Treatment Of Complex Aortic Disease Research Articles

Next-Generation Frozen Elephant Trunk Technique in the Era of Precision Medicine.

The frozen elephant trunk (FET) technique can be applied to extensive aortic pathology, including lesions in the aortic arch and proximal descending thoracic aorta. FET is useful for tear-oriented surgery in dissections, managing malperfusion syndrome, and promoting positive aortic remodeling. Despite these benefits, complications such as distal stent-induced new entry and spinal cord ischemia can pose serious problems with the FET technique. To prevent these complications, careful sizing and planning of the FET are crucial. Additionally, since the FET technique involves total arch replacement, meticulous surgical skills are essential, particularly for young surgeons. In this article, we propose several techniques to simplify surgical procedures, which may lead to better outcomes for patients with extensive aortic pathology. In the era of precision medicine, the next-generation FET device could facilitate the treatment of complex aortic diseases through a patient-tailored approach.

A national census for the off-label treatment of complex aortic aneurysms

ObjectiveDespite regulatory challenges, device availability, and rapidly expanding techniques, off-label endovascular repair of complex aortic aneurysms (cAAs) has expanded in the past decade. Given the lack of United States Food and Drug Administration-approved endovascular technology to treat cAAs, we performed a national census to better understand volume and current practice patterns in the United States. MethodsTargeted sampling identified vascular surgeons with experience in off-label endovascular repair of cAAs. An electronic survey was distributed with institutional review board approval from the University of Rochester to 261 individuals with a response rate of 38% (n = 98). ResultsA total of 93 respondents (95%) reported off-label endovascular repair of cAAs. Mean age was 45.7 ± 8.3 years, and 84% were male. Most respondents (59%) were within the first 10 years of practice, and 69% trained at institutions with a high-volume of off-label endovascular procedures for complex aortic aneurysms with or without a physician-sponsored investigational device exemption (PS-IDE). Twelve respondents from 11 institutions reported institutional PS-IDEs for physician-modified endografts (PMEGs), in-situ laser fenestration (ISLF), or parallel grafting technique (PGT), including sites with PS-IDEs for custom-manufactured devices. Eighty-nine unique institutions reported elective off-label endovascular repair with a mean of 20.2 ± 16.5 cases/year and ∼1757 total cases/year nationally. Eighty reported urgent/emergent off-label endovascular repair with a mean of 5.7 ± 5.4 cases/year and ∼499 total cases/year nationally. There was no correlation between high-volume endovascular institutions (>15 cases/year) and institutions with high volumes of open surgical repair for cAAs (>15 cases/year; odds ratio, 0.7; 95% confidence interval, 0.3-1.5; P = .34). Elective techniques included PMEG (70%), ISLF (30%), hybrid PMEG/ISLF (18%), and PGT (14%), with PMEG being the preferred technique for 63% of respondents. Techniques for emergent endovascular treatment of complex aortic disease included PMEG (52%), ISLF (40%), PGT (20%), and hybrid-PMEG/ISLF (14%), with PMEG being the preferred technique for 41% of respondents. Thirty-nine percent of respondents always or frequently offer referrals to institutions with PS-IDEs for custom-manufactured devices. The most common barrier for referral to PS-IDE centers included geographic distance (48%), longitudinal relationship with patient (45%), and costs associated with travel (33%). Only 61% of respondents participate in the Vascular Quality Initiative for complex endovascular aneurysm repair, and only 57% maintain a prospective institutional database. Eighty-six percent reported interest in a national collaborative database for off-label endovascular repair of cAA. ConclusionsEstimates of off-label endovascular repair of cAAs are likely underrepresented in the literature based on this national census. PMEG was the most common technique for elective and emergent procedures. Under-reported off-label endovascular repair of cAA outcomes data appears to be limited by non-standardized PS-IDE reporting to the United States Food and Drug Administration, and the lack of Vascular Quality Initiative participation and prospective institutional data collection. Most participants are interested in a national collaborative database for endovascular repair of cAAs.

Results of using thoraflextm hybrid prothesis for the treatment of complex aortic disease at Viet Duc University Hospital

