Real world experience with the TREO device in standard EVAR: Mid-term results of 150 cases from a German Multicenter study.

Background: The objective of the study was to analyze mid-term results of unselected patients treated with the TREO (Terumo Aortic, Florida, USA) device at six German hospital sites. Methods: A multicenter, retrospective analysis of patients treated within and outside instructions for use (IFU) from January 2017 to November 2020 was performed. Primary outcomes were technical success, mortality and endograft related complications according to IFU status. Secondary outcomes were aneurysm/procedure related re-interventions. Results: 150 patients (92% male, mean age 73 ±8 years) were treated (within IFU 84% vs. outside IFU 16%) with the TREO device for abdominal aortic aneurysms (n=127 intact, n=17 symptomatic and n=6 ruptured; p=0.30). Technical success was achieved in 147/150 (within IFU 99% vs. outside IFU 92%, p=0.08). 30-day mortality was 2%, one year and overall mortality was 3% and 5%. During a mean follow-up of 28.4 months (range: 1-67.4 months), 35 (25%; within IFU 23% vs. outside IFU 35%, p=0.23) patients suffered from endoleaks. The majority were endoleaks type II (n=33), the remaining type Ia (n=5) and type Ib (n=3). No endoleaks type III-V, migrations or aneurysm ruptures occurred. Overall, 19 patients (13%; within IFU 13% vs. 15% outside IFU, p=0.70) received a secondary intervention: nine endoleak related endovascular procedures, three open conversions, two endograft limb related interventions, four surgical revisions of the femoral access sites and two bowl ischemia related procedures, respectively. Conclusions: This non industry-sponsored, multicenter trial indicates that using the TREO device in a real-world setting (both within and outside IFU) seems feasible in the treatment of patients suffering from AAA. While the rate of complications and secondary interventions is in line with previously published data, the findings highlight the fact that standard EVAR is associated with serious adverse events.

Ascending Geometry After Thoracic Endovascular Aortic Repair for Descending Aortic Dissection.

BACKGROUND: This study aimed to assess geometry changes of the ascending aorta after thoracic endovascular aortic repair (TEVAR) for descending aortic dissection and identify potential risk factors for diameter and length change. METHODS: Between April 2009 and July 2021, 102 patients were treated for acute descending aortic dissections (type B and non-A non-B) with TEVAR and were included in this analysis. Computed tomography angiographic scans were transferred to a dedicated imaging software and detailed aortic measurements (including length, diameter and area) were taken in multiplanar reconstruction postoperatively, after 6 months and annually thereafter. RESULTS: Sixty-five (58%) patients were male, with a mean age of 66 (±11). Four (4%) patients were diagnosed with connective tissue disease. Before TEVAR, 79% of our patients were treated with a mean of 1.5 (±1.2) different classes of antihypertensive medications. This number rose to 98% after TEVAR and 2.7 (±1.0) different antihypertensive drugs. There was no significant change in length, diameter, cross-sectional area, or volume of the ascending aorta during the follow-up of 3 years after TEVAR. Body height was a negative predictor for mean ascending aortic diameter (P value = -0.013; B = -8.890) and mean aortic diameter at the level of the brachiocephalic trunk (P value = 0.039; B = -14.763). CONCLUSIONS: Our data suggest no significant changes in the ascending aorta following TEVAR of the descending thoracic aorta during mid-term follow-up when under stringent blood pressure medication. Additionally, we did not find any modifiable risk factors for geometry parameter increase.

Clinical cases referring to the 2023 EACTS/STS Guidelines for diagnosing and treating acute and chronic syndromes of the aortic organ.

Clinical cases referring to the EACTS/STS Guidelines for diagnosing and treating acute and chronic syndromes of the aortic organ aim to assist physicians in selecting the best management strategies for individual patients with a given condition. These expert opinions consider the impact on patient outcomes as well as the risk-benefit ratio of different diagnostic or therapeutic methods. These cases serve as a vital tool to aid physicians in making decisions in their daily practice. However, in essence, although these recommendations serve as a valuable resource to guide clinical practice, their application should be tailored to the needs of the individual patient. Each patient's case is unique, presenting its own set of variables and circumstances. This editorial is a tool designed to support, but not supersede, the decision-making process of physicians, based on their knowledge, expertise and understanding of their patients' individual situations. Furthermore, these clinical cases are based on the EACTS/STS Guidelines for diagnosing and treating acute and chronic syndromes of the aortic organ but should not be interpreted as legally binding documents. The legal responsibilities of healthcare professionals remain firmly grounded in applicable laws and regulations, and the guidelines and the clinical cases presented in this document do not alter these obligations.

