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1.
J Endovasc Ther ; : 15266028241252097, 2024 May 09.
Article in English | MEDLINE | ID: mdl-38721876

ABSTRACT

INTRODUCTION: Endoleaks represent one of the main complications after endovascular aortic repair (EVAR) and can lead to increased re-intervention rates and secondary rupture. Serial lifelong surveillance is required and traditionally involves cross-sectional imaging with manual axial measurements. Artificial intelligence (AI)-based imaging analysis has been developed and may provide a more precise and faster assessment. This study aims to evaluate the ability of an AI-based software to assess post-EVAR morphological changes over time, detect endoleaks, and associate them with EVAR-related adverse events. METHODS: Patients who underwent EVAR at a tertiary hospital from January 2017 to March 2020 with at least 2 follow-up computed tomography angiography (CTA) were analyzed using PRAEVAorta 2 (Nurea). The software was compared to the ground truth provided by human experts using Sensitivity (Se), Specificity (Sp), Negative Predictive Value (NPV), and Positive Predictive Value (PPV). Endovascular aortic repair-related adverse events were defined as aneurysm-related death, rupture, endoleak, limb occlusion, and EVAR-related re-interventions. RESULTS: Fifty-six patients were included with a median imaging follow-up of 27 months (interquartile range [IQR]: 20-40). There were no significant differences overtime in the evolution of maximum aneurysm diameters (55.62 mm [IQR: 52.33-59.25] vs 54.34 mm [IQR: 46.13-59.47]; p=0.2162) or volumes (130.4 cm3 [IQR: 113.8-171.7] vs 125.4 cm3 [IQR: 96.3-169.1]; p=0.1131) despite a -13.47% decrease in the volume of thrombus (p=0.0216). PRAEVAorta achieved a Se of 89.47% (95% confidence interval [CI]: 80.58 to 94.57), a Sp of 91.25% (95% CI: 83.02 to 95.70), a PPV of 90.67% (95% CI: 81.97 to 95.41), and an NPV of 90.12% (95% CI: 81.70 to 94.91) in detecting endoleaks. Endovascular aortic repair-related adverse events were associated with global volume modifications with an area under the curve (AUC) of 0.7806 vs 0.7277 for maximum diameter. The same trend was observed for endoleaks (AUC of 0.7086 vs 0.6711). CONCLUSIONS: The AI-based software PRAEVAorta enabled a detailed anatomic characterization of aortic remodeling post-EVAR and showed its potential interest for automatic detection of endoleaks during follow-up. The association of aortic aneurysmal volume with EVAR-related adverse events and endoleaks was more robust compared with maximum diameter. CLINICAL IMPACT: The integration of PRAEVAorta AI software into clinical practice promises a transformative shift in post-EVAR surveillance. By offering precise and rapid detection of endoleaks and comprehensive anatomic assessments, clinicians can expect enhanced diagnostic accuracy and streamlined patient management. This innovation reduces reliance on manual measurements, potentially reducing interpretation errors and shortening evaluation times. Ultimately, PRAEVAorta's capabilities hold the potential to optimize patient care, leading to more timely interventions and improved outcomes in endovascular aortic repair.

