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1.
Article in English | MEDLINE | ID: mdl-38697255

ABSTRACT

OBJECTIVE: Fenestrated or branched endovascular repairs (f/bEVAR) are valuable treatments in patients with chronic post-dissection thoraco-abdominal aneurysms (PD-TAAA). This study aimed to analyse early and follow up outcomes of f/bEVAR. DESIGN: Thirty day and follow up outcomes of consecutive patients with PD-TAAA treated with f/bEVAR in a tertiary centre over 8 years were retrospectively analysed. METHODS: All patients presenting with PD-TAAA and managed with f/bEVAR, were eligible. Modified Crawford's classification system was used. Thirty day mortality and major adverse events (MAE) were analysed. Time to event data were estimated with Kaplan-Meier survival analysis. RESULTS: Fifty five patients (80% men, mean age 63.7 ± 7.7 years) were included: 12 (22%) were managed urgently; 25 (46%) for chronic type B aortic dissection; and the remainder for residual type A aortic dissection. Of these patients, 88% had undergone previous thoracic endovascular aortic repair. Prophylactic cerebrospinal fluid drainage (CSFD) was used in 91%. Fifteen (27%) patients were treated with fEVAR, nine (16%) with fenestrations and branches, and 31 (56%) with bEVAR. False lumen adjunctive procedures were used in 56%. Technical success was achieved in 96% of patients. Thirty day mortality was 7% and MAE rate was 20%. Spinal cord injury (SCI) grades 1 - 3 and grade 3 rates were 13% and 2%, respectively. Mean follow up was 33.0 ± 18.4 months. Survival and freedom from unscheduled re-intervention were 86% (SE 5%) and 55% (SE 8%) at 24 months, respectively. Freedom from target vessel stenosis and occlusion was higher in fEVAR at the 12 month follow up (p = .006) compared with bEVAR. CONCLUSION: Fenestrated or branched endovascular repairs in patients with PD-TAAA showed high technical success, with acceptable early mortality and MAE rates. The SCI rate was > 10%, despite CSFD use and staged procedures. Almost one-half of patients needed an unscheduled re-intervention within 24 months after f/bEVAR.

2.
J Endovasc Ther ; : 15266028241251985, 2024 May 06.
Article in English | MEDLINE | ID: mdl-38708984

ABSTRACT

PURPOSE: The treatment of thoracoabdominal aortic aneurysms (TAAAs) using branched endovascular aortic repair (BEVAR) is safe and effective. During deployment, the superior mesenteric artery (SMA) branch can unintentionally open into the celiac trunk (CT) ostium and switched catheterization of the SMA from the CT branch and the CT from the SMA branch can be used as an alternative technique in these cases. This study aimed to investigate the outcome of exchanging the intended target vessels (TVs) for the CT and SMA branches during BEVAR. MATERIALS AND METHODS: A single-center retrospective analysis of patients with TAAAs who underwent BEVAR, using off-the-shelf or custom-made devices (CMDs), with an unintended exchange of TVs for the CT and SMA branches was performed. RESULTS: Between 2014 and 2023, 397 patients were treated with BEVAR for TAAA. Eighteen (4.5%) of those patients were treated with an exchange of TVs for the CT and SMA branches. T-branch was used in 9 cases (50%) and the remaining patients were treated with CMDs. Twelve patients were treated electively, 3 were symptomatic and 3 presented with rupture. Of 36 mesenteric TVs in those 18 patients, 34 (94%) were catheterized successfully, including all 18 SMAs and 16 of the 18 CTs. No branch stenosis or occlusion of the switched mesenteric TVs was detected during follow-up. During 30-day follow-up, 3 patients died and during a median follow-up of 3 (interquartile range [IQR]: 1-15) months 3 more patients died. None of the deaths or the 2 unintended reinterventions was induced by the mesenteric TV exchange. The median hospital stay was 14 (IQR: 9-22) days with a median of 4 (IQR: 2-11) days at the intensive care unit. CONCLUSION: The exchange of the mesenteric TVs for the CT and SMA branches during BEVAR with off-the-shelf and CMD endografts is feasible with good TV patency and freedom from TV-related reinterventions. This alternative technique should be considered in selected cases when direct catheterization via the intended branch is deemed more time-consuming or not feasible. CLINICAL IMPACT: This is the first description of using an exchange of target vessels for the celiac trunk and the superior mesenteric artery branches in patients with thoracoabdominal aortic aneurysms undergoing BEVAR, using off-the-shelf or custom-made devices. The high success rate as well as the good clinical results without any branch stenosis or occlusion during follow-up highlight the feasibility of this alternative technique. It could help in challenging cases when catheterization of the intended target vessels is not possible or too time consuming, resulting in higher success rates of BEVAR and better clinical results.

