Treatment results in patients with acute limb ischemia

Aim. Acute limb ischemia (ALI) is one of the most serious subjects for life quality declining and often results in patients’ disability. The incidence of ALI increases from year to year and currently counts about 50 to 100 cases per 100 000 persons in EU and USA. Methods and results. 188 cases were studied, 61% male, 39% female. The average age was 66,8±4,2 years. Among clinical events that caused ALI were atherothrombosis in 90 (47,87%) patients, embolisms in 92 (48,94%) cases, acute thrombosis of bypass graft in 6 (3,19%) patients. Conclusion. Limb salvage rate in patients after complex revascularization surgery was 100%. Thus we can state, that thrombectomy with following one stage angioplasty or bypass grafting improves clinical outcomes and limb salvation rate in patients with ALI

Surgical treatment of abdominal aortic aneurysm in combination with obliterating atherosclerosis of the lower extremities

The treatment of abdominal aortic aneurysms in combination with obliterating atherosclerosis of the lower extremities is a very difficult problem in the definition of surgical approach. Its caused by increased frequency of atherosclerosis as the basis of this disease, old age and the presence of comorbidities, especially coronary heart disease (CHD), which determines the capabilities of this treatment and its prognosis. The aim of this research was to analyze the results of diagnostics and treatment of the patients with abdominal aortic aneurysm in combination with obliterating atherosclerosis of the lower extremities. Materials and methods: The research was conducted during the past 20 years in the Department of Vascular Surgery in Zaporizhzhya Regional Clinical Hospital in the age group of 40 to 80 years. 92 patients had aneurysm of the abdominal aorta in combination with obliterating atherosclerosis of the lower extremities. In this study were analyzed the results of treatment of the patients who underwent surgery only in a planned manner. All of them had manifestations of the lower limbs ischemia and severe comorbidities. Herewith, 8 patients had occlusion of the iliac arteries on both sides and 15 patients had occlusion of the iliac arteries on one side. 87 patients had iliac artery stenosis of varying severity. 53 patients from the same group had occlusion of the superficial femoral artery with the deep femoral artery stenosis. Choice of the surgical method was determined by the data of aneurysm’s state in the dynamics received by instrumental methods, the presence of comorbidities, patient’s age, the state of vital functions and the risk of bleeding and restore of the lower limbs circulation. The basic way of surgical interventions for abdominal aortic aneurysm in combination with obliterating atherosclerosis of the lower extremities was a resection of the aneurysm with opening of the aneurysmal bag and prosthetics of the aorta. Aorto-aortic (linear) prosthesis was performed in a case of spreading the aneurysm to the bifurcation of the aorta and absence of severe stenosis or dilatation of the iliac arteries; aortoiliac bifurcation prosthesis - in patients with severe lesions of common iliac arteries, aneurysmal expansion or occlusive-stenotic process but in a case of adequate arteries; aortofemoral bifurcation prosthesis - in a case of total injury of common and external iliac arteries by aneurysmal or stenotic process. To stabilize the results of surgical treatment in postoperative period were appointed drugs that can improve blood circulation in the lower extremities. Use of stent-grafts has not found widespread clinical application, so native experience in restoration of a blood flow in stenotic or occluded arteries using stents - grafts is still too young to be able to do any definitive conclusions about all the possibilities of this method of treatment, but the low invasiveness and relative ease of replacement demonstrate its clear advantages, and high clinical efficacy will include intravascular technology to the tactics of the "first choice." The results and discussion: The results of surgical treatment of aneurysms of the abdominal aorta in conjunction with obliterating atherosclerosis were positive in 84 of 92 patients. Postoperatively, 7 patients (7.5%) died from the acute cardiovascular failure. One patient had a myocardial infarction with symptoms of acute cardiovascular collapse with cardiac arrest, resuscitation measures were effective, the patient has recovered. The relief of the process was achieved in all patients who had chronic ischemia of the lower limbs. Conclusions: The presence of abdominal aortic aneurysm, regardless of its size in combination with obliterating diseases of the arteries of the lower extremities is an absolute indication for surgery. Choice of the surgical method in a case of combination of abdominal aortic aneurysm with obliterating atherosclerosis is strictly individual and should be aimed at the elimination of the aneurysm as a possible source of bleeding and at the restore of the circulation in the lower extremities. Modern approaches in patient’s preparations for surgery and choice of treatment allowed us to get positive results in 91.3% of the patients

Хірургічне лікування ускладнень операцій у хворих на облітеруючий атеросклероз аорти й артерій нижніх кінцівок