Background: The aim of this study was to introduce and evaluate the early results after the frozen elephant trunk (FET) procedure with ThoraflexTM Hybrid prothesis for the treatment of complex aortic disease at Viet Duc University Hospital. Methods: This is a retrospective descriptive study of all acceptable patients after the frozen elephant trunk (FET) procedure with ThoraflexTM Hybrid prothesis at Viet Duc University Hospital from January 2021 to May 2023. Results: There were 21 patients with a male rate of 85.7% and an average age 58.2±10 years old (range 40–73). History of patients with hypertension: 19 (90.5%); post-dissection aortic aneurysm: 2 (9.5%) patients. By cause, the number of patients with thoracic aortic aneurysm was 03 (14.3%), acute aortic dissection type A was 16 (76.1%), and aortic dissection type B was 02 (9.5%). In which there were 16 cases of emergency surgery (76.1%). Replacement of the aortic arch was performed under moderate hypothermic (280 °C on average) circulatory arrest and bilateral selective antegrade cerebral perfusion with permanent monitoring of cerebral tissue oxygenation by the MASIMO machine. Average cardio-pulmonary bypass time, aortic cross clamp time, distal hypothermic circulatory arrest time, and operating time were 137,5±22,9 minutes; 86,3±17,6 minutes; 25,2±8,9 minutes; and 7,7±10,3 hours. The average ventilation time, length of intensive care unit stay, and hospital stay were 7,2±9,7 days, 18,8±20,7 days, and 19,9 ± 6,5 days. There was one patient with post-operative cerebrospinal fluid drainage. No patient had bleeding complications, recurrent nerve palsy, reoperation, or in-hospital mortality. Conclusion: The initial results after the frozen elephant trunk procedure with ThoraflexTM Hybrid prothesis for the treatment of complex aortic disease at Viet Duc University Hospital were safe, good, and feasible.

Long-Term Results with 187 Frozen Elephant Trunk Procedures.

The frozen elephant trunk (FET) technique is an established therapeutic option in the treatment of complex aortic diseases. We report our long-term clinical outcomes after FET repair. A total of 187 consecutive patients underwent FET repair at our department between 8/2005 and 3/2023. Indications included acute and chronic aortic dissections and thoracic aneurysms. Endpoints included operative morbidity and mortality, long-term survival, and the need for reinterventions. Operative mortality, spinal cord injury and permanent stroke rates were: 9.6%, 2.7% and 10.2%, respectively. At five years, overall survival was 69.9 ± 3.9% and freedom from aortic-related death was 82.5 ± 3.0%, whereas at ten years, overall survival was 53.0 ± 5.5% and freedom from aortic-related death was 75.8 ± 4.8%. Sixty-one reinterventions on the thoracic aorta were necessary. Freedom from secondary interventions at ten years was 44.7 ± 6.4% overall (63.1 ± 10.0% for acute dissections, 40.8 ± 10.3% for chronic dissections and 28.9 ± 13.1% for aneurysms, respectively). The high reintervention rate for chronic dissections and for aneurysms is related to the pre-existing aortic pathology. Late aortic growth of untreated segments with potentially fatal outcome occurs even after ten years, so careful annual follow-up is mandatory in this patient cohort.

Single stem visceral debranching for complex aortic disease

What this paper adds Treatment of complex aortic diseases including thoracoabdominal aortic aneurysms and aortic dissection is highly challenging. Hybrid repair may be useful in some situations wherein anatomy, the need of emergent repair or patient comorbidities preclude the use of total endovascular or direct open reconstruction. This paper details an original hybrid repair in which a single branch is used to reroute all visceral vessels. Abstract: Objective: Hybrid treatment of complex aortic disease has been described with various techniques of retrograde visceral bypass. The use of a single branch to revascularize all renal and visceral vessels may be less cumbersome than multiple synthetic branches and may seems to be efficient in terms of patency. Methods: We retrospectively included 15 patients between 2013 and 2021. Indication was aortic dissection (AD) (type A, acute or chronic type B), thoracoabdominal aortic aneurysms (TAA), visceral occlusive disease. Surgery consisted in median laparotomy, visceral vessel debranching from native aorta or from an aortic graft. In case of AD, surgical fenestration was performed. Additional TEVAR completed the treatment when indicated, during the same procedure or later on Results: Mean age was 60 years. 9 (60%) patients were treated for AD, 3 (20%) for TAA, 3 (20%) for occlusive disease. A total of 65 target vessels were debranched through the single stem retrograde vascular graft (SSRVG) technique. Aortic surgical fenestrations were performed in 8 cases and TEVAR in 4 cases. In the postoperative course, 3 TAA patients died,7 patients developed renal insufficiency (47%), 4 patients presented pneumonia (27%) and 3 colonic ischemia (20%). After a mean follow up of 21 months, all vessels (but 2 IMAs) were patent and no endoleak was noted. Conclusion: SSRVG technique offers a feasible and safe solution in various complex aortic diseases. The use of a single graft makes the technique straightforward by reducing the volume of multiple branch assembly in the retroperitoneal space with satisfying patency rates. Further studies with larger patient sample size and longer follow up are needed to elucidated the efficacy and durability of the technique.

