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PURPOSE: This study aimed to assess the feasibility and short-term outcomes of different manufactured proximal and distal stent graft components during fenestrated endovascular aortic repair (FEVAR). MATERIALS AND METHODS: A multicenter retrospective review was conducted at 3 aortic centers, involving all consecutive patients who underwent FEVAR utilizing a customized Dacron-based tubular proximal and a distal bifurcated polytetrafluoreten (PTFE)-based commercially available stent grafts. Primary outcomes were 30 day mortality, major adverse events, and technical and clinical success. Secondary outcomes assessed stent graft migration, occurrence of types I/III endoleak, and reintervention. RESULTS: A total of 23 FEVAR cases across all centers were included in this study. Technical success was achieved in all cases, with a median procedure time of 183 (153-244) minutes. There were no major adverse events, except for 1 transient acute renal failure. The median follow-up period was 23 (17-28) months. All target vessels retained patent with the exception of 1 right renal fenestration that showed signs of kinking at the first follow-up, and despite secondary intervention with relining and distal extension, there was an occlusion afterward and 1 hepatic artery with a separate fenestration. This and 1 successful relining of a superior mesenteric artery kink were the only reinterventions in this cohort. One case of persistent type 1b endoleak was reported in a patient with chronic type B aortic dissection, which resolved with distal extension on the external iliac artery 5 months after the index procedure. No deaths occurred throughout the follow-up with, and there were no signs of stent graft migration or type 3 endoleak. CONCLUSION: The use of commercially available PTFE-based bifurcated stent grafts to extend distally the tubular graft appears to be a feasible approach during FEVAR, with promising short-term outcomes. Further studies are necessary to define the applicability of this solution and evaluate long-term outcomes. CLINICAL IMPACT: This multicentric study on fenestrated endovascular aortic repair (FEVAR) demonstrates the feasibility and good short-term outcomes of utilizing a PTFE-based commercially available stent graft to extend the proximal tubular custom-made fenestrated stent graft. The high technical success rate, absence of major adverse events, and low occurrence of complications such as stent graft migration and endoleaks highlight the potential clinical benefits of this approach with an off-the-shelf distal extension whose delivery system does not cross the fenestrations intraoperatively.
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Background: We sought to investigate the differential impact of EVAR (endovascular aneurysm repair) vis-à-vis OSR (open surgical repair) on ruptured AAA (abdominal aortic aneurysm) mortality by sex and geographically. Methods: We performed a retrospective study of administrative data on EVAR from state statistical agencies, vascular registries, and academic publications, as well as ruptured AAA mortality rates from the World Health Organization for 14 14 states across Australasia, East Asia, Europe, and North America. Results: Between 2011-2016, the proportion of treatment of ruptured AAAs by EVAR increased from 26.1 to 43.8 percent among females, and from 25.7 to 41.2 percent among males, and age-adjusted ruptured AAA mortality rates fell from 12.62 to 9.50 per million among females, and from 34.14 to 26.54 per million among males. The association of EVAR with reduced mortality was more than three times larger (2.2 vis-à-vis 0.6 percent of prevalence per 10 percentage point increase in EVAR) among females than males. The association of EVAR with reduced mortality was substantially larger (1.7 vis-à-vis 1.1 percent of prevalence per 10 percentage point increase in EVAR) among East Asian states than European+ states. Conclusions: The increasing adoption of EVAR coincided with a decrease in ruptured AAA mortality. The relationship between EVAR and mortality was more pronounced among females than males, and in East Asian than European+ states. Sex and ethnic heterogeneity should be further investigated.