3.
Br J Surg ; 111(1)2024 Jan 03.
Article in English | MEDLINE | ID: mdl-38091972

ABSTRACT

BACKGROUND: Repair of thoracic aortic aneurysms with either endovascular repair (TEVAR) or open surgical repair (OSR) represents major surgery, is costly and associated with significant complications. The aim of this study was to establish accurate costs of delivering TEVAR and OSR in a cohort of UK NHS patients suitable for open and endovascular treatment for the whole treatment pathway from admission and to discharge and 12-month follow-up. METHODS: A prospective study of UK NHS patients from 30 NHS vascular/cardiothoracic units in England aged ≥18, with distal arch/descending thoracic aortic aneurysms (CTAA) was undertaken. A multicentre prospective cost analysis of patients (recruited March 2014-July 2018, follow-up until July 2019) undergoing TEVAR or OSR was performed. Patients deemed suitable for open or endovascular repair were included in this study. A micro-costing approach was adopted. RESULTS: Some 115 patients having undergone TEVAR and 35 patients with OSR were identified. The mean (s.d.) cost of a TEVAR procedure was higher £26 536 (£9877) versus OSR £17 239 (£8043). Postoperative costs until discharge were lower for TEVAR £7484 (£7848) versus OSR £28 636 (£23 083). Therefore, total NHS costs from admission to discharge were lower for TEVAR £34 020 (£14 301), versus OSR £45 875 (£43 023). However, mean NHS costs for 12 months following the procedure were slightly higher for the TEVAR £5206 (£11 585) versus OSR £5039 (£11 994). CONCLUSIONS: Surgical procedure costs were higher for TEVAR due to device costs. Total in-hospital costs were higher for OSR due to longer hospital and critical care stay. Follow-up costs over 12 months were slightly higher for TEVAR due to hospital readmissions.


Subject(s)
Aortic Aneurysm, Thoracic , Blood Vessel Prosthesis Implantation , Endovascular Procedures , Humans , Prospective Studies , Blood Vessel Prosthesis Implantation/methods , Endovascular Procedures/adverse effects , Treatment Outcome , Aortic Aneurysm, Thoracic/surgery , Hospital Costs , Retrospective Studies , Postoperative Complications/etiology , Risk Factors
4.
Emerg Med J ; 41(3): 153-161, 2024 Feb 20.
Article in English | MEDLINE | ID: mdl-38050049

ABSTRACT

BACKGROUND: Standardisation of referral pathways and the transfer of patients with acute aortic syndromes (AAS) to regional centres are recommended by NHS England in the Acute Aortic Dissection Toolkit. The aim of the Transfer of Thoracic Aortic Vascular Emergencies to Regional Specialist INstitutes Group study was to establish an interdisciplinary consensus on the interhospital transfer of patients with AAS to specialist high-volume aortic centres. METHODS: Consensus on the key aspects of interhospital transfer of patients with AAS was established using the Delphi method, in line with Conducting and Reporting of Delphi Studies guidelines. A national patient charity for aortic dissection was involved in the design of the Delphi study. Vascular and cardiothoracic surgeons, emergency physicians, interventional radiologists, cardiologists, intensivists and anaesthetists in the United Kingdom were invited to participate via their respective professional societies. RESULTS: Three consecutive rounds of an electronic Delphi survey were completed by 212, 101 and 58 respondents, respectively. Using predefined consensus criteria, 60 out of 117 (51%) statements from the survey were included in the consensus statement. The study concluded that patients can be taken directly to a specialist aortic centre if they have typical symptoms of AAS on the background of known aortic disease or previous aortic intervention. Accepted patients should be transferred in a category 2 ambulance (response time <18 min), ideally accompanied by transfer-trained personnel or Adult Critical Care Transfer Services. A clear plan should be agreed in case of a cardiac arrest occurring during the transfer. Patients should reach the aortic centre within 4 hours of the initial referral from their local hospital. CONCLUSIONS: This consensus statement is the first set of national interdisciplinary recommendations on the interhospital transfer of patients with AAS. Its implementation is likely to contribute to safer and more standardised emergency referral pathways to regional high-volume specialist aortic units.


Subject(s)
Aortic Dissection , Adult , Humans , Delphi Technique , Aortic Dissection/therapy , Referral and Consultation , United Kingdom , England
5.
Ann Vasc Surg ; 101: 105-119, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38160705

