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1.
J Vasc Surg ; 79(2): 420-435.e1, 2024 Feb.
Article En | MEDLINE | ID: mdl-37944771

OBJECTIVE: Despite the publication of various national/international guidelines, several questions concerning the management of patients with asymptomatic (AsxCS) and symptomatic (SxCS) carotid stenosis remain unanswered. The aim of this international, multi-specialty, expert-based Delphi Consensus document was to address these issues to help clinicians make decisions when guidelines are unclear. METHODS: Fourteen controversial topics were identified. A three-round Delphi Consensus process was performed including 61 experts. The aim of Round 1 was to investigate the differing views and opinions regarding these unresolved topics. In Round 2, clarifications were asked from each participant. In Round 3, the questionnaire was resent to all participants for their final vote. Consensus was reached when ≥75% of experts agreed on a specific response. RESULTS: Most experts agreed that: (1) the current periprocedural/in-hospital stroke/death thresholds for performing a carotid intervention should be lowered from 6% to 4% in patients with SxCS and from 3% to 2% in patients with AsxCS; (2) the time threshold for a patient being considered "recently symptomatic" should be reduced from the current definition of "6 months" to 3 months or less; (3) 80% to 99% AsxCS carries a higher risk of stroke compared with 60% to 79% AsxCS; (4) factors beyond the grade of stenosis and symptoms should be added to the indications for revascularization in AsxCS patients (eg, plaque features of vulnerability and silent infarctions on brain computed tomography scans); and (5) shunting should be used selectively, rather than always or never. Consensus could not be reached on the remaining topics due to conflicting, inadequate, or controversial evidence. CONCLUSIONS: The present international, multi-specialty expert-based Delphi Consensus document attempted to provide responses to several unanswered/unresolved issues. However, consensus could not be achieved on some topics, highlighting areas requiring future research.


Carotid Stenosis , Stroke , Humans , Carotid Stenosis/diagnosis , Carotid Stenosis/diagnostic imaging , Consensus , Delphi Technique , Stroke/diagnosis , Stroke/etiology , Constriction, Pathologic
2.
Eur J Vasc Endovasc Surg ; 66(1): 7-14, 2023 Jul.
Article En | MEDLINE | ID: mdl-37105268

OBJECTIVE: It has been suggested that peri-operative complications after carotid surgery may be higher in women than in men. This assumption may affect the treatment patterns, and it is thus possible that carotid endarterectomy (CEA) is provided to women less often. The aim of the current VASCUNET study was to determine sex related differences in operative risk in routine clinical practice among non-selected patients undergoing carotid revascularisation. METHODS: Data on CEA and carotid artery stenting (CAS) from 14 vascular registries were collected and amalgamated. Comprehensive data were available for 223 626 carotid artery procedures; these were analysed overall and by country. The primary outcome was any stroke and or death within 30 days of carotid revascularisation. Secondary outcomes were stroke, death, or any major cardiac event or haemorrhage leading to re-operation. RESULTS: Of the procedures, 34.8% were done in women. The proportion of CEA for asymptomatic stenosis compared with symptomatic stenosis was significantly higher among women than men (38.4% vs. 36.9%, p < .001). The proportion of octogenarians was higher among women than men who underwent CEA in both asymptomatic (21.2% vs. 19.9%) and symptomatic patients (24.3% vs. 21.4%). In the unadjusted analysis of symptomatic and asymptomatic patients, there were no significant differences between men and women in the rate of post-operative combined stroke and or death, any major cardiac event, or combined death, stroke, and any major cardiac event after CEA. Also, after stenting for asymptomatic or symptomatic carotid stenosis, there were no significant differences between men and women in the rate of post-operative complications. In adjusted analyses, sex was not significantly associated with any of the end points. Higher age and CAS vs. CEA were independently associated with all four end points. CONCLUSION: This study confirmed that, in a large registry among non-selected patients, no significant sex related differences were found in peri-operative complication rates after interventions for carotid stenosis.

3.
Eur J Vasc Endovasc Surg ; 63(1): 80-89, 2022 01.
Article En | MEDLINE | ID: mdl-34686452

OBJECTIVE: To perform a scoping review of how patients with COVID-19 are affected by acute limb ischaemia (ALI) and evaluate the recommendations of the 2020 ESVS ALI Guidelines for these patients. METHODS: Research questions were defined, and a systematic literature search was performed following the PRISMA guidelines. Abstracts and unpublished literature were not included. The definition of ALI in this review is in accordance with the ESVS guidelines. RESULTS: Most identified papers were case reports or case series, although population based data and data from randomised controlled trials were also identified. In total, 114 unique and relevant papers were retrieved. Data were conflicting concerning whether the incidence of ALI increased, or remained unchanged, during the pandemic. Case reports and series reported ALI in patients who were younger and healthier than usual, with a greater proportion affecting the upper limb. Whether or not this is coincidental remains uncertain. The proportion of men/women affected seems unchanged. Most reported cases were in hospitalised patients with severe COVID-19. Patients with ALI as their first manifestation of COVID-19 were reported. Patients with ALI have a worse outcome if they have a simultaneous COVID-19 infection. High levels of D-dimer may predict the occurrence of arterial thromboembolic events in patients with COVID-19. Heparin resistance was observed. Anticoagulation should be given to hospitalised COVID-19 patients in prophylactic dosage. Most of the treatment recommendations from the ESVS Guidelines remained relevant, but the following were modified regarding patients with COVID-19 and ALI: 1) CTA imaging before revascularisation should include the entire aorta and iliac arteries; 2) there should be a high index of suspicion, early testing for COVID-19 infection and protective measures are advised; and 3) there should be preferential use of local or locoregional anaesthesia during revascularisation. CONCLUSION: Although the epidemiology of ALI has changed during the pandemic, the recommendations of the ESVS ALI Guidelines remain valid. The above mentioned minor modifications should be considered in patients with COVID-19 and ALI.


