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1.
Artículo en Inglés | MEDLINE | ID: mdl-38042252

RESUMEN

OBJECTIVE: This study reports the development of an innovative, interactive Massive Open Online Course (MOOC) teaching radiation safety principles in the vascular workplace, using stepwise e-learning with multiple choice question tests (MCQs), educational videos, and a serious game. The aim was to study the MOOC impact on radiation safety knowledge and assess its feasibility and acceptability. METHODS: An international multicentre prospective study included team members active in the hybrid operating room. The MOOC was offered voluntarily via a secure online learning platform. A standardised MCQ test (15 questions) assessed radiation safety knowledge pre- and post-course (range 0 - 100%). Acceptability and feasibility were tested via the previously validated, Evaluating e-learning system success (EESS) model, using five point Likert scales. RESULTS: In eight centres across four countries, 150 of 203 invited endovascular team members consented. Over a seven week study period, surgeons (28%, including vascular surgery trainees and consultants), nurses (27%, including scrub, circulating and anaesthetic nurses), anaesthetists (43%, including trainees and consultants), and radiographers (3%) participated. Of those, 67% completed the course. The average radiation knowledge improved by 22.8% (95% CI 19.5 - 26.0%; p < .001) after MOOC completion, from 48% to 71% (standard deviation [SD] 14 and 15% respectively), requiring a mean time investment of 169 minutes (SD 89 minutes). In centres with a radiographer, mean knowledge gain after MOOC completion was significantly smaller (14%, SD 19% vs. 24%, SD 16%, p = .036). The course was deemed feasible and acceptable according to the EESS model with a total mean score of 3.68/5. CONCLUSION: This newly developed, multimodal MOOC was deemed feasible and effective across multiple international centres. The MOOC significantly contributes to radiation safety education of the entire endovascular team, improving radiation safety knowledge. The course may optimise workplace radiation safety behaviour and therefore enhance team and patient safety.

3.
J Cardiovasc Surg (Torino) ; 64(1): 82-92, 2023 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-36168949

RESUMEN

BACKGROUND: The hybrid room (HR) is a complex, high-risk environment, requiring teams (surgeons, anesthesiologists, nurses, technologists) to master various skills, including the 'As Low As Reasonably Achievable' principle of radiation safety. This prospective single center cohort reports the first use of the Operating Room Black Box (ORBB) in a HR. This medical data recording system captures procedural and audio-visual data to facilitate structured team performance analysis. METHODS: Patients planned for endovascular repair of an infrarenal abdominal aortic aneurysm (EVAR) or treatment of symptomatic iliac-femoral-popliteal atherosclerotic disease (Peripheral Vascular Interventions or PVI) were included. Validated measures and established assessment tools were used to assess (non-)technical skills, radiation safety performance and environmental distractions. RESULTS: Six EVAR and sixteen PVI procedures were captured. Technical performance for one EVAR was rated 19/35 on the procedure-specific scale, below the 'acceptable' score of 21. Technical skills were rated above acceptable in all PVI procedures. Shared decision making and leadership were rated highly in 12/22 cases, whereas surgical communication and nurses' task management were rated low in 14/22 cases. Team members rarely stepped back from the C-arm during digital subtraction angiography. Radiation safety behavior was scored below 'acceptable' in 14/22 cases. A median (interquartile range) number of 12 (6-23) auditory distractions was observed per procedure. CONCLUSIONS: The ORBB facilitates holistic workplace-based assessment of endovascular performance in a HR by combining objective assessment parameters and rating scale-based evaluations. Strengths and weaknesses were identified in team members' (non-)technical and radiation safety practices. This technology has the potential to improve vascular surgical practice, though human input remains crucial. (NCT04854278).


Asunto(s)
Aneurisma de la Aorta Abdominal , Implantación de Prótesis Vascular , Procedimientos Endovasculares , Humanos , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Aneurisma de la Aorta Abdominal/cirugía , Implantación de Prótesis Vascular/efectos adversos , Implantación de Prótesis Vascular/métodos , Procedimientos Endovasculares/efectos adversos , Procedimientos Endovasculares/métodos , Estudios Prospectivos , Resultado del Tratamiento
4.
J Vasc Surg ; 75(3): 1021-1029.e2, 2022 03.
Artículo en Inglés | MEDLINE | ID: mdl-34923068

RESUMEN

OBJECTIVE: We evaluated whether a combination of intraoperative contrast-enhanced cone beam computed tomography (ceCBCT) and postoperative contrast-enhanced ultrasound (CEUS) after infrarenal endovascular abdominal aortic aneurysm repair (EVAR) could reduce late stent graft-related complications and, consequently, reintervention. METHODS: All consecutive patients who had received infrarenal bifurcated stent grafts in our hybrid room (IGS 730; GE Healthcare, Île-de-France, France) during two discrete periods were included in the present study. From November 2012 to September 2013, two-dimensional completion angiography was performed after each EVAR, followed by computed tomography angiography (CTA) before discharge (group 1). From October 2013 to January 2015, intraoperative ceCBCT was performed, followed by CEUS within the first postoperative days (group 2). Comparative analyses of the outcomes were performed. The primary endpoint was late stent graft-related complications, a composite factor incorporating aneurysm-related death, type I or III endoleaks, kink or occlusion of the iliac limb, and aortic sac enlargement after the first 30 postoperative days. The secondary endpoint was all stent graft-related reinterventions. All-cause and aneurysm-related deaths were also recorded. RESULTS: Overall, 100 consecutive patients (50 each in groups 1 and 2) were enrolled, with a median follow-up of 60 months (interquartile range, 41-69 months). At 60 months after the index procedure, the freedom from late stent graft-related complications in each group was 61.6% (95% confidence interval [CI], 47.0%-80.6%) for group 1 and 81.7% (95% CI, 70.1%-95.2%) for group 2 (P = .033). The use of intraoperative ceCBCT was independently associated with a reduced rate of late stent graft-related complications on multivariate analysis (hazard ratio, 0.39; 95% CI, 0.16-0.95; P = .038) but did not appear to significantly protect against stent graft-related reinterventions (hazard ratio, 0.53; 95% CI, 0.20-1.39; P = .198) or all-cause death (P = .47). CONCLUSIONS: To the best of our knowledge, the present study is the first to report the influence of routine ceCBCT on late outcomes after EVAR. The use of ceCBCT shows the potential for reducing late stent graft-related complications associated.


