Remote clinical quality management of endovascular care

Aim. To assess the effectiveness of remote clinical quality management of endovascular care.Methods. The system of clinical quality management of medical care in myocardial infarction (MI) including the quality of remote control of endovascular care was developed and introduced into the health care system of the Moscow Region as a part of the comprehensive study in 2008–2020. The number of people under the study was 8375. The ground for assessing the effectiveness of remote clinical management in 2019–2020 was the health care system of megapolis. Based on the analysis of 2966 endovascular procedures protocols, the treatment tactics effectiveness of intraoperative decisions was studied after an emergency coronary angiography (ECA) had been performed by interventional cardiologists. The system of remote clinical quality management of endovascular care included a complex of audiovisual communications, computer system processes, mentoring and the algorithm for making an intraoperative decision. The effectiveness of remote clinical quality management of endovascular care was investigated on the number of percutaneous coronary interventions (PCI) in MI, mortality of patients with MI in the Regional vascular center in 2019–2020. The T-criteria was used to assess the reliability. The material statistical processing was carried out in the Statistica 6.0 package calculating adequate statistical indicators and their reliability at p≤0.005.Results. Ratio PCI/ECA in 2019, January-March 2020 counted up to 48.95%. In AprilDecember 2020 it increased up to 71.6% (p<0.001). The frequency of performing PCI increased by 1.46 times (p<0.001). Hospital mortality from MI decreased during the following period 2019, April-December 2020 from 9.7% to 8.2% (p = 0.005).Conclusion. Remote clinical management based on telemedicine and mentoring process technologies contributes to improving the quality of endovascular care in MI.Aim. To assess the effectiveness of remote clinical quality management of endovascular care.Methods. The system of clinical quality management of medical care in myocardial infarction (MI) including the quality of remote control of endovascular care was developed and introduced into the health care system of the Moscow Region as a part of the comprehensive study in 2008–2020. The number of people under the study was 8375. The ground for assessing the effectiveness of remote clinical management in 2019–2020 was the health care system of megapolis. Based on the analysis of 2966 endovascular procedures protocols, the treatment tactics effectiveness of intraoperative decisions was studied after an emergency coronary angiography (ECA) had been performed by interventional cardiologists. The system of remote clinical quality management of endovascular care included a complex of audiovisual communications, computer system processes, mentoring and the algorithm for making an intraoperative decision. The effectiveness of remote clinical quality management of endovascular care was investigated on the number of percutaneous coronary interventions (PCI) in MI, mortality of patients with MI in the Regional vascular center in 2019–2020. The T-criteria was used to assess the reliability. The material statistical processing was carried out in the Statistica 6.0 package calculating adequate statistical indicators and their reliability at p≤0.005.Results. Ratio PCI/ECA in 2019, January-March 2020 counted up to 48.95%. In AprilDecember 2020 it increased up to 71.6% (p<0.001). The frequency of performing PCI increased by 1.46 times (p<0.001). Hospital mortality from MI decreased during the following period 2019, April-December 2020 from 9.7% to 8.2% (p = 0.005).Conclusion. Remote clinical management based on telemedicine and mentoring process technologies contributes to improving the quality of endovascular care in MI

Модель врача-специалиста на этапе первичной медико-санитарной помощи при сердечно-сосудистых заболеваниях