COVID-19/virology , Ischemia/surgery , Peripheral Arterial Disease/surgery , SARS-CoV-2/pathogenicity , Vascular Surgical Procedures/standards , COVID-19 Testing/methods , Humans , Ischemia/complications
4.
Orv Hetil ; 162(31): 1233-1243, 2021 08 01.
Article Hu | MEDLINE | ID: mdl-34333458

Összefoglaló. Bevezetés: Az elmúlt évtizedekben számos országban jelentos mértékben változott a hasi aortaaneurysmák sebészi kezelése az eredményesebb ellátás céljából: endovascularis beavatkozások terjedése, nagy betegforgalmú aortacentrumok kialakítása. Célkituzés: A Magyarországon, infrarenalis aortaaneurysmák miatt végzett beavatkozások rövid távú eredményeinek elemzése elsosorban mutéti technika (endovascularis vs. nyitott aortareconstructio), intézeti betegforgalom (kis vs. nagy betegforgalmú intézet) és idoszak (2010-2014 vs. 2015-2019) alapján. Módszer: A Nemzeti Érsebészeti Regiszterben 2010. 01. 01. és 2019. 12. 31. között prospektíven rögzített multicentrikus adatok retrospektív feldolgozása. Eredmények: A regiszterben 3206 infrarenalis aortaaneurysma-mutétet rögzítettek. A második öt évben jelentosen nott az endovascularis aortareconstructio aránya a nyitotthoz képest (p<0,0001), illetve a nagy betegforgalmú intézetek szignifikánsan több rupturált aortaaneurysmát láttak el, mint a kis betegforgalmú intézetek (p<0,0001) az elso öt évhez viszonyítva. A perioperatív mortalitás rupturált aortaaneurysma miatt a nagy betegforgalmú intézetekben végzett nyitott aortareconstructio esetén szignifikánsan alacsonyabb volt a kis betegforgalmú intézetekkel szemben az elso öt évben (p = 0,0011), illetve a nagy betegforgalmú intézetekben végzett endovascularis aortareconstructio esetén szignifikánsan alacsonyabb volt a nyitottal szemben a második öt évben (p = 0,029). A nem rupturált aortaaneurysma-mutétek perioperatív mortalitása a nagy betegforgalmú intézetekben végzett nyitott aortareconstructio esetén szignifikánsan alacsonyabb volt a kis betegforgalmú intézetekhez képest az elso és a második öt évben is (p = 0,0007; p = 0,004). Mind a nagy, mind a kis betegforgalmú intézetekben végzett endovascularis aortareconstructio esetén szignifikánsan alacsonyabb volt a perioperatív mortalitás a második öt évben (p<0,0001; p<0,0001). A rupturált és a nem rupturált aortaaneurysmák perioperatív mortalitásának független rizikófaktora az intézetek betegforgalma (p = 0,006; p = 0,004), a betegek életkora (p<0,0001; p = 0,001), a preoperatív renalis megbetegedés (p = 0,007; p = 0,007), a transzfúzióigény (p<0,0001; p<0,0001), illetve nem rupturált aortaaneurysmák esetében a mutéti technika (p<0,0001) is. Következtetés: Endovascularis aortareconstructio és nagy betegforgalmú intézetek esetében szignifikánsan alacsonyabb perioperatív mortalitás érheto el. Orv Hetil. 2021; 162(31): 1233-1243. INTRODUCTION: The organisation of aortic disease care has changed significantly in many countries over the last decade: centralized, high-volume centers were established. OBJECTIVE: To analyse the perioperative mortality and the number of the infrarenal aortic aneurysm repairs according to the type of procedure (endovascular vs. open), patient volume (low vs. high) and time period (2010-2014 vs. 2015-2019). METHODS: The multicentric data registered prospectively in the Hungarian National Vascular Registry between 01. 01. 2010 and 31. 12. 2019 were analysed retrospectively. RESULTS: 3206 infrarenal aortic aneurysms were recorded. The endovascular-open repair rate was significantly higher (p<0.0001) and the high-volume institutes managed significantly more ruptured aneurysms (p<0.0001) in the second period. The perioperative mortality of the open repair of ruptured aneurysms was significantly lower in the high-volume institutes than in the low-volume ones in the first period (p = 0.0011), and the mortality of endovascular repair was significantly lower compared with open repair in the high-volume institutes in the second period (p = 0.029). The perioperative mortality of the open repair of non-ruptured aneurysm was significantly lower in the high-volume institutes in both periods (p = 0.0007; p = 0.004). Furthermore, the mortality of endovascular repair was significantly lower compared with open repair both in the high- and the low-volume institutes in the second period (p<0.0001; p<0.0001). Patient volume (p = 0.006; p = 0.004), age (p<0.0001; p = 0.001), preoperative renal insufficiency (p = 0.007; p = 0.007) and the need of blood transfusion (p<0.0001; p<0.0001) were independent risk factors of the perioperative mortality of ruptured and non-ruptured aneurysms. Type of the procedure was also an independent risk factor in the case of non-ruptured aneurysms (p<0.0001). CONCLUSION: Endovascular repair and aortic surgery in the high-volume institutes result in significantly lower perioperative mortality. Orv Hetil. 2021; 162(31): 1233-1243.