Thoracic endovascular aortic repair completion following frozen elephant trunk: how it's done and device selection.

INTRODUCTION: Since its introduction in the mid-1990s the frozen elephant trunk (FET) technique has quickly evolved into an effective hybrid treatment option for patients with various thoracic aortic pathologies, acute and chronic. However, a notable incidence of and risk for distal aortic reinterventions persists after the implementation of the FET device. In this review, the authors analyze the indications and outcomes of thoracic endovascular aortic repair completion following FET. AREAS COVERED: For this review, we looked not only at our own data but also searched PubMed for relevant studies, comments, and current recommendations of the European Association for Cardio-Thoracic Surgery (EACTS) and the European Society for Vascular Surgery (ESVS). Additionally, we outline our approach in this 2-stage-treatment plan. EXPERT OPINION: The treatment of acute or chronic aortic pathologies involving the aortic arch frequently requires a 2-stage treatment approach. Sometimes, a tertiary procedure is needed to fix the entire aortic pathology. Thoracic endovascular aortic repair completion following FET requires careful planning to achieve the excellent clinical outcomes that we and numerous other aortic centers have shown. Only a dedicated aortic clinic provides the long-term continuous follow-up required to identify the few patients in need of a tertiary procedure.

Endovascular aortic repair in patients with Marfan and Loeys-Dietz syndrome is safe and durable when employed by a multi-disciplinary aortic team.

OBJECTIVES: The aim of this study was to report on mid-term outcomes after endovascular aortic repair (EVAR) in patients with Marfan (MFS) or Loeys-Dietz (LDS) syndrome. METHODS: We analysed data from 2 European centres of patients with MFS and LDS undergoing EVAR. Patients were analysed based on (i) timing of the procedure (planned versus emergency procedure) and (ii) the nature of the landing zone (safe versus non-safe). The primary end-point was freedom from reintervention. Secondary end-points were freedom from stroke, bleeding and death. RESULTS: A population of 419 patients with MFS (n = 352) or LDS (n = 67) was analysed for the purpose of this study. Thirty-nine patients (9%) underwent EVAR. Indications for thoracic endovascular aortic repair or EVAR were aortic dissection in 13 (33%) patients, aortic aneurysm in 22 (57%) patients and others (intercostal patch aneurysm, penetrating atherosclerotic ulcer, pseudoaneurysm, kinking of frozen elephant trunk (FET)) in 4 (10%) patients. Thoracic endovascular repair was performed in 34 patients, and abdominal endovascular aortic repair was performed in 5 patients. Mean age at 1st thoracic endovascular aortic repair/EVAR was 48.5 ± 15.4 years. Mean follow-up after 1st thoracic endovascular aortic repair/EVAR was 5.9 ± 4.4 years. There was no statistically significant difference in the rate of reinterventions between patients with non-safe landing zone and the patients with safe proximal landing zone (P = 0.609). Furthermore, there was no increased probability for reintervention after planned endovascular intervention compared to emergency procedures (P = 0.916). Mean time to reintervention, either open surgical or endovascular, after planned endovascular intervention was in median 3.9 years (95% confidence interval 2.0-5.9 years) and 2.0 years (95% confidence interval -1.1 to 5.1 years) (P = 0.23) after emergency procedures. CONCLUSIONS: EVAR in patients with MFS and LDS and a safe landing zone is feasible and safe. Endovascular treatment is a viable option when employed by a multi-disciplinary aortic team even if the landing zone is in native tissue.

Risk factors for long-term mortality after acute aortic dissection-results of the German registry for acute aortic dissection type a long-term follow-up.