Preliminary experience with the new off-the-shelf 4 inner branches E-nside for the treatment of complex aortic disease

Abstract Objective In case of complex aortic aneurysmal disease, fenestrated or branched EVAR (b/f-EVAR) is considered as a valid and safe alternative to open surgery. However, one the main limitation is the time required for manufacture, limiting its use in emergent situations. The new off-the-shelf 4 inner branches E-nside (Jotec, Hechingen, Germany) has been developed to offer a solution in such circumstances. The aim of this study was to report our preliminary monocentric experience with this new device. Methods Retrospective analysis of prospective data retrieved from 1 center between November 2020 and January 2022 was done. Endpoints were technical success, postoperative morbidity, rate of endoleak and any aneurysm-related re-interventions during follow-up. Results In this study, 15 patients (mean age 73 years, range 59–90) were identified. There was a majority of male (9/15) and all of them but 3 were asymptomatic. The mean aneurysmal diameter was 60 mm (range 50–100). There were 3 cases of juxtarenal aortic aneurysms (20%), 1 Crawford type I (7%), 4 type II (27%), 4 type III (27%) and 3 type IV (20%) aneurysms. In 7 cases, a 2-steps procedure was done with a TEVAR first followed by Enside implantation. There was a technical success in 93% with 1 open conversion for a mesenterical bypass. There was no death in the post-operative period. During the post-operative period, 33% of patients (5/15) presented complications with 3 complications related to the femoral or iliac access and 2 cases of spinal cord ischemia (13%). One case occurred in an emergent setting of a type III aneurysm rupture. The other case was the open conversion and the patient also developed a colic ischemia and finally died 4 months alter. The mean length of stay was 9 days. During the follow-up, 2 reinterventions were necessary, 1 for a type Ic endoleak with distal prolongation of the stent and 1 renal stent occlusion treated by relining. The overall target vessel patency was 98%. Conclusion The use of the off-the-shelf 4 inner branches E-nside appears to be safe with good technical success for the treatment of complex aortic aneurysmal disease. It is associated with an acceptable rate of complications and allows for treatment of a wide variety of diseases in an emergent setting. Further patients and longer follow-up are required to better evaluate the exact role of this new device.

Cause-specific Long-Term Mortality After Physician-Modified Branched/Fenestrated Endovascular Aortic Repair

Physician-modified endografts (PMEG) are being increasingly used for treatment of complex aortic diseases. Several series describe short and mid-term outcomes, but limited long-term data is available. Here we sought to evaluate the long-term causes of death after PMEG, and the association with type and complexity of repair. A single, high-volume, academic aortic referral center retrospectively reviewed all consecutive branched/fenestrated PMEG procedures from 2010 to 2016, which allowed all subjects the opportunity for 5 or more years of survival time. All subjects were deemed either high anatomic and/or physiologic risk for open repair. Commercial custom and chimney EVAR procedures were excluded. Death certificates, obituary websites, and electronic medical records were reviewed to assign cause-specific mortality. The primary end point was all-cause mortality. Secondary end points included cause-specific-death categorized as: major adverse cardiovascular event (myocardial infarction, malignant arrythmia, congestive heart failure, sudden death), malignancy, pulmonary (chronic obstructive pulmonary disease/respiratory failure), infection, aorta-related, and other (including metabolic, stroke, and trauma). Kaplan-Meier methodology was used to estimate survival. A total of 232 consecutive PMEG procedures were analyzed (male, 72%; mean age, 73 ± 8 years). Indications included thoracoabdominal aneurysm (extent I-V; 58%), pararenal AAA (33%), postsurgical pseudoaneurysm or failed EVAR (6%), chronic dissection (2%), and penetrating paravisceral ulceration (1%). A majority were performed electively (75%, n = 174) while the remaining were completed for symptomatic or intact (20%, n = 47) and emergent or ruptured (5%, n = 11) presentations. We included 762 target vessels (celiac, n = 179; superior mesenteric artery, n = 204; renal, n = 379) and most procedures had four-vessel revascularization (61%, n = 142). The 30-day mortality rates were: elective, 3% (n = 5/174) and nonelective, 14% (n = 8/58). Secondary interventions occurred in 18% (n = 42). The mean survival was 4.9 ± 3.2 years (median, 5.4; interquartile range, 1.9-7.5; 95% confidence interval [CI], 4.9-6.1) and 57% (n = 132/232) died during follow-up. Among 132 documented deaths, 10% (n = 13/132) occurred before hospital discharge and/or at 30 days or less, whereas 90% (n = 119/132) occurred after 30 days and/or after hospital discharge. Cause-specific mortality was attributed to major adverse cardiovascular events (21%), other causes (18%), aorta related (13%), unknown (13%), pulmonary (12.5%), infection (12.5%), and malignancy (10%). Causes of late aorta-related death (n = 16/232, 6.9% overall; 12.1% of all deaths recorded) were rupture (n = 5) and mesenteric ischemia (n = 2), respectively. Freedom from long-term all-cause and aorta-related mortality was: 5-years, 56 ± 3% and 90 ± 2%; 8-years, 43 ± 4% and 87 ± 3%, respectively (Fig 1). Nonelective presentation had higher long-term risk of all-cause and aorta-related mortality (all-cause: hazard ratio [HR], 1.6; 95% confidence interval, 1.1-2.4; aorta-related: HR; 3.2; 95% confidence interval, 1.2-8.5) (Fig 2). Four-vessel repairs were associated with improved survival (vs fewer than 4 vessels: HR, 0.6; 95% confidence interval, 0.4-0.9). PMEG in high-risk patients was durable and provided excellent long-term outcomes in patients deemed high risk for open repair. Cardiovascular morbidity is the most significant factor leading to late mortality after PMEG. Aorta-related mortality is low; however, elective repairs with more proximal coverage appear to be protective from poor long-term outcomes.Fig 2Freedom from aorta-related death after physician-modified endograft (PMEG) by presentation (includes perioperative deaths).View Large Image Figure ViewerDownload Hi-res image Download (PPT)