Aortic Aneurysm , Humans , Hungary , Registries , Retrospective Studies , Risk Factors
5.
6.
Vascular ; 29(6): 938-944, 2021 Dec.
Article En | MEDLINE | ID: mdl-33427096

OBJECTIVES: Perioperative stress affects the outcome of carotid endarterectomy performed under regional anesthesia. Here we aimed to explore the temporal profile of the stress marker cortisol and its relationship to high-sensitivity troponin-T, matrix metalloproteinase-9, tissue inhibitor of metalloproteinase-1, and S100B as an indicator of blood-brain barrier alteration in the systemic circulation. METHODS: Prospective part of the study: a total of 31 patients with significant carotid stenosis scheduled for carotid endarterectomy in regional anesthesia were enrolled. Follow-up part of the study and retrospective analysis of the outcome: each patient was followed up to five years and morbidity as well as mortality data were collected from an electronic database. Blood samples from each patient were serially taken; prior to surgery (T1), at the time of reperfusion (T2), 24 h (T3) and 72 h later postoperatively (T4), then the plasma concentration of each biomarker was measured. Besides, the clinical and surgical factors and perioperative adverse events were recorded. RESULTS: More positive correlations were found between: the early change of S100B (T2-T1) and late change in plasma cortisol level (T4-T3) (r = 0.403; p < 0.05); the early change of cortisol (T2-T1) and the early postoperative change of plasma matrix metalloproteinase-9 level (T3-T2) (r = 0.432; p = 0.01); the plasma concentration of tissue inhibitor of metalloproteinase-1 at 24 postoperative hours and the late change in plasma high-sensitivity troponin-T level (T4-T3) (r = 0.705; p < 0.001). Five patients needed an intraoperative shunt in whom the high-sensitivity troponin-T was elevated even prior to surgery, but definitive stroke never occurred. Plasma matrix metalloproteinase-9 concentration at reperfusion independently predicted the five-year mortality with a cut-off value of 456 ng/ml (sensitivity: 86%, specificity: 84%, area 0.887, p = 0.002). CONCLUSIONS: A higher intraoperative change in S100B level reflecting carotid endarterectomy induced acute silent brain ischemia was associated with more pronounced post-operative change of cortisol. An early elevation of cortisol was found to be associated with a delayed increase of matrix metalloproteinase-9. Importantly, an increased high-sensitivity troponin-T even prior to carotid endarterectomy may predict clamp intolerance, and elevated matrix metalloproteinase-9 at reperfusion suggests a poor outcome.


Carotid Stenosis/surgery , Endarterectomy, Carotid/adverse effects , Troponin T/blood , Aged , Anesthesia, Conduction/adverse effects , Biomarkers/blood , Carotid Stenosis/blood , Carotid Stenosis/diagnostic imaging , Female , Humans , Hydrocortisone/blood , Male , Matrix Metalloproteinase 9/blood , Middle Aged , Predictive Value of Tests , Prospective Studies , S100 Calcium Binding Protein beta Subunit/blood , Time Factors , Tissue Inhibitor of Metalloproteinase-1/blood , Treatment Outcome , Up-Regulation
7.
Eur J Vasc Endovasc Surg ; 60(5): 721-729, 2020 Nov.
Article En | MEDLINE | ID: mdl-32807672

OBJECTIVE: Popliteal artery aneurysm (PAA) is the second most common arterial aneurysm. Vascunet is an international collaboration of vascular registries. The aim was to study treatment and outcomes. METHODS: This was a retrospective analysis of prospectively registered population based data. Fourteen countries contributed data (Australia, Denmark, Finland, France, Hungary, Iceland, Italy, Malta, New Zealand, Norway, Portugal, Serbia, Sweden, and Switzerland). RESULTS: During 2012-2018, data from 10 764 PAA repairs were included. Mean values with between countries ranges in parenthesis are given. The incidence was 10.4 cases/million inhabitants/year (2.4-19.3). The mean age was 71.3 years (66.8-75.3). Most patients, 93.3%, were men and 40.0% were active smokers. The operations were elective in 73.2% (60.0%-85.7%). The mean pre-operative PAA diameter was 32.1 mm (27.3-38.3 mm). Open surgery dominated in both elective (79.5%) and acute (83.2%) cases. A medial surgical approach was used in 77.7%, and posterior in 22.3%. Vein grafts were used in 63.8%. Of the emergency procedures, 91% (n = 2 169, 20.2% of all) were for acute thrombosis and 9% for rupture (n = 236, 2.2% of all). Thrombosis patients had larger aneurysms, mean diameter 35.5 mm, and 46.3% were active smokers. Early amputation and death were higher after acute presentation than after elective surgery (5.0% vs. 0.7%; 1.9% vs. 0.5%). This pattern remained one year after surgery (8.5% vs. 1.0%; 6.1% vs. 1.4%). Elective open compared with endovascular surgery had similar one year amputation rates (1.2% vs. 0.2%; p = .095) but superior patency (84.0% vs. 78.4%; p = .005). Veins had higher patency and lower amputation rates, at one year compared with synthetic grafts (86.8% vs. 72.3%; 1.8% vs. 5.2%; both p < .001). The posterior open approach had a lower amputation rate (0.0% vs. 1.6%, p = .009) than the medial approach. CONCLUSION: Patients presenting with acute ischaemia had high risk of amputation. The frequent use of endovascular repair and prosthetic grafts should be reconsidered based on these results.