Asunto(s)
Aorta Abdominal/cirugía , Aneurisma de la Aorta Abdominal/cirugía , Aortografía , Implantación de Prótesis Vascular , Tomografía Computarizada de Haz Cónico , Procedimientos Endovasculares , Cuidados Intraoperatorios , Anciano , Anciano de 80 o más Años , Aorta Abdominal/diagnóstico por imagen , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Aneurisma de la Aorta Abdominal/mortalidad , Prótesis Vascular , Implantación de Prótesis Vascular/efectos adversos , Implantación de Prótesis Vascular/instrumentación , Implantación de Prótesis Vascular/mortalidad , Procedimientos Endovasculares/efectos adversos , Procedimientos Endovasculares/instrumentación , Procedimientos Endovasculares/mortalidad , Femenino , Humanos , Masculino , Persona de Mediana Edad , Complicaciones Posoperatorias/prevención & control , Valor Predictivo de las Pruebas , Estudios Retrospectivos , Medición de Riesgo , Factores de Riesgo , Stents , Factores de Tiempo , Resultado del Tratamiento , Ultrasonografía
5.
J Vasc Interv Radiol ; 32(9): 1360-1370.e2, 2021 09.
Artículo en Inglés | MEDLINE | ID: mdl-34087358

RESUMEN

PURPOSE: To evaluate the impact of preemptive inferior mesenteric artery (IMA) embolization on outcomes of endovascular abdominal aortic aneurysm (AAA) repair (EVAR). MATERIALS AND METHODS: From January 2015 to July 2017, all patients undergoing elective EVAR or fenestrated EVAR (F-EVAR) for asymptomatic AAA in a single tertiary hospital were retrospectively included. Three groups of patients were defined: patients with a patent IMA who underwent embolization during EVAR/F-EVAR (group 1), those with a patent IMA who did not undergo embolization during EVAR/F-EVAR (group 2), and those with a chronically occluded IMA (group 3). Preoperative aortic morphology, demographics, and procedural details were recorded. Aneurysmal growth (≥5 mm), reintervention, and overall mortality rates were analyzed using multivariate proportional hazard multivariate modeling. Propensity scores were constructed, and inverse probability weighting was applied to a new set of multivariate analyses to perform a sensitivity analysis. RESULTS: A total of 266 patients (male, 95% [n = 249]) with a median age of 70 (65-77) years were included, with F-EVAR procedures comprising 87 (32.7%) of the interventions. There were 52, 142, and 72 patients in groups 1, 2, and 3, respectively. Changes in aneurysmal sac size did not differ between groups, nor did overall survival or reintervention rates at 24 months. IMA embolization was not identified as an independently protective factor for aneurysmal growth during follow-up (relative risk [RR] = 2.82/mm [0.96-8.28], P = .060), whereas accessory renal arteries (RR = 5.07/mm [1.72-14.96], P = .003) and a larger preoperative aneurysmal diameter (RR = 1.09/mm [1.03-1.15], P = .004) were independent risk factors for sac enlargement. CONCLUSIONS: Preventive embolization of the IMA during EVAR or F-EVAR did not promote aneurysmal sac shrinking or decrease the reintervention rate at 2-year follow-up.


Asunto(s)
Aneurisma de la Aorta Abdominal , Implantación de Prótesis Vascular , Procedimientos Endovasculares , Anciano , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Aneurisma de la Aorta Abdominal/cirugía , Implantación de Prótesis Vascular/efectos adversos , Endofuga , Procedimientos Endovasculares/efectos adversos , Femenino , Humanos , Masculino , Arteria Mesentérica Inferior/diagnóstico por imagen , Estudios Retrospectivos , Factores de Riesgo , Resultado del Tratamiento
6.
Eur J Vasc Endovasc Surg ; 62(4): 550-558, 2021 10.
Artículo en Inglés | MEDLINE | ID: mdl-33846076

RESUMEN

OBJECTIVE: Myocardial injury after non-cardiac surgery (MINS) is an independent predictor of post-operative mortality in non-cardiac surgery patients and may increase health costs. Few data are available for MINS in vascular surgery patients, in general, and those undergoing fenestrated/branched endovascular aortic repairs (F/BEVAR), in particular. The incidence of MINS after F/BEVAR, the associated risk factors, and prognosis have not been determined. The aim of the present study was to help fill these knowledge gaps. METHODS: A single centre, retrospective study was carried out at a high volume F/BEVAR centre in a university hospital. Adult patients who underwent F/BEVAR between October 2010 and December 2018 were included. A high sensitivity troponin T (HsTnT) assay was performed daily in the first few post-operative days. MINS was defined as a HsTnT level ≥ 14 ng/L (MINS14) or ≥ 20 ng/L (MINS20). After assessment of the incidence of MINS, survival up to two years was estimated in a Kaplan-Meier analysis and the groups were compared according to MINS status. A secondary aim was to identify predictors of MINS. RESULTS: Of the 387 included patients, 240 (62.0%) had MINS14 and 166 (42.9%) had MINS20. In multivariable Cox models, both conditions were significantly associated with poor two year survival (MINS14: adjusted hazard ratio [aHR] 2.15, 95% confidence interval [CI] 1.10 - 4.19; MINS20: aHR 2.43, 95% CI 1.36 - 4.34). In a multivariable logistic regression, age, revised cardiac risk index, duration of surgery, pre-operative estimated glomerular filtration rate (eGFR), and haemoglobin level were independent predictors of MINS. CONCLUSION: After F/BEVAR surgery, the incidence of MINS was particularly high, regardless of the definition considered (MINS14 or MINS20). MINS was significantly associated with poor two year survival. The modifiable predictors identified were duration of surgery, eGFR, and haemoglobin level.