Wrapping technique of ascending aorta in Hybrid procedure for complex aortic arch disease

Background: The hybrid procedure proved to be very suitable for Vietnamese conditions in the treatment of complex aortic diseases in the arch and on supra-renal lesion. There is a difficult situation when the ascending aorta is more dilated than can be accommodated by stent-grafts. Wrapping techique is a solution to this situation. Methods: Report on a clinical case of successful application of aortic wraping technique to treat complex aortic cross injuries at Cardiovascular and Thoracic Center, Viet Duc University Hospital. Results: A 73-year-old female patient was admitted to the hospital because of sudden chest pain. History of high blood pressure, heart failure, dyslipidemia and hypothyroidism. MSCT revealed type B aortic dissection, left hemothorax complication, the entire ascending aorta and a part of cross dilated to 50mm (maximum stent-graft size is 46mm). Poor general condition, severe and complicated acute aortic injury, if the classic surgery requires total thoracic aorta replacement – ​​the risk of death is very high, so the hybrid solution is a reasonable choice if having the solution is to solve the problem to create a landing zone for stent-graft. Hybrid surgery was started with open sternotomy, bilateral aortic - carotid bypass with Dacron prothesis 9mm, using a large artificial vessel to wrap around the ascending aorta to reduce the medium size to 38mm. Drain and close the sternum. Next is endovascular intervention – installing a stent-grafts of 42x42x200 and 42x38x150 then 38x34x150 to the diaphragm, plug for left subclavian artery. Left pleural drainage. The patient was discharged 10 days after surgery. Follow-up after 2 years for good results. Conclusion: The hybrid procedure can still be applied in the situation of ascending aorta dilatation with wrapping technique – decreasing the size of the aorta to fit the size of the stent-graft in some high-risk situations. with classic surgery.

Wrapping technique of ascending aorta in Hybrid procedure for complex aortic arch disease

Background: The hybrid procedure proved to be very suitable for Vietnamese conditions in the treatment of complex aortic diseases in the arch and on supra-renal lesion. There is a difficult situation where the ascending aorta is more dilated than can be accommodated by stent-grafts. Wrapping techique is a solution to this situation. Methods: Report on a clinical case of successful application of aortic wrap technique to treat complex aortic cross injuries at Cardiovascular and Thoracic Center, Viet Duc University Hospital. Results: A 73-year-old female patient was admitted to the hospital because of sudden chest pain. History of high blood pressure, heart failure, dyslipidemia and hypothyroidism. MSCT revealed type B aortic dissection, left hemothorax complication, the entire ascending aorta and a part of cross dilated to 50mm (maximum stent-graft size is 46mm). Poor general condition, severe and complicated acute aortic injury, if the classic surgery requires total thoracic aorta replacement – ​​the risk of death is very high, so the hybrid solution is a reasonable choice if having the solution is to solve the problem to create a landing zone for stent-graft. Hybrid surgery was started with open sternotomy, bilateral aortic - carotid bypass with Dacron prothesis 9mm, using a large artificial vessel to wrap around the ascending aorta to reduce the medium size to 38mm. Drain and close the sternum. Next is endovascular intervention – installing a stent-grafts of 42x42x200 and 42x38x150 then 38x34x150 to the diaphragm, plug for left subclavian artery. Left pleural drainage. The patient was discharged 10 days after surgery. Follow-up after 2 years for good results. Conclusion: The hybrid procedure can still be applied in the situation of ascending aorta dilatation with wrapping technique – decreasing the size of the aorta to fit the size of the stent-graft in some high-risk situations. with classic surgery.