Aneurysm/surgery , Ischemia/surgery , Limb Salvage/statistics & numerical data , Popliteal Artery/pathology , Thrombosis/surgery , Acute Disease/epidemiology , Acute Disease/therapy , Aged , Amputation, Surgical/statistics & numerical data , Aneurysm/complications , Aneurysm/epidemiology , Aneurysm/pathology , Australia/epidemiology , Brazil/epidemiology , Elective Surgical Procedures/adverse effects , Elective Surgical Procedures/methods , Elective Surgical Procedures/statistics & numerical data , Endovascular Procedures/adverse effects , Endovascular Procedures/methods , Europe/epidemiology , Female , Global Burden of Disease , Humans , Incidence , Ischemia/epidemiology , Ischemia/etiology , Limb Salvage/adverse effects , Limb Salvage/methods , Male , Middle Aged , New Zealand/epidemiology , Popliteal Artery/surgery , Prospective Studies , Registries/statistics & numerical data , Retrospective Studies , Risk Factors , Thrombosis/epidemiology , Thrombosis/etiology , Treatment Outcome , Vascular Grafting/adverse effects , Vascular Grafting/methods , Vascular Grafting/statistics & numerical data , Vascular Patency
9.
Ann Vasc Surg ; 63: 311-318, 2020 Feb.
Article En | MEDLINE | ID: mdl-31563659

BACKGROUND: Carotid endarterectomy in regional anesthesia is often associated with increased perioperative stress. We assumed that carotid endarterectomy performed under awake sedation with propofol is more beneficial to prevent such stress than alprazolam premedication only. METHODS: A total of 47 consecutive patients with significant carotid artery stenosis were enrolled into this investigation and followed up for 5 years to explore vascular complications. All operations were performed under regional anesthesia. As premedication, all patients took 0.5 mg of alprazolam 30 minutes before the procedure. After randomization, 22 patients had awake sedation with target controlled propofol infusion, and the other 25 had only premedication. Cortisol plasma levels were serially analyzed: before surgery (T1), before (T2) and after release of carotid clamp (T3), and at 2 (T4) and 24 postoperative hours (T5). Alprazolam levels were also measured before and after the surgery. RESULTS: The plasma concentration of cortisol was significantly lower in the propofol sedation group at T2 (P < 0.001), T3 (P = 0.001), and T4 (P < 0.001) than in the alprazolam-only group. Alprazolam levels did not correlate with cortisol levels at any time point. A significant positive correlation was found between the clamp time and plasma cortisol level at T3 (P = 0.018), similarly between the degree of contralateral carotid stenosis and plasma cortisol level at T3 (P = 0.03). Plasma cortisol concentration 2 hours after the operation (T4) proved to be an independent predictor of carotid restenosis during the 5-year follow-up (odds ratio: 1.67, 95% confidence interval: 1.02-2.73, P = 0.04). CONCLUSIONS: An additional intraoperative propofol sedation provides better stress relief than alprazolam-only premedication during awake carotid endarterectomy.


Alprazolam/administration & dosage , Anesthesia, Conduction , Carotid Stenosis/surgery , Conscious Sedation , Endarterectomy, Carotid , Hypnotics and Sedatives/administration & dosage , Propofol/administration & dosage , Stress, Physiological , Aged , Alprazolam/adverse effects , Anesthesia, Conduction/adverse effects , Biomarkers/blood , Carotid Stenosis/blood , Carotid Stenosis/diagnostic imaging , Conscious Sedation/adverse effects , Endarterectomy, Carotid/adverse effects , Female , Humans , Hungary , Hydrocortisone/blood , Hypnotics and Sedatives/adverse effects , Male , Middle Aged , Preanesthetic Medication/adverse effects , Propofol/adverse effects , Prospective Studies , Risk Factors , Time Factors , Treatment Outcome
10.
Eur J Vasc Endovasc Surg ; 58(4): 609-613, 2019 10.
Article En | MEDLINE | ID: mdl-31444047

OBJECTIVES: Vascunet has previously published an international comparison of registry data within vascular surgery. Data validity and completeness in participating registries is essential for a meaningful interpretation of differences between countries. The Vascunet collaboration has therefore developed a methodology for validation of international vascular registry data, previously used for validation of two national registries. This study aimed to assess the internal and external validity of the Danish vascular registry, Karbase, by independent Vascunet validators. METHODS: Three of seven hospitals performing vascular surgery, covering 51% of carotid operations and 78% of abdominal aortic aneurysm (AAA) repairs in Denmark in 2016, were visited by two international validators. Independent evaluation was performed of carotid endarterectomy and AAA repair. Local administrative data were compared with Karbase registry data. External validation compared the numbers of cases in these two systems of data collection. Internal validation compared data accuracy and completeness with individual patient records. RESULTS: Hospital administrative data identified 227/231 carotid and 522/576 abdominal aortic aneurysm (AAA) procedures, whereas Karbase identified 230/231 carotid and 567/576 AAAs. External validity was 99.6% for carotids and 98.4% for AAAs. In internal validation, 1.0% of variables were missing in hospital data whereas 1.7% were missing in Karbase. Data contained within the data fields of Karbase and hospital data were the same in 95.2% (95% CI 91.6-98.8%) for carotids and 97.4% (95% CI 95.4-98.8%) for AAAs. CONCLUSIONS: This study used the Vascunet template for international validation of registry data and demonstrated that Karbase is a reliable system of quality data collection for Danish vascular surgery, especially regarding endpoints. Data quality in the Karbase registry was clearly superior to local administrative data.