Asunto(s)
Aneurisma de la Aorta/cirugía , Implantación de Prótesis Vascular/efectos adversos , Procedimientos Endovasculares/efectos adversos , Cardiopatías/epidemiología , Anciano , Aneurisma de la Aorta/diagnóstico por imagen , Aneurisma de la Aorta/mortalidad , Biomarcadores/sangre , Implantación de Prótesis Vascular/mortalidad , Procedimientos Endovasculares/mortalidad , Femenino , Francia/epidemiología , Tasa de Filtración Glomerular , Cardiopatías/diagnóstico por imagen , Cardiopatías/mortalidad , Hemoglobinas/metabolismo , Humanos , Incidencia , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Medición de Riesgo , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento
7.
J Endovasc Ther ; 28(3): 415-424, 2021 06.
Artículo en Inglés | MEDLINE | ID: mdl-33660577

RESUMEN

PURPOSE: Evaluate the impact of hybrid operating room (HOR) guidance on the long-term clinical outcomes following fenestrated and branched endovascular repair (F-BEVAR) for complex aortic aneurysms. MATERIALS AND METHODS: Prospectively collected registry data were retrospectively analyzed to compare the procedural, short- and long-term outcomes of consecutive F-BEVAR performed from January 2010 to December 2014 under standard mobile C-arm versus hybrid room guidance in a high-volume aortic center. RESULTS: A total of 262 consecutive patients, including 133 patients treated with a mobile C-arm equipped operating room and 129 with a HOR guidance, were enrolled in this study. Patient radiation exposure and contrast media volume were significantly reduced in the HOR group. Short-term clinical outcomes were improved despite higher case complexity in the HOR group, with no statistical significance. At a median follow-up of 63.3 months (Q1 33.4, Q3 75.9) in the C-arm group, and 44.9 months (Q1 25.1, Q3 53.5, p=0.53) in the HOR group, there was no statistically significant difference in terms of target vessel occlusion and limb occlusion. When the endograft involved 3 or more fenestrations and/or branches (complex F-BEVAR), graft instability (36% vs 25%, p=0.035), reintervention on target vessels (20% vs 11%, p=0.019) and total reintervention rates (24% vs 15%, p=0.032) were significantly reduced in the HOR group. The multivariable Cox regression analysis did not show statistically significant differences for long-term death and aortic-related death between the 2 groups. CONCLUSION: Our study suggests that better long-term clinical outcomes could be observed when performing complex F-BEVAR in the latest generation HOR.


Asunto(s)
Aneurisma de la Aorta Abdominal , Implantación de Prótesis Vascular , Procedimientos Endovasculares , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Aneurisma de la Aorta Abdominal/cirugía , Prótesis Vascular , Implantación de Prótesis Vascular/efectos adversos , Procedimientos Endovasculares/efectos adversos , Humanos , Quirófanos , Estudios Retrospectivos , Factores de Riesgo , Resultado del Tratamiento
8.
J Endovasc Ther ; 28(2): 315-322, 2021 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-33554706

RESUMEN

PURPOSE: To review a single-center experience with fenestrated and branched endovascular aneurysm repair (f/bEVAR) in patients with challenging iliac anatomies. MATERIALS AND METHODS: A retrospective review of the department's database identified 398 consecutive patients who underwent complex endovascular repair f/bEVAR between January 2010 and June 2018; of these, 67 had challenging accesses. The strategies implemented to overcome access issues were reviewed, using a dedicated scoring system to evaluate the access (integrating diameter, tortuosity, calcification, and previous open or endovascular repair). RESULTS: In this subgroup of patients, the most common graft design was a 4-vessel fenestrated endograft (27, 40.3%). Hostile access was due to small diameter (<7 mm) in 25 patients (37.3%) and/or concentric calcifications in 19 patients (26.9%). Mean iliac diameter was 5.5±2.6 mm on the right side and 6.0±2.5 mm on the left side. Previous open or endovascular aortoiliac repair had been performed in 15 patients (22.4%), and 20 patients (29.9%) had a stent previously implanted in at least 1 iliac artery, resulting in the inability to perform standard fenestrated repair with access from both sides. Five patients (7.5%) had a single patent iliac access. Eight distinctive strategies were identified to overcome these access issues, including the use of preloaded renal catheters in the endograft delivery system, angioplasty, graft modification (branches instead of fenestrations or 4 preloaded fenestrations), a conduit via a retroperitoneal approach, iliac artery recanalization, and/or the multiple puncture technique. Technical success was achieved in 62 cases (92.5%). Four patients had access complications and 1 died in the early postoperative period of multiorgan failure. Median follow-up was 24.6 months (IQR 7.2, 41.3). Clinical success at the end of follow-up was achieved in 57 patients (85.1%). During follow-up, 14 patients died, including 4 from an aorta-related cause. CONCLUSION: Dedicated strategies can be implemented to overcome hostile iliac access in patients with complex aneurysms when f/bEVAR is required. Typically, these maneuvers are associated with favorable outcomes.


