database. New CTA-applied software was used to determine the available apposition surface in the proximal and distal landing zones, apposition of the endograft fabric with the aortic wall, shortest apposition length, endograft inflow and outflow diameters, shortest distance between the left subclavian artery and the proximal endograft fabric, and shortest distance between the celiac trunk and the distal endograft fabric on each CTA. Interobserver variability for these parameters was assessed with the repeatability coefficient and the intraclass correlation coefficient. Results: Excellent interobserver agreement was found for all measurements. Interobserver variability of surface and shortest apposition length calculations was larger for the distal site compared with the proximal site, with a mean difference of 10% vs 2% of the mean available apposition surface, 12% vs 5% of the endograft apposition surface, and 16% vs 8% of the shortest apposition length, respectively. Inflow and outflow diameters of the endograft showed low variability, with a mean difference of 0.1 mm with 95% of the interobserver difference within 1.8 mm. Mean interobserver differences of the proximal and distal shortest fabric distances were 1.0 and 0.9 mm (both 2% of the mean lengths). Conclusion: Assessment of apposition, dilatation, and position of the proximal and distal parts of an endograft in the descending thoracic aorta is feasible after TEVAR with the new software. Interobserver agreement for all measured parameters was excellent for the proximal and distal landing zones. The new method allows detection of subtle changes during follow-up. However, a larger study is needed to quantify how parameters change over time in complicated and uncomplicated TEVAR cases and to define the real added value of the new methodology.

Retrograde Type A Intramural Hematoma Treated Endovascularly in Two Cases.

Type A aortic dissection is a highly lethal condition, which warrants swift open surgical intervention to prevent death by rupture or malperfusion. The aim is to resect the proximal intimal tear and realign the dissected wall layers. We describe two patients who recently presented in our center with a retrograde type A intramural hematoma and a clear intimal tear distal to the left subclavian artery, that were treated in emergency by endovascular means instead of open surgery, with satisfactory short-term and one-year follow-up results. In conclusion, in selected cases, less invasive thoracic endovascular aortic repair can treat retrograde type A intramural hematoma originating from an intimal tear distal to the left subclavian artery, with good one-year results.

Ascending Aortic Aneurysm Secondary to Isolated Noninfectious Ascending Aortitis.

Isolated noninfectious ascending aortitis (I-NIAA) is increasingly diagnosed at histopathologic review after resection of an ascending aortic aneurysm. PubMed was searched using the term aortitis; publications addressing the issue were reviewed, and reference lists of selected articles were also reviewed. Eleven major studies investigated the causes of an ascending aortic aneurysm or dissection requiring surgical repair: the prevalence of noninfectious aortitis ranged from 2% to 12%. Among 4 studies of lesions limited to the ascending aorta, 47% to 81% of cases with noninfectious aortitis were I-NIAA, more frequent than Takayasu arteritis or giant cell arteritis. Because of its subclinical nature and the lack of "syndromal signs" as in Takayasu arteritis or giant cell arteritis, I-NIAA is difficult to diagnose before complications occur, such as an aortic aneurysm or dissection. Therefore, surgical specimens of dissected aortic tissue should always be submitted for pathologic review. Diagnostic certainty requires the combination of a standardized histopathologic and clinical investigation. This review summarizes the current knowledge on I-NIAA, followed by a suggested approach to diagnosis, management, and follow-up. An illustrative case of an uncommon presentation is also presented. More follow-up studies on I-NIAA are needed, and diagnosis and follow-up of I-NIAA may benefit from the development of diagnostic biomarkers.

Predictors of aortic growth in uncomplicated type B aortic dissection from the Acute Dissection Stent Grafting or Best Medical Treatment (ADSORB) database.