OBJECTIVES: Several short-term analyses from German Registry for Acute Aortic Dissection Type A (GERAADA) have been published. This study investigated whether short-term risk factors are transferable to the long-term prognosis of patients. METHODS: Thirty-three centres with 2686 patients participated in the long-term follow-up. A total of 1164 patients died, 1063 survived and 459 were lost to follow-up during the follow-up timeframe (mean duration: 10.2 years). Long-term mortality of the cohort was compared with an age-stratified, German population. RESULTS: One, 5 and 10 years after initial surgery, the survival of the GERAADA patient cohort was 71.4%, 63.4% and 51%, respectively. Without the early deaths (90-day mortality 25.4%), survival was calculated after 1, 5 and 10 years: 95.6%, 83.5% and 68.3%. Higher age, longer extracorporeal circulation time, shorter perioperative ventilation time and postoperative neurologic deficits were predictive of long-term prognosis. In an age-divided landmark analysis, the mortality of aortic dissection surgery survivors was found to be similar to that of the general German population. If patients are sorted in risk groups according to the GERAADA score, long-term survival differs between the risk groups. CONCLUSIONS: If patients have survived an acute postoperative period of 90 days, life expectancy comparable to that of the general German population can be assumed in lower- and medium-risk patients. Whether the GERAADA score can provide valuable insights into the long-term prognosis of patients undergoing surgery for acute aortic dissection type A is still unclear.

Radiographic complicated and uncomplicated descending aortic dissections: aortic morphological differences by CT angiography and risk factor analysis.

AIMS: To identify radiographic differences between patients with uncomplicated and complicated descending aortic dissections. METHODS AND RESULTS: Between April 2009 and July 2021, 209 patients with acute descending aortic dissections were analysed as complicated (malperfusion, rupture, diameter progress, and diameter ≥ 55 mm) or uncomplicated. Detailed CTA measurements (slice thickness ≤ 3 mm) were taken in multiplanar reconstruction. A composite endpoint (early aortic failure) was defined as reoperation, diameter progression, and early mortality. Seventy-seven patients were female (36.8%) [complicated n = 27 (36.5%); uncomplicated n = 50 (37.0%) P = 1.00]. Seventy-four (35%) patients were categorized as morphologically complicated, and 135 (65%) as uncomplicated. In patients with complicated dissections, the dissection extended more frequently to the aortic bifurcation (P = 0.044), the coeliac trunk (P = 0.003), the superior mesenteric artery (P = 0.007), and both iliac arteries (P < 0.001) originated less frequently from the true lumen. The length of the most proximal communication (entry) in type B aortic dissection was longer, 14.0 mm [12.0 mm; 27.0 mm] vs. 6.0 mm [4,0 mm; 13.0 mm] in complicated cases (P = 0.005). Identified risk factors for adverse aortic events were connective tissue disease [HR 8.0 (1.9-33.7 95% CI HR)], length of the aortic arch [HR 4.7 (1.5-15.1 95% CI HR)], a false lumen diameter > 19.38 mm [HR 3.389 (1.1-10.2 95% CI HR)], and origin of the inferior mesenteric artery from the false lumen [HR 4.2 (1.0-5.5 95% CI HR)]. CONCLUSION: We identified significant morphological differences and predictors for adverse events in patients presenting complicated and uncomplicated descending dissections. Our morphological findings will help guide future aortic therapies, taking a tailored patient approach.

Outcome of Revascularizing the Left Subclavian Artery via Carotid-Subclavian Bypass.

BACKGROUND: Endovascular thoracic aortic treatment frequently requires extending the proximal landing zone up into the aortic arch with consecutive covering of the left subclavian artery orifice. Our aim was to report on our outcome of left subclavian artery revascularization using carotid-subclavian bypass via lateral access to the subclavian artery. METHODS: Patients' charts in our aortic center were screened for all those who had undergone carotid-subclavian bypass during endovascular thoracic aortic repair procedures. We analyzed perioperative complications such as cervical plexus nerve or phrenic nerve injury, bleeding, and primary and follow-up graft patency. RESULTS: Between 2001 and 2020, 118 patients underwent carotid-subclavian bypass implantation. Postoperative complications included left-sided stroke in 3% and axillary, phrenic, and recurrent laryngeal nerve palsy in 3, 2, and 3%, respectively. Carotid-subclavian bypass-related death rate was 0%. Bypass patency was 92 ± 7% at 5 years. We documented nine (8%) bypass late occlusions with one left upper extremity ischemia and one late stroke due to an embolized thrombus formed at the bypass anastomosis. All others were asymptomatic. CONCLUSION: Carotid-subclavian bypass surgery is associated with very low risk of death, stroke, or any nerve palsy. Lateral access to the left subclavian artery reduces the risk of phrenic nerve injury.