ABSTRACT

BACKGROUND: Thoracoabdominal aortic aneurysms (TAAA) pose significant risks of morbidity and mortality. Considering the evolving techniques for TAAA intervention and the growing interest in quality of life (QoL) outcomes for decision-making, we aimed to evaluate the impact of patient and perioperative characteristics on short-term, medium-term, and long-term postoperative QoL in TAAA repair patients. METHODS: A systematic search was conducted in CINAHL, APA PsycINFO, EMBASE, Medline and Cochrane to identify primary research studies evaluating QoL post TAAA surgery, published in English or Swedish between January 01, 2012 and September 26, 2022. A narrative synthesis was reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. The quality of evidence was assessed using the Critical Appraisal Skills Program and Joanna Briggs Institute checklists. RESULTS: Eight studies of low or moderate quality with 455 patients were included. Preoperative QoL in TAAA patients was lower compared to the general population. While there is an initial short-term improvement in postoperative QoL, patients fail to reach baseline levels even after 7 years, with physical activity and functioning domains being particularly affected. Experiencing postoperative complications, including paraplegia and cardiovascular events, negatively impacts postoperative QoL. Patients with uncomplicated postoperative status had improved QoL. Prolonged hospital stay negatively affects physical functioning. CONCLUSIONS: Individuals with TAAA are likely to have lower baseline QoL compared to the general population. Following TAAA repair, postoperative QoL may remain lower than baseline levels, persisting over the long-term. Comorbidities, postoperative complications, and hospitalization duration appear to exert adverse effects on postoperative QoL.


Subject(s)
Aortic Aneurysm, Thoracic , Aortic Aneurysm, Thoracoabdominal , Blood Vessel Prosthesis Implantation , Humans , Quality of Life , Aortic Aneurysm, Thoracic/diagnostic imaging , Aortic Aneurysm, Thoracic/surgery , Aortic Aneurysm, Thoracic/etiology , Blood Vessel Prosthesis Implantation/adverse effects , Treatment Outcome , Time Factors , Postoperative Complications/etiology , Postoperative Complications/surgery , Retrospective Studies , Risk Factors
7.
JAMA Surg ; 158(8): 832-839, 2023 08 01.
Article in English | MEDLINE | ID: mdl-37314760

ABSTRACT

Importance: Endovascular treatment is not recommended for aortic pathologies in patients with connective tissue diseases (CTDs) other than in redo operations and as bridging procedures in emergencies. However, recent developments in endovascular technology may challenge this dogma. Objective: To assess the midterm outcomes of endovascular aortic repair in patients with CTD. Design, Setting, and Participants: For this descriptive retrospective study, data on demographics, interventions, and short-term and midterm outcomes were collected from 18 aortic centers in Europe, Asia, North America, and New Zealand. Patients with CTD who had undergone endovascular aortic repair from 2005 to 2020 were included. Data were analyzed from December 2021 to November 2022. Exposure: All principal endovascular aortic repairs, including redo surgery and complex repairs of the aortic arch and visceral aorta. Main Outcomes and Measures: Short-term and midterm survival, rates of secondary procedures, and conversion to open repair. Results: In total, 171 patients were included: 142 with Marfan syndrome, 17 with Loeys-Dietz syndrome, and 12 with vascular Ehlers-Danlos syndrome (vEDS). Median (IQR) age was 49.9 years (37.9-59.0), and 107 patients (62.6%) were male. One hundred fifty-two (88.9%) were treated for aortic dissections and 19 (11.1%) for degenerative aneurysms. One hundred thirty-six patients (79.5%) had undergone open aortic surgery before the index endovascular repair. In 74 patients (43.3%), arch and/or visceral branches were included in the repair. Primary technical success was achieved in 168 patients (98.2%), and 30-day mortality was 2.9% (5 patients). Survival at 1 and 5 years was 96.2% and 80.6% for Marfan syndrome, 93.8% and 85.2% for Loeys-Dietz syndrome, and 75.0% and 43.8% for vEDS, respectively. After a median (IQR) follow-up of 4.7 years (1.9-9.2), 91 patients (53.2%) had undergone secondary procedures, of which 14 (8.2%) were open conversions. Conclusions and Relevance: This study found that endovascular aortic interventions, including redo procedures and complex repairs of the aortic arch and visceral aorta, in patients with CTD had a high rate of early technical success, low perioperative mortality, and a midterm survival rate comparable with reports of open aortic surgery in patients with CTD. The rate of secondary procedures was high, but few patients required conversion to open repair. Improvements in devices and techniques, as well as ongoing follow-up, may result in endovascular treatment for patients with CTD being included in guideline recommendations.