4.
Expert Rev Med Devices ; : 1-4, 2024 May 27.
Article in English | MEDLINE | ID: mdl-38803133

ABSTRACT

INTRODUCTION: The management of the false lumen (FL) when dealing with aortic dissection is a crucial aspect since inducing its thrombosis is necessary in order to achieve aortic remodeling. One of the pitfalls of endovascular treatment of aortic dissection (AD) is retrograde distal FL perfusion and pressurization, which prevents FL thrombosis and thus aortic remodeling, while being associated with aneurysmal degeneration of the FL and poor long-term outcomes. AREAS COVERED: Currently, there is no CE/FDA approved device for FL closure, however different techniques and devices have been proposed to overcome this challenge, the most known of which is the Candy Plug (CP). This review aims to describe the CP device, its implantation technique, and the available data in the literature (PubMed, Cochrane, and EMBASE databases; last queried, December 31, 2023). EXPERT OPINIONS: While the treatment of AD remains technically challenging, the use of the CP technique to close any distal FL reperfusion proved to be feasible and safe with excellent rates of both technical and clinical success. Furthermore, recent studies have shown a quick learning curve with this technique.

5.
J Endovasc Ther ; : 15266028241245341, 2024 Apr 10.
Article in English | MEDLINE | ID: mdl-38597263

ABSTRACT

OBJECTIVES: Electrosurgery has been long used in endovascular procedures, with only case reports in the aortic field. Our aim is to present a case series with the use of an electrified wire to perform catheter-based electrosurgery by applying external current through an electrocautery pen. METHODS: Single-center retrospective case series of all patients undergoing complex aortic surgery from October 2020 to August 2023, in whom the electrified wire technique was used: (1) Perforation of a dissection flap or left subclavian artery (LSA) in situ endograft fenestration-a 0.014" polytetrafluoroethylene (PTFE) insulated guidewire is detached from the insulation with a scalpel at the end and a cautery pen is here attached with a clamp. A curved tip catheter or sheath is positioned against the aortic flap or the endograft (through a left brachial access in this case) and the wire pushed, crossing the flap by activating the electrocautery pen and (2) slicing a dissection flap ("powered cheese-wire technique")-after same preparation as above, the middle section of the 0.014 guidewire is removed from the PTFE and bent into a V-shape. Once in the aorta, the guidewire crosses from the true lumen (TL) to the false lumen (FL) and a through-and-through access is obtained. Sheaths are positioned against the flap from both sides and moved up or down while the electricity is activated, slicing the flap and communicating both lumens. Technical success and technical-related complications were evaluated. RESULTS: Eleven cases concerning aortic dissections and 1 case of aortic atresia were treated. Four patients presented urgently, whereas the rest were planned procedures. Seven cases underwent perforation of a dissection flap, 2 cases underwent the powered cheese-wire technique, in 2 cases for an LSA in situ fenestration, and in 1 case to cross an aortic atresia at the aortic isthmus. The technique was in all cases successfully applied. No complications related to the technique occurred. CONCLUSIONS: The "electrified wire" technique is a feasible and ready-available tool that can be safely used in complex aortic interventions, especially to perforate aortic tissue like dissection flaps or to perform in situ fenestrated repairs by perforation of the endograft fabric. CLINICAL IMPACT: The electrified wire technique described herein is a straightforward technique that uses readily available tools to perform electrosurgery. We present its use in complex aortic procedures. However, it could be envisioned for any vascular procedure that requires crossing of the vessel or even prosthetic material. As we have described in this series, when used along with an adequate properative planning, it can be a safe tool of great utility, as has already been demonstarted in the field of the interventional cardiology.

6.
J Vasc Surg ; 2024 Apr 03.
Article in English | MEDLINE | ID: mdl-38580160

ABSTRACT

OBJECTIVE: Fenestrated and branched thoracic endovascular repair (f/bTEVAR) have been successfully applied in patients with diverse aortic arch pathologies. The aim of this study is to present the early and mid-term outcomes of patients with native proximal aortic landing (NPAL) managed with f/bTEVAR. METHODS: A single-center retrospective analysis of patients with NPAL, managed with f/bTEVAR, between September 1, 2011, and June 30, 2022, was conducted. All patients were treated with custom-made devices (Cook Medical) with landing within Ishimaru zones 0 to 2. Primary outcomes were technical success, mortality, stroke, and retrograde type A dissection at 30 days. Follow-up outcomes were considered secondary. RESULTS: A total of 126 patients were included (69.8% males; mean age, 70.8 ± 4.2 years; 18.3% urgent). The main indications (60.4%) for repair were aortic arch (29.4%) and thoracoabdominal aortic aneurysms (31.0%). Seventy-two patients (57.1%) were managed with fTEVAR. Proximal landing in zone 0 and 1 was chosen in 97.6%. Technical success was 94.4%, and 30-day mortality was 11.9%. Strokes were diagnosed in 13.5% of patients and major strokes were identified in 7.9% cases. Retrograde type A dissection rate was 3.9%. The multivariate analysis confirmed landing in Ishimaru zone 0 as an independently related factor for stroke (P = .005), whereas stroke (P < .001), pericardial effusion (P < .001), and acute kidney injury (P < .001) were independently related to 30-day mortality. Mean follow-up was 17.5 ± 9.3 months. The estimated survival rate and the freedom from reintervention rate were 72.6% (standard error, 4.4%) and 46.4% (standard error, 6.0%) at 24-month follow-up, respectively. CONCLUSIONS: Stroke rate after endovascular arch repair was alarming among patients with NPAL. Proximal landing to zone 0 was related to higher risk of stroke. Reinterventions were common within the 24-month follow-up.