Asunto(s)
Aneurisma de la Aorta Abdominal , Implantación de Prótesis Vascular , Procedimientos Endovasculares , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Aneurisma de la Aorta Abdominal/cirugía , Prótesis Vascular , Implantación de Prótesis Vascular/efectos adversos , Procedimientos Endovasculares/efectos adversos , Humanos , Diseño de Prótesis , Estudios Retrospectivos , Stents , Resultado del Tratamiento
9.
Biomater Sci ; 9(1): 212-220, 2021 Jan 05.
Artículo en Inglés | MEDLINE | ID: mdl-33179639

RESUMEN

Drug-eluting stents have demonstrated efficiency in in-stent restenosis (ISR) but induced a risk of late acute thrombosis by delaying strut re-endothelialization. Polydopamine (PDA), a biocompatible polymer inspired from adhesive proteins of mussels, has been reported to promote endothelial cell (EC) proliferation while limiting SMC proliferation in vitro, thus suggesting the pro-healing potential. This study aimed at evaluating in vivo the impact of the pro-healing PDA-coated stent on ISR and on the quality of the strut re-endothelialization in a rat model. PDA-coated stents demonstrated a significant reduction in ISR in vivo compared to bare metal stents (ratio neointima/media = 0.48 (±0.26) versus 0.83 (±0.42), p < 0.001). Western blot analyses identified a trend towards an increased activation of p38 MAPK phosphorylation and its anti-proliferative effects on vascular SMC that could explain the results observed in morphological analyses. This bioinspired and biocompatible polydopamine layer could intrinsically limit ISR. In addition, according to its latent reactivity, PDA offers the possibility to immobilize some relevant drugs on the PDA-functionalized stent to provide potential synergistic effects.


Asunto(s)
Reestenosis Coronaria , Stents Liberadores de Fármacos , Animales , Materiales Biocompatibles Revestidos , Indoles , Polímeros , Ratas , Stents
10.
Eur J Vasc Endovasc Surg ; 60(3): 374-385, 2020 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-32682690

RESUMEN

OBJECTIVE: Occupational exposure is a growing concern among the endovascular specialist community. Several types of imaging equipment are available, such as mobile C arms or hybrid rooms, and some have been shown to deliver higher levels of radiation. A literature review was conducted to identify studies reporting dose data during standard (EVAR) and complex abdominal aortic endovascular repair (fenestrated/branched EVAR [F/BEVAR]). METHODS: A search of the MEDLINE and the Cochrane databases was performed by two independent investigators using the medical subject heading terms "aortic aneurysms", "radiation", and "humans" over a search period of 10 years. Studies with full text available in English and reporting radiation data independently from the imaging equipment type were included. Experimental studies were excluded. RESULTS: The lowest dose-area product levels during EVAR and F/BEVAR were identified in hybrid rooms, while the highest were with fixed systems. When adherence to the as low as reasonably achievable principles was stipulated by the authors, dose reports tended to be among the lowest. Several studies, especially of F/BEVAR, report concerning levels of radiation for both patients and staff. CONCLUSION: Modern imaging equipment type, team involvement with radiation management, and the support of recent imaging technologies such as fusion help to reduce the dose delivered during standard and complex EVAR. Investment in modern imaging technology should be considered in every centre providing endovascular management of aortic aneurysms.


Asunto(s)
Aorta Abdominal/cirugía , Aneurisma de la Aorta Abdominal/cirugía , Procedimientos Endovasculares , Exposición Profesional , Salud Laboral , Quirófanos , Dosis de Radiación , Exposición a la Radiación , Radiografía Intervencional , Aorta Abdominal/diagnóstico por imagen , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Procedimientos Endovasculares/efectos adversos , Humanos , Exposición Profesional/efectos adversos , Exposición Profesional/prevención & control , Exposición a la Radiación/efectos adversos , Exposición a la Radiación/prevención & control , Protección Radiológica , Radiografía Intervencional/efectos adversos , Medición de Riesgo , Factores de Riesgo , Dispersión de Radiación
11.
Cardiovasc Intervent Radiol ; 43(9): 1331-1341, 2020 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-32686038

RESUMEN

PURPOSE: Radiation safety performance is often evaluated using dose parameters measured by personal dosimeters and/or the C-arm, which provide limited information about teams' actual radiation safety behaviors. This study aimed to develop a rating scale to evaluate team radiation safety behaviors more accurately and investigate its reliability. MATERIALS AND METHODS: A modified Delphi consensus was organized involving European vascular surgeons (VS), interventional radiologists, and interventional cardiologists. Initial items and anchors were drafted a priori and rated using five-point Likert scales. Participants could suggest additional items or adjustments. Consensus was defined as ≥ 80% agreement (rating ≥ 4) with Cronbach's alpha ≥ .80. Two VS with expertise in radiation safety evaluated 15 video-recorded endovascular repairs of infrarenal aortic aneurysms (EVAR) to assess usability, inter and intrarater reliability. RESULTS: Thirty-one of 46 invited specialists completed three rating rounds to generate the final rating scale. Five items underwent major adjustments. In the final round, consensus was achieved for all items (alpha = .804; agreement > 87%): 'Pre-procedural planning', 'Preparation in angiosuite/operating room', 'Shielding equipment', 'Personal protective equipment', 'Position of operator/team', 'Radiation usage awareness', 'C-arm handling', 'Adjusting image quality', 'Additional dose reducing functions', 'Communication/leadership', and 'Overall radiation performance and ALARA principle'. All EVARs were rated, yielding excellent Cronbach's alpha (.877) with acceptable interrater and excellent intrarater reliability (ICC = .782; ICC = .963, respectively). CONCLUSION: A reliable framework was developed to assess radiation safety behaviors in endovascular practice and provide teams with formative feedback. The final scale is provided in this publication.