Subject(s)
Aortic Aneurysm, Thoracic , Connective Tissue Diseases , Ehlers-Danlos Syndrome, Type IV , Endovascular Procedures , Loeys-Dietz Syndrome , Marfan Syndrome , Humans , Male , Middle Aged , Female , Marfan Syndrome/complications , Marfan Syndrome/surgery , Loeys-Dietz Syndrome/complications , Retrospective Studies , Treatment Outcome , Endovascular Procedures/methods , Connective Tissue Diseases/complications , Connective Tissue Diseases/surgery , Aorta
9.
Front Health Serv ; 3: 1103624, 2023.
Article in English | MEDLINE | ID: mdl-37089454

ABSTRACT

Background and aim: Elective surgery can be overwhelming for children, leading to pre-operative anxiety, which is associated with adverse clinical and behavioural outcomes. Evidence shows that paediatric preparation digital health interventions (DHIs) can contribute to reduced pre-operative anxiety and negative behavioural changes. However, this evidence does not consider their design and development in the context of behavioural science. This systematic review used the Theoretical Domains Framework (TDF) to evaluate the design and development of DHIs used to support children up to 14 years of age and their parents, prepare for hospital procedures, and determine any correlation to health outcomes. It also considered whether any behavioural frameworks and co-production were utilised in their design. Methods: A search of the MEDLINE, EMBASE, PsycINFO, and HMIC databases was carried out, looking for original, empirical research using digital paediatric preparation technologies to reduce pre-operative anxiety and behavioural changes. Limitations for the period (2000-2022), English language, and age applied. Results: Seventeen studies were included, sixteen randomised control trials and one before and after evaluation study. The results suggest that paediatric preparation DHIs that score highly against the TDF are (1) associated with improved health outcomes, (2) incorporate the use of co-production and behavioural science in their design, (3) are interactive, and (4) are used at home in advance of the planned procedure. Conclusion: Paediatric preparation DHIs that are co-produced and designed in the context of behavioural science are associated with reduced pre-operative anxiety and improved health outcomes and may be more cost-effective than other interventions. Systematic Review Registration: https://www.crd.york.ac.uk/prospero/, identifier: CRD42022274182.

10.
BMJ Open ; 13(4): e067605, 2023 04 27.
Article in English | MEDLINE | ID: mdl-37105705

ABSTRACT

INTRODUCTION: Thoracic endovascular aortic repair (TEVAR) carries a 3%-6.1% stroke risk, including risk of 'silent' cerebral infarction (SCI). Stent-grafts are manufactured in room air and retain air. Instructions for use recommend saline flushing to 'de-air' the system prior to insertion, but substantial amounts of air are released when deploying them, potentially leading to downstream neuronal injury and SCI. Carbon dioxide (CO2) is more dense and more soluble in blood than air, without risk of bubble formation, so could be used in addition to saline to de-air stents. This pilot trial aims to assess the feasibility of a full-scale randomised controlled trial (RCT) investigating the neuroprotective benefit against SCI with the use of CO2-flushed aortic stent-grafts. METHODS AND ANALYSIS: This is a multicentre pilot RCT, which is taking place in vascular centres in the UK, USA and New Zealand. Patients identified for TEVAR will be enrolled after informed written consent. 120 participants will be randomised (1:1) to TEVAR-CO2 or TEVAR-saline, stratified according to TEVAR landing zone. Participants will undergo preoperative neurocognitive tests and quality of life assessments, which will be repeated at 6 weeks, or first outpatient appointment, and 6 months. Inpatient neurological testing will be performed within 48 hours of return to level 1 care for clinical stroke or delirium. Diffusion-weighted MRI will be undertaken within 72 hours postoperatively (1-7 days) and at 6 months to look for evidence and persistence of SCI. Feasibility will be assessed via measures of recruitment and retention, informing the design of a full-scale trial. ETHICS AND DISSEMINATION: The study coordination centre has obtained approval from the London Fulham Research Ethics Committee (19/LO/0836) and Southern Health and Disability Ethics Committee (NZ) and UK's Health Regulator Authority (HRA). The study has received ethical approval for recruitment in the UK (Fulham REC, 19/LO/0836), New Zealand (21/STH/192) and the USA (IRB 019-264, Ref 378630). Consent for entering into the study will be taken using standardised consent forms by the local study team, led by a local PI. The results of the trial will be submitted for publication in an open access journal. TRIAL REGISTRATION NUMBER: NCT03886675.