Single Stem Visceral Debranching for Complex Aortic Disease

ObjectiveThe treatment of complex aortic disease has been described with various retrograde visceral bypass techniques. An original technique with a single stem retrograde visceral graft (SSRVG) is presented.MethodsThis was a single centre retrospective study including 16 patients between 2015 and 2019. Patients were treated for aortic dissection (AD; type A and acute or chronic type B), thoraco-abdominal aortic aneurysms (TAAAs), and visceral occlusive disease. Surgery consisted of visceral vessel debranching from the native infrarenal aorta or from an aortic graft. In the case of AD, surgical fenestration was performed. Additional thoracic endovascular aneurysm repair (TEVAR) completed the treatment when indicated, during the same procedure or later. Patient outcomes and reconstruction patency were studied.ResultsThe mean patient age was 64 years (median 68 ± 12.6). Ten (62%) patients were treated for AD, three (19%) for TAAA, and three (19%) for occlusive disease. Sixty-nine target vessels were debranched with this SSRVG technique. Aortic surgical fenestration was performed in eight cases and TEVAR in four. During their hospital stay, three (19%) TAAA patients died, seven cases of renal insufficiency (44%), four cases of pneumonia (25%), and three colonic ischaemia cases (19%) were noted. After a mean follow up of 21 months, no other deaths occurred. All vessels (except two inferior mesenteric arteries) were patent and no endoleak was noted.ConclusionThe SSRVG technique can be offered in various complex aortic diseases. The use of a single graft is feasible and reduces the volume of multiple branch assembly in the retroperitoneal space. The observed patency rate is high.

Frozen elephant trunk procedure for complex aortic arch surgery: The Salerno experience with Thoraflex hybrid.

Background and Aim of the StudyTo report early clinical outcomes of the frozen elephant trunk (FET) technique for the treatment of complex aortic diseases after transition from conventional elephant trunk.MethodsA single‐center, retrospective study of patients who underwent hybrid aortic arch and FET repair for aortic arch and/or proximal descending aortic aneurysms, acute and chronic Stanford type A aortic dissection with arch and/or proximal descending involvement, Stanford type B acute and chronic aortic dissections with retrograde aortic arch involvement.ResultsBetween December 2017 and May 2020, 70 consecutive patients (62.7 ± 10.6 years, 59 male) were treated: 41 (58.6%) for emergent conditions and 29 (41.4%) for elective. Technical success was 100%. In‐hospital mortality was 14.2% (n = 12, 17.1% emergent vs. 10.3% elective, P = NS); 2 (2.9%) major strokes; 1 (1.4%) spinal cord injury. Mean follow‐up was 12.5 months (interquartile range, 3.7–22.3). Overall survival at 3, 6, 12, and 24 months was 90% (95% confidence interval [CI], 83.2—97.3), 85.6% (95% CI, 77.7–94.3), 79.1% (95% CI, 69.9–89.5), 75.6% (95% CI, 65.8–86.9) and 73.5% (95% CI, 63.3–85.3). There were no aortic re‐interventions and no distal stent graft‐induced new entry (dSINE); 5 patients with residual type B dissection underwent TEVAR completion.ConclusionsIn a real‐world setting, FET with Thoraflex Hybrid demonstrated feasibility and good clinical outcomes, even in emergent setting. Our implant technique optimize cerebral perfusion reporting good results in terms of neurological complications. Techniques to perfect the procedure and to reduce remaining risks, and consensus on considerations such as standardized cerebral protection need to be reported.

Evolution of fenestrated/branched endovascular aortic aneurysm repair complexity and outcomes at an organized center for the treatment of complex aortic disease

BackgroundFenestrated/branched endovascular aneurysm repair (F/BEVAR) volume has increased rapidly, with favorable outcomes at centers of excellence. We evaluated changes over time in F/BEVAR complexity and associated outcomes at a single-center complex aortic disease program. MethodsProspectively collected data of all F/BEVAR (definition: requiring ≥1 fenestration/branch), procedures performed in an institutional review board-approved registry and/or physician-sponsored investigational device exemption trial (IDE# G130210), were reviewed (11/2010-2/2019). Patients were stratified by surgery date into thirds: early experience, mid experience, and recent experience. Patient and operative characteristics, aneurysm morphology, device types, perioperative and midterm outcomes (survival, freedom from type I or III endoleak, target artery patency, freedom from reintervention), were compared across groups. ResultsFor 252 consecutive F/BEVARs (early experience, n = 84, mid experience, n = 84, recent experience, n = 84), 194 (77%) company-manufactured custom-made devices, 11 (4.4%) company-manufactured off-the-shelf devices, and 47 (19%) physician-modified devices, were used to treat 5 (2.0%) common iliac, 97 (39%) juxtarenal, 31 (12%) pararenal, 116 (46%) thoracoabdominal, and 2 (0.8%) arch aneurysms. All patients had follow-up for 30-day events. The mean follow-up time for the entire cohort was 589 days (interquartile range, 149-813 days). On 1-year Kaplan-Meier analysis, survival was 88%, freedom from type I or III endoleak was 91%, and target vessel patency was 92%. When stratified by time period, significant differences included aneurysm extent (thoracoabdominal, 33% early experience, 40% mid experience, and 64% recent experience; P < .001) and target vessels per case (four-vessel case, 31% early experience, 39% mid experience, and 67% recent experience; P < .0001). There was no difference, but a trend toward improvement, in composite 30-day events (early experience, 39%; mid experience, 23%; recent experience, 27%; P = .05). On Kaplan-Meier analysis, there was no difference in survival (P = .19) or target artery patency (P = .6). There were differences in freedom from reintervention (P < .01) and from type I or III endoleak (P = .02), with more reinterventions in the early experience, and more endoleaks in the recent period. ConclusionsDespite increasing repair complexity, there has been no significant change in perioperative complications, overall survival, or target artery patency, with favorable outcomes overall. Type I or III endoleaks remain a significant limitation, with increased incidence as the number of branch arteries incorporated into the repairs has increased.