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OBJECTIVE: Vascular surgery registries report on procedures and outcomes to promote patient safety and drive quality improvement. International registries have contributed significantly to the VASCUNET collaborative abdominal aortic aneurysm (AAA) outcome projects. This scoping review aimed to outline the national registries in vascular surgery that currently participate in the VASCUNET collaborative AAA projects. METHODS: A scoping review of all published VASCUNET AAA studies and validation reports between 1997 and 2024 was undertaken. A survey was conducted among representatives of the international vascular registries contributing to VASCUNET collaborative AAA projects. RESULTS: Currently, vascular registries from 10 countries (Australia, Denmark, Finland, Hungary, Iceland, New Zealand, Norway, Sweden, Switzerland, and the UK) contribute to the current VASCUNET collaborative AAA project, of which eight have national coverage. In the past, three countries (Germany, Malta, and Italy) have participated in previous VASCUNET AAA projects, and a further three countries (Serbia, Greece, and Portugal) have planned participation in future projects. External validity is high for all current registries, with most reporting rates of > 90%. The majority have internal validation processes to assess data accuracy. VASCUNET mediated validation has also been performed by the consortium for five countries to date (Hungary, Sweden, Denmark, Malta, and Switzerland), for which a high degree of external and internal validity was identified. Most registries have established mechanisms for data linkage with national administrative datasets or insurance claims datasets and contribute to quality improvement through regular reporting to participating centres. CONCLUSION: National vascular registries from nations participating in the VASCUNET collaborative AAA projects are largely comprehensive, with high case ascertainment rates and good quality data with internal quality assurance. This provides a template for new registries wishing to join the VASCUNET collaboration and a benchmark for future research.
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Anévrysme de l'aorte abdominale , Enregistrements , Procédures de chirurgie vasculaire , Humains , Anévrysme de l'aorte abdominale/chirurgie , Anévrysme de l'aorte abdominale/épidémiologie , Procédures de chirurgie vasculaire/normes , Coopération internationale , Europe/épidémiologie , Résultat thérapeutique , Amélioration de la qualitéSujet(s)
Anévrysme de l'aorte , , Humains , /chirurgie , /imagerie diagnostique , Pays nordiques et scandinaves , Anévrysme de l'aorte/chirurgie , Anévrysme de l'aorte/imagerie diagnostique , Essais contrôlés randomisés comme sujet , Résultat thérapeutique , Procédures endovasculaires/effets indésirablesRÉSUMÉ
BACKGROUND: By this survey, we aim to gain national-based information regarding trends in endovascular repair (ER) for the treatment of aortic disease in patients with genetically-triggered aortic disease (GTAD) and connective tissue disorder (CTD) over the last two decades. METHODS: All Italian vascular surgery centers (N.=80) were invited to participate in an anonymous electronic cross-sectional survey on ER for GTAD/CTD. RESULTS: Overall, 29 institutions completed the survey, thereby yielding a 36% response rate. The percentage of responding institutions rises to 64% if only regional hubs were considered (23/36). The median number of index procedures per center was 6.2, and a steady increase in the overall number of interventions over time was also noted. Most patients were males (73%) with a median age of 48 years. The most common endovascular procedure was TEVAR (N.=101), followed by F/BEVAR (N.=43) and EVAR (N.=37). The overall technical success rate was 83.4% while major adverse events and mortality at thirty days were reported at 18.2% and 9.9%, respectively. An additional 5.0% mortality rate was noted for an overall one-year mortality of 14.9%, while 3.7% of all treated patients were diagnosed with a type 1 endoleak. CONCLUSIONS: This national cross-sectional survey, investigating trends in ER of GTADs and CTDs over two decades, highlights a consistent increase in the use of endovascular techniques for their treatment. Early mortality was acceptably low, yet influenced by the urgency of presentation. At one-year follow-up, a 5% additional death rate was noted, and the reintervention rate remained below one in ten.
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OBJECTIVE: To determine the peri-operative mortality rate for intact and ruptured abdominal aortic aneurysm (AAA) repair in 10 countries and to compare practice and outcomes over a six year period by age, sex, and geographic location. METHODS: This VASCUNET study used prospectively collected data from vascular registries in 10 countries on primary repair of intact and ruptured AAAs undertaken between January 2014 and December 2019. The primary outcome was peri-operative death (30 day or in hospital). Logistic regression models were used to estimate the association between peri-operative death, patient characteristics, and type of procedure. Factors associated with the use of endovascular aortic aneurysm repair (EVAR) were also evaluated. RESULTS: The analysis included 50 642 intact and 9 453 ruptured AAA repairs. The proportion of EVARs for intact repairs increased from 63.4% in 2014 to 67.3% in 2016 before falling to 62.3% in 2019 (p < .001), but practice varied between countries. EVAR procedures were more common among older patients (p < .001) and men (p < .001). Overall peri-operative mortality after intact AAA repair was 1.4% (95% confidence interval [CI] 1.3 - 1.5%) and did not change over time. Mortality rates were stable within countries. Among ruptured AAA repairs, the proportion of EVARs increased from 23.7% in 2014 to 35.2% in 2019 (p < .001). The average aortic diameter was 7.8 cm for men and 7.0 cm for women (p < .001). The overall peri-operative mortality rate was 31.3% (95% CI 30.4 - 32.2%); the rates were 36.0% (95% CI 34.9 - 37.2%) for open repair and 19.7% (95% CI 18.2 - 21.3%) for EVAR. This difference and shift to EVAR reduced peri-operative mortality from 32.6% (in 2014) to 28.7% (in 2019). CONCLUSION: The international practice of intact AAA repair was associated with low mortality rates in registry reported data. There remains variation in the use of EVAR for intact AAAs across countries. Overall peri-operative mortality remains high after ruptured AAA, but an increased use of EVAR has reduced rates over time.