520 reconstructive vascular operations have been made in surgery clinic for past 10 years. Analysis of remote complications in 124 cases (23,8%), shows thrombosis to be most often exposed – 60,2%, aneurysm of anastomoses – 23,3% and late suppurations – in 16,5% of patients. All patients were clinically observed: ultrasound imaging, angiography, fi stulography. Thrombectomy or allograftreplacement with reconstruction of distal anastomosis were provided in patient with thrombosis. Aneurysm dissection and distal anastomosis reconstructive surgery applied to patients with distal anastomosis aneurysm. All patients with suppuration undergone surgical elimination of suppurative inflammation and extra anatomical bypassing if possible. Positive results were achieved in 66,1% cases.В клинике госпитальной хирургии за последние 10 лет выполнено 520 реконструктивных операций. У 124 (23,8%) пациентов развились различные отдаленные осложнения. Наиболее часто выявлены тромбозы – у 60,2%, аневризмы анастомозов – у 23,3% и поздние нагноения – у 16,5% больных. Все пациенты обследованы (УЗДГ, ангиография, фистулография). При тромбозах выполняли тромбэктомию или замену бифуркационного протеза с реконструкцией дистального анастомоза, при аневризме – ее иссечение и реконструкцию дистального анастомоза, у больных с нагноением – ликвидацию гнойного очага и, по возможности, экстраанатомическое шунтирование. Положительные результаты получены у 66,1% больных.У клініці госпітальної хірургії за останні 10 років виконано 520 реконструктивних операцій. У 124 (23,8%) пацієнтів розвинулись різні віддалені ускладнення. Найчастіше виявлено тромбози – у 60,2%, аневризми анастомозів – у 23,3% і пізні нагноєння – у 16,5% хворих. Всі хворі обстежені (УЗДГ, ангіографія, фістулографія). При тромбозах виконували тромбектомію або заміну біфуркаційного протеза з реконструкцією дистального анастомозу, при аневризмі – її висічення та реконструкцію дистального анастомозу, у хворих з нагноєнням – ліквідацію гнійного запалення і, за можливості, екстраанатомічне шунтування. Позитивні результати отримано у 66,1% хворих

Результати лікування хворих з гострою артеріальною ішемією кінцівок

Aim. Acute limb ischemia (ALI) is one of the most serious subjects for life quality declining and often results in patients’ disability. The incidence of ALI increases from year to year and currently counts about 50 to 100 cases per 100 000 persons in EU and USA.Methods and results. 188 cases were studied, 61% male, 39% female. The average age was 66,8±4,2 years. Among clinical events that caused ALI were atherothrombosis in 90 (47,87%) patients, embolisms in 92 (48,94%) cases, acute thrombosis of bypass graft in 6 (3,19%) patients.Conclusion. Limb salvage rate in patients after complex revascularization surgery was 100%. Thus we can state, that thrombectomy with following one stage angioplasty or bypass grafting improves clinical outcomes and limb salvation rate in patients with ALI.Острая артериальная ишемия конечностей, вопросы диагностики и методов хирургического лечения которой остаются открытыми, – одна из основных причин ухудшения качества жизни пациентов и их ранней инвалидизации. С целью изучения влияния выбора тактики хирургического лечения на восстановление функциональности пораженной конечности проведено исследование, включающее 188 пациентов с острой артериальной ишемией (61% – мужчины, 39% – женщины). Установлено, что ни у одного пациента после выполнения тромбэктомии с пластикой артерии декомпенсированное кровообращение не развилось. Это свидетельствует о целесообразности выполнения тромбэктомии в сочетании с пластикой артерии или шунтированием и проведением адекватно подобранной консервативной терапии. Гостра артеріальна ішемія кінцівок, питання діагностики та методів хірургічного лікування якої залишаються відкритими, є однією з основних причин погіршення якості життя пацієнтів та їхньої ранньої інвалідизації. З метою вивчення впливу тактики хірургічного лікування на відновлення функціональності ураженої кінцівки здійснили дослідження, що включало 188 пацієнтів із гострою артеріальною ішемією (61% – чоловіки, 39% – жінки). Встановили, що в жодного пацієнта після виконання тромбектомії з пластикою артерії декомпенсований кровообіг не розвинувся. Це свідчить про доцільність виконання тромбектомії в поєднанні з пластикою артерії чи шунтуванням і проведенням адекватно підібраної консервативної терапії

Apixaban for Extended Treatment of Venous Thromboembolism

BACKGROUND: Apixaban, an oral factor Xa inhibitor that can be administered in a simple, fixed-dose regimen, may be an option for the extended treatment of venous thromboembolism. METHODS: In this randomized, double-blind study, we compared two doses of apixaban (2.5 mg and 5 mg, twice daily) with placebo in patients with venous thromboembolism who had completed 6 to 12 months of anticoagulation therapy and for whom there was clinical equipoise regarding the continuation or cessation of anticoagulation therapy. The study drugs were administered for 12 months. RESULTS: A total of 2486 patients underwent randomization, of whom 2482 were included in the intention-to-treat analyses. Symptomatic recurrent venous thromboembolism or death from venous thromboembolism occurred in 73 of the 829 patients (8.8%) who were receiving placebo, as compared with 14 of the 840 patients (1.7%) who were receiving 2.5 mg of apixaban (a difference of 7.2 percentage points; 95% confidence interval [CI], 5.0 to 9.3) and 14 of the 813 patients (1.7%) who were receiving 5 mg of apixaban (a difference of 7.0 percentage points; 95% CI, 4.9 to 9.1) (P<0.001 for both comparisons). The rates of major bleeding were 0.5% in the placebo group, 0.2% in the 2.5-mg apixaban group, and 0.1% in the 5-mg apixaban group. The rates of clinically relevant nonmajor bleeding were 2.3% in the placebo group, 3.0% in the 2.5-mg apixaban group, and 4.2% in the 5-mg apixaban group. The rate of death from any cause was 1.7% in the placebo group, as compared with 0.8% in the 2.5-mg apixaban group and 0.5% in the 5-mg apixaban group. CONCLUSIONS: Extended anticoagulation with apixaban at either a treatment dose (5 mg) or a thromboprophylactic dose (2.5 mg) reduced the risk of recurrent venous thromboembolism without increasing the rate of major bleeding. (Funded by Bristol-Myers Squibb and Pfizer; AMPLIFY-EXT ClinicalTrials.gov number, NCT00633893.)