Treatment strategies of spinal cord ischemia after endovascular repair of thoracoabdominal aortic aneurysm

It is more than 20 years since the first endovascular repair of thoracoabdominal aortic aneurysm was performed. Significantly reducing risk of morbidity and mortality compared with open aortic repair, the advent of endovascular repair has revolutionized the treatment of complex aortic disease. It is now the first-line treatment for most thoracoabdominal aortic aneurysm patients. However, spinal cord ischemia (SCI) remains one of the most threatening complications after the procedure, and significantly reduces overall survival. The pathophysiology of spinal cord ischemia remains unclear but may well be multifactorial. Risk factors for SCI include excessive aortic coverage, detriment to the collateral network through occlusion of the left subclavian or internal iliac arteries, perioperative hypotension and chronic renal failure. SCI could be predicted, prevented and ameliorated through the application of motor evoked potential, permissive perioperative hypertension, cerebrospinal fluid drainage (CSFD), preoperative or concomitant left subclavian artery (LSA) revascularization and some drugs. However, there are certain complications and contraindications for CSFD and arterial revascularization. As a result, we must balance the pros and cons of these invasive measures. So we summarize our clinical experience and propose the employment of LSA revascularization and CSFD in certain kinds of high-risk patients respectively. With the development of technology and preventive measures, we believe that SCI could be minimized in the forseeable future.

One-Year Results From the SURPASS Observational Registry of the CTAG Stent-Graft With the Active Control System

Purpose: To report the outcomes from the observational SURPASS registry, which was created to assess the performance of the Conformable TAG (CTAG) stent-graft with the Active Control System (ACS) in patients undergoing thoracic endovascular aortic repair (TEVAR) in a real-world setting. Materials and Methods: The SURPASS registry (ClinicalTrials.gov; identifier NCT03286400) was an observational, prospective, single-arm, post-market, international study that enrolled patients undergoing TEVAR using the CTAG with ACS for both acute and chronic thoracic aortic disease between October 2017 and July 2018. The CTAG with ACS features 2-stage deployment of the stent-graft and an optional angulation mechanism that modifies only the proximal end of the stent-graft. During the observation period, 127 patients (mean age 67.1±12.1 years, range 27–86; 92 men) were enrolled and treated for an array of aortic pathologies, including chronic and acute lesions and 4 ruptured descending thoracic aneurysms. The primary outcome of this study was technical success; secondary outcomes were clinical success and major adverse events at 30 days and 12 months. The numbers of 2-stage device deployments and applications of the angulation mechanism were recorded, along with the reasons for use. Results: Technical success of the TEVAR was 97.6% owing to unintentional partial coverage of supra-aortic branches in 3 cases (the vessels were patent on imaging). The stent-graft was repositioned at its intermediate diameter in 79 patients (62.2%), and the angulation feature was applied in 64 cases (50.4%), mainly to improve proximal wall apposition and orthogonality in the aorta. The desired effect was achieved in 60 cases (93.8%). There was no device compression, bird-beak configuration, fracture, or graft occlusion. The 30-day and 12-month clinical success rates were 97.6% and 92.9%, respectively. There were 3 aorta-related deaths at 30 days and a further 3 at 12 months. Fatalities were due to a retrograde type A dissection (0.8%), paraplegia, bowel ischemia, sepsis in the setting of a mycotic aneurysm, aneurysm rupture post aortoesophageal fistula, and multiorgan dysfunction syndrome. Three endoleaks (2 type Ia and 1 type III) required reintervention. Conclusion: In the SURPASS registry, the use of the CTAG device with ACS showed promising outcomes despite the challenging pathologies. The new delivery system enables a controlled staged delivery with in situ adjustments during positioning, facilitating the treatment of complex aortic disease.

Comparison between Arch Zones in Modified Frozen Elephant Trunk Procedure for Complex Thoracic Aortic Diseases.