BACKGROUND: The high-risk patient cohort of uncomplicated type B aortic dissections (uTBADs) needs to be clarified. We compared uTBAD patients treated with best medical treatment (BMT), with and without aortic growth, from the Acute Dissection Stent Grafting or Best Medical Treatment (ADSORB) trial database. Furthermore, we looked for trends in outcome for aortic growth and remodeling after BMT and thoracic endovascular aortic repair (TEVAR) and BMT (TEVAR+BMT). METHODS: BMT patients with available baseline and a 1-year follow-up arterial computed tomography scan were identified. True lumen and false lumen diameter was assessed at baseline and at follow-up. Patients with false lumen growth (group I) and without false lumen growth (group II) were compared. Predictors of false lumen and total lumen (aortic) growth were identified. Lastly, BMT outcomes were compared with BMT+TEVAR for false lumen thrombosis and change in false lumen and total aortic diameter in four sections: 0 to 10 cm (A), 10 to 20 cm (B), 20 to 30 cm (C), and 30 to 40 cm (D) from the left subclavian artery. RESULTS: The dissection was significantly longer in group I than in group II (43.2 ± 4.9 cm vs 30.4 ± 8.8 cm; P = .002). The number of vessels originating from the false lumen at baseline was identified as an independent predictor of false lumen growth (odds ratio, 22.1; 95% confidence interval, 1.01-481.5; P = .049). Increasing age was a negative predictor of total aortic diameter growth (odds ratio, 0.902; 95% confidence interval, 0.813-1.00; P = .0502). The proximal sections A and B showed complete thrombosis in 80.6% in the BMT+TEVAR group compared with 9.5% in the BMT group. In these sections, changes from patent to partial or partial to complete thrombosis were observed in 90.3% of the TEVAR+BMT group vs 31.0% in the BMT group. In sections C and D, the change in thrombosis was 74.1% for the TEVAR+BMT group vs 20.6% for the BMT group. The false lumen diameter increase at section C was larger in the BMT group. Total lumen diameter decreased in sections A and B in the TEVAR+BMT group compared with an increase in the BMT group (-4.8 mm vs +2.9 mm, and -1.5 mm vs +3.8 mm, respectively). Sections C and D showed minimal and comparable expansion in both treatment groups. CONCLUSIONS: The new imaging analysis of the ADSORB trial patients identified the number of vessels originating from the false lumen as an independent predictor of false lumen growth in uTBAD patients. Increasing age was a negative predictor of aortic growth. Our analysis may help to identify which uTBAD patients are at higher risk and should receive TEVAR or be monitored closely during follow-up.

Results From a Nationwide Registry on Scalloped Thoracic Stent-Grafts for Short Landing Zones.

PURPOSE: To report the perioperative results and short-term follow-up of patients treated with scalloped thoracic stent-grafts. METHODS: A multicenter registry in the Netherlands captured data on 30 patients (mean age 68 years; 17 men) with thoracic aortic pathology and a short (<20 mm) proximal or distal landing zone who received a custom-made scalloped stent-graft between January 2013 and February 2016. Patients were treated for saccular (n=13) aneurysms, fusiform (n=9) aneurysms, pseudoaneurysms (n=4), or chronic type B dissections (n=4). The scallop was used to preserve flow in the left subclavian artery (LSA) (n=17), left common carotid artery (n=5), innominate artery (n=1), and celiac trunk (n=7). In 7 (23%) patients, the scallop also included the adjacent artery. RESULTS: Technical success was achieved in 28 (93%) patients. In 1 patient, a minor type Ia endoleak was observed intraoperatively, which was no longer visible on computed tomography angiography at 3 months. In another patient, the LSA was unintentionally obstructed due to migration of the stent-graft on deployment. Concomitant carotid-carotid or carotid-subclavian bypass was performed in 4 patients. There was no retrograde type A dissection or conversion to open surgery. In-hospital mortality was 3%, and the perioperative ischemic stroke rate was 3%. At a mean follow-up of 9.7 months (range <1 to 31), 29 of 30 target vessels were patent. CONCLUSION: The scalloped stent-graft appears to be a safe and relatively simple alternative for the treatment of thoracic aortic lesions with short landing zones. Larger patient series and long-term follow-up are required to confirm these early results.

A Feasibility Study of Off-the-Shelf Scalloped Stent-Grafts in Acute Type B Aortic Dissection.

PURPOSE: To evaluate the applicability of an off-the-shelf scalloped stent-graft to preserve left subclavian artery (LSA) flow in thoracic endovascular aortic repair (TEVAR) for acute type B aortic dissection. METHODS: The computed tomography angiograms (CTA) of 70 consecutive patients (median age 64 years; 44 men) with acute Stanford type B aortic dissection were retrospectively analyzed to identify patients in whom a short proximal landing zone (<15 mm from the retrogradely dissected wall layers) would require LSA overstenting during TEVAR. A scalloped stent-graft was deemed possible in those patients with the intimal entry tear located at least 20 mm distant from the LSA ostium. RESULTS: The LSA needed to be covered in 56 (80%) patients. Of these, an off-the-shelf scalloped stent-graft would have been applicable in 23 (41%) patients. In the latter group, the median aortic diameter was 31 mm (range 26-37), the median length of the LSA ostium was 13 mm (range 10-20), and the median width of the LSA ostium was 15 mm (range 11-24). Three differently sized off-the-shelf stent-grafts with the largest scallop possible could have adequately treated 20 (36%) of the 56 patients in the acute phase. CONCLUSION: In this single-center imaging-based study, involvement of the LSA in the setting of acute type B aortic dissection was seen in 80% of patients treated with TEVAR. Three off-the-shelf stent-grafts would suffice to treat one-third of these acute type B aortic dissections and may offer a relatively simple solution to preserve LSA flow, thereby lowering the risk of malperfusion of the (posterior) cerebrum, spinal cord, and left arm in an urgent/emergent setting.