Oral Apixaban for the Treatment of Acute Venous Thromboembolism

BACKGROUND: Apixaban, an oral factor Xa inhibitor administered in fixed doses, may simplify the treatment of venous thromboembolism. METHODS: In this randomized, double-blind study, we compared apixaban (at a dose of 10 mg twice daily for 7 days, followed by 5 mg twice daily for 6 months) with conventional therapy (subcutaneous enoxaparin, followed by warfarin) in 5395 patients with acute venous thromboembolism. The primary efficacy outcome was recurrent symptomatic venous thromboembolism or death related to venous thromboembolism. The principal safety outcomes were major bleeding alone and major bleeding plus clinically relevant nonmajor bleeding. RESULTS: The primary efficacy outcome occurred in 59 of 2609 patients (2.3%) in the apixaban group, as compared with 71 of 2635 (2.7%) in the conventional-therapy group (relative risk, 0.84; 95% confidence interval [CI], 0.60 to 1.18; difference in risk [apixaban minus conventional therapy], -0.4 percentage points; 95% CI, -1.3 to 0.4). Apixaban was noninferior to conventional therapy (P<0.001) for predefined upper limits of the 95% confidence intervals for both relative risk (<1.80) and difference in risk (<3.5 percentage points). Major bleeding occurred in 0.6% of patients who received apixaban and in 1.8% of those who received conventional therapy (relative risk, 0.31; 95% CI, 0.17 to 0.55; P<0.001 for superiority). The composite outcome of major bleeding and clinically relevant nonmajor bleeding occurred in 4.3% of the patients in the apixaban group, as compared with 9.7% of those in the conventional-therapy group (relative risk, 0.44; 95% CI, 0.36 to 0.55; P<0.001). Rates of other adverse events were similar in the two groups. CONCLUSIONS: A fixed-dose regimen of apixaban alone was noninferior to conventional therapy for the treatment of acute venous thromboembolism and was associated with significantly less bleeding (Funded by Pfizer and Bristol-Myers Squibb; ClinicalTrials.gov number, NCT00643201)

Edoxaban versus warfarin for the treatment of symptomatic venous thromboembolism.

BACKGROUND: Whether the oral factor Xa inhibitor edoxaban can be an alternative to warfarin in patients with venous thromboembolism is unclear. METHODS: In a randomized, double-blind, noninferiority study, we randomly assigned patients with acute venous thromboembolism, who had initially received heparin, to receive edoxaban at a dose of 60 mg once daily, or 30 mg once daily (e.g., in the case of patients with creatinine clearance of 30 to 50 ml per minute or a body weight below 60 kg), or to receive warfarin. Patients received the study drug for 3 to 12 months. The primary efficacy outcome was recurrent symptomatic venous thromboembolism. The principal safety outcome was major or clinically relevant nonmajor bleeding. RESULTS: A total of 4921 patients presented with deep-vein thrombosis, and 3319 with a pulmonary embolism. Among patients receiving warfarin, the time in the therapeutic range was 63.5%. Edoxaban was noninferior to warfarin with respect to the primary efficacy outcome, which occurred in 130 patients in the edoxaban group (3.2%) and 146 patients in the warfarin group (3.5%) (hazard ratio, 0.89; 95% confidence interval [CI], 0.70 to 1.13; P&lt;0.001 for noninferiority). The safety outcome occurred in 349 patients (8.5%) in the edoxaban group and 423 patients (10.3%) in the warfarin group (hazard ratio, 0.81; 95% CI, 0.71 to 0.94; P=0.004 for superiority). The rates of other adverse events were similar in the two groups. A total of 938 patients with pulmonary embolism had right ventricular dysfunction, as assessed by measurement of N-terminal pro-brain natriuretic peptide levels; the rate of recurrent venous thromboembolism in this subgroup was 3.3% in the edoxaban group and 6.2% in the warfarin group (hazard ratio, 0.52; 95% CI, 0.28 to 0.98). CONCLUSIONS: Edoxaban administered once daily after initial treatment with heparin was noninferior to high-quality standard therapy and caused significantly less bleeding in a broad spectrum of patients with venous thromboembolism, including those with severe pulmonary embolism. (Funded by Daiichi-Sankyo; Hokusai-VTE ClinicalTrials.gov number, NCT00986154.)