IntroductionThe aim of this study is to compare postoperative outcomes and follow-up of two different modifications facilitating surgical technique of frozen elephant trunk (FET) procedure for complex thoracic aortic diseases - zone 0 (fixation with total arch debranching) and zone 3 (fixation with islet-shape arch repair).MethodsFrom May 2012 to December 2018, data were collected from 139 patients who had been treated with FET procedure for complex thoracic aortic diseases. According to Ishimaru arch map, patients with proximal anastomotic site of hybrid graft at zone 0 and zone 3 were grouped as Group A (n=58, 41.7%) and Group B (n=81, 58.3%), respectively. Mean age of study population was 54.7±11.4 years, and 111 patients were male (79.9%).ResultsIn-hospital mortality was observed in 20 (14.4%) patients (n=12, acute type A aortic dissection, and n=4, previous aortic dissection surgery). There was no significant difference between both groups in terms of in-hospital mortality. Four patients from Group A and three patients from Group B had permanent neurological deficit (P=0.32). Three patients from both groups had transient spinal cord ischemia (P=0.334). Although mean total perfusion time was longer in Group A, duration of visceral ischemia, when compared with Group B, was shorter (P<0.001). Five-year survival rate was 82.8% in Group A and 81.5% in Group B (P=0.876).ConclusionFET procedure is a feasible repair technique in the treatment of complex aortic diseases, providing satisfactory early results. Because of its advantageous aspects, zone 0 fixation with debranching is the preferred technique in our clinic.

Evolution of Fenestrated/Branched Aortic Aneurysm Repair Complexity and Outcomes at an Organized Center for the Treatment of Complex Aortic Disease

Fenestrated/branched endovascular aneurysm repair (F/BEVAR) volume has increased rapidly, with favorable outcomes at centers of excellence. We evaluated changes over time in F/BEVAR complexity and associated outcomes at a single-center complex aortic disease program. Prospectively collected data of all F/BEVAR procedures (definition: requiring one or more fenestrations or branches) in an Institutional Review Board-approved registry or physician-sponsored investigational device exemption trial (#G130210) were reviewed (November 2010-February 2019). Patients were stratified by surgery date: early experience, mid experience, and recent experience. Patient/operative characteristics, aneurysm morphology, device types, and perioperative and midterm outcomes (survival, freedom from type I or type III endoleak, target artery patency, freedom from reintervention) were compared. For 252 consecutive F/BEVARs (early experience, n = 84; mid experience, n = 84; recent experience, n = 84), 194 (77%) company-manufactured custom-made devices, 11 (4.4%) company-manufactured off-the-shelf devices, and 47 (19%) physician-modified devices were used to treat 5 (2.0%) common iliac, 97 (39%) juxtarenal, 31 (12%) pararenal, 116 (46%) thoracoabdominal, and 2 (0.8%) arch aneurysms. All patients had follow-up for 30-day events (Fig). Mean follow-up was 589 days (interquartile range, 149-813 days). On 1-year Kaplan-Meier analysis, survival was 88%, freedom from type I or type III endoleak was 91%, and target vessel patency was 92%. When stratified by time period, significant differences included aneurysm extent (thoracoabdominal: 64% recent experience, 40% mid experience, and 33% early experience; P < .001) and target vessels per case (four-vessel case: 67% recent experience, 39% mid experience, and 31% early experience; P < .0001). There was no difference but a trend toward improvement in composite 30-day events (early experience, 39%; mid experience, 23%; recent experience, 27%; P = .05). On Kaplan-Meier analysis, there was no difference in survival (P = .19) or target artery patency (P = .6). There were differences in freedom from reintervention (P < .01) and from type I or type III endoleak (P = .02), with more reinterventions in the early experience, and more endoleaks in the recent period. Despite increasing repair complexity, there has been no significant change in perioperative complications, overall survival, or target artery patency, with favorable outcomes overall. Freedom from reintervention has improved over time, but type I or type III endoleaks have not and remain a significant limitation in need of further innovation.

Mid- and Long-Term Effects of Endovascular Surgery and Hybrid Procedures for Complex Aortic Diseases.

Objective To assess the efficacy and short- and mid-term results of endovascular surgery and hybrid surgical procedures in treatment of complex aortic dissection. Methods Clinical data of 90 patients with complex aortic dissection admitted from June 2012 to June 2018 were retrospectively analyzed. Among the patients, 60 cases were male and 30 cases were female, and their ages were ranged from 32 to 79, with an average age of 55 years old; different endovascular techniques and/or hybrid procedures were performed in these patients. Results Technical success rate was 100% for the entire group of patients. Type I endoleak occurred in 8 patients immediately after stent-graft placement, which in 2 cases disappeared after a proximal Cuff placement, and the other cases received no special treatment. Follow-up was conducted from 1 month to 72 months, with an average of 36.3 months, and no stent-graft migration or organ ischemia was noted. In the follow-up patients, no type I endoleak occurred but type II endoleak was found in 2 cases, which were cured without treatment; no patient had paraplegia. Conclusion Endovascular surgery and hybrid procedures have demonstrable mid- and long-term efficacy in treatment of complex aortic diseases. However, this conclusion still requires multicenter, large-sample studies to further confirm.