Asunto(s)
Competencia Clínica , Consenso , Traumatismos por Radiación/prevención & control , Radiólogos/normas , Radiología Intervencionista/normas , Humanos , Dosis de Radiación , Reproducibilidad de los Resultados
12.
Mater Sci Eng C Mater Biol Appl ; 113: 110967, 2020 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-32487386

RESUMEN

Current vascular drug-eluting stents based on immuno-proliferative drugs would reduce the rate of in-stent restenosis (ISR) but may be associated with a higher risk of acute stent thrombosis due to non-selective activity. In this paper, we aimed to develop a polydopamine (PDA) coated chromium­cobalt (CoCr) stent functionalised with EP224283 (Endotis Pharma SA), which combines both a GPIIbIIIa antagonist (tirofiban moiety) and a factor Xa inhibitor (idraparinux moiety) to reduce acute stent thrombosis. PDA-coated chromium­cobalt (CoCr) samples were first immersed in a polyethylenimine (PEI, pH 8.5) solution to increase amine function density (36.0 ± 0.1 nmol/cm2) on the CoCr surface. In a second step, avidin was grafted onto CoCr-PDA-PEI through the biotin linkage (strategy 1) or directly by coupling reactions (strategy 2). The HABA titration proved the fixation of biotin onto CoCr-PDA-PEI surface with a density of 0.74 nmol/cm2. The fixation of avidin was demonstrated by water contact angle (WCA) and surface plasmon resonance (SPR). SEM micrograph shows the flexibility of the thin layer coated onto the stent after balloon inflation. Independently of the strategy, a qualitative SEM analysis showed a reduction in platelet activation when the molecule EP224283 was immobilised on avidin. In parallel, the measurement of anticoagulant activity (anti-Xa) revealed a higher anti-factor Xa activity (2.24 IU/mL vs. 0.09 IU/mL in control) when EP224283 was immobilised on avidin. Interestingly, after seven days of degradation, the anticoagulant activity was persistent in both strategies and looked more important with the strategy 2 than in strategy 1. Throughout this work, we developed an innovative vascular stent through the immobilisation of EP224283 onto CoCr-PDA-PEI-(avidin) system, which provides a promising solution to reduce ISR and thrombosis after stent implantation.


Asunto(s)
Materiales Biocompatibles/química , Biotina/análogos & derivados , Stents Liberadores de Fármacos , Indoles/química , Oligosacáridos/química , Polímeros/química , Avidina/química , Materiales Biocompatibles/farmacología , Biotina/química , Biotina/farmacología , Supervivencia Celular/efectos de los fármacos , Cromo/química , Cobalto/química , Factor Xa/química , Factor Xa/metabolismo , Células Endoteliales de la Vena Umbilical Humana , Humanos , Oligosacáridos/metabolismo , Oligosacáridos/farmacología , Activación Plaquetaria/efectos de los fármacos , Adhesividad Plaquetaria/efectos de los fármacos , Polietileneimina/química , Propiedades de Superficie
13.
Eur J Vasc Endovasc Surg ; 60(5): 677, 2020 11.
Artículo en Inglés | MEDLINE | ID: mdl-32386791
14.
J Am Heart Assoc ; 9(6): e014916, 2020 03 17.
Artículo en Inglés | MEDLINE | ID: mdl-32172643

RESUMEN

Background Ultrasound (US) guidance provides the unique opportunity to control the puncture zone of the artery during transfemoral transcatheter aortic valve replacement and may decrease major vascular complications (VC) and life-threatening or major bleeding complications. This study aimed to evaluate the clinical impact of US guidance using a propensity score-matched comparison. Methods and Results US guidance was implemented as the default approach for all transfemoral transcatheter aortic valve replacement cases in our institution in June 2013. We defined 3 groups of consecutive patients according to the method of puncture (fluoroscopic/US guidance) and the use of a transcatheter heart valve. Patients in the US-guided second-generation group (Sapien XT [Edwards Lifesciences, Irvine, CA], Corevalve [Medtronic, Dublin, Ireland]) were successfully 1:1 matched with patients in the fluoroscope-guided second-generation group (n=95) with propensity score matching. In a second analysis we described the consecutive patients of the US-guided third-generation group (Evolut-R [Medtronic], Sapien 3 [Edwards Lifesciences], n=308). All vascular and bleeding complications were reduced in the US-guided second-generation group compared with the fluoroscope-guided second-generation group: VC (16.8% versus 6.3%; P=0.023); life-threatening or major bleeding (22.1% versus 6%; P=0.004); and VC related to vascular access (12.6% versus 4.2%; P=0.052). In the US-guided third-generation group the rates of major VC and life-threatening or major bleeding were 3.2% (95% CI, 1.6% to 5.9%) and 3.6% (95% CI, 1.8% to 6.3%). In the overall population (n=546), life-threatening or major bleeding was associated with a 1.7-fold increased mortality risk (P=0.02). Conclusions We demonstrated that US guidance effectively reduced VC and bleeding complications for transfemoral transcatheter aortic valve replacement and should be considered the standard puncture method. Registration URL: http://www.clinicaltrials.gov. Unique identifier: NCT02628509.