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Anévrysme de l'aorte abdominale , Rupture aortique , Procédures endovasculaires , Enregistrements , Humains , Anévrysme de l'aorte abdominale/chirurgie , Anévrysme de l'aorte abdominale/mortalité , Mâle , Femelle , Sujet âgé , Procédures endovasculaires/effets indésirables , Procédures endovasculaires/mortalité , Procédures endovasculaires/statistiques et données numériques , Rupture aortique/chirurgie , Rupture aortique/mortalité , Sujet âgé de 80 ans ou plus , Résultat thérapeutique , Facteurs de risque , Mortalité hospitalière , Implantation de prothèses vasculaires/effets indésirables , Implantation de prothèses vasculaires/mortalité , Adulte d'âge moyen , Facteurs temps , Facteurs sexuels , Appréciation des risquesRÉSUMÉ
BACKGROUND: The aims of this study were: i) to assess fragility indices (FIs) of individual randomized controlled trials (RCTs) that compared paclitaxel-based drug-coated balloons (DCBs) or drug-eluting stents (DESs) versus standard endovascular devices, and ii) to meta-analyze mid-term and long-term safety and efficacy outcomes from available RCT data while also estimating the FI of pooled results. METHODS: This systematic review has been registered in the PROSPERO public database (CRD42022304326 http://www.crd.york.ac.uk/PROSPERO). A query of PubMed (Medline), EMBASE (Excerpta Medical Database), Scopus, and CENTRAL (Cochrane Central Register of Controlled Trials) databases was performed to identify eligible RCTs. Rates of primary patency (PP) and target lesion revascularization (TLR) were assessed as efficacy outcomes, while lower limb amputation (LLA) consisting of major amputation that is. below or above the knee and all-cause mortality were estimated as safety outcomes. All outcomes were pooled with a random effects model to account for any clinical and study design heterogeneity. The analyses were performed by dividing the RCTs according to their maximal follow-up length (mid-term was defined as results up to 2-3 years, while long-term was defined as results up to 4-5 years). For each individual outcome, the FI and reverse fragility index (RFI) were calculated according to whether the outcome results were statistically significant or not, respectively. The fragility quotient (FQ) and reverse fragility quotient (RFQ), which are the FI or RFI divided by the sample size, were also calculated. RESULTS: A total of 2,337 patients were included in the systematic review and meta-analysis. There were 2 RCTs examining DES devices and 14 RCTs evaluating different DCBs. For efficacy outcomes, there was evidence that paclitaxel-based endovascular therapy increased the PP rate and reduced the TLR rate at mid-term, with a calculated pooled risk ratio (RR) of 1.66 for patency (95% CI, 1.55-1.86; P < 0.001), with a corresponding number needed-to-treat (NNT) of 3 patients (95% CI, 2.9-3.8) and RR of 0.44 for TLR (95% CI, 0.35-0.54; P = 0.027), respectively. Similarly, there was evidence that paclitaxel-based endovascular therapy both increased PP and decreased TLR rates at long-term, with calculated pooled RR values of 1.73 (95% CI, 1.12-2.61; P = 0.004) and 0.53 (95% CI, 0.45-0.62; P = 0.82), respectively. For safety outcomes, there was evidence that paclitaxel-based endovascular therapy increased all-cause mortality at mid-term, with a calculated pooled RR of 2.05 (95% CI, 1.21-3.24). However, there was no difference between treatment arms in LLA at mid-term (95% CI, 0.1-2.7; P = 0.68). Similarly, neither all-cause mortality nor LLA at long-term differed between treatment arms, with a calculated pooled RR of 0.66, 1.02 (95% CI, 0.31-3.42) and 1.02 (95% CI, 0.30-5.21; P = 0.22), respectively. The pooled estimates of PP at mid-term were robust (FI = 28 and FQ = 1.9%) as were pooled rates of TLR (FI = 18 and FQ = 0.9%). However, when safety outcomes were analyzed, the robustness of the meta-analysis decreased significantly. In fact, the relationship between the use of paclitaxel-coated devices and all-cause mortality at mid-term showed very low robustness (FI = 4 and FQ = 0.2%). At 5 years, only the benefit of paclitaxel-based devices to reduce TLR remained robust, with an FI of 32 and an FQ of 3.1%. CONCLUSIONS: The data supporting clinical efficacy endpoints of RCTs that examined paclitaxel-based devices in the treatment of femoral-popliteal arterial occlusive disease were robust; however, the pooled safety endpoints were highly fragile and prone to bias due to loss of patient follow-up in the original studies. These findings should be considered in the ongoing debate concerning the safety of paclitaxel-based devices.