Effectiveness of 3D printed models in the treatment of complex aortic diseases.

The treatment of complex aortic diseases has known in the last years an extraordinary improvement, thanks to the development of new devices and techniques, especially concerning endovascular surgery. In this field, technological evolution has enabled vascular surgeons to overcome anatomical concerns and impairments that in the past made endovascular treatment unfeasible in many cases. However, the full exploitation of the devices offered by medical industry requires more and more powerful and accurate tools for case-by-case analysis and preoperative planning. Beside traditional imaging techniques, such as computed tomographic angiography (CTA), and virtual 3D reconstructions, an increasing interest towards 3D printing has been reported in the latest years. The purpose of this paper is to assess the actual value of this technology by reporting its use in 25 cases of complex aortic surgery. For each patient, we have 3D printed a preoperative life-sized model of the vascular aortic lumen, deciding and planning the most suitable procedure by its direct examination. After the intervention, we have examined the corresponding model printed derived from postoperative CTA to check the outcome and discuss possible further corrections, if needed. All the cases for which a surgical or endovascular procedure was decided were treated successfully, in absence of major complications or intra-operative mortality. Optimal resolution of anatomical details and immediate comprehension of the most important technical aspects were reported by examining the models. 3D printing has proved a valuable tool in dealing with complex aortic diseases.

Large, single-center databases and the evolution of endovascular therapy for complex aortic aneurysms

Fenestrated and branched endograft repair of complex aortic disease has revolutionized the approach to treatment of this life-threatening problem. Several sites have developed long-standing programs evaluating the application and outcomes of this technology. These reports are based on the development of large, single-center databases. These centers have helped to pioneer the evolution of this approach, and their assessments have led to significant improvements and identified areas that require improvement in the ensuing years. Four main centers that are known to have developed large, single-center databases were identified. A literature review was performed to collect the contributions that were made on the topic of fenestrated/branched endograft repair of complex aortic aneurysms were selected and reviewed. Nearly a decade and a half of progress has been made in developing endovascular treatment of complex aortic disease. The application of this technology has been limited in the United States due to its investigational nature, but has achieved commercialization in Europe. These centers that have accrued large numbers of patients and have defined the initial expected perioperative outcomes. In addition, they have identified areas of high risk for these patients including perioperative renal failure and the development of spinal cord ischemia. Long-term outcomes are being developed with a special interest in evaluating branch patency, renal function, and device and aortic durability. Endovascular approaches to treat complex aortic disease, while more than a decade old, are still in the early phases of its wide-spread application. Improvements in device design will occur throughout the next several years, which will ease the placement of these devices and improve perioperative and long-term outcomes.

Early period results for repair of complex thoracic aortic diseases with E-vita open stent graft

Aim: Nowadays, usage of hybrid techniques in complex aortic diseases, especially in the high risk patient group for conventional surgery, enables us to cope with the challenges posed in major surgery and reduce complications. In this study, we evaluate our early results in patients who underwent Frozen Elephant Trunk procedure using e-Vita Open stent grafts for complex aortic disease. Methodology: A total of 61 patients (mean age 56 ±11.5, 50 patients (81.9%) were male) who underwent E-vita Open Plus repair between January 2013 and October 201, with the diagnosis of either acute / chronic type I aortic dissection, acute / chronic type III aortic dissection, or thoracic aortic aneurysm were analyzed retrospectively. 21 patients (34.4%) had acute / chronic type I aortic dissection, 22 (36.0%) had acute / chronic type III aortic dissection, 11 (18.0%) had thoracic aortic aneurysm and 7 (11.4%) had residual type I aortic dissection. Results: Arterial cannulation sites were right subclavian artery in 57 patients (93.4%), brachiocephalic artery in 2 patients (3.2%) and ascending aorta in 2 patients (3.2%). The mean times for antegrade cerebral perfusion and cardiopulmonary bypass were 80 minutes (range 52-167) and 178 minutes (range 105-350) respectively. First 30-day mortality rate was 7 (11.4%). In terms of neurological deficit, 2 patients (3.2%) had paraplegia, 3 (4.9%) had major stroke/coma and one (1.6%) had right hemiplegia. Patients with paraplegia and hemiplegia recovered completely and were free of any neurological deficits during discharge. Conclusion: Frozen elephant trunk procedure is a good alternative method which makes the techniques of surgical repair more feasible in the treatment of complex aortic diseases and enables us to use the combination of surgery and endovascular techniques to reduce complications.