Comparison of bare and nonbare stent grafts during thoracic endovascular aneurysm repair of the aortic arch.

OBJECTIVE: We compared the outcomes of patients treated with nonbare stents (NBS) and proximal bare stents (PBS) endografts with a proximal landing zone in the aortic arch during thoracic endovascular aortic repair (TEVAR). METHODS: We conducted a retrospective cohort, observational, multicenter study that included 361 consecutive TEVAR procedures undertaken between November 2005 and December 2021. TEVAR patients with both BS and NBS Relay stent graft configurations with proximal landing in zones 1, 2, or 3 were enrolled. Preoperative anamnestic and morphological data, clinical outcomes, and aortic modifications 30 days after surgery and at the latest follow-up available were collected. The primary outcome was freedom from proximal endoleak (type IA) comparing the two configurations. Total and detailed endoleak rates, clinical and technical success, intraoperative additional maneuvers, major adverse events, and reinterventions were secondary outcomes. RESULTS: The median follow-up was 4.9 (interquartile range, 2.0-8.1) years. No statistically significant difference between NBS and PBS patients concerning 30-day major adverse events, retrograde aortic dissection, disabling stroke, or late type IA endoleak (10.8% vs 7.8%; P = .597). Aneurysmal disease (P = .026), PLZ diameter of >34 mm (P = .026), aortic tortuosity index of >1.4 (P = .008), type III aortic arch (P = .068), and PLZ thrombus (P = .014) identified as risk factors by univariate Cox regression analysis. PLZ thrombus was the only type IA endoleak risk factor at multivariate Cox regression (P = .016). CONCLUSIONS: We found no statistically significant difference in freedom from type IA endoleak, retrograde dissection, or disabling stroke observed between the NBS and the BS configuration of the Relay endograft. Proximal landing zone thrombotic apposition was a prominent risk factor for type IA endoleak after TEVAR.

Treatment of right-sided aortic arch aneurysms with aberrant left subclavian artery with Kommerell's diverticulum using the frozen elephant trunk technique.

OBJECTIVES: The ideal treatment for aneuryms of aberrant left subclavian arteries with Kommerell's diverticulum arising from right aortic arches remains open. METHODS: Between January 2015 and December 2020, 5 patients with aneurysms from a right-sided aortic arch with aberrant left subclavian artery and Kommerell's diverticulum underwent repair by using the frozen elephant trunk technique in 3 aortic centres. Patients' characteristics were retrospectively reviewed and the surgical procedure and outcomes are presented. RESULTS: The median age of the 2 male and 3 female patients was 59 (range from 49 to 63) years. The median operative times were as follows: surgery 405 min (range from 335 to 534), cardiopulmonary bypass time 244 min (range from 208 to 280) and aortic clamp time 120 min (from 71 to 184). The mean core temperature was 25.94°C (from 24 to 28). The intensive care unit stay was 4 days (range from 1 to 8) and the in-hospital stay 21 days (from 16 to 34). All patients were discharged and we observed no stroke or spinal cord ischaemia postoperatively. During the median follow-up time of 1003 days (range from 450 to 2306), 3 patients required subsequent thoracic endovascular distal stent graft extension. CONCLUSIONS: The frozen elephant trunk technique is a good treatment option for patients with aneuryms of an aberrant left subclavian artery with Kommerell's diverticulum arising from right aortic arches. Secondary stent graft extension is a frequently needed component of the treatment concept.

Retrospective investigation of >400 patients undergoing thoracic endovascular aortic repair with or without cerebrospinal fluid drainage.