Asunto(s)
Cateterismo Periférico , Arteria Femoral/diagnóstico por imagen , Hemorragia Posoperatoria/prevención & control , Radiografía Intervencional , Reemplazo de la Válvula Aórtica Transcatéter , Ultrasonografía Intervencional , Lesiones del Sistema Vascular/prevención & control , Anciano , Anciano de 80 o más Años , Cateterismo Periférico/efectos adversos , Cateterismo Periférico/mortalidad , Femenino , Arteria Femoral/lesiones , Fluoroscopía , Humanos , Masculino , Hemorragia Posoperatoria/etiología , Hemorragia Posoperatoria/mortalidad , Puntaje de Propensión , Punciones , Radiografía Intervencional/efectos adversos , Radiografía Intervencional/mortalidad , Estudios Retrospectivos , Medición de Riesgo , Factores de Riesgo , Factores de Tiempo , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Reemplazo de la Válvula Aórtica Transcatéter/mortalidad , Resultado del Tratamiento , Ultrasonografía Intervencional/efectos adversos , Ultrasonografía Intervencional/mortalidad , Lesiones del Sistema Vascular/etiología , Lesiones del Sistema Vascular/mortalidad
16.
J Vasc Surg ; 69(5): 1342-1355, 2019 05.
Artículo en Inglés | MEDLINE | ID: mdl-30477943

RESUMEN

BACKGROUND: The objective of this study was to evaluate outcomes after fenestrated and branched endovascular aneurysm repair (F-BEVAR) performed in high-risk patients to treat pararenal (PR) aneurysms and thoracoabdominal aortic aneurysms (TAAAs) and to identify those patients likely to benefit from this treatment. METHODS: A prospective single-center review of patients treated electively for PR aneurysm and TAAA using F-BEVAR between 2004 and 2016 was performed. Survival was estimated using the Kaplan-Meier method. Risk factors associated with 30-day morbidity and mortality during follow-up were determined using multivariate statistical techniques and a Cox regression model including all variables that were significant on univariate analysis (P < .05). RESULTS: There were 468 patients (median age, 71.6 years) identified, with American Society of Anesthesiologists score ≥3 in 94.7%. There were 221 (47.2%) type I to type III TAAAs and 247 (52.8%) type IV and type V TAAAs and PR aneurysms, with a median diameter of 58 mm. Technical success for target vessel stenting was 99.1% (1493/1506). The 30-day mortality rate was 4.9% (23 patients). The spinal cord ischemia rate was 3.8% (18 patients). Twenty patients (4.3%) required postoperative dialysis and four patients (0.8%) long-term dialysis after discharge. Median follow-up was 29 months. Survival at 1 year, 3 years, and 5 years was 86.7% (95% confidence interval [CI], 83.1-89.6), 73.3% (95% CI, 68.3-77.6), and 59.6% (95% CI, 53.4-65.2), respectively. Freedom from any target vessel occlusion and freedom from secondary procedures were 96.2% (95% CI, 93.8-97.7) and 88.2% (95% CI, 84.8-90.9) at 1 year and 90.0% (95% CI, 84.5-91.9) and 70.2% (95% CI, 63.9-75.6) at 5 years, respectively. In multivariate analysis, early mortality was associated with procedure time (hazard ratio [HR], 1.007 per minute; 95% CI, 1.003-1.010; P < .001), TAAA preoperative diameter (HR, 1.053 per millimeter; 95% CI, 1.020-1.087; P = .001), and chronic kidney disease (HR, 3.139; 95% CI, 1.369-7.196; P = .007). Mortality during the first 24 months of follow-up was associated with Crawford types I to III (HR, 1.526; 95% CI, 1.061-2.196; P = .023) compared with infradiaphragmatic repairs, chronic kidney disease (HR, 1.874; 95% CI, 1.294-2.712; P < .001), and TAAA preoperative diameter (HR, 1.027 per millimeter; 95% CI, 1.010-1.044; P = .002). In addition to these risk factors, mortality after 24 months of follow-up was also associated with age at repair (HR, 1.055 per year; 95% CI, 1.021-1.090; P = .001). CONCLUSIONS: F-BEVAR performed in high-risk patients is associated with favorable outcomes. Judicious selection of patients should take into consideration the reported risk factors associated with early and late mortality.


Asunto(s)
Aneurisma de la Aorta Abdominal/cirugía , Aneurisma de la Aorta Torácica/cirugía , Implantación de Prótesis Vascular/mortalidad , Procedimientos Endovasculares/mortalidad , Complicaciones Posoperatorias/mortalidad , Anciano , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Aneurisma de la Aorta Abdominal/mortalidad , Aneurisma de la Aorta Torácica/diagnóstico por imagen , Aneurisma de la Aorta Torácica/mortalidad , Prótesis Vascular , Implantación de Prótesis Vascular/efectos adversos , Implantación de Prótesis Vascular/instrumentación , Procedimientos Endovasculares/efectos adversos , Procedimientos Endovasculares/instrumentación , Femenino , Humanos , Masculino , Estudios Retrospectivos , Medición de Riesgo , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento
17.
J Cardiovasc Surg (Torino) ; 60(4): 518-525, 2019 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-29943958