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Amputation chirurgicale , Angioplastie par ballonnet , Agents cardiovasculaires , Matériaux revêtus, biocompatibles , Endoprothèses à élution de substances , Artère fémorale , Paclitaxel , Maladie artérielle périphérique , Artère poplitée , Essais contrôlés randomisés comme sujet , Degré de perméabilité vasculaire , Humains , Paclitaxel/effets indésirables , Paclitaxel/administration et posologie , Artère poplitée/physiopathologie , Artère fémorale/physiopathologie , Maladie artérielle périphérique/thérapie , Maladie artérielle périphérique/physiopathologie , Maladie artérielle périphérique/mortalité , Résultat thérapeutique , Facteurs temps , Agents cardiovasculaires/effets indésirables , Agents cardiovasculaires/administration et posologie , Agents cardiovasculaires/usage thérapeutique , Angioplastie par ballonnet/effets indésirables , Angioplastie par ballonnet/instrumentation , Angioplastie par ballonnet/mortalité , Facteurs de risque , Dispositifs d'accès vasculaires , Sujet âgé , Mâle , Sauvetage de membre , Femelle , Adulte d'âge moyen , Procédures endovasculaires/effets indésirables , Procédures endovasculaires/mortalité , Procédures endovasculaires/instrumentation , Appréciation des risquesRÉSUMÉ
BACKGROUND: Burnout among physicians has widespread negative consequences. Little is known about burnout among European vascular surgeons (VS). A previously published study found that 82% of VS and vascular surgical trainees (VST) in Denmark experience burnout symptoms. The present study aimed to investigate work- and health-related consequences of burnout. STUDY DESIGN: An electronic survey was distributed to all VS/VST in Denmark in January 2020. Validated assessment tools were used to measure burnout, mental health, and psychosocial work environment aspects. RESULTS: Of 104 invited VS/VST, 82% (n = 85) completed the survey. VS accounted for 72% (n = 61) of the respondents, and 40% (n = 33) were female. Statistically significant associations were found between higher levels of burnout and a range of work- and health-related outcomes, including a sense of meaning at work, workplace commitment, conflicts between work and private life, work stress, sick leave, and depressive symptoms. VS/VST using pain medication daily or weekly had significantly higher burnout scores than respondents who rarely or never use pain medication. A significant association between burnout and job satisfaction and retention was found, with respondents indicating an intention to stay within the specialty having significantly lower burnout scores than those who considered leaving within 5 years. Among those who indicated leaving the specialty, 35% (n = 13) attributed this to their current working conditions. CONCLUSIONS: Burnout among VS/VST in Denmark is negatively associated with various work- and health-related outcomes. The work environment seems to play an essential role in these associations, and alterations in workplace organization may remedy this situation.