Aortic Aneurysm, Abdominal/surgery , Carotid Artery Diseases/surgery , Data Accuracy , Databases, Factual/standards , Registries/standards , Vascular Surgical Procedures , Aortic Aneurysm, Abdominal/diagnosis , Aortic Aneurysm, Abdominal/mortality , Carotid Artery Diseases/diagnosis , Carotid Artery Diseases/mortality , Denmark/epidemiology , Endarterectomy, Carotid , Humans , International Cooperation , Postoperative Complications/mortality , Reproducibility of Results , Time Factors , Treatment Outcome , Vascular Surgical Procedures/adverse effects , Vascular Surgical Procedures/mortality
11.
J Vasc Surg ; 70(5): 1642-1651, 2019 11.
Article En | MEDLINE | ID: mdl-30926276

OBJECTIVE: New formulations and applications of hemostatic adjuncts such as fibrin sealant (FS) to support local hemostasis and sutures continue to be developed. In a pivotal, confirmatory, controlled, prospective, single-blinded, randomized, multicenter phase III clinical trial, the efficacy and safety of FS Grifols during vascular surgeries were evaluated. METHODS: Patients undergoing a nonemergency, open, peripheral vascular surgical procedure with moderate arterial bleeding were recruited. In an initial preliminary part of the study, all patients were treated with FS Grifols. In a subsequent primary part, patients were randomized (2:1) to FS Grifols or manual compression (MC). The primary efficacy end point was the proportion of the primary part patients achieving hemostasis by 4 minutes after the start of treatment. Cumulative proportion and time to hemostasis were secondary efficacy end points. Safety end points (in pooled preliminary and primary parts) included adverse events (AEs), vital signs, physical assessments, clinical laboratory tests, viral markers, and immunogenicity. RESULTS: The primary efficacy end point was met by 76.1% of patients (83/109) for the FS Grifols group versus 22.8% of patients (13/57) for the MC group (P < .001). The cumulative proportion of patients at 5, 7, and 10 minutes was 80.7%, 84.4%, and 88.1%, respectively, in the FS Grifols treatment group, and 28.1%, 35.1%, and 45.6% in the MC treatment group (P < .001). The median time to hemostasis was shorter in the FS Grifols group (4 minutes vs ≥10 minutes in the MC group; P < .001). The nature of AEs reported were those expected in the study patient profile. The percentage of patients experiencing treatment-emergent AEs were similar in both the FS Grifols (pooled n = 59 + 109) and MC groups (81.0% and 77.2%, respectively), most recurrent being procedural pain (34.5% and 36.8%, respectively) and pyrexia (11.3% and 10.5%, respectively). CONCLUSIONS: FS Grifols was superior in efficacy and similar in safety to MC as an adjunct local hemostatic agent in patients undergoing open vascular surgeries.


Blood Loss, Surgical/prevention & control , Fibrin Tissue Adhesive/administration & dosage , Hemostasis, Surgical/methods , Vascular Surgical Procedures/adverse effects , Adult , Aged , Aged, 80 and over , Blood Loss, Surgical/statistics & numerical data , Female , Fibrin Tissue Adhesive/adverse effects , Humans , Male , Middle Aged , Pressure , Prospective Studies , Single-Blind Method , Treatment Outcome , Young Adult
12.
J Vasc Res ; 55(5): 287-298, 2018.
Article En | MEDLINE | ID: mdl-30231254

AIMS: Prosthetic graft infection frequently requires graft replacement. Among other options, a biological graft could serve as an alternative choice. Decellularization reduces tissue immunogenicity. Our aim was to determine an efficient decellularization method and to evaluate the decellularized porcine biografts' adaptability. METHODS: Four different protocols were implemented to decellularize porcine aortic segments (n = 4). Cell removal effectiveness and matrix structure preservation were histologically examined. Mechanical tests were performed. Decellularized porcine grafts were interpositioned in a porcine aorta. After a 6-month period, implanted samples were removed and evaluated using light and electron microscopy. RESULTS: Histological results showed complete removal of cells and preserved connective tissue fiber structure following decellularization, using sodium dodecyl sulfate and sodium azide. Pressure tests demonstrated similar compliance to fresh vessels. In 9 out of 10 cases, pigs survived the follow-up period. Graft rejection, intimal hyperplasia, reocclusion and/or aneurysm formation were not observed. Presence of host cells and neoendothelialization were microscopically confirmed. CONCLUSIONS: This decellularization protocol enables a cost-effective preparation of biological grafts featuring reduced immunogenicity. The implanted grafts did not degenerate during the 6-month follow-up period, the lack of graft rejection suggests acceptable immunological tolerance, while recipient cells migrate into, proliferate and differentiate, thus creating the possibility for further use as an optional vascular graft.


Aorta/transplantation , Bioprosthesis , Blood Vessel Prosthesis Implantation/instrumentation , Blood Vessel Prosthesis , Allografts , Animals , Aorta/ultrastructure , Graft Survival , Microscopy, Electron, Transmission , Models, Animal , Prosthesis Design , Sus scrofa , Time Factors
13.
Eur J Vasc Endovasc Surg ; 56(3): 391-399, 2018 09.
Article En | MEDLINE | ID: mdl-29859821

OBJECTIVES: To study international differences in incidence and practice patterns as well as time trends in lower limb amputations related to peripheral arterial disease and/or diabetes mellitus. METHODS: Data on lower limb amputations during 2010-2014 were collected from population based administrative data from countries in Europe and Australasia participating in the VASCUNET collaboration. Amputation rates, time trends, in hospital or 30 day mortality and reimbursement systems were analysed. RESULTS: Data from 12 countries covering 259 million inhabitants in 2014 were included. Individuals aged ≥ 65 years ranged from 12.9% (Slovakia) to 20.7% (Germany) and diabetes prevalence among amputees from 25.7% (Finland) to 74.3% (Slovakia). The mean incidence of major amputation varied between 7.2/100,000 (New Zealand) and 41.4/100,000 (Hungary), with an overall declining time trend with the exception of Slovakia, while minor amputations increased over time. The older age group (≥65 years) was up to 4.9 times more likely to be amputated compared with those younger than 65 years. Reported mortality rates were lowest in Finland (6.3%) and highest in Hungary (20.3%). Countries with a fee for service reimbursement system had a lower incidence of major amputation compared with countries with a population based reimbursement system (14.3/100,000 versus 18.4/100,000, respectively, p < .001). CONCLUSIONS: This international audit showed large geographical differences in major amputation rates, by a factor of almost six, and an overall declining time trend during the 4 year observation of this study. Diabetes prevalence, age distribution, and mortality rates were also found to vary between countries. Despite limitations attributable to registry data, these findings are important, and warrant further research on how to improve limb salvage in different demographic settings.


