Outcomes Following Intact and Ruptured Aneurysm Repair across Nations: Analysis of International Registry Data from the VASCUNET Collaboration 2014 - 2019.

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.

Editor's Choice - Sex Related Differences in Indication and Procedural Outcomes of Carotid interventions in VASCUNET.

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.

Contemporary Treatment of Popliteal Artery Aneurysms in 14 Countries: A Vascunet Report.

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.

Editor's Choice - International Variations and Sex Disparities in the Treatment of Peripheral Arterial Occlusive Disease: A Report from VASCUNET and the International Consortium of Vascular Registries.

OBJECTIVE: The aim of this study was to determine sex specific differences in the invasive treatment of symptomatic peripheral arterial occlusive disease (PAOD) between member states participating in the VASCUNET and International Consortium of Vascular Registries. METHODS: Data on open surgical revascularisation and peripheral vascular intervention (PVI) of symptomatic PAOD from 2010 to 2017 were collected from population based administrative and registry data from 11 countries. Differences in age, sex, indication, and invasive treatment modality were analysed. RESULTS: Data from 11 countries covering 671 million inhabitants and 1 164 497 hospitalisations (40% women, mean age 72 years, 49% with intermittent claudication, 54% treated with PVI) in Europe (including Russia), North America, Australia, and New Zealand were included. Patient selection and treatment modality varied widely for the proportion of female patients (23% in Portugal and 46% in Sweden), the proportion of patients with claudication (6% in Italy and 69% in Russia), patients' mean age (70 years in the USA and 76 years in Italy), the proportion of octogenarians (8% in Russia and 33% in Sweden), and the proportion of PVI (24% in Russia and 88% in Italy). Numerous differences between females and males were observed in regard to patient age (72 vs. 70 years), the proportion of octogenarians (28% vs. 15%), proportion of patients with claudication (45% vs. 51%), proportion of PVI (57% vs. 51%), and length of hospital stay (7 days vs. 6 days). CONCLUSION: Remarkable differences regarding the proportion of peripheral vascular interventions, patients with claudication, and octogenarians were seen across countries and sexes. Future studies should address the underlying reasons for this, including the impact of national societal guidelines, reimbursement, and differences in health maintenance.

The Norwegian Stroke in the Young Study (NOR-SYS): rationale and design.

BACKGROUND: Ischemic stroke in young adults is a major health problem being associated with a higher vascular morbidity and mortality compared to controls, and a stroke recurrence rate of 25% during the first decade. The assumed cause of infarction and the detected risk factors determine the early- and long-term treatment. However, for many patients the cause of stroke remains unknown. Risk factor profile and etiology differ in young and elderly ischemic stroke patients, and atherosclerosis is the determined underlying condition in 10 to 15%. However, subclinical atherosclerosis is probably more prevalent and may go unrecognized. METHODS/DESIGN: NOR-SYS is a prospective long-term research program. Standardized methods are used for anamnestic, clinical, laboratory, imaging, and ultrasound data collection in ischemic stroke patients aged ≤60 years, their partners and joint adult offspring. The ultrasound protocol includes the assessment of intracranial, carotid and femoral arteries, abdominal aorta, and the estimation of VAT. To date, the study is a single centre study with approximately 400 patients, 250 partners and 350 adult offspring expected to be recruited at our site. DISCUSSION: NOR-SYS aims to increase our knowledge about heredity and the development of arterial vascular disease in young patients with ischemic stroke and their families. Moreover, optimization of diagnostics, prophylaxis and early intervention are major targets with the intention to reduce stroke recurrence and other clinical arterial events, physical disability, cognitive impairment and death.

Scandinavian trial of uncomplicated aortic dissection therapy: study protocol for a randomized controlled trial.

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.

Mineralization in a Critical Size Bone-Gap in Sheep Tibia Improved by a Chitosan-Calcium Phosphate-Based Composite as Compared to Predicate Device.

Deacetylated chitin derivatives have been widely studied for tissue engineering purposes. This study aimed to compare the efficacy of an injectable product containing a 50% deacetylated chitin derivative (BoneReg-Inject™) and an existing product (chronOS Inject®) serving as a predicate device. A sheep model with a critical size drill hole in the tibial plateau was used. Holes of 8 mm diameter and 30 mm length were drilled bilaterally into the proximal area of the tibia and BoneReg-Inject™ or chronOS Inject® were injected into the right leg holes. Comparison of resorption and bone formation in vivo was made by X-ray micro-CT and histological evaluation after a live phase of 12 weeks. Long-term effects of BoneReg-Inject™ were studied using a 13-month live period. Significant differences were observed in (1) amount of new bone within implant (p < 0.001), higher in BoneReg-InjectTM, (2) signs of cartilage tissue (p = 0.003), more pronounced in BoneReg-InjectTM, and (3) signs of fibrous tissue (p < 0.001), less pronounced in BoneReg-InjectTM. Mineral content at 13 months postoperative was significantly higher than at 12 weeks (p < 0.001 and p < 0.05, for implant core and rim, respectively). The data demonstrate the potential of deacetylated chitin derivatives to stimulate bone formation.

Bone remodeling effect of a chitosan and calcium phosphate-based composite.

Chitosan is a biocompatible polymer that has been widely studied for tissue engineering purposes. The aim of this research was to assess bone regenerative properties of an injectable chitosan and calcium phosphate-based composite and identify optimal degree of deacetylation (%DDA) of the chitosan polymer. Drill holes were generated on the left side of a mandible in Sprague-Dawley rats, and the hole was either left empty or filled with the implant. The animals were sacrificed at several time points after surgery (7-22 days) and bone was investigated using micro-CT and histology. No significant new bone formation was observed in the implants themselves at any time points. However, substantial new bone formation was observed in the rat mandible further away from the drill hole. Morphological changes indicating bone formation were found in specimens explanted on Day 7 in animals that received implant. Similar bone formation pattern was seen in control animals with an empty drill hole at later time points but not to the same extent. A second experiment was performed to examine if the %DDA of the chitosan polymer influenced the bone remodeling response. The results suggest that chitosan polymers with %DDA between 50 and 70% enhance the natural bone remodeling mechanism.

[Finger necrosis following arterial cannulation - a case report].

Arterial cannulation is a common procedure in critically ill patients, as it facilitates continuous monitoring of blood pressure, titration of inotropes, vasopressors and fluids and is also used for blood sampling. Serious complications from arterial lines are very rare, permanent ischemic damage occurs in less than 0,1% of patients. We report the case of a 60-year-old woman in septic shock caused by a perforated duodenal ulcer which was treated with emergent laparoscopic repair. She required high doses of vasopressors and received several arterial lines, including lines in both the ulnar and the radial arteries of the left arm. After two weeks in the intensive care unit she developed ischemia in all fingers of her left hand. She received anticoagulative therapy which was complicated by serious gastrointestinal bleeding and the therapy had to be discontinued. Eight weeks later she had demarcated necrosis in all fingers of her left hand and underwent partial amputation of fingers II-V, the thumb recovered without surgery. The cause of the necrosis was believed to be arterial embolism or ischemia secondary to arte- rial cannulations in combination with her underlying critical septic condition.

[Intermittent claudication--diagnosis and treatment]. / Claudicatio intermittens--diagnostikk og behandling.

BACKGROUND: Intermittent claudication occurs in 5% of the population over 60 years, and may involve reduced walking distance, pain and a reduced quality of life. The mortality rate is 5% per year and the annual amputation rate 1%. This review article gives an update on diagnosis and medical, endovascular and surgical treatment of intermittent claudication. MATERIAL AND METHODS: The article is based on publications found on Pubmed, supplemented by clinical experience. RESULTS AND INTERPRETATION: The aims of medical, endovascular and surgical treatments are to enable the patient to walk further, obtain an improved quality of life and to live longer. Patients should first be treated medically. Endovascular treatment or open surgery, are options for patients with reduced quality of life due to limited walking distance. The treatment choice depends on the location of the arterial lesions and if the patient has any other illness.

Local infections after above-knee prosthetic femoropopliteal bypass for intermittent claudication.

BACKGROUND: The use of prosthetic grafts in the treatment of intermittent claudication is still a controversy. Prosthetic bypass for this usually benign condition may in some cases lead to a graft infection. This potentially disastrous complication is difficult to manage. METHODS: One hundred forty-one consecutive operations done on 129 patients between January, 1990 and December, 2001 in a single university vascular unit have been studied. Lymphatic complications and local infections have been related to preoperative risk factors, complications, secondary procedures, and outcome. RESULTS: During a mean follow-up period of 42 months, lymph complications occurred after 18 operations, surgical site infection after 11 procedures, and graft infection after 17 operations. Eleven infected grafts were treated successfully without graft excision. Six of these grafts healed with antibiotics only. The risk of developing a local infection was significantly correlated with postoperative lymph fistula. Reoperative surgery was associated with graft infection. Graft infection caused by Staphylococcus aureus always warranted surgery, either local revision or graft excision. CONCLUSIONS: The present series had a high frequency of graft infections. Our data suggest that a selective approach should be taken towards excision of infected femoropopliteal prostheses. The need for and extent of surgery should be individualized according to the clinical presentation of the graft infection and the type of bacteria involved. We advocate a conservative attitude towards surgical treatment of intermittent claudication.

[Stenting of failing above-knee femoropopliteal percutaneous transluminal angioplasty]. / Stentbehandling i det femoropopliteale segmentet ovenfor kneet.

BACKGROUND: Percutaneous transluminal angioplasty (PTA) is increasingly used in the treatment of stenoses and short occlusions of the superficial femoral and proximal popliteal arteries. Routine treatment with arterial stents does not seem to improve the results compared to PTA without stent but the efficacy of stenting as a repair procedure of a failing PTA is not known. PATIENTS AND METHODS: In our hospital, intraluminal arterial stenting of the above knee femoropopliteal segment has been used as a repair procedure when PTA alone fails because of dissection or recoil. From 1995 to 2001, 264 above-knee femoropopliteal PTAs were performed in 203 patients. Fifteen procedures were considered failures; these cases are reported in this study. RESULTS: Arterial stents were successfully implanted in all fifteen patients. One year postoperatively, five stents had occluded, seven reconstructions were still patent. Three patients could not be followed up; they were diseased at the time of the study. INTERPRETATION: In spite of the limited patency achieved, intraluminal arterial stenting in the above-knee femoropopliteal segment can be useful as a repair procedure when PTA alone fails.

[Use of stents in abdominal aortic aneurysms]. / Bruk av stentgraft ved abdominale aortaaneurismer.

BACKGROUND: Endovascular treatment of aortic aneurysms has acquired a widespread application. We present the results of endovascular treatment of infrarenal, abdominal aortic aneurysms in our hospital from 1995 through 2002. MATERIAL AND METHOD: Seventy-one stent graft procedures were performed on 69 patients (64 men), mean age 72 years (range 48-96 years). Mean aneurysm diameter was 57 mm (range 35-100 mm). Sixty-nine procedures were elective and two were emergency procedures. All data were registered prospectively. RESULTS: Two procedures failed initially because of technical problems. Both patients underwent a successful procedure later. Immediate conversion to open surgery was done in one case because of a collapse of the graft into the aneurysm sac. There was no 30-day mortality for elective procedures. The conversion rate after a mean observation time of 42 months was 11%. Late complications resulted in 47 re-interventions in 29 patients, of which 96% were done in cases treated with Stentor or Vanguard prostheses. CONCLUSION: Endovascular treatment of aortic aneurysms is an alternative to open surgery. Stent graft failure can be serious and difficult to predict. This treatment should not be recommended to patients younger than 70 years and fit for open surgery.

Treatment of a hepatic artery aneurysm by endovascular stent-grafting.

Aneurysms of the visceral arteries are rare. Traditional treatment has been surgical or endovascular with coil embolization. Recently, however, reports on endovascular therapy with stent-grafts have been published. We report the case of a 61-year-old man who was successfully treated with a stent-graft for a symptomatic combined celiac/hepatic artery aneurysm.

Flow measurement before and after papaverine injection in above-knee prosthetic femoropopliteal bypass.

OBJECTIVE: To investigate the value of intraoperative blood flow measurements on early and long-term patency of above-knee prosthetic femoropopliteal bypass. METHODS: Flow was measured with a transit time flowmeter before (basal flow) and after an intragraft injection of papaverine (papaverine flow) in 87 operations (86 patients) between January 1990 and December 2001. Sixty-one grafts were of polyester, and 26 were of polytetrafluoroethylene. The operations were done under epidural anesthesia. The preoperative angiographic run-off score and clinical risk factors were recorded. Patency rates were analyzed with the product limit method and compared with the log-rank test. Variables found to be near significantly related to patency rates (P < .1) were included in a multivariate analysis performed with the Cox proportional hazard model. RESULTS: Basal flow measurements were not related to patency. The 2- and 5-year patency rates for grafts with a papaverine flow < or = 500 mL/min were 48% and 18% compared with 66% and 52% for grafts with a papaverine flow > or = 500 mL/min. These differences were statistically significant (P = .012, hazard ratio, 2.6). Two- and 5-year patency rates for smokers vs nonsmokers were 44% and 18% vs 69% and 54%. The patency rates for patients with poor vs good run-off were 42% and 27% vs 66% and 31%. Smoking (P = .008, hazard ratio, 2.75) and poor run-off score (P = .009, hazard ratio, 2.38) were found to be independent risk factors for reduced patency rates. Poor run-off score did not correlate with low values of measured basal or papaverine flow. CONCLUSIONS: Papaverine flow of < or = 500 mL/min is associated with reduced mid- and long-term patency rates. Additional antithrombotic medication and frequent follow-up for these grafts should be considered. The inferior patency rates of smokers and patients with poor run-off indicate that prosthetic bypass is less suitable for these groups of patients.