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Épuisement professionnel , Stress professionnel , Chirurgiens , Humains , Femelle , Mâle , Épuisement professionnel/psychologie , Stress professionnel/psychologie , Chirurgiens/psychologie , Enquêtes et questionnaires , Douleur , Danemark/épidémiologie , Satisfaction professionnelleRÉSUMÉ
PURPOSE: The present scoping review aims to describe and analyze available clinical data on the most commonly reported risk prediction indices in vascular surgery for perioperative mortality, with a particular focus on ruptured abdominal aortic aneurysm (rAAA). MATERIALS AND METHODS: A scoping review following the PRISMA Protocols Extension for Scoping Reviews was performed. Available full-text studies published in English in PubMed, Cochrane and EMBASE databases (last queried, 30 March 2023) were systematically reviewed and analyzed. The Population, Intervention, Comparison, Outcome (PICO) framework used to construct the search strings was the following: in patients with aortic pathologies, in particular rAAA (population), undergoing open or endovascular surgery (intervention), what different risk prediction models exist (comparison), and how well do they predict post-operative mortality (outcomes)? RESULTS: The literature search and screening of all relevant abstracts revealed a total of 56 studies in the final qualitative synthesis. The main findings of the scoping review, grouped by the risk score that was investigated in the original studies, were synthetized without performing any formal meta-analysis. A total of nine risk scores for major vascular surgery or elective AAA, and 10 scores focusing on rAAA, were identified. Whilst there were several validation studies suggesting that most risk scores performed adequately in the setting of rAAA, none reached 100% accuracy. The Glasgow aneurysm score, ERAS and Vancouver score risk scores were more frequently included in validation studies and were more often used in secondary studies. Unfortunately, the published literature presents a heterogenicity of results in the validation studies comparing the different risk scores. To date, no risk score has been endorsed by any of the vascular surgery societies. CONCLUSIONS: The use of risk scores in any complex surgery can have multiple advantages, especially when dealing with emergent cases, since they can inform perioperative decision making, patient and family discussions, and post hoc case-mix adjustments. Although a variety of different rAAA risk prediction tools have been published to date, none are superior to others based on this review. The heterogeneity of the variables used in the different scores impairs comparative analysis which represents a major limitation to understanding which risk score may be the "best" in contemporary practice. Future developments in artificial intelligence may further assist surgical decision making in predicting post-operative adverse events.
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OBJECTIVE: The need for open surgical conversion (OSC) after failed endovascular aortic aneurysm repair (EVAR) persists, despite expanding endovascular options for secondary intervention. The VASCUNExplanT project collected international data to identify risk factors for failed EVAR, as well as OSC outcomes. This retrospective cross sectional study analysed data after OSC for failed EVAR from the VASCUNET international collaboration. METHODS: VASCUNET queried registries from its 28 member countries, and 17 collaborated with data from patients who underwent OSC (2005 - 2020). Any OSC for infection was excluded. Data included demographics, EVAR, and OSC procedural details, as well as post-operative mortality and complication rates. RESULTS: There were 348 OSC patients from 17 centres, of whom 33 (9.4%) were women. There were 130 (37.4%) devices originally deployed outside of instructions for use. The most common indication for OSC was endoleak (n = 143, 41.1%); ruptures accounted for 17.2% of cases. The median time from EVAR to OSC was 48.6 months [IQR 29.7, 71.6]; median abdominal aortic aneurysm diameter at OSC was 70.5 mm [IQR 61, 82]. A total of 160 (45.6%) patients underwent one or more re-interventions prior to OSC, while 63 patients (18.1%) underwent more than one re-intervention (range 1 - 5). Overall, the 30 day mortality rate post-OSC was 11.8% (n = 41), 11.1% for men and 18.2% for women (p = .23). The 30 day mortality rate was 6.1% for elective cases, and 28.3% for ruptures (p < .0001). The predicted 90 day survival for the entire cohort was 88.3% (95% CI 84.3 - 91.3). Multivariable analysis revealed rupture (OR 4.23; 95% CI 2.05 - 8.75; p < .0001) and total graft explantation (OR 2.10; 95% CI 1.02 - 4.34; p = .04) as the only statistically significant predictive factors for 30 day death. CONCLUSION: This multicentre analysis of patients who underwent OSC shows that, despite varying case mix and operative techniques, OSC is feasible but associated with significant morbidity and mortality rates, particularly when performed for rupture.
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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.