Subject(s)
Carbon Dioxide , Stroke , Humans , Pilot Projects , Stents , Aorta, Thoracic/surgery , Stroke/prevention & control , Randomized Controlled Trials as Topic , Multicenter Studies as Topic
11.
BMJ Lead ; 7(1): 72-74, 2023 03.
Article in English | MEDLINE | ID: mdl-37013886

ABSTRACT

AIM: System leadership is the requirement for a leader of a single organisation to operate on behalf of a wider system, rather than their individual organisation. The current policy landscape does not incentivise system leadership, as many national structures emphasise a focus on individual organisations. This study aims to understand how chief executives in the National Health Service (NHS) in England implement system leadership in practice when faced with decisions that benefit the system to the detriment of their own trust. METHODOLOGY: Semistructured interviews were conducted with ten chief executives from various NHS trust types to understand their perceptions and decision-making process in practice. Semantic thematic analysis was used to draw out themes in relation to how chief executives approach decisions which weigh up the system and organisation. RESULTS: Interviewees expressed advantages (such as support in managing demand) and disadvantages (such as increased bureaucracy) of system leadership and practical considerations in operationalisation (such as the importance of interpersonal relationships). Interviewees endorsed system leadership in principle, but did not feel that current organisational incentives support the implementation of system leadership in practice. However, this was not seen as a major challenge or impediment to effective leadership. CONCLUSION: As a specific policy area, a direct focus on systems leadership is not necessarily helpful. Chief executives should be supported to make decisions in a complex environment, without a specific focus on healthcare systems as a unit of operation.


Subject(s)
Leadership , State Medicine , Delivery of Health Care , England , Interpersonal Relations
12.
Eur J Vasc Endovasc Surg ; 65(5): 719, 2023 May.
Article in English | MEDLINE | ID: mdl-36894125
13.
J Vasc Surg ; 78(2): 549-557.e23, 2023 08.
Article in English | MEDLINE | ID: mdl-36813007

ABSTRACT

OBJECTIVES: Survivorship encompasses the physical, psychological, social, functional, and economic experience of a living with a chronic condition for both the patient and their caregiver. It is made up of nine distinct domains and remains understudied in nononcological pathologies, including infrarenal abdominal aortic aneurysmal disease (AAA). This review aims to quantify the extent to which existing AAA literature addresses the burden of survivorship. METHODS: The MEDLINE, EMBASE, and PsychINFO databases were searched from 1989 through September 2022. Randomized controlled trials, observational studies, and case series were included. Eligible studies had to detail outcomes related to survivorship in patients with AAA. Owing to the heterogeneity between studies and outcomes, no meta-analysis was conducted. Study quality was assessed with specific risk of bias tools. RESULTS: A total of 158 studies were included. Of these, only five (treatment complications, physical functioning, comorbidities, caregivers, and mental health) of the nine domains of survivorship have been studied previously. The available evidence is of variable quality; most studies display a moderate to high risk of bias, are of an observational study design, are based within a limited number of countries, and consist of an insufficient follow-up period. The most frequent complication after EVAR was endoleak. EVAR is associated with poorer long-term outcomes compared with open surgical repair in most studies retrieved. EVAR showed better outcomes in regard to physical functioning in the short term, but this advantage was lost in the long term. The most common comorbidity studied was obesity. No significant differences were found between open surgical repair and EVAR in terms of impact on caregivers. Depression is associated with various comorbidities and increased the risk of a nonhospital discharge. CONCLUSIONS: This review highlights the absence of robust evidence regarding survivorship in AAA. As a result, contemporary treatment guidelines rely on historic quality-of-life data that are narrow in scope and nonrepresentative of contemporary clinical practice. As such, there is an urgent need to reevaluate the aims and methodology associated with traditional quality-of-life research moving forward.