Amputation, Surgical/trends , Peripheral Arterial Disease/surgery , Practice Patterns, Physicians'/trends , Process Assessment, Health Care/trends , Surgeons/trends , Aged , Amputation, Surgical/adverse effects , Amputation, Surgical/mortality , Australia/epidemiology , Comorbidity , Europe/epidemiology , Female , Health Care Surveys , Healthcare Disparities/trends , Hospital Mortality/trends , Humans , Incidence , Male , Medical Audit , Middle Aged , New Zealand/epidemiology , Peripheral Arterial Disease/diagnosis , Peripheral Arterial Disease/mortality , Prevalence , Registries , Risk Factors , Time Factors , Treatment Outcome
14.
Eur J Vasc Endovasc Surg ; 56(2): 217-237, 2018 Aug.
Article En | MEDLINE | ID: mdl-29776646

OBJECTIVE/BACKGROUND: To achieve consensus on the minimum core data set for evaluation of peripheral arterial revascularisation outcomes and enable collaboration among international registries. METHODS: A modified Delphi approach was used to achieve consensus among international vascular surgeons and registry members of the International Consortium of Vascular Registries (ICVR). Variables, including definitions, from registries covering open and endovascular surgery, representing 14 countries in ICVR, were collected and analysed to define a minimum core data set and to develop an optimum data set for registries. Up to three different levels of variable specification were suggested to allow inclusion of registries with simpler versus more complex data capture, while still allowing for data aggregation based on harmonised core definitions. RESULTS: Among 31 invited experts, 25 completed five Delphi rounds via internet exchange and face to face discussions. In total, 187 different items from the various registry data forms were identified for potential inclusion in the recommended data set. Ultimately, 79 items were recommended for inclusion in minimum core data sets, including 65 items in the level 1 data set, and an additional 14 items in the more specific level 2 and 3 recommended data sets. Data elements were broadly divided into (i) patient characteristics; (ii) comorbidities; (iii) current medications; (iv) lesion treated; (v) procedure; (vi) bypass; (vii) endarterectomy (viii) catheter based intervention; (ix) complications; and (x) follow up. CONCLUSION: A modified Delphi study allowed 25 international vascular registry experts to achieve a consensus recommendation for a minimum core data set and an optimum data set for peripheral arterial revascularisation registries. Continued global harmonisation of registry infrastructure and definition of items will overcome limitations related to single country investigations and enhance the development of real world evidence.


Consensus , Data Collection , Vascular Surgical Procedures , Delphi Technique , Endarterectomy/methods , Female , Humans , Male , Registries , Treatment Outcome
15.
J Vasc Surg ; 65(1): 76-81, 2017 Jan.
Article En | MEDLINE | ID: mdl-28010870

OBJECTIVE: This study investigated the diameter of internal iliac artery (IIA) aneurysms (IIAAs) at the time of rupture to evaluate whether the current threshold diameter for elective repair of 3 cm is reasonable. The prevalence of concomitant aneurysms and results of surgical treatment were also investigated. METHODS: This was a retrospective analysis of patients with ruptured IIAA from seven countries. The patients were collected from vascular registries and patient records of 28 vascular centers. Computed tomography images taken at the time of rupture were analyzed, and maximal diameters of the ruptured IIA and other aortoiliac arteries were measured. Data on the type of surgical treatment, mortality at 30 days, and follow-up were collected. RESULTS: Sixty-three patients (55 men and 8 women) were identified, operated on from 2002 to 2015. The patients were a mean age of 76.6 years (standard deviation, 9.0; range 48-93 years). A concomitant common iliac artery aneurysm was present in 65.0%, 41.7% had a concomitant abdominal aortic aneurysm, and 36.7% had both. IIAA was isolated in 30.0%. The mean maximal diameter of the ruptured artery was 68.4 mm (standard deviation, 20.5 mm; median, 67.0 mm; range, 25-116 mm). One rupture occurred at <3 cm and four at <4 cm (6.3% of all ruptures). All patients were treated, 73.0% by open repair and 27.0% by endovascular repair. The 30-day mortality was 12.7%. Median follow-up was 18.3 months (interquartile range, 2.0-48.3 months). The 1-year Kaplan-Meier estimate for survival was 74.5% (standard error, 5.7%). CONCLUSIONS: IIAA is an uncommon condition and mostly coexists with other aortoiliac aneurysms. Follow-up until a diameter of 4 cm seems justified, at least in elderly men, although lack of surveillance data precludes firm conclusions. The mortality was low compared with previously published figures and lower than mortality in patients with ruptured abdominal aortic aneurysm.