RESUMEN

Connective tissue disease (CTD) represents a group of genetic conditions characterized by disruptive matrix remodeling. When this process involves aortic and vascular wall, patients with CTD have a high risk of developing arterial aneurysms, dissections and ruptures. Open surgical repair is still the gold standard therapy for patients with CTD with reasonable morbidity and mortality risk. The surgical treatment of CTD often requires multiple operations. In the endovascular era, fenestrated and branched stent grafts may play a role in reducing the complications of multiple open operations. Although the long-term results of endovascular treatment in the setting of CTD are unknown, it is generally accepted that endovascular treatment is restricted to selected patients with high surgical risk. In an emergency setting, endovascular intervention can serve as a lifesaving bridge to elective open aortic repair. Aortic centers performing a large volume of complex open and endovascular aortic repairs have started to combine these two techniques in a staged fashion. The goal is to reduce the morbidity and mortality associated with extensive aortic repairs in CTD patients. For this reason, recommend endovascular therapy when a "graft-to-graft" approach is possible. In this scenario, the surgeon who performs the open repair must take into consideration future interventions. Surgical repair in any aortic segment should allow creation of proximal and distal landing zones over 4 cm to secure the sealing of a future stent graft. Connective tissue disease should be treated with a multidisciplinary approach, in high volume centers. Endovascular treatment represents a potential option in patients at high risk for open repair. Staged hybrid procedures have emerged as a way to reduce spinal cord ischemia and avoid multiple open surgeries. The aim of this article is to discuss the management of aortic diseases in CTD, focusing on to the role of standard open surgery and emerging endovascular treatment, and to give an overview of the few series published regarding this topic with a small number of patients.


Asunto(s)
Aneurisma de la Aorta/cirugía , Enfermedades del Tejido Conjuntivo/complicaciones , Síndrome de Ehlers-Danlos/tratamiento farmacológico , Síndrome de Marfan/tratamiento farmacológico , Aneurisma de la Aorta/etiología , Síndrome de Ehlers-Danlos/complicaciones , Procedimientos Endovasculares , Humanos , Síndrome de Marfan/complicaciones
18.
Eur J Vasc Endovasc Surg ; 56(3): 426-433, 2018 09.
Artículo en Inglés | MEDLINE | ID: mdl-29895398

RESUMEN

OBJECTIVE: To evaluate radiation exposure in standard endovascular aneurysm repair (EVAR) using intra-operative guidance with pre-operative computed tomographic angiography (CTA) fusion and strict ALARA guidelines in a modern hybrid room. MATERIAL AND METHODS: Between February and November 2016, consecutive patients with AAA undergoing EVAR with a bifurcated device in a hybrid room under fusion imaging guidance were prospectively enrolled in six aortic centres from the United States (n = 1), Europe (n = 4), and Japan (n = 1). Demographic data including body mass index (BMI), indirect dose area product (DAP), cumulative air kerma (CAK), variables influencing dose delivery, and contrast media volume were collected. RESULTS: 85 patients (90.4% males) were included. The median age was 75 (IQR 69-81), with a median BMI of 27.4 (IQR 24.7-30.6). Median DAP and CAK were 14.7 (IQR 10.0-27.7) Gy·cm2 and 107 (IQR 68.0-189.0) mGy, respectively. The median contrast volume was 47 mL (IQR 35-70) (equivalent to 14.1g of iodine [IQR 10.5-21.0]). Median DAP per centre was 28.1 (n = 16, IQR 12.6-47.1), 15.9 (n = 11, IQR 11.9-22.5), 14.2 (n = 12, IQR 10.9-25.7), 20.2 (n = 18, IQR 7.0-39.5), 10.3 (n = 27, IQR 8.2-14.7) and 26.5 (n = 1) Gy·cm2. In multivariable analysis, collimation was the only factor that was significantly associated with DAP reduction, (coefficient = -0.014 per percentage of collimation, 95% CI -0.019 to -0.008, p < .001). CONCLUSIONS: With adherence to the ALARA principle and routine application of fusion imaging guidance for EVAR, low radiation exposure compared with the published literature can be achieved in a real world setting.


Asunto(s)
Aneurisma de la Aorta Abdominal/cirugía , Implantación de Prótesis Vascular , Procedimientos Endovasculares , Dosis de Radiación , Exposición a la Radiación/prevención & control , Protección Radiológica/métodos , Radiografía Intervencional , Anciano , Anciano de 80 o más Años , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Aortografía/métodos , Implantación de Prótesis Vascular/efectos adversos , Implantación de Prótesis Vascular/normas , Angiografía por Tomografía Computarizada , Medios de Contraste/administración & dosificación , Medios de Contraste/efectos adversos , Procedimientos Endovasculares/efectos adversos , Procedimientos Endovasculares/normas , Europa (Continente) , Femenino , Adhesión a Directriz , Humanos , Japón , Masculino , Ciudad de Nueva York , Tempo Operativo , Seguridad del Paciente , Guías de Práctica Clínica como Asunto , Valor Predictivo de las Pruebas , Estudios Prospectivos , Exposición a la Radiación/efectos adversos , Exposición a la Radiación/normas , Monitoreo de Radiación , Protección Radiológica/normas , Radiografía Intervencional/efectos adversos , Radiografía Intervencional/normas , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento
19.
Eur J Vasc Endovasc Surg ; 55(4): 504-510, 2018 04.
Artículo en Inglés | MEDLINE | ID: mdl-29501401