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Anévrysme de l'aorte thoracique , Maladies du tissu conjonctif , , Procédures endovasculaires , Syndrome de Loeys-Dietz , Syndrome de Marfan , Humains , Mâle , Adulte d'âge moyen , Femelle , Syndrome de Marfan/complications , Syndrome de Marfan/chirurgie , Syndrome de Loeys-Dietz/complications , Études rétrospectives , Résultat thérapeutique , Procédures endovasculaires/méthodes , Maladies du tissu conjonctif/complications , Maladies du tissu conjonctif/chirurgie , AorteRÉSUMÉ
Vascular graft and endograft infections (VGEIs) are a feared complication because of their morbidity, cost, and mortality. Despite broad and varying strategies, as well as limited evidence, societal guidelines do exist. The objective of this review was to supplement current guidelines with emerging and multimodal techniques for treatment. An electronic search was performed using PubMed with specific search terms from 2019 to 2022 in which VGEIs were described or analyzed in the carotid, thoracic aorta, abdominal, or lower extremity arteries. A total of 12 studies were collected from the electronic search. Articles describing all of the anatomic areas were present. The incidence of VGEIs depends on the anatomic location, varying from <1% to 18%. Gram-positive bacteria are the most common organism. Referral of patients with VGEIs to centers of excellence is paramount, as is pathogen identification, preferably from direct sampling techniques. The MAGIC (Management of Aortic Graft Infection Collaboration) criteria have been endorsed for all VGEIs and validated for aortic VGEI. They are well supplemented with additional diagnostic techniques. Treatment must be individualized, although the goal should be the removal of infected material with appropriate revascularization. VGEIs remain a devastating complication, despite changing or improving medical surgical techniques in vascular surgery. Prophylactic measures, early diagnosis, and patient-specific therapy remain the cornerstones of treatment for this feared complication.
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Anévrysme de l'aorte abdominale , Implantation de prothèses vasculaires , Procédures endovasculaires , Infections dues aux prothèses , Greffe vasculaire , Humains , Prothèse vasculaire/effets indésirables , Implantation de prothèses vasculaires/effets indésirables , Infections dues aux prothèses/diagnostic , Infections dues aux prothèses/thérapie , Infections dues aux prothèses/étiologie , Procédures endovasculaires/effets indésirables , Greffe vasculaire/effets indésirables , Résultat thérapeutique , Études rétrospectives , Anévrysme de l'aorte abdominale/chirurgieSujet(s)
Anévrysme de l'aorte thoracique , Implantation de prothèses vasculaires , Procédures endovasculaires , Humains , Réparation endovasculaire d'anévrysme , Anévrysme de l'aorte thoracique/chirurgie , Résultat thérapeutique , Implantation de prothèses vasculaires/effets indésirables , Procédures endovasculaires/effets indésirables , Études rétrospectivesRÉSUMÉ
BACKGROUND: Contemporary management of uncomplicated type B aortic dissections (uTBAD) is based on the acuity and various morphological features. Medical therapy is mandatory, while the risks of early thoracic endovascular aortic repair (TEVAR) are balanced against the potential for rupture, complex surgery, and death. Improved aortic morphology following TEVAR is documented, but evidence for improved overall survival is lacking. The costs and impact on quality of life are also needed. METHODS: The trial is a randomized, open-label, superiority clinical trial with parallel assignment of subjects at 23 clinical sites in Denmark, Norway, Sweden, Finland, and Iceland. Eligibility includes patients aged ≥ 18 with uTBAD of < 4 weeks duration. Recruited subjects will be randomized to either standard medical therapy (SMT) or SMT + TEVAR, where TEVAR must be performed between 2-12 weeks from the onset of symptoms. DISCUSSION: This trial will evaluate the primary question of whether early TEVAR improves survival at 5 years among uTBAD patients. Moreover, the costs and the impact on quality of life should provide sorely needed data on other factors that play a role in treatment strategy decisions. The common Nordic healthcare model, with inclusion of all aortic centers, provides a favorable setting for carrying out this trial, while the robust healthcare registries ensure data validity. TRIAL REGISTRATION: ClinicalTrials.gov NCT05215587. Registered on January 31, 2022.