Aneurysm, Ruptured/epidemiology , Iliac Aneurysm/epidemiology , Aged , Aged, 80 and over , Aneurysm, Ruptured/diagnostic imaging , Aneurysm, Ruptured/mortality , Aneurysm, Ruptured/surgery , Aortic Aneurysm/diagnostic imaging , Aortic Aneurysm/epidemiology , Aortography/methods , Australia/epidemiology , Blood Vessel Prosthesis Implantation , Computed Tomography Angiography , Disease Progression , Elective Surgical Procedures , Europe/epidemiology , Female , Humans , Iliac Aneurysm/diagnostic imaging , Iliac Aneurysm/mortality , Iliac Aneurysm/surgery , Kaplan-Meier Estimate , Male , Medical Records , Middle Aged , New Zealand/epidemiology , Predictive Value of Tests , Prevalence , Registries , Retrospective Studies , Risk Assessment , Risk Factors , Time Factors , Treatment Outcome
16.
Orv Hetil ; 157(50): 1994-2001, 2016 Dec.
Article Hu | MEDLINE | ID: mdl-27936879

INTRODUCTION: Cryosclerosis was introduced by Milleret and Le Pivert in the 1980s. METHOD: A prospective non-randomized comparative study has been performed on initial 96 patients. 48 patients were treated by cryosclerosis and the others received conventional stripping. 52 cases were analyzed for 2-years. The primary end-point of the study was to determine the occlusion rate of cryosclerosis. The clinical failure, the improvement in the Clinical Etiologic Anatomic Pathophysiologic classification and Venous Clinical Severity Scores were analyzed as secondary outcome. RESULTS: Total recanalization of the great saphenous vein causing clinical failure was observed in one case (4%). The reopening of the great saphenous vein was observed in 4 limbs (15%) that did not cause the incompetence of the trunk. The occlusion rate was 81%. Recurrent varicosity was observed by 35% and 42% of the patients in the cryosclerosis and stripping groups respectively. There was no significant difference between the groups (log rank test, p = 0.391). There was significant improvement in both the Clinical Etiologic Anatomic Pathophysiologic classification and Venous Clinical Severity Scores in each group without remarkable differences observed between the groups either at baseline or on the mid-term. CONCLUSIONS: Cryosclerosis seems to be effective in the remodeling of the great saphenous vein. The method has no remarkable mid-term clinical advantages over classical stripping so far. Orv. Hetil., 2016, 157(50), 1994-2001.


Cryosurgery/methods , Saphenous Vein/surgery , Varicose Veins/surgery , Venous Insufficiency/surgery , Female , Humans , Ligation/methods , Male , Minimally Invasive Surgical Procedures/methods , Prospective Studies , Saphenous Vein/diagnostic imaging , Ultrasonography, Doppler, Color , Varicose Veins/complications , Varicose Veins/diagnostic imaging , Vascular Surgical Procedures/methods , Venous Insufficiency/diagnostic imaging , Venous Insufficiency/etiology
17.
J Vasc Res ; 53(3-4): 230-242, 2016.
Article En | MEDLINE | ID: mdl-27889777

Acute kidney injury (AKI) remains an independent risk factor for mortality and morbidity after vascular surgery (affecting the renal arteries) or aortic surgery (requiring suprarenal aortic clamping). These types of vascular surgery produce renal ischemia/reperfusion (I/R) injury, a common cause of AKI. The present studies aimed at monitoring the course of renal I/R injury at the cellular level and investigating the efficacy of long-term preoperative and single-shot intraoperative administration of sodium pentosan polysulfate (PPS) to protect renal tissue from acute I/R injury both in native and diabetic kidneys in rats. Western blot analyses of the proapoptotic (bax) and antiapoptotic (bcl-2) signaling pathways, as well as the extent of DNA damage (phospho-p53), were performed. Oxidative stress followed upon the termination of malondialdehyde, reduced glutathione, thiol group, and superoxide dismutase plasma levels. Inflammatory changes were measured by the determination of serum tumor necrosis factor-α and interleukin-1 levels. Morphological changes were detected by histological examinations. Our results showed that the long-term administration of PPS has an advantage in reducing I/R kidney injury in diabetic rats, while high-dose, single-shot parenteral administration of PPS prior to revascularization might be useful in nondiabetic rats.


Acute Kidney Injury/prevention & control , Anti-Inflammatory Agents/pharmacology , Antioxidants/pharmacology , Inflammation Mediators/blood , Kidney/drug effects , Oxidative Stress/drug effects , Pentosan Sulfuric Polyester/pharmacology , Reperfusion Injury/prevention & control , Acute Kidney Injury/etiology , Acute Kidney Injury/metabolism , Acute Kidney Injury/pathology , Animals , Apoptosis Regulatory Proteins/metabolism , Biomarkers/blood , DNA Damage , Diabetes Mellitus, Experimental , Interleukin-1/blood , Kidney/metabolism , Kidney/pathology , Lipid Peroxidation/drug effects , Male , Rats, Wistar , Reperfusion Injury/etiology , Reperfusion Injury/metabolism , Reperfusion Injury/pathology , Tumor Necrosis Factor-alpha/blood
18.
Indian J Med Res ; 143(2): 220-6, 2016 Feb.
Article En | MEDLINE | ID: mdl-27121520

BACKGROUND & OBJECTIVES: Ischaemic stroke is a life burdening disease for which carotid endarterectomy (CEA) is considered a gold standard intervention. Pro-inflammatory markers like matrix metalloproteinases (MMPs) and their inhibitors (TIMPs) and S-100 Beta (S100B) may have a role in the early inflammation and cognitive decline following CEA. This study was aimed to describe the perioperative time courses and correlations between of MMP-9, TIMP-1 and S100B following CEA. METHODS: Fifty four patients scheduled for CEA were enrolled. Blood samples were collected at four time points, T 1 : preoperative, T 2 : 60 min after cross-clamp release, T 3 : first postoperative morning, T 4 : third postoperative morning. Twenty atherosclerotic patients were included as controls. Plasma MMP-9, TIMP-1 and S100B levels were estimated by ELISA. RESULTS: TIMP-1 was decreased significantly in the CEA group (P<0.01). Plasma MMP-9 was elevated and remained elevated from T 1-4 in the CEA group (P<0.05) with a marked elevation in T 3 compared to T 1 (P<0.05). MMP-9/TIMP-1 was elevated in the CEA group and increased further by T 2 and T 3 (P<0.05). S100B was elevated on T 2 and decreased on T 3-4 compared to T 1 . INTERPRETATION & CONCLUSIONS: Our study provides information on the dynamic changes of MMP-9-TIMP-1 system and S100B in the perioperative period. Preoperative reduction of TIMP-1 might be predictive for shunt requirement but future studies are required for verification.


Endarterectomy, Carotid/adverse effects , Matrix Metalloproteinase 9/blood , S100 Calcium Binding Protein beta Subunit/blood , Stroke/surgery , Tissue Inhibitor of Metalloproteinase-1/blood , Aged , Biomarkers/blood , Carotid Arteries/physiopathology , Carotid Arteries/surgery , Female , Humans , Inflammation/blood , Inflammation/physiopathology , Male , Middle Aged , Perioperative Period , Stroke/blood , Stroke/physiopathology
19.
Vascular ; 24(6): 649-657, 2016 Dec.
Article En | MEDLINE | ID: mdl-27126643

OBJECTIVE: The aim of this review article was to evaluate the long-term technical success rates of the known endovenous ablation procedures in the treatment of the incompetence of the great saphenous vein. METHODS: A literature search was conducted in the PubMed-database until the 5 January 2016. All publications with four to five years follow-up were eligible. Meta-analysis was performed by the IVhet-model. RESULTS: Eight hundred and sixty-two unique publications were found; 17 of them were appropriate for meta-analysis. Overall, 1420 limbs were included in the trial, 939 for endovenous laser ablation, 353 for radiofrequency ablation and 128 for ultrasound guided foam sclerotherapy. Overall, technical success rates were 84.8% for endovenous laser ablation, 88.7% for radiofrequency ablation and 32.8% for ultrasound guided foam sclerotherapy. There were no significant differences between endovenous laser ablation, radiofrequency ablation and ultrasound guided foam sclerotherapy regarding the great saphenous vein reopening (p = 0.66; OR: 0.22; 95% of CI: 0.08-0.62 for radiofrequency ablation vs. endovenous laser ablation; p = 0.96; OR: 0.11; 95% of CI: 0.06-0.20 for endovenous laser ablation vs. ultrasound guided foam sclerotherapy; p = 0.93; OR: 3.20; 95% of CI: 0.54-18.90 for ultrasound guided foam sclerotherapy vs. radiofrequency ablation). CONCLUSION: Both endovenous laser ablation and radiofrequency ablation are efficient in great saphenous vein occlusion on the long term. Lacking long-conducted large trials, the efficacy and reliability of ultrasound guided foam sclerotherapy to treat great saphenous vein-reflux is not affirmed.


Catheter Ablation , Laser Therapy , Saphenous Vein/surgery , Sclerotherapy , Varicose Veins/therapy , Venous Insufficiency/therapy , Catheter Ablation/adverse effects , Humans , Laser Therapy/adverse effects , Saphenous Vein/diagnostic imaging , Sclerotherapy/adverse effects , Time Factors , Treatment Outcome , Ultrasonography, Interventional , Varicose Veins/diagnostic imaging , Venous Insufficiency/diagnostic imaging
20.
Orv Hetil ; 156(49): 1991-2002, 2015 Dec 06.
Article Hu | MEDLINE | ID: mdl-26614541

INTRODUCTION: The Hungarian Society for Vascular Surgery decided to analyse and publish regularly the data of the Hungarian Vascular Registry. AIM: The aim of the authors was to present the outcome of infrarenal aortic aneurysm surgeries performed during the past five years. METHOD: Prospectively collected multicentric data obtained from the Hungarian Vascular Registry between January 1, 2010 and December 31, 2014 were analysed retrospectively. Statistical analysis was performed using Fisher's exact test and odds ratio calculation. RESULTS: It was found that 16.72% of the 1435 operations were performed for ruptured aneurysms. Five institutes having the highest capacity performed 78.4% of the operations. In the ruptured aortic aneurysm group the age of patients was 71.77±9.82 years (mean±SD), and perioperative mortality was 33.75%. In the intact aortic aneurysm group the age of patients was 69.50±8.46 years and the perioperative mortality was 3.51%. In both groups perioperative mortality (ruptured: p<0,05, OR = 0.11; intact: p<0.05, OR = 0.26) and the length of hospital stay (ruptured: p<0.05, OR = 4.55; intact: p<0.001, OR = 4.27) were significantly lower in patients who had endovascular repair compared to those with open repair. In both groups perioperative mortality (ruptured: p<0.0001, OR = 0.32; intact: p<0.0001, OR = 0.23) and length of hospital stay (ruptured: p<0.05, OR = 3.16; intact: p<0.001, OR = 3.84) were significantly lower in the five institutes having the highest capacity than in the remaining institutes. CONCLUSIONS: In patients having endovascular repair and in institutes with high capacity the perioperative mortality and length of hospital stay were significantly lower.


Aortic Aneurysm, Abdominal/surgery , Aortic Rupture/surgery , Endovascular Procedures/statistics & numerical data , Kidney , Length of Stay/statistics & numerical data , Perioperative Period/mortality , Postoperative Complications/epidemiology , Vascular Grafting/statistics & numerical data , Adult , Aged , Aged, 80 and over , Aortic Aneurysm, Abdominal/mortality , Aortic Rupture/mortality , Endovascular Procedures/adverse effects , Endovascular Procedures/mortality , Female , Hospital Bed Capacity , Humans , Hungary/epidemiology , Male , Middle Aged , Odds Ratio , Postoperative Complications/etiology , Registries , Retrospective Studies , Risk Factors , Treatment Outcome , Vascular Grafting/adverse effects , Vascular Grafting/mortality
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