RESUMEN

OBJECTIVES: To evaluate the outcomes of the second generation BeGraft balloon expandable covered stent Graft System (Bentley InnoMed, Hechingen, Germany) implanted as bridging stent grafts during fenestrated endovascular aortic repair (FEVAR) of complex aneurysms. DESIGN: This was a single centre prospective study including all consecutive patients treated by FEVAR performed with second generation BeGraft stent grafts as bridging stents. METHODS: Demographics of patients, diameter and length of the bridging stent grafts, technical success, re-interventions, occlusions, post-operative events, and imaging (Cone Beam CT and/or CT scan, and contrast enhanced ultrasound) were prospectively collected in an electronic database. Duplex ultrasound was performed before discharge and at 6 month follow-up. At 1 year, patients were evaluated clinically and by imaging (CT and ultrasound). RESULTS: Between November 2015 and September 2016, 39 consecutive patients (one woman) were treated with custom made fenestrated endografts (2-5 fenestrations) for complex aneurysms or type 1 endoleak after EVAR, using a variety of bridging stents including the BeGraft. All 101 BeGraft stent grafts were successfully delivered and deployed. There was no in hospital mortality. Early fenestration patency rate was 99% (96/97); the sole target vessel post-operative occlusion was secondary to a dissection of the renal artery distal to the stent. Complementary stenting was unsuccessful in recovering renal artery patency; bilateral renal stent occlusion was observed in the same patient on a CT scan performed 2 months after the procedure. He required post-operative dialysis. No additional renal impairment was observed. During follow-up (median 13 months [11-15]), all fenestrations stented with BeGraft stent grafts remained patent (95/97, 98%). One type 1b endoleak was detected and treated (2.6%). CONCLUSIONS: BeGraft stent grafts used as bridging stents during FEVAR are associated with favourable outcomes at 1 year follow-up. Long-term follow-up is required to confirm these promising results.


Asunto(s)
Aneurisma de la Aorta Abdominal/cirugía , Aneurisma de la Aorta Torácica/cirugía , Implantación de Prótesis Vascular/instrumentación , Prótesis Vascular , Procedimientos Endovasculares/instrumentación , Stents , Anciano , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Aneurisma de la Aorta Abdominal/fisiopatología , Aneurisma de la Aorta Torácica/diagnóstico por imagen , Aneurisma de la Aorta Torácica/fisiopatología , Aortografía/métodos , Implantación de Prótesis Vascular/efectos adversos , Angiografía por Tomografía Computarizada , Bases de Datos Factuales , Endofuga/etiología , Procedimientos Endovasculares/efectos adversos , Femenino , Oclusión de Injerto Vascular/etiología , Oclusión de Injerto Vascular/fisiopatología , Humanos , Masculino , Estudios Prospectivos , Diseño de Prótesis , Factores de Tiempo , Resultado del Tratamiento , Ultrasonografía Doppler Dúplex , Grado de Desobstrucción Vascular
20.
J Vasc Surg ; 67(3): 685-693, 2018 03.
Artículo en Inglés | MEDLINE | ID: mdl-29153441

RESUMEN

OBJECTIVE: We report our experience of the treatment of postdissection arch aneurysms and thoracoabdominal aortic aneurysms (TAAAs) by endovascular repair using fenestrated and branched endografts. METHODS: This study includes all patients presenting with chronic postdissection aneurysms >55 mm in diameter deemed unfit for open surgery and treated by complex endografting between October 2011 and April 2017. Where appropriate, staged management strategies including left subclavian artery revascularization, thoracic endografting, dissection flap fenestration, and tear enlargement were performed before the complex endovascular repair. Outcome data were collected prospectively, specifically including technical success, endoleaks, target vessel patency, aneurysm diameter, adverse events, reinterventions, and mortality. RESULTS: We treated 40 patients with a median age of 63 years (55-71 years). In total, 43 procedures were performed: 19 arch repairs using inner branch endografts (one to three branches) and 24 TAAA repairs using fenestrated or branched endografts. Three patients were treated using both arch and TAAA repair. The median time between initial presentation with acute dissection and the first complex aortic repair was 5 years (3.0-10.0 years). Staged procedures were performed in 33 of 40 patients (82.5%). The technical success rate was 93%, the median procedure length was 240 minutes (170-285 minutes), and the median dose-area product was 80 Gy · cm2 (54.3-138.4 Gy · cm2). The 30-day and in-hospital mortality rates were 2.3% (1/43) and 4.7% (2/43), respectively. The spinal cord ischemia rate was 7% and occurred only after TAAA repair. One stroke with partial recovery and one transient ischemic attack were observed (4.7%) after arch repair. Six early reinterventions (14%) were performed: three for access complications, two to treat acute hemorrhage, and one to treat a type II endoleak. Median follow-up was 25.5 months (11-42.25 months). The 1- and 5-year survival rates were 90% and 76.4%, respectively. Late reinterventions were required in eight patients, two in the arch group (to treat endoleaks at 3 and 33 months) and six in the TAAA group (2 iliac and 1 bifurcated endograft extensions, 2 additional renal stents, 1 inferior mesenteric artery embolization). Aneurysm diameter was stable (72%) or shrank (23%) during follow-up. Enlargement was shown in two patients with endoleaks. CONCLUSIONS: Complex endovascular repair of postdissection aneurysms is a safe procedure in patients deemed unfit for open surgery. Our experience suggests that close follow-up is mandatory as secondary procedures are frequently required to completely exclude the false lumen.


Asunto(s)
Aneurisma de la Aorta Torácica/cirugía , Implantación de Prótesis Vascular , Procedimientos Endovasculares , Anciano , Aneurisma de la Aorta Torácica/diagnóstico por imagen , Aneurisma de la Aorta Torácica/mortalidad , Aortografía/métodos , Prótesis Vascular , Implantación de Prótesis Vascular/efectos adversos , Implantación de Prótesis Vascular/instrumentación , Implantación de Prótesis Vascular/mortalidad , Angiografía por Tomografía Computarizada , Procedimientos Endovasculares/efectos adversos , Procedimientos Endovasculares/instrumentación , Procedimientos Endovasculares/mortalidad , Femenino , Humanos , Estimación de Kaplan-Meier , Masculino , Persona de Mediana Edad , Complicaciones Posoperatorias/mortalidad , Complicaciones Posoperatorias/terapia , Diseño de Prótesis , Estudios Retrospectivos , Factores de Riesgo , Stents , Factores de Tiempo , Resultado del Tratamiento
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