OBJECTIVES: The aim of this study was to analyse the risks and benefits of cerebrospinal fluid drainage (CSFD) placement in patients undergoing thoracic endovascular aortic repair. METHODS: Between 2009 and 2020, 411 patients underwent thoracic endovascular aortic repair in 1 institution where 236 patients (57%) received a preoperative CSFD. Patient and outcome characteristics were retrospectively analysed and compared between patients with and without preoperative CSFD placement. RESULTS: Preoperative CSFD was performed significantly more frequently in elective patients, especially those undergoing distal stent graft extension following frozen elephant trunk-stent placement (P < 0.001). Significantly fewer CSFD was placed in patients with acute aortic injury (P < 0.001). The incidence of permanent spinal cord ischaemia (SCI) was higher in patients without preoperative CSFD [10 patients (2%) vs 1 patient (0.2%), P = 0.001]. Postoperative CSFD was placed in 3 patients (0.7%). Severe CSFD-associated complications affected 2 patients (0.5%) namely, a subdural spinal haematoma causing permanent paraplegia in one of those 2 patients. CONCLUSIONS: CSFS placement is associated with low procedural risk and can potentially help to prevent SCI. However, the SCI incidence is most likely also associated with other preoperative factors including the patient's haemodynamics. Hence, a general recommendation for placing a preoperative CSFD cannot be made when relying on the present evidence.

Perioperative Mass Transfusion Affects In-Hospital but Not Follow-Up Survival in Patients with Acute Type A Aortic Dissection.

Background and Objectives: The aim of this study was to analyze the influence of mass transfusion on the postoperative outcome and survival in patients presenting with acute Type A aortic dissection. Materials and Methods: Between 2002 and 2020, a total of 505 patients were surgically treated for an acute Type A aortic dissection. Mass transfusion was defined as the peri- and postoperative replacement by transfusion of 10 units. Patient characteristics and outcomes were analyzed and compared between patients with and without mass transfusion. Results: Mass transfusion occurred in 105 patients (20%). The incidences of symptomatic coronary malperfusion (p = 0.017) and tamponade (p = 0.043) were higher in patients with mass transfusion. There was no statistically significant difference in the distal extension of the aortic dissection between the two groups. A valved conduit was significantly more common in patients with mass transfusion (p = 0.007), while the distal aortic repair was similar between the two groups. Cardiopulmonary bypass time (p < 0.001), cross clamp time (p < 0.001) and in-hospital mortality were significantly higher in patients with mass transfusion (p < 0.001), but the survival after discharge (landmark-analysis) showed equal survival between patients with and without mass transfusion (log rank: p = 0.4). Mass transfusion was predictive of in-hospital mortality (OR: 3.308, p < 0.001) but not for survival after discharge (OR: 1.205, p = 0.661). Conclusions: Mass transfusion is necessary in many patients with acute Type A aortic dissection. These patients present sicker and require longer surgery. However, mass transfusion does not influence survival after discharge.

Comparative Study of Male and Female Patients Undergoing Frozen Elephant Trunk Total Arch Replacement.

BACKGROUND: Our aim was to investigate outcomes and long-term survival in male and female patients after frozen elephant trunk (FET) total arch replacement. METHODS: Between March 2013 and January 2023, 362 patients underwent aortic arch replacement via the FET technique. We compared patient characteristics and intra- and postoperative data between male and female patients. RESULTS: Male patients were significantly younger (p = 0.012) but revealed a higher incidence of coronary artery disease (p = 0.008) and preoperative dialysis (p = 0.017). More male patients presented with type A aortic dissections (p = 0.042) while more female patients had aortic aneurysms (p = 0.025). The aortic root was replaced in significantly more male patients (p = 0.013), resulting in significantly longer cardiopulmonary bypass duration (p < 0.001) and operative times (p < 0.001). There were no statistically significant differences in postoperative outcome parameters including in-hospital mortality (p = 0.346). However, new in-stent thrombus formation was significantly more frequent in female patients (p = 0.002). Age in years (odds ratio (OR): 1.026, p = 0.049), an acute pathology (OR: 1.941, p = 0.031) and preoperative dialyses (OR: 3.499, p = 0.010) were predictive for long-term mortality in our Cox regression model, sex (p = 0.466) was not. There was no statistical difference in overall survival (log rank: p = 0.425). CONCLUSIONS: Female patients are older but reveal fewer cardiovascular risk factors; aneurysms are more common in female than male patients. As female patients undergo concomitant surgical procedures less often, their operative times are shorter. While survival and outcomes were similar, female patients suffered from postoperative new in-stent thrombus formation significantly more often.

Branched endovascular iliac artery repair using the Zenith® Branch Endovascular Iliac Bifurcation graft: outcomes and reinterventions in our retrospective cohort.

Background: The aim of this retrospective cohort study was to analyze the outcomes and the need for reinterventions following branched iliac artery repair using the Zenith® Branch Endovascular Iliac Bifurcation (ZBIS; Cook Medical Europe LTD, Limerick, Ireland) graft. Methods: Patient characteristics and follow-up data on 63 patients following branched iliac artery repair using the ZBIS device were evaluated and compared between patients with and without iliac reinterventions. A competing risk regression model was analyzed to identify independent predictors of reinterventions, and to predict the reintervention risk. Results: ZBIS implantation's technical success rate was 100%, and we observed no in-hospital mortality. Internal iliac artery patency was 93% during a median [first quartile, third quartile] follow-up of 19 [5, 39] months. Thirty-two iliac reinterventions were performed in 23 patients (37%) after a mean time of 3.0 months (IQR: 0.4-6.8) (time to first reintervention). Endoleaks type I and II were the most common indication for reinterventions (n=14, 61%). The internal iliac artery's diameter [subdistribution hazard ratio (sHR): 1.046; P=0.0015] and a prior abdominal aortic intervention (sHR: 0.3331; P=0.0370) were identified as significant variables in the competing risk regression model for a reintervention. The risk for reintervention was 33% (95% CI: 20-46%), and 46% (95% CI: 28-63%) after 12 and 36 months, respectively. Conclusions: Endovascular repair of degenerative iliac artery aneurysms with Zenith Branch Iliac Bifurcation device is a feasible and safe option. Perioperative morbidity and mortality are low with good graft patency rates. The risk for secondary iliac artery interventions is considerable and highlights the need for patients with iliac disease to undergo continuous follow-up in a dedicated vascular center.

Training in Aortic Arch Surgery as a Blueprint for a Structured Educational Team Approach: A Review.

Background and objectives: The treatment of pathologies of the aortic arch is a complex field of cardiovascular surgery that has witnessed enormous progress recently. Such treatment is mainly performed in high-volume centres, and surgeons gain great experience in mastering potential difficulties even under emergency circumstances, thereby ensuring the effective therapy of more complex pathologies with lower complication rates. As the numbers of patients rise, so does the need for well-trained surgeons in aortic arch surgery. But how is it possible to learn surgical procedures in a responsible way that, in addition to surgical techniques, also places particular demands on the overall surgical management such as perfusion strategy and neuro-protection? This is why a good training programme teaching young surgeons without increasing the risk for patients is indispensable. Our intention was to highlight the most challenging aspects of aortic arch surgery teaching and how young surgeons can master them. Materials and Methods: We analysed the literature to find out which methods are most suitable for such teaching goals and what result they reveal when serving as teaching procedures. Results: Several studies were found comparing the surgical outcome of young trainees with that of specialists. It was found that the results were comparable whether the procedure was performed by a specialist or by a trainee assisted by the specialist. Conclusions: We thus came to the conclusion that even for such a complex type of intervention, the responsible training of young surgeons by experienced specialists is possible. However, it requires a clear strategy and team approach to ensure a safe outcome for the patient.

Thoracic aortic emergencies involving the aortic arch: An integrated cardiovascular surgical treatment approach.

Thoracic aortic emergencies involving the aortic arch are potentially fatal conditions that require the entire surgical repertoire of conventional surgery, such as complete aortic arch replacement using the frozen-elephant-trunk technique, through hybrid procedures, to full surgical endovascular options with conventional or delivered/fenestrated stent-grafts. An interdisciplinary aortic team should choose the optimal treatment of the pathologies of the aortic arch, considering the morphology of the entire aorta, from the root to beyond the bifurcation, as well as the clinical comorbidities. The treatment goal is a complication-free postoperative result and lasting freedom from aortic reinterventions. Irrespective of the selected therapy method, patients should then be connected to a specialized aortic outpatient clinic. The aim of this review was to provide an overview of pathophysiology and current treatment options in emergencies of the thoracic aorta, also involving the aortic arch. We wanted to summarize the preoperative considerations, intraoperative settings, and strategies, as well the postoperative follow-up.