7.
Article in English | MEDLINE | ID: mdl-38677467

ABSTRACT

OBJECTIVE: Female sex is a risk factor for adverse events after endovascular aortic repair. Sex comparative early and mid term outcomes of fenestrated and branched endovascular aortic arch repair (f/b-Arch) are presented. METHODS: Single centre retrospective sex comparative analysis of consecutive patients managed with f/b-Arch according to STROBE. Primary outcomes were sex comparative technical success, mortality, and cerebrovascular morbidity at 30 days. Kaplan-Meier estimates were used for follow up outcomes. RESULTS: Among 209 patients, 38.3% were women. Coronary artery disease (p < .001) and previous myocardial infarction (p = .001) were more common in women. Non- native proximal aortic landing was higher in women (women: 51.3%; men: 31.8%, p = .005) and aortic dissection rate was lower (28.8% vs. 48.1%, p = .005). Proximal landing to Ishimaru zones showed no difference (zone 0: p = .18; zone 1: p = .47; zone 2: p = .39). Graft configurations were equally distributed. In total, 416 supra-aortic trunks were bridged. Median number of revascularisations per patient was 2 (interquartile range 1, 3), with no difference between sexes (p = .54). Technical success (women: 97.5%; men: 96.7%, p = .80), 30 day mortality (women: 10%; men: 9.3%, p = .86), and cerebrovascular morbidity (women: 11.3%; men: 17.1%, p = .25) were similar. Women presented more access related complications (women: 32.5%; men: 16.3%, p = .006), without affecting access related re-interventions (p = .55). Survival (women: 81.1%, 95% confidence interval [CI] 76.3 - 85.9%; men: 79.8%, 95% CI 76.0 - 83.6%) and freedom from re-intervention (women: 56.6%, 95% CI 50.4 - 62.8%); men: 55.3%, 95% CI 50.1 - 60.5%) at 12 months were similar (log rank, p = .40 and p = .41, respectively). CONCLUSION: Both sexes presented similar outcomes after f/b-Arch. Appropriate patient selection may decrease the effect of sex in f/b-Arch outcomes.

8.
Ann Surg ; 2024 Mar 19.
Article in English | MEDLINE | ID: mdl-38501239

ABSTRACT

OBJECTIVE: This study aimed to present the early and mid-term outcomes of fenestrated/branched thoracic endovascular aortic repair (f/bTEVAR) for aortic arch pathologies. BACKGROUND: f/bTEVAR represents a less invasive treatment option for aortic arch diseases. Previous published series showed decreased early mortality and morbidity compared to open repair. METHODS: A single-center retrospective analysis of consecutive patients, managed with f/bTEVAR (Cook Medical, Bloomington, IN, USA) between 01.09.11and 30.06.22 was conducted. Primary outcomes were technical success, 30-day mortality and stroke. Data during follow-up and factors affecting early mortality and stroke were analyzed. RESULTS: 209 patients were included (38.3% females; mean age 69.8±3.4years; mean aortic diameter 61±4.7 mm); 14.4% were managed urgently. Fenestrations/scallop configuration was used in 39.7%, branched devices in 55.5% and branch/scallop combination in 4.8%. Landing to zone 0 was performed in 65.5% and in zone 1 in 32.1%. Non-native aortas were used for landing in 39.2%. Technical success was 97.1% and 30-day mortality 9.5%. Strokes were identified in 10%; 5.7% major. Non-native proximal aortic landing zone was an independent protective factor for stroke (P=0.002). Post-operative stroke (P<0.001) and pericardial effusion (P<0.001) were independently related to 30-day mortality. The mean follow-up was 21±8 months. The estimated survival and freedom from reintervention rates were 79.5% (standard error; SE3.1%) and 47.1% (SE 4.3%) at 24months, respectively. CONCLUSIONS: f/bTEVAR presented high technical success and acceptable 30-day mortality. Non-native proximal landing zone was related to lower stroke rate. Half of patients needed a reintervention within the 24-month follow-up.

9.
Ann Vasc Surg ; 104: 237-247, 2024 Mar 16.
Article in English | MEDLINE | ID: mdl-38492732

ABSTRACT

BACKGROUND: Fenestrated (FEVAR) and chimney (ChEVAR) endovascular aortic repair have been applied in anatomically suitable complex aortic aneurysms. However, local hemodynamic changes may occur after repair. This study aimed to compare FEVAR's and ChEVAR's hemodynamic properties, focusing on visceral arteries. METHODS: Preoperative and postoperative computed tomography angiographies have been used to reconstruct patient-based models. Data of 3 patients, for each modality, were analyzed. Following geometric reconstruction, computational fluid dynamics simulations were used to extract near-wall and intravascular hemodynamic indicators, such as pressure drops, velocity, wall shear stress, time averaged wall shear stress, oscillatory shear index, relative residence time, and local normalized helicity. RESULTS: An overall improvement in hemodynamics was detected after repair, with either technique. Preoperatively, a disturbed prothrombotic wall shear stress profile was recorded in several zones of the sac. The local normalized helicity results showed a better organization of the helical structures at postoperative setting, decreasing thrombus formation, with both modalities. Similarly, time averaged wall shear stress increased and oscillatory shear index decreased postoperatively, signaling nondisturbed blood flow. The relative residence time was locally reduced. The flow in visceral arteries tended to be more streamlined in ChEVAR, compared to evident recirculation regions at renal and superior mesenteric artery fenestrations (P = 0.06). CONCLUSIONS: ChEVAR and FEVAR seem to improve hemodynamics toward normal values with a reduction of recirculation zones in the main graft and aortic branches. Visceral artery flow comparison revealed that ChEVAR tended to present lower recirculation regions at parallel grafts' entries while FEVAR showed less intense flow regurgitation in visceral stents.

10.
J Vasc Surg ; 79(3): 457-468.e2, 2024 Mar.
Article in English | MEDLINE | ID: mdl-38453660

ABSTRACT

BACKGROUND: Fenestrated and branched endovascular aortic repair (F/BEVAR) of thoracoabdominal aortic aneurysms (TAAAs) has shown high technical success and low early mortality rates. Aneurysm extent has been reported as a factor affecting outcomes. This study aimed to assess the early and midterm follow-up outcomes of patients managed by F/BEVAR for types I through III TAAAs. METHODS: A single-center retrospective analysis was conducted, including data from consecutive, elective and urgent (symptomatic and ruptured cases), patients treated for types I through III TAAAs, between October 1, 2011, and October 1, 2022, using F/BEVAR. Degenerative and postdissection TAAAs were included. Patients received prophylactic cerebrospinal fluid drainage (CSFD), except those under therapeutic anticoagulation, those who were hemodynamically unstable, or those with failed CSFD application. When an initial thoracic endovascular aortic repair was performed, as part of a staged procedure, no CSFD was used. Later stages and nonstaged procedures were performed under CSFD. Thirty-day mortality and major adverse events (MAEs) were analyzed. Kaplan-Meier estimates were used for follow-up outcomes. RESULTS: F/BEVAR for types I through III TAAAs was performed in 209 patients (56.9% males; mean age, 69.6 ± 3.2 years; mean aneurysm diameter, 65.2 ± 6.2 mm); 29.2% type I, 57.9% type II, and 12.9% type III. Urgent repair was performed in 26.7% of patients (56 cases; 23 ruptured and 33 symptomatic cases) and 153 were treated electively. Thirty-two patients (15.3%) were classified as American Society of Anesthesiologists (ASA) class IV. CSFD was used in 91% and staged thoracic endovascular aortic repair was performed in 51.2% of patients. Technical success was 93.8% (96.7% in elective vs 94.6% in urgent cases; P = .92). Thirty-day mortality was 11.0% (4.6% in elective vs 28.5% in urgent cases; P < .001) and MAEs were recorded in 17.2% of cases (7.8% in elective vs 42.8% in urgent cases; P < .001). Spinal cord ischemia rate was 20.5% (17.6% in elective vs 28.7% in urgent cases; P = .08), whereas 2.9% of patients presented paraplegia (1.3% in elective and 7.1% in urgent cases; P = .03). The mean follow-up was 16 ± 5 months. Survival was 75.0% (standard error, 4.0%) and freedom from reintervention was 73.3% (standard error, 4.4%) at 36 months. ASA IV and urgent repair were detected as independent factors related to early mortality and MAE, whereas ruptured aneurysm status was related to spinal cord ischemia evolution. CONCLUSIONS: Endovascular repair for types I through III TAAAs provides encouraging early outcomes in terms of mortality, MAE, and paraplegia, especially in an elective setting. Setting of repair and baseline ASA score should be taken into consideration during decision-making.


Subject(s)
Aortic Aneurysm, Abdominal , Aortic Aneurysm, Thoracic , Blood Vessel Prosthesis Implantation , Endovascular Procedures , Spinal Cord Ischemia , Male , Humans , Aged , Female , Endovascular Aneurysm Repair , Blood Vessel Prosthesis , Aortic Aneurysm, Thoracic/diagnostic imaging , Aortic Aneurysm, Thoracic/surgery , Aortic Aneurysm, Abdominal/surgery , Blood Vessel Prosthesis Implantation/adverse effects , Retrospective Studies , Risk Factors , Treatment Outcome , Endovascular Procedures/adverse effects , Spinal Cord Ischemia/etiology , Paraplegia/etiology
11.
J Endovasc Ther ; : 15266028241233163, 2024 Feb 18.
Article in English | MEDLINE | ID: mdl-38369733

ABSTRACT

PURPOSE: Blunt thoracic aortic injury (BTAI) represents a potentially life-threatening condition and thoracic endovascular aortic repair (TEVAR) is recommended as the first-line treatment (Class I level of evidence C) by the current guidelines. The aim of this systematic review was to determine the perioperative and mid-term follow-up outcomes of patients with BTAI treated with TEVAR. MATERIALS AND METHODS: We reviewed the English literature published between 2000 and 2022, via Ovid, using MEDLINE, EMBASE, and CENTRAL databases, until July 30, 2022. Observational studies and case series, with ≥5 patients, reporting on the perioperative and follow-up outcomes of patients who underwent TEVAR for BTAI were included. The Newcastle-Ottawa Scale was used to assess the risk of bias. Primary outcomes were technical success and 30-day mortality, cerebrovascular morbidity. Secondary outcomes were mortality and re-interventions during the mid-term follow-up. RESULTS: From 5201 articles identified by the literature search, 35 eligible studies were included in this review. All studies had a retrospective study design. In total, 991 patients were included. The mean age was 34.5±16.5 years (range=16-89 years). Technical success was 98.0% (odds ratio [OR], 95% confidence interval [CI]=0.98, 0.99, p<0.001, I2=0%). Mortality at 30 days was 5.0% (OR, 95% CI=0.03, 0.06, p<0.001, I2=5.56%). Spinal cord ischemia occurred in 1.0% (OR, 95% CI=0.01, 0.02, p<0.001, I2=0%) and stroke rate was 2.0% (OR, 95% CI=0.01, 0.02, p<0.001, I2=0%). The available follow-up was estimated at 29 months (range=3-119 months) with mortality rate at 2.0% (OR, 95% CI=0.01, 0.02, p<0.001, I2=0%) and re-intervention rate at 1.0% (OR, 95% CI=0.01, 0.02, p<0.001, I2=10.5%). CONCLUSION: Thoracic endovascular aortic repair showed high technical success and low early cerebrovascular morbidity and mortality rates. In the mid-term follow-up, the estimated mortality and re-intervention rates were also low. Furthermore, higher quality prospective studies are needed. CLINICAL IMPACT: Thoracic endovascular aortic repair (TEVAR) is recommended as the first line treatement in patients with blunt thoracic aortic injuries (BTAI). This systematic review of 35 retrospective studies and 991 patients showed high technical success (98.0%) with an associated 30-day mortality at 5.0% and low spinal cord ischemia (1%) and stroke rates (2.0%). Mid-term mortality and re-intervention rates reassure the effectiveness of TEVAR in BTAI cases.

12.
J Vasc Surg ; 79(6): 1306-1314.e2, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38368998

ABSTRACT

OBJECTIVE: Radiation exposure during complex endovascular aortic repair may be associated with tangible adverse effects in patients and operators. This study aimed to identify the steps of highest radiation exposure during fenestrated endovascular aortic repair (FEVAR) and to investigate potential intraoperative factors affecting radiation exposure. METHODS: Prospective data of 31 consecutive patients managed exclusively with four-fenestration endografts between March 1, 2020, and July 1, 2022 were retrospectively analyzed. Leveraging the conformity of the applied technique, every FEVAR operation was considered a combination of six overall stages composed of 28 standardized steps. Intraoperative parameters, including air kerma, dose area product, fluoroscopy time, and number of digital subtraction angiographies (DSAs) and average angulations were collected and analyzed for each step. RESULTS: The mean procedure duration and fluoroscopy time was 140 minutes (standard deviation [SD], 32 minutes), and 40 minutes (SD, 9.1 minutes), respectively. The mean air kerma was 814 mGy (SD, 498 mGy), and the mean dose area product was 66.8 Gy cm2 (SD, 33 Gy cm2). The percentage of air kerma of the entire procedure was distributed throughout the following procedure stages: preparation (13.9%), main body (9.6%), target vessel cannulation (27.8%), stent deployment (29.1%), distal aortoiliac grafting (14.3%), and completion (5.3%). DSAs represented 23.0% of the total air kerma. Target vessel cannulation and stent deployment presented the highest mean lateral angulation (67 and 63 degrees, respectively). Using linear regression, each minute of continuous fluoroscopy added 18.9 mGy of air kerma (95% confidence interval, 17.6-20.2 mGy), and each DSA series added 21.1 mGy of air kerma (95% confidence interval, 17.9-24.3 mGy). Body mass index and lateral angulation were significantly associated with increased air kerma (P < .001). CONCLUSIONS: Cannulation of target vessels and bridging stent deployment are the steps requiring the highest radiation exposure during FEVAR cases. Optimized operator protection during these steps is mandatory.


Subject(s)
Blood Vessel Prosthesis Implantation , Endovascular Procedures , Radiation Dosage , Radiation Exposure , Humans , Endovascular Procedures/adverse effects , Endovascular Procedures/instrumentation , Radiation Exposure/prevention & control , Radiation Exposure/adverse effects , Retrospective Studies , Male , Female , Aged , Blood Vessel Prosthesis Implantation/adverse effects , Blood Vessel Prosthesis Implantation/instrumentation , Time Factors , Radiography, Interventional/adverse effects , Risk Factors , Blood Vessel Prosthesis , Aged, 80 and over , Stents , Treatment Outcome , Risk Assessment , Operative Time , Aortography , Middle Aged , Angiography, Digital Subtraction , Occupational Exposure/prevention & control , Occupational Exposure/adverse effects , Fluoroscopy , Endovascular Aneurysm Repair
13.
J Endovasc Ther ; : 15266028241234497, 2024 Feb 26.
Article in English | MEDLINE | ID: mdl-38409773

ABSTRACT

INTRODUCTION: The aim of this study is to present single-center outcomes in patients treated with in situ laser fenestration thoracic endovascular aortic repair (LFTEVAR) for various aortic arch pathologies and assess the impact of increasing experience. METHODS: The STrengthening the Reporting of OBservational studies in Epidemiology (STROBE) statement was followed. A retrospective analysis of prospectively collected single aortic center data was conducted, including baseline information and peri- and post-operative outcomes of consecutive patients managed with LFTEVAR for aortic arch pathologies. Patients were enrolled from April 1, 2017 to January 31, 2023. The cohort was dichotomized to compare early (2017-2019) and late experience (2020-2023). Primary outcomes were peri-operative mortality and cerebrovascular morbidity. RESULTS: Thirty patients were included (63.3% males, mean age 69.8±9.6 years); 21.4% presented with aortic ruptures. Aortic aneurysm involving the aortic arch was the most frequent pathology (53.3%). Forty target vessels (TVs) were revascularized, including 19 left subclavian arteries (47.5%) and 17 left common carotid arteries (42.5%). Double fenestrations were performed in 10 patients. The proximal landing zone was Ishimaru zone 0 in 5 patients (16.7%) and zone 1 in 13 patients (43.3%). Technical success was 93%. No spinal cord ischemia was recorded, and 3 patients (10%) suffered a post-operative stroke, of which 1 was major (3.3%). The median follow-up was 12 months (range=1-48 months). Thirty-day and follow-up mortality rates were 13.5% and 15.3%, respectively. Target vessel instability was 10%, of which 3.8% required reintervention. There was no statistically significant difference in outcomes between the early and late experience groups. CONCLUSIONS: Laser fenestration thoracic endovascular aortic repair of the aortic arch performed in experienced aortic centers is associated with low early mortality and stroke rates. It is a safe and effective therapeutic option in patients considered unfit for open repair. CLINICAL IMPACT: Custom-made devices for arch pathologies requiring urgent repair are not an option because of manufacturing delays. Off-the-shelf devices with single branch arch prostheses, and outside IFU techniques such as parallel-grafts and surgeon-modified endografts have been proposed in this setting. Another off-the-shelf alternative is in situ laser fenestration thoracic endovascular repair (LFTEVAR), which addresses many limitations of the other off-the-shelf options. Our study reports the outcomes of 30 patients treated with LFTEVAR, showing that it is a viable therapeutic option in patients considered unfit for open repair acknowledging that sufficient experience with complex endovascular aortic repair is mandatory to achieve acceptable outcomes in these high-risk patients with challenging aortic anatomies.

14.
Article in English | MEDLINE | ID: mdl-38320646

ABSTRACT

OBJECTIVE: Iliac branch devices (IBDs) have shown good results but there is little evidence for the risk of internal iliac artery (IIA) endoleak, so there are no clear recommendations on the maximum diameter it should be. Based on limited evidence, it was hypothesised that an IIA of ≥ 11 mm in diameter presents an increased risk of type Ic endoleak. METHODS: This was a single centre, retrospective case control study. Patients undergoing an IBD with the main trunk of the IIA as the target vessel, between 2015 and 2021, were identified. Two groups were created: those with a main trunk diameter of < 11 mm; and those with a diameter of ≥ 11 mm. Technical success, freedom from type Ic endoleak, and re-intervention rates were compared. A receiver operating characteristic (ROC) curve was performed to show a cutoff IIA diameter value for risk of type Ic endoleak. Multivariate analysis was performed to assess the risk of type Ic endoleak and the presence of calcification, stenosis, and landing zone length in the IIA. RESULTS: There were 182 IBDs identified. The dilated IIA group (54 IBDs) had significantly lower technical success (91% vs. 98.4%; p = .002), lower freedom from type Ic endoleak (77% vs. 97.1% at 24 months; p = .001), and lower freedom from re-interventions (70% vs. 92.4% at 24 months; p = .002). The ROC curve showed that 10.5 mm was the cutoff diameter for type Ic endoleak. Moderate or severe calcification as well as landing zone length < 5 mm also correlated with type Ic endoleak. CONCLUSION: IBDs have a statistically significantly higher rate of technical failure, lower freedom from type Ic endoleak, and lower freedom from re-intervention when the IIA is ≥ 11 mm in diameter.

15.
J Endovasc Ther ; : 15266028241231905, 2024 Feb 21.
Article in English | MEDLINE | ID: mdl-38380515

ABSTRACT

INTRODUCTION: Data on target vessel (TV)-related outcomes in patients managed with branched thoracic endovascular aortic repair (BTEVAR) are limited. This study aimed to present the TV-related outcomes of BTEVAR in patients managed for aortic arch pathologies at 30 days and during follow-up. METHODS: A retrospective analysis of consecutive patients, managed between September 1, 2011, and June 30, 2022, with custom-made aortic arch endografts (Cook Medical, Bloomington, IN, USA), presenting at least one branch configuration, were eligible. Primary outcomes were technical success, TV-related patency, and reinterventions at 30 days. RESULTS: In total, 255 TVs were revascularized using branches: 107 innominate arteries (IAs), 108 left common carotid arteries (LCCAs), and 40 left subclavian arteries (LSAs). Covered stents were used as bridging stents of which 10.2% were balloon expandable. Relining, using bare-metal stents (BMS), was performed in 14.0% of IAs, 35.2% of LCCAs, and 22.5% of LSAs. Technical success on case basis was 99.2%; no failure was related to unsuccessful TV bridging. At 30 day follow-up, no TV occlusion was detected. In 5.6% of cases, a type Ic or III endoleak, attributed to TVs, was recorded. Two patients needed early branch-related reintervention. The mean follow-up was 18.3±9.2 months. Freedom from TV instability was 94.6% (standard error [SE] 2.5%] at 12 months. No TV stenosis or occlusion was detected up to 48 months of follow-up. Freedom from TV-related reinterventions was 95.4% [SE 2.4%] at 12 months. CONCLUSION: TV stenosis or occlusion in BTEVAR cases is rare and TV-related reinterventions and instability events are mainly attributed to type Ic and III endoleak formation. CLINICAL IMPACT: Previous studies focusing on target vessel (TV) outcomes after endovascular aortic arch repair are limited. In this study, including 255 TVs revascularized using branched arch devices, bridging was performed with covered stents, of which 90% were self-expanding. Relining was at the discretion of the operator and was 14% for the innominate, 35.2% for the left common carotid and 22.5% for the left subclavian artery branches. No 30-day occlusion was detected. The freedom from TV instability was almost 95% at 12 months. TV instability and reintervention were mainly attributed to endoleaks type Ic and IIIc.

17.
J Vasc Surg ; 79(5): 1251-1261.e4, 2024 May.
Article in English | MEDLINE | ID: mdl-37757916

ABSTRACT

OBJECTIVE: Despite open surgical repair (OSR) of abdominal aortic aneurysms being considered as a durable solution, disease progression and para-anastomotic aneurysms may require further repair, and fenestrated and branched endovascular aneurysm repair (F/BEVAR) may be applied to address these pathologies. The aim of this systematic review was to assess technical success, mortality, and morbidity (acute kidney injury, spinal cord ischemia) at 30 days, and mortality and reintervention rates during the available follow-up, in patients managed with F/BEVAR after previous OSR. METHODS: The PRISMA statement was followed, and the study was pre-registered to the PROSPERO (CRD42022363214). The English literature was searched, via Ovid, using MEDLINE, EMBASE, and CENTRAL databases, through November 30, 2022. Observational studies and case series with ≥5 patients (2000-2022), reporting on F/BEVAR outcomes after OSR, were considered eligible. The Newcastle-Ottawa Scale and GRADE were used to assess the risk of bias and quality of evidence. The primary outcome was technical success, mortality, and morbidity at 30 days. Data on the outcomes of interest were synthesized using proportional meta-analysis. RESULTS: The initial search yielded 1694 articles. Eight retrospective studies (476 patients) were considered eligible. In 78.3% of cases, disease progression set the indication for reintervention. Technical success was estimated at 96% (95% confidence interval [CI], 89%-98%; I2 = 0%; 95% prediction interval [PI], 79%-99%). Thirty-day mortality was 2% (95% CI, 1%-9%; I2 = 0%; 95% PI, 0%-28%). The estimated spinal cord ischemia and acute kidney injury rates were 3% (95% CI, 1%-9%; I2 = 0%; 95% PI, 0%-30%) and 6% (95% CI, 2%-15%; I2 = 0%; 95% PI, 1%-40%), respectively. During follow-up, overall mortality was 5% (95% CI, 2%-12%; I2 = 34%; 95% PI, 0%-45%) and aorta-related mortality was 1% (95% CI, 0%-2%; I2 = 0%; 95% PI, 0%-3%). The rate of reinterventions was 16% (95% CI, 9%-26%; I2 = 22%; 95% PI, 3%-50%). CONCLUSIONS: According to the available literature, F/BEVAR after OSR may be performed with high technical success and low mortality and morbidity during the perioperative period. Follow-up aortic-related mortality was 1%, whereas the reintervention rates were within the standard range following F/BEVAR.

18.
J Endovasc Ther ; : 15266028231210214, 2023 Nov 19.
Article in English | MEDLINE | ID: mdl-37981580

ABSTRACT

INTRODUCTION: This study aimed to evaluate the impact of COVID on total case load and peri-operative outcomes in patients undergoing open surgical repair (OSR) and endovascular repair (ER) of complex aortic aneurysms (cAAs). METHODS: A single-center retrospective analysis of prospective data of patients managed with elective cAA ER or OSR from January 2018 to December 2021 was conducted. A comparative analysis on the impact of the COVID-19 pandemic on the case volume and on the 30-day outcomes was assessed using time periods, before (2018-2019) and during the pandemic (2020-2021). RESULTS: During the 4-year study period, 255 patients with cAA were managed with ER and 576 with OSR. The pandemic did not reduce the cAA ER volume (p=0.12), but a statistically significant reduction in OSR case load was recorded (p=0.04). Following OSR, hospital length of stay (11.1 vs 10.3 days), and early mortality (6.94% vs 4.63%), were similar before and during the pandemic. In the ER cohort, baseline characteristics, early mortality (3.6% vs 4.1%, p=0.976), and morbidity (10% vs 14%, p=0.44), were comparable during the 2 periods. For ER cases, the hospital and intensive care unit (ICU) stay both decreased significantly (8±8-6±7 days, p<0.001 and 2±4 vs 1±6 days p=0.01, respectively) during the pandemic. CONCLUSION: Resource pressures drove modifications in clinical practice to reduce the length of hospitalization, without compromising the clinical outcomes, in patients undergoing ER of cAA. This modification was not effective in patients undergoing OSR that resulted in a significant decrease of this activity. CLINICAL IMPACT: The pandemic did not reduce complex endovascular repair (ER) volume (p=0.12) while a significant reduction in open surgical repair (OSR) case load was recorded (p=0.04). For the endovascular cohort, early mortality (p=0.976) and morbidity (p=0.44) remained stable, while the hospital and intensive care unit (ICU) stay decreased (p<0.001 and p=0.01, respectively) during the pandemic.

19.
J Endovasc Ther ; : 15266028231208657, 2023 Oct 30.
Article in English | MEDLINE | ID: mdl-37902437

ABSTRACT

OBJECTIVE: To report on the outcomes of patients undergoing an iliac branch device implantation after previous open or endovascular aorto-biliac repair, using exclusively femoral access for catheterization and delivery of the covering stent to the hypogastric artery. METHODS: Single-center retrospective study in which all patients in whom an iliac branch device was implanted after previous open or endovascular aorto-biliac repair were identified. Patients in whom the hypogastric artery catheterization and delivery of the bridging cover stent were achieved via exclusive femoral access were included. Different techniques were used based on surgeon preference. Technical success and access-related complications, as well as iliac branch device endoleak or occlusions during follow-up, were evaluated. RESULTS: From 2015 to 2021, 28 patients with a prior open or endovascular aorto-biliac repair underwent 34 iliac branch device implantations. Most (71%) had juxtarenal or thoracoabdominal aortic aneurysms, 82% had common iliac artery aneurysms, and 25% had hypogastric artery aneurysms. Bilateral iliac branch device implantations were performed in 21% of the patients, and in 26% of cases, landing in the superior gluteal artery was obtained. An "up-and-over" technique from the contralateral groin was used in 65% of the cases, and a steerable sheath in 35%. Technical success was 94%, with no complications related to access or technique to catheterize and deliver the stents in the hypogastric artery. The cohort had 20% of major complications, with 3 perioperative deaths. Kaplan-Meier estimated an iliac branch device freedom from occlusion and endoleak was 92% and 83% at 2 years. CONCLUSIONS: The implantation of an iliac branch device over previous aortic or open endografts involving the aortic bifurcation is feasible and safe. We suggest using a femoral approach as the primary access of choice. CLINICAL IMPACT: In this study we present 28 patients with previous aortoiliac grafts in which iliac branch devices were performed as a subsequent step.We demonstrated the feasibility of the technique despite the difficulty of crossing a neobifurcation, with a steep angle, without complications associated with the technique. Based on our experience, we recommend transfemoral access as the first option for bypassing the hypogastric artery stent, preserving upper extremity access and its possible complications.

20.
J Endovasc Ther ; : 15266028231208159, 2023 Oct 30.
Article in English | MEDLINE | ID: mdl-37902445

ABSTRACT

PURPOSE: Artificial intelligence (AI) using an automated, deep learning-based method, Augmented Radiology for Vascular Aneurysm (ARVA), has been verified as a viable aide in aneurysm morphology assessment. The aim of this study was to evaluate the accuracy of ARVA when analyzing preoperative and postoperative computed tomography angiography (CTA) in patients managed with fenestrated endovascular repair (FEVAR) for complex aortic aneurysms (cAAs). MATERIALS AND METHODS: Preoperative and postoperative CTAs from 50 patients (n=100 CTAs) who underwent FEVAR for cAAs were extracted from the picture archiving and communication system (PACS) of a single aortic center equipped with ARVA. All studies underwent automated AI aneurysm morphology assessment by ARVA. Appropriate identification of the outer wall of the aorta was verified by manual review of the AI-generated overlays for each patient. Maximum outer-wall aortic diameters were measured by 2 clinicians using multiplanar reconstruction (MPR) and curved planar reformatting (CPR), and among studies where the aortic wall was appropriately identified by ARVA, they were compared with ARVA automated measurements. RESULTS: Identification of the outer wall of the aorta was accurate in 89% of CTA studies. Among these, diameter measurements by ARVA were comparable to clinician measurements by MPR or CPR, with a median absolute difference of 2.4 mm on the preoperative CTAs and 1.6 mm on the postoperative CTAs. Of note, no significant difference was detected between clinician measurements using MPR or CPR on preoperative and postoperative scans (range 0.5-0.9 mm). CONCLUSION: For patients with cAAs managed with FEVAR, ARVA provides accurate preoperative and postoperative assessment of aortic diameter in 89% of studies. This technology may provide an opportunity to automate cAA morphology assessment in most cases where time-intensive, manual clinician measurements are currently required. CLINICAL IMPACT: In this retrospective analysis of preoperative and postoperative imaging from 50 patients managed with FEVAR, AI provided accurate aortic diameter measurements in 89% of the CTAs reviewed, despite the complexity of the aortic anatomies, and in post-operative CTAs despite metal artifact from stent grafts, markers and embolization materials. Outliers with imprecise automated aortic overlays were easily identified by scrolling through the axial AI-generated segmentation MPR cuts of the entire aorta.This study supports the notion that such emerging AI technologies can improve efficiency of routine clinician workflows while maintaining excellent measurement accuracy when analyzing complex aortic anatomies by CTA.

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