Subject(s)
Aortic Aneurysm, Abdominal , Blood Vessel Prosthesis Implantation , Endovascular Procedures , Humans , Survivorship , Endovascular Procedures/adverse effects , Endoleak/etiology , Aortic Aneurysm, Abdominal/diagnostic imaging , Aortic Aneurysm, Abdominal/surgery , Aortic Aneurysm, Abdominal/etiology , Treatment Outcome , Blood Vessel Prosthesis Implantation/adverse effects , Risk Factors , Retrospective Studies , Observational Studies as Topic
14.
Br J Surg ; 110(4): 481-488, 2023 03 30.
Article in English | MEDLINE | ID: mdl-36722039

ABSTRACT

BACKGROUND: This study investigated whether sex-specific differences in preoperative/perioperative standard of care (SOC) account for disparity in outcomes after elective infrarenal abdominal aortic aneurysm repair. METHODS: This was a retrospective cohort study of elective infrarenal abdominal aortic aneurysm repairs (2013-2020) using depersonalized patient-level National Vascular Registry data. SOC was defined for waiting times, preoperative assessment (multidisciplinary/anaesthetic review), cardiovascular risk prevention, and perioperative medication. The primary outcome was major cardiovascular event and/or death (MACED). RESULTS: Some 21 810 patients with an infrarenal abdominal aortic aneurysm were included, 2380 women and 19 430 men. Women less often underwent aneurysm repair within SOC waiting times (51.5 versus 59.3 per cent; P < 0.001), but were equally likely to receive preoperative assessment (72.1 versus 72.5 per cent; P = 0.742). Women were less likely to receive secondary prevention for known cardiac disease (34.9 versus 39.6 per cent; P = 0.015), but more often met overall cardiovascular risk prevention standards (52.1 versus 47.3 per cent; P < 0.001). Women were at greater risk of MACED (open: 12.0 versus 8.9 per cent, P < 0.001; endovascular: 4.9 versus 2.9 per cent, P < 0.001; risk-adjusted OR 1.33, 95 per cent c.i. 1.12 to 1.59). A significant reduction in the odds of MACED was associated with preoperative assessment (OR 0.86, 0.75 to 0.98) and SOC waiting times (OR 0.78, 0.69 to 0.87). There was insufficient evidence to confirm a significant sex-specific difference in the effect of SOC preoperative assessment (women: OR 0.69, 0.50 to 0.97; men: OR 0.89, 0.77 to 1.03; interaction P = 0.170) or SOC waiting times (women: OR 0.84, 0.62 to 1.16; men: OR 0.76, 0.67 to 0.87; interaction P = 0.570) on the risk of MACED. CONCLUSION: SOC waiting times and preoperative assessment were not met for both sexes, which was associated with an increased risk of MACED. Sex-specific differences in SOC attenuated but did not fully account for the increased risk of MACED in women.


Subject(s)
Aortic Aneurysm, Abdominal , Blood Vessel Prosthesis Implantation , Endovascular Procedures , Male , Humans , Female , Retrospective Studies , Standard of Care , Treatment Outcome , Vascular Surgical Procedures , Aortic Aneurysm, Abdominal/surgery , Endovascular Procedures/adverse effects , Risk Factors , Risk Assessment
15.
J Endovasc Ther ; 30(3): 449-460, 2023 06.
Article in English | MEDLINE | ID: mdl-35297713

ABSTRACT

PURPOSE: The purpose of the study was to provide a consensus definition of the infrarenal sealing zone and develop an algorithm to determine when and if adjunctive procedure(s) or reintervention should be considered in managing patients undergoing endovascular aortic repair (EVAR) for infrarenal abdominal aortic aneurysm (AAA). METHODS: A European Advisory Board (AB), made up of 11 vascular surgeons with expertise in EVAR for AAA, was assembled to share their opinion regarding the definition of preoperative and postoperative infrarenal sealing zone. Information on their current clinical practice and level of agreement on proposed reintervention paths was used to develop an algorithm. The process included 2 virtual meetings and 2 rounds of online surveys completed by the AB (Delphi method). Consensus was defined as reached when ≥ 8 of 11 (73%) respondents agreed or were neutral. RESULTS: The AB reached complete consensus on definitions and measurement of the pre-EVAR target anticipated sealing zone (TASZ) and the post-EVAR real achieved sealing zone (RASZ), namely, the shortest length between the proximal and distal reference points as defined by the AB, in case of patients with challenging anatomies. Also, agreement was achieved on a list of 4 anatomic parameters and 3 prosthesis-/procedure-related parameters, considered to have the most significant impact on preoperative and postoperative sealing zones. Furthermore, the agreement was reached that in the presence of visible neck-related complications, both adjunctive procedure(s) and reintervention should be contemplated (100% consensus). In addition, adjunctive procedure(s) or reintervention can be considered in the following cases (% consensus): insufficient sealing zone on completion imaging (91%) or on the first postoperative computed tomography (CT) scan (91%), suboptimal sealing zone on completion imaging (73%) or postoperative CT scan (82%), and negative evolution of the actual sealing zone over time (91%), even in the absence of visible complications. CONCLUSIONS: AB members agreed on definitions of the pre- and post-EVAR infrarenal sealing zone, as well as factors of influence. Furthermore, a clinical decision algorithm was proposed to determine the timing and necessity of adjunctive procedure(s) and reinterventions.


Subject(s)
Aortic Aneurysm, Abdominal , Blood Vessel Prosthesis Implantation , Endovascular Procedures , Humans , Blood Vessel Prosthesis Implantation/adverse effects , Blood Vessel Prosthesis Implantation/methods , Endovascular Aneurysm Repair , Delphi Technique , Consensus , Expert Testimony , Treatment Outcome , Endovascular Procedures/adverse effects , Aortic Aneurysm, Abdominal/diagnostic imaging , Aortic Aneurysm, Abdominal/surgery , Risk Factors , Retrospective Studies , Blood Vessel Prosthesis
16.
Clin Appl Thromb Hemost ; 28: 10760296221144307, 2022.
Article in English | MEDLINE | ID: mdl-36514251

ABSTRACT

Anastomotic bleeding in vascular surgery can be difficult to control. Patients, in particular those undergoing carotid surgery, have often been started on treatment with dual antiplatelet agents and receive systemic heparinization intraoperatively. The use of local hemostatic agents as an adjunct to conventional methods is widely reported. 3-D Matrix's absorbable hemostatic material RADA16 (PuraStat®), is a fully synthetic resorbable hemostatic agent. The aim of this study is to confirm the safety and performance of this agent when used to control intraoperative anastomotic bleeding during carotid endarterectomy (CEA). A prospective, single-arm, multicenter study involving 65 patients, undergoing CEA, in whom the hemostatic agent was applied to the suture line after removal of arterial clamps. Patients were followed up at 24 h, discharge, and one month after surgery. Time to hemostasis was measured as the primary endpoint. Secondary endpoints included hemostasis efficacy and safety outcomes, blood loss, intraoperative and postoperative administration of blood products, and incidence of reoperation for bleeding. A total of 65 cases (51 male and 14 female) undergoing CEA, utilizing patch reconstruction (90. 8%), eversion technique (6.1%), and direct closure (3.1%) were analyzed. All patients received dual antiplatelet therapy preoperatively and were administered systemic intravenous heparin intraoperatively, as per local protocol. The mean time to hemostasis was 83 s ± 105 s (95% CI: 55-110 s). Primary hemostatic efficacy was 90.8%. The mean volume of product used was 1.7 mL ± 1.1 mL. Hemostasis was achieved with a single application of the product in 49 patients (75.3%). Two patients required a transfusion of blood products intraoperatively. There were no blood product transfusions during the postoperative period. The intraoperative mean blood loss was 127 mL ± 111.4 mL and postoperatively, the total mean drainage volume was 49.0 mL ± 51.2 mL. The mean duration of surgery was 119 ± 35 min, and the mean clamp time was 35 min 12 s ± 19 min 59 s. In 90.8% of patients, there was no presence of hematoma at 24 h postoperatively. Three returned to theatre due to bleeding (2 in the first 24 h), however, none of these cases were considered product related. Overall, there were no device-related serious adverse events (SAE) or unanticipated device-related SAEs reported. Use of the hemostatic agent PuraStat® is associated with a high rate of hemostatic efficacy (90.8%) and a short time to hemostasis. The safety of the product for use on vascular anastomoses has been demonstrated.


Subject(s)
Hemostatics , Humans , Male , Female , Prospective Studies , Hemostatics/therapeutic use , Blood Loss, Surgical/prevention & control , Platelet Aggregation Inhibitors/adverse effects , Carotid Arteries/surgery , Treatment Outcome
19.
J Vasc Surg ; 76(5): 1364-1373.e3, 2022 11.
Article in English | MEDLINE | ID: mdl-35697306

ABSTRACT

OBJECTIVE: Complete excision in patients with aortic vascular graft and endograft infections (VGEIs) is a significant undertaking, and many patients never undergo definitive treatment. Knowing their fate is important to be able to assess the risks of graft excision vs alternative strategies. This study analyzed their life expectancy and sepsis-free survival. METHODS: VGEIs were diagnosed according to the Aortic Graft Infection (MAGIC) criteria, and patients turned down for graft removal from November 2006 to December 2020 were included. Primary endpoints were aortic-related and sepsis-free survival estimated using the Kaplan-Meier method. A Cox proportional hazards regression analysis was used to compute the hazard ratio (HR) and 95% confidence interval (CI) as estimates of survival without sepsis. RESULTS: Seventy-four patients were included, with a median age of 71 years (range, 63-79 years). The index aortic repair was either open (n = 33; 44.6%), endovascular (n = 19; 25.7%), or hybrid (n = 22; 29.7%). Causative organisms were identified in 56 patients (75.7%). At presentation, 26 patients (35.1%) required salvage surgery, open (n = 22; 29.7%) or endovascular (n = 8; 10.8%), and 17 radiological drainage (23.0%). During follow-up, eight required drainage and 11 (14.9%) graft removal (five complete). Infectious complications included pseudoaneurysms (n = 14; 18.9%), rupture (n = 9; 12.2%), gastro-intestinal bleeding (n = 13; 17.6%), septic embolisms (n = 4; 5.4%), and thrombosis (n = 12; 16.2%). In-hospital mortality was 20.3% (n = 15), freedom from aortic-related death and overall survival was 77.1% (95% CI, 65.2%-85.3%) and 70.4% (95% CI, 58.3%-79.7%) at 1 year, and 61.7% (95% CI, 46.1%-74.0%) and 43.1% (95% CI, 29.2%-56.3%) at 5 years. Sepsis recurrence occurred in 37 patients (50.0%). Seven (16.3%) developed acquired antimicrobial resistance. Malnutrition (HR, 3.3; 95% CI, 1.4-7.6; P = .005), hemorrhagic shock at presentation (HR, 2.9; 95% CI, 1.0-8.2; P = .048), aorto-enteric fistulae (HR, 3.3; 95% CI, 1.3-8.4; P = .011), fungal coinfection (HR, 3.5; 95% CI, 1.2-11.5; P = .030), and infection with resistant micro-organisms (HR, 3.1; 95% CI, 1.1-8.3; P = .023) were significantly associated with worse survival without sepsis. CONCLUSIONS: In-hospital and aortic-related mortality were significant, but with salvage surgery and antibiotic therapy, the median survival was 3 years. Sepsis recurrence remained frequent, and further procedures were needed. These outcomes should be considered when graft excision is proposed. Known predictors of adverse outcomes should become important points for discussion in multidisciplinary team meetings.


Subject(s)
Anti-Infective Agents , Aortic Aneurysm, Abdominal , Blood Vessel Prosthesis Implantation , Endovascular Procedures , Humans , Middle Aged , Aged , Blood Vessel Prosthesis Implantation/adverse effects , Blood Vessel Prosthesis/adverse effects , Risk Factors , Retrospective Studies , Anti-Bacterial Agents/therapeutic use , Endovascular Procedures/adverse effects , Treatment Outcome , Aortic Aneurysm, Abdominal/surgery
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