Standardized Protocol to Analyze Computed Tomography Imaging of Type B Aortic Dissections.

PURPOSE: To propose a standard measuring protocol for type B aortic dissections so as to improve comparability between studies reporting aortic dimensions. METHODS: Fifteen computed tomography (CT) scans of type B aortic dissections were measured with a standard protocol by 2 independent observers using postprocessing software. The following parameters were assessed: true, false, and total lumen diameter; true and false lumen volume; and entry tear size, location, and number. Diameters were measured in a perpendicular plane at 2, 10, and 20 cm from the left subclavian artery and 5 cm from the most distal renal artery. True lumen volume was assessed from the left subclavian artery to the aortic bifurcation, while the false lumen volume was from the start to end up to the aortic bifurcation. Entry tear location was assessed in relation to the left subclavian artery. Intra- and interobserver repeatability and agreement were evaluated using the Bland-Altman method, an a priori set of acceptable differences, and Lin's concordance correlation coefficient (LCCC). RESULTS: Intra- and interobserver mean differences for aortic diameter and true and false lumen volumes were generally within the limits of agreement and the a priori differences; the LCCC showed excellent agreement. Entry tear location, size, and number were difficult to measure in a repeatable manner, with inconsistent correlation coefficients, especially between the 2 observers. CONCLUSION: This protocol showed acceptable repeatability for aortic diameter and aortic volume measurements. Assessment of entry tears proved challenging and associated with less favorable results. Additionally, investigators are urged to be more transparent regarding the measurement methodology used in studies describing aortic dimensions.

Thoracic aorta stent grafting through transapical access.

BACKGROUND: To describe the transapical approach for thoracic endovascular aortic repair (TEVAR). METHODS: Three patients, 2 elective and 1 emergent, with thoracic aorta aneurysm are described with vascular or direct aortic inaccessible access, who underwent TEVAR through transapical access. The technique is described in detail emphasizing the usefulness of the through-and-through guidewire, rapid pacing, and transesophageal echocardiography guidance. RESULTS: All patients were technical successfully treated with TEVAR through transapical access. The emergent patient, however, died due to multiorgan failure. CONCLUSIONS: Our early experience shows that the transapical approach for TEVAR procedures is feasible in experienced hands. The selection of the patient and careful planning based on imaging are of paramount importance and should lead to the most suitable access site tailored to the need of the individual patient.

The systemic inflammatory response syndrome predicts short-term outcome after transapical transcatheter aortic valve implantation.

OBJECTIVE: Despite the minimally invasive nature of transcatheter aortic valve implantation (TAVI), the incidence of acute kidney injury (AKI) and mortality is of major concern. Several studies showed that outcome was influenced by the systemic inflammatory response syndrome (SIRS) in patients undergoing percutaneous TAVI. The purpose of this study was to investigate whether SIRS after transapical TAVI was associated with short-term outcome. DESIGN: Retrospective analysis of prospectively collected data. SETTING: Intensive care unit in a tertiary-care hospital. PARTICIPANTS: In 121 patients undergoing transapical TAVI for severe aortic stenosis between March 2010 and October 2013, the incidence of SIRS during the first 48 hours was studied. The relation between the occurrence of SIRS and any adverse event during hospital stay was investigated. Any adverse event was defined as the composite of mortality, AKI, infection, stroke, myocardial infarction, and bleeding. INTERVENTION: none. MEASUREMENTS AND MAIN RESULTS: Sixty-five (53.7%) patients developed SIRS during 48 hours after transapical TAVI. The occurrence of SIRS was associated independently with an increased risk of any adverse event (adjusted odds ratio: 4.0, 95% confidence interval [CI]: 1.6-9.6; p=0.002), which was mainly an increased risk of death (odds ratio: 5.5, 95% CI: 1.1-25.9; p=0.031). Patients with SIRS had a longer median duration of intensive care unit stay compared with patients without SIRS (2 v 1 day; p<0.001). CONCLUSIONS: SIRS predicts short-term outcome in patients undergoing transapical TAVI.