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Anévrysme de l'aorte thoracique , , Implantation de prothèses vasculaires , Procédures endovasculaires , Humains , Anévrysme de l'aorte thoracique/imagerie diagnostique , Anévrysme de l'aorte thoracique/chirurgie , Implantation de prothèses vasculaires/effets indésirables , Qualité de vie , Résultat thérapeutique , Procédures endovasculaires/effets indésirables , /chirurgie , Études rétrospectives , Facteurs de risque , Endoprothèses , Essais contrôlés randomisés comme sujetRÉSUMÉ
OBJECTIVE: The effect of body mass index (BMI) on post-operative outcomes after abdominal aortic aneurysm (AAA) repair remains poorly defined. The association between BMI and death following elective endovascular aneurysm repair (EVAR) and open aneurysm repair (OAR) of AAA in a large national quality registry is investigated. METHODS: All elective AAA repairs within the Society for Vascular Surgery Vascular Quality Initiative (VQI; 2010 to September 2021) were reviewed (EVAR, n = 53 426; OAR, n = 9 479). All analyses were conducted separately for EVAR and OAR patients. The primary end points were 30 day mortality and five year survival rates. Study cohorts were divided into World Health Organisation BMI categories (C1 < 18.5, C2 18.5 ≤ BMI < 25, C3 25 ≤ BMI < 30, C4, 30 ≤ BMI < 35, C5 35 ≤ BMI < 40, C6 ≥ 40). BMI was examined as both a categorical and continuous variable. Logistic and Cox proportional hazards regression were used for risk adjustment. RESULTS: Among EVAR patients, BMI distribution was C1, 1 216 (2%); C2, 14 687 (28%); C3, 20 516 (38%); C4, 11 352 (21%); C5, 3 947 (7%); C6, 1 708 (3%). Class 1, 2, and 6 BMI patients experienced an increased 30 day mortality rate (C1 2.6%; C2 1.3%; C6 1.4% vs. C3 - 5 0.7%; p < .001) and C1 and C2 had correspondingly inferior long term survival (five years: C1 69 ± 3%; C2 79 ± 1% vs. C3 - 6 86 - 88 ± 2%; log rank p < .001). These survival disparities persisted after risk adjustment for multiple confounders. In the OAR cohort, BMI distribution was C1, 280 (3%); C2, 2 862 (30%); C3, 3 587 (38%); C4, 1 940 (21%); C5, 581 (6%); C6, 229 (2%). Crude 30 day mortality rates were increased for both the lowest and highest BMI patients (C1 12%, C6 7% vs. C2 - 5 3 - 4%; p < .001); these differences also persisted in long term survival (five years: C1 71 ± 6%, C6 82 ± 6% vs. C2 - 6 85 - 88 ± 3%; log rank p < .001). In risk adjusted analysis, both low and high BMI OAR patients had an increased 30 day and long term mortality rate. CONCLUSION: Within the VQI, both the extreme low (< 18.5) and high (≥ 40) BMI groups experienced an increased 30 day mortality rate after both elective EVAR and OAR. By comparison, while the lowest BMI cohort was significantly associated with decreased long term survival after both procedures, the highest BMI group only experienced reduced long term survival after OAR. Based upon this large real world registry analysis of elective AAA repairs, differential metabolic signatures exist within extreme BMI categories, which may inform peri-operative risk stratification and clinical decision making.
Sujet(s)
Anévrysme de l'aorte abdominale , Implantation de prothèses vasculaires , Procédures endovasculaires , Humains , Procédures endovasculaires/effets indésirables , Indice de masse corporelle , Anévrysme de l'aorte abdominale/imagerie diagnostique , Anévrysme de l'aorte abdominale/chirurgie , Anévrysme de l'aorte abdominale/complications , Facteurs de risque , Résultat thérapeutique , Implantation de prothèses vasculaires/effets indésirables , Études rétrospectivesRÉSUMÉ
OBJECTIVE: Although physical exercise has established benefits for long-term cardiovascular health, concern regarding further aortic events has limited the evidence for exercise among aortic dissection (AD) patients. The objective was to perform a scoping review of the current concepts and gaps in the literature regarding the benefit and safety of cardiovascular testing and rehabilitation among post-AD patients. REVIEW METHODS: A scoping review of the literature search was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR). Eligibility criteria included any studies with AD in relation to exercise rehabilitation or testing and physical or mental health. Electronic databases were queried for relevant studies (last queried, November 1, 2021). RESULTS: Six observational studies were included with a total of 381 patients with AD, all of whom underwent surgical intervention. Study heterogeneity prevented data synthesis and a formal systematic review, although four dominant themes emerged: cardiovascular-related outcomes, aorta-related outcomes, quality of life (QoL), and serious adverse events. Patients with AD have reduced baseline physical capacity and QoL. Rehabilitation programs may increase both physical status and QoL. Rates of serious adverse rates are minimal yet poorly defined. CONCLUSIONS: Within the context of apparent benefits from cardiovascular testing and rehabilitation for patients with AD who have undergone intervention, this scoping review highlights the need for increased comparative research specific to exercise among patients with AD and outcomes such as mortality and reinterventions.