Highlights. Ineffective clinical management of primary health care in the form of staffing shortage and low competence within the model of cardiovascular surgeons further contribute to the progression and complication of cardiovascular diseases. Primary health care specialist for cardiovascular diseases acts as a functional basis for clinical and organizational management of the processes of primary and secondary prevention of cardiovascular complications, the development of patients' adherence to recommendations and the formation of a healthy lifestyle. Improving professional skills and competencies of cardiovascular surgeons providing comprehensive medical care – surgical and conservative (the functional medicine model) remains an urgent healthcare issue.Aim. To develop a model of a PHC specialist (cardiovascular surgeon) in CVD and evaluate the clinical and managerial effectiveness of its implementation.Methods. The study (2016–2022) was conducted at the clinical diagnostic center of the Central Clinical Hospital “Russian Railways-Medicine” (Moscow), “SM-Clinic” (Moscow) and Department of Health Organization, Medication Provision, Medical Technologies and Hygiene of the Medical institute RUDN University. The subject of the study is the competencies and skills of a cardiovascular surgeon in primary care. The development of a model of a PHC specialist was carried out on the basis of personal improvement and integration of professional competencies and skills of cardiovascular surgeons in the aspect of applying clinical management technology in CVD (Kicha D.I., Goloshchapov-Aksenov R.S., 2019). The study included patients over 65 years of age (n = 422). The mean age of the patients was 77±8.6 years. The subjects of the study were cardiovascular surgeons (n = 4) with ≥5 years of work experience. The effectiveness of the model was evaluated according to clinical and managerial indicators of achieving the goal in the implementation of the author's algorithm for the organizational and technological management of PHC (2020). The follow-up was 36 months. We compared the results of 2016–2018 – before the introduction of the model and 2019–2022 – period of use of the model. Research methods were as follows: content analysis, statistical, mathematical, analytical, comparative, expert. The t-White test was used to assess the significance. Differences in the compared parameters were considered significant at p<0.05.Results. The developed model of a PHC specialist included components of patient orientation, the time of primary and repeated outpatient consultations, competencies and skills, adherence to surgical care and long-term clinical management, informatization, automation and systematization of the PHC process, interdisciplinary integration, implementation of the PHC algorithm and assessment efficiency. The obtained performance of the model is confirmed by significant differences in the compared indicators for the periods of 2016–2017 and 2018–2022: an increase in the availability of surgical endovascular care for patients with advanced atherosclerosis from 7 to 100% and the commitment of cardiovascular surgeons to surgical care and long-term continuous clinical management for the basis of improving and integrating the skills and competencies of mastering surgical and endovascular treatment technologies (from 25 to 100%); decrease in the frequency of repeated hospitalizations of patients during 3 years from 33% to 13% (p<0.05) and ambulance calls from 9% to 0.13% (p<0.05), a decrease in the incidence of acute cardiovascular diseases – primary acute myocardial infarction from 12 to 0% (p<0.05) and recurrence of critical ischemia of the lower extremities from 36 to 0.1% (p<0.05). The 3-year survival of patients was 96%. The main cause of death (sudden) in 17 patients (mean age 85±1.03 years) was the progression of heart failure.Conclusion. The developed model of a PHC specialist in cardiovascular diseases is an effective component that contributes to 96% survival rate of elderly and senile patients during 3 years of follow-up.Основные положения. Неэффективное клиническое управление процессами первичной медико-санитарной помощи в аспекте кадрового дефицита и несовершенство компетентностного компонента модели сердечно-сосудистых хирургов способствуют прогрессированию и осложненному течению сердечно-сосудистых заболеваний. Врач-специалист на этапе первичной медико-санитарной помощи при заболеваниях сердца и сосудов выступает функциональной основой клинико-организационного управления процессами первичной и вторичной профилактики сердечно-сосудистых осложнений, развития приверженности пациентов выполнению рекомендаций врача и формирования здорового образа жизни. Совершенствование профессиональных навыков и компетенций сердечно-сосудистых хирургов, оказывающих комплексную медицинскую помощь – хирургическую и консервативную на основе функционального моделирования, является актуальной проблемой здравоохранения.Цель. Разработать модель врача-специалиста на этапе первичной медико-санитарной помощи (ПМСП) при сердечно-сосудистых заболеваниях (ССЗ) и оценить клинико-управленческую эффективность ее внедрения.Материалы и методы. Базы исследования (2016–2022) – клинико-диагностический центр Центральной клинической больницы «РЖД-Медицина», ООО «СМ-Клиника»  и кафедра организации здравоохранения, лекарственного обеспечения, медицинских технологий и гигиены ФНМО Медицинского института РУДН. Предмет исследования – компетенции и навыки сердечно-сосудистого хирурга ПМСП. Разработку модели врача-специалиста на этапе ПМСП осуществляли на основании персонального совершенствования и интеграции профессиональных компетенций и навыков сердечно-сосудистых хирургов в аспекте применения технологии клинического управления при ССЗ). Объекты исследования – сердечно-сосудистые хирурги (n = 4) со стажем работы ≥5 лет. Субъекты исследования – 422 пациента старше 65 лет (средний возраст 77±8,6 года). Методику разработки модели и оценку ее эффективности реализовывали на основе авторского алгоритма организационно-технологического управления ПМСП (2020). Период наблюдения больных составил 36 мес. Сравнивали результаты 2016–2018 гг., