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1.
Artículo en Inglés | MEDLINE | ID: mdl-38705454

RESUMEN

OBJECTIVE: This study aimed to report the initial experience with a novel bidirectional double cuff inner branch design for incorporation of renal and mesenteric arteries in patients undergoing fenestrated and branched endovascular aortic repair (F/BEVAR). METHODS: A retrospective review was undertaken of the experience of F/BEVAR with grafts integrating at least one bidirectional double cuffed inner branch implanted at three tertiary aortic centres between March 2022 and June 2023. All consecutive patients were included. Baseline characteristics, operative and follow up data were collected. Results were presented as number or median (interquartile) unless otherwise stated. RESULTS: Thirteen patients (10 male; median age 72 [68, 77] years) had F/BEVAR using a total of 15 bidirectional double cuffed inner branches (30 cuffs). Indications for bidirectional doubled cuffed inner branches included cranial vessel orientation or double renal arteries in four patients each, common coeliomesenteric trunk in three patients, and early renal artery bifurcation, renal artery origin from a false lumen requiring a flexible route for catheterisation, and surplus configuration in one patient each. Twenty three of the 30 cuffs were used, whereas the remaining seven cuffs were intentionally occluded with vascular plugs. Target vessel incorporation was successful in all bidirectional branches. There was one technical failure related to unsuccessful catheterisation of a left renal artery targeted through a unidirectional caudal inner branch. During a median follow up of seven months there were no instances of target vessel instability or re-interventions and two patients died of causes unrelated to the bidirectional branches. CONCLUSION: The results of the use of bidirectional double cuff inner branches are promising, with high technical success and no short term branch related complications in this preliminary experience. This could potentially expand the applicability of branch endografting of complex endovascular aortic repairs, but long term results are still missing.

2.
Artículo en Inglés | MEDLINE | ID: mdl-38697255

RESUMEN

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.

3.
J Endovasc Ther ; : 15266028241251985, 2024 May 06.
Artículo en Inglés | MEDLINE | ID: mdl-38708984

RESUMEN

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.
Artículo en Inglés | MEDLINE | ID: mdl-38677467

RESUMEN

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.

5.
Expert Rev Med Devices ; : 1-8, 2024 Apr 18.
Artículo en Inglés | MEDLINE | ID: mdl-38629872

RESUMEN

INTRODUCTION: Endovascular treatment of type B aortic dissections (TBAD) has currently acquired a primary therapeutic role when anatomically feasible. The main issue with thoracic endovascular aortic repair (TEVAR) for aortic dissection is the actual nature of the aortic wall, which is structurally compromised and more fragile. Indeed, a wealth of data have shown that TEVAR for TBAD will lead, in a substantial proportion of cases, to a device-related adverse event named distal stent-graft induced new entry (dSINE). AREAS COVERED: Currently available aortic stent-grafts have not been specifically devised for the treatment of aortic dissection. A novel dissection specific stent-graft (DSSG) was developed, which is a custom-made device based on the Zenith Alpha Thoracic platform (Cook Medical). The DSSG has several unique properties that, in principle, make its use optimal in TBAD patients. EXPERT OPINION: TEVAR in the setting of aortic dissections remains technically challenging. The occurrence of dSINE represents a unique complication in this scenario and may lead to high rates of aortic-related adverse events and need for secondary interventions. The use of a novel custom-made DSSG in the setting of chronic TBAD has been proven to be safe, feasible and effective. However, even this approach may fail to completely prevent dSINE formation.

7.
J Endovasc Ther ; : 15266028241245341, 2024 Apr 10.
Artículo en Inglés | MEDLINE | ID: mdl-38597263

RESUMEN

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.

8.
J Vasc Surg ; 2024 Apr 03.
Artículo en Inglés | MEDLINE | ID: mdl-38580160

RESUMEN

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.

9.
Chirurgie (Heidelb) ; 95(5): 395-405, 2024 May.
Artículo en Alemán | MEDLINE | ID: mdl-38498123

RESUMEN

INTRODUCTION: The medical development in the previous 15 years and the changes in treatment reality of the comprehensive elective treatment of abdominal aortic aneurysms necessitate a re-evaluation of the quality assurance guidelines of the Federal Joint Committee in Germany (QBAA-RL). In the current version this requires a specialist further training quota for nursing personnel in intensive care wards of 50%. The quota was determined in 2008 based on expert opinions, although a direct empirical evidence base for this does not exist. METHODS: Representatives from the fields of patient representation, physicians, nursing personnel and other relevant interface areas were invited to participate in a modified Delphi procedure. Following a comprehensive narrative literature search, a survey and focus group discussions with national and international experts, a total of three anonymized online-based voting rounds were carried out for which previously determined key statements were assessed with a 4­point Likert scale (totally disagree up to totally agree). In addition, the expert panel had also defined a recommendation for a minimum quota for the specialist training of nursing personnel on intensive care wards in the treatment of abdominal aortic aneurysms, whereby an a priori agreement of 80% of the participants was defined as the consensus limit. RESULTS: Overall, 37 experts participated in the discussions and three successive voting rounds (participation rate 89%). The panel confirmed the necessity of a re-evaluation of the guideline recommendations and recommended the introduction of a shift-related minimum quota of 30% of the full-time equivalent of nursing personnel on intensive care wards and the introduction of structured promotional programs for long-term elevation of the quota. CONCLUSION: In this national Delphi procedure with medical and nursing experts as well as representatives of patients, the fundamental benefits and needs of professional specialist qualifications in the field of intensive care medicine were confirmed. The corresponding minimum quota for specialist further training of intensive care nursing personnel should generally apply without limitations to specific groups. The expert panel stipulates a shift-related minimum quota for intensive care nursing personnel with specialist training of 30% of the nursing personnel on intensive care wards and the obligatory introduction of structured and transparent promotion programs for the long-term enhancement.


Asunto(s)
Aneurisma de la Aorta Abdominal , Enfermeras y Enfermeros , Personal de Enfermería , Humanos , Unidades de Cuidados Intensivos , Cuidados Críticos , Aneurisma de la Aorta Abdominal/terapia
10.
Ann Surg ; 2024 Mar 19.
Artículo en Inglés | MEDLINE | ID: mdl-38501239

RESUMEN

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.

11.
Artículo en Inglés | MEDLINE | ID: mdl-38490356

RESUMEN

OBJECTIVE: The midterm outcomes of the low profile Zenith Alpha Abdominal Endovascular Graft from the ZEnith alPHa for aneurYsm Repair (ZEPHYR) registry are reported. METHODS: The ZEPHYR registry is a physician initiated, multicentre, non-randomised, core laboratory controlled, prospective registry. Inclusion criteria were patients with a non-ruptured abdominal aortic aneurysm with a maximum diameter ≥ 50 mm or enlargement > 5 mm within 6 months, with a site reported infrarenal neck length of ≥ 10 mm and with the intention to electively implant the Zenith Alpha abdominal endograft. Patients from 14 sites across Germany, Belgium, and the Netherlands were included. The primary endpoint was treatment success, defined as technical success and clinical success. Technical success was defined as successful delivery and deployment of the endograft in the planned position without unintentional coverage of internal iliac or renal arteries, with successful removal of the delivery system. Clinical success was defined as freedom from aneurysm sac expansion > 5 mm, type I or type III endoleaks, aneurysm rupture, stent graft migration > 10 mm, open conversion, and stent graft occlusion. RESULTS: Three hundred and forty-seven patients were included in the ZEPHYR registry. The median clinical follow up was 743 days (interquartile range [IQR] 657, 806) with a median imaging follow up of 725 days (IQR 408, 788). Treatment success at 6 months, 1, and 2 years was 92.5%, 90.4%, and 85.3%, respectively. Freedom from secondary intervention was 94.3%, 93.4%, and 86.9%, respectively. The predominant reason for secondary intervention was limb complications. Freedom from limb occlusion (per patient) at 6 months, 1, and 2 years was 97.2%, 95.8%, and 92.5%, respectively. Univariable and multivariable Cox regression analyses could not identify any independent predictor for limb complications. CONCLUSION: While treatment success is comparable with other commercially available grafts, the rate of limb complications at 2 years is of concern. The manufacturer's instructions for use should be followed closely. Further studies are necessary to investigate the root cause of the increased rate of limb complications with the Zenith Alpha Abdominal Endovascular Graft.

12.
J Vasc Surg ; 79(3): 457-468.e2, 2024 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-38453660

RESUMEN

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.


Asunto(s)
Aneurisma de la Aorta Abdominal , Aneurisma de la Aorta Torácica , Implantación de Prótesis Vascular , Procedimientos Endovasculares , Isquemia de la Médula Espinal , Masculino , Humanos , Anciano , Femenino , Reparación Endovascular de Aneurismas , Prótesis Vascular , Aneurisma de la Aorta Torácica/diagnóstico por imagen , Aneurisma de la Aorta Torácica/cirugía , Aneurisma de la Aorta Abdominal/cirugía , Implantación de Prótesis Vascular/efectos adversos , Estudios Retrospectivos , Factores de Riesgo , Resultado del Tratamiento , Procedimientos Endovasculares/efectos adversos , Isquemia de la Médula Espinal/etiología , Paraplejía/etiología
13.
Artículo en Inglés | MEDLINE | ID: mdl-38320646

RESUMEN

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.

14.
Ann Surg ; 2024 Feb 07.
Artículo en Inglés | MEDLINE | ID: mdl-38323417

RESUMEN

OBJECTIVE: To analyze the outcomes of urgent/emergent endovascular aortic repair of patients with free/contained ruptured thoracoabdominal aortic aneurysms (rTAAA). BACKGROUND: Endovascular repair of rTAAA has been scarcely described in emergent setting. METHODS: An international multicenter retrospective observational study (ClinicalTrials.govID:NCT05956873) from January-2015 to January-2023 in 6 European and 1 United States Vascular Surgery Centers. Primary end-points were technical success, 30-day and/or in-hospital mortality and follow-up survival. RESULTS: A total of 100 rTAAA patients were included (75 male; mean age 73 y). All patients (86 contained and 14 free ruptures) were symptomatic and treated within 24-hours from diagnosis: multi-branched off-the-shelf devices (Zenith t-branch,Cook Medical Inc.Bjaeverskov,Denmark) in 88 patients, physician-modified endografts in 8, patient-specific device or parallel grafts in two patients each. Primary technical success was achieved in 89 patients and 30-day and/or in-hospital mortality was 24%. Major adverse events (MAEs) occurred in 34% of patients (permanent dialysis and paraplegia in 4 and 8 patients, respectively). No statistical differences were detected in mortality rates between free and contained ruptured patients (43%vs.21%; P =0.075). Multivariate analysis revealed contained rupture favoring technical success (Odd-Ratio10.1;95%Confidence-Interval:3.0-33.6; P =<0.001). MAEs (OR9.4;95%C-I:2.8-30.5; P =<0.001) and pulmonary complications (OR11.3;95%CI:3.0-41.5; P =<0.001) were independent risk factors for 30-day and/or in-hospital mortality. Median follow-up time was 13 months (interquartile range 5-24); 1-year survival rate was 65%. Aneurysm diameter>80 mm (Hazard-Ratio:2.0;95%CI:1.0-30.5; P =0.037), technical failure (HR:2.6;95%CI:1.1-6.5; P =0.045) and pulmonary complications (HR:3.0;95%CI:1.2-7.9; P =0.021) were independent risk factors for follow-up mortality. CONCLUSION: Endovascular repair of rTAAA shows high technical success; the presence of free rupture alone appear not to correlate with early mortality. Effective prevention/management of post-operative complications is crucial for survival.

15.
J Endovasc Ther ; : 15266028241233163, 2024 Feb 18.
Artículo en Inglés | MEDLINE | ID: mdl-38369733

RESUMEN

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.

16.
Eur J Vasc Endovasc Surg ; 67(2): 192-331, 2024 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-38307694

RESUMEN

OBJECTIVE: The European Society for Vascular Surgery (ESVS) has developed clinical practice guidelines for the care of patients with aneurysms of the abdominal aorta and iliac arteries in succession to the 2011 and 2019 versions, with the aim of assisting physicians and patients in selecting the best management strategy. METHODS: The guideline is based on scientific evidence completed with expert opinion on the matter. By summarising and evaluating the best available evidence, recommendations for the evaluation and treatment of patients have been formulated. The recommendations are graded according to a modified European Society of Cardiology grading system, where the strength (class) of each recommendation is graded from I to III and the letters A to C mark the level of evidence. RESULTS: A total of 160 recommendations have been issued on the following topics: Service standards, including surgical volume and training; Epidemiology, diagnosis, and screening; Management of patients with small abdominal aortic aneurysm (AAA), including surveillance, cardiovascular risk reduction, and indication for repair; Elective AAA repair, including operative risk assessment, open and endovascular repair, and early complications; Ruptured and symptomatic AAA, including peri-operative management, such as permissive hypotension and use of aortic occlusion balloon, open and endovascular repair, and early complications, such as abdominal compartment syndrome and colonic ischaemia; Long term outcome and follow up after AAA repair, including graft infection, endoleaks and follow up routines; Management of complex AAA, including open and endovascular repair; Management of iliac artery aneurysm, including indication for repair and open and endovascular repair; and Miscellaneous aortic problems, including mycotic, inflammatory, and saccular aortic aneurysm. In addition, Shared decision making is being addressed, with supporting information for patients, and Unresolved issues are discussed. CONCLUSION: The ESVS Clinical Practice Guidelines provide the most comprehensive, up to date, and unbiased advice to clinicians and patients on the management of abdominal aorto-iliac artery aneurysms.

17.
J Endovasc Ther ; : 15266028241231905, 2024 Feb 21.
Artículo en Inglés | MEDLINE | ID: mdl-38380515

RESUMEN

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.

20.
J Vasc Surg ; 79(5): 1251-1261.e4, 2024 May.
Artículo en Inglés | MEDLINE | ID: mdl-37757916

RESUMEN

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.

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