Sujet(s)
, Qualité de vie , Humains , Exercice physique , Épreuve d'effort , Traitement par les exercices physiquesRÉSUMÉ
OBJECTIVE: There is no consensus regarding the terminology, definition, classification, diagnostic criteria, and algorithm, or reporting standards for the disease of infective native aortic aneurysm (INAA), previously known as mycotic aneurysm. The aim of this study was to establish this by performing a consensus study. METHODS: The Delphi methodology was used. Thirty-seven international experts were invited via mail to participate. Four two week Delphi rounds were performed, using an online questionnaire, initially with 22 statements and nine reporting items. The panellists rated the statements on a five point Likert scale. Comments on statements were analysed, statements revised, and results presented in iterative rounds. Consensus was defined as ≥ 75% of the panel selecting "strongly agree" or "agree" on the Likert scale, and consensus on the final assessment was defined as Cronbach's alpha coefficient > .80. RESULTS: All 38 panellists completed all four rounds, resulting in 100% participation and agreement that this study was necessary, and the term INAA was agreed to be optimal. Three more statements were added based on the results and comments of the panel, resulting in a final 25 statements and nine reporting items. All 25 statements reached an agreement of ≥ 87%, and all nine reporting items reached an agreement of 100%. The Cronbach's alpha increased for each consecutive round (round 1 = .84, round 2 = .87, round 3 = .90, and round 4 = .92). Thus, consensus was reached for all statements and reporting items. CONCLUSION: This Delphi study established the first consensus document on INAA regarding terminology, definition, classification, diagnostic criteria, and algorithm, as well as reporting standards. The results of this study create essential conditions for scientific research on this disease. The presented consensus will need future amendments in accordance with newly acquired knowledge.
RÉSUMÉ
OBJECTIVE: To report the mid-term outcomes of fenestrated-branched endovascular aneurysm repair (F-BEVAR) following a failed previous endovascular aneurysm repair (pEVAR) or previous open aneurysm repair (pOAR). METHODS: Data from consecutive patients who underwent F-BEVAR for pEVAR or pOAR from 2006 to 2021 from 17 European vascular centers were analyzed. Endpoints included technical success, major adverse events, 30-day mortality, and 5-year estimates of survival, target vessel primary patency, freedom from reinterventions, type I/III endoleaks, and sac growth >5 mm. BACKGROUND: Treatment of a failed previous abdominal aortic aneurysm repair is a complex undertaking. F-BEVAR is becoming an increasingly attractive option, although comparative data are limited regarding associated risk factors, indications for treatment, and various outcomes. RESULTS: There were 526 patients included, 268 pOAR and 258 pEVAR. The median time from previous repair to F-BEVAR was 7 (interquartile range, 4-12) years, 5 (3-8) for pEVAR, and 10 (6-14) for pOAR, P <0.001. Predominant indication for treatment was type Ia endoleak for pEVAR and progression of the disease for pOAR. Technical success was 92.8%, pOAR (92.2%), and pEVAR (93.4%), P =0.58. The 30-day mortality was 6.5% overall, 6.7% for pOAR, and 6.2% for pEVAR, P =0.81. There were 1853 treated target vessels with 5-year estimates of primary patency of 94.4%, pEVAR (95.2%), and pOAR (94.4%), P =0.03. Five-year estimates for freedom from type I/III endoleaks were similar between groups; freedom from reintervention was lower for pEVAR (38.3%) than for pOAR (56.0%), P =0.004. The most common indication for reinterventions was for type I/III endoleaks (37.5%). CONCLUSIONS: Repair of a failed pEVAR or pOARis safe and feasible with comparable technical success and survival rates. While successful treatment can be achieved, significant rates of reintervention should be anticipated, particularly for issues related to instability of target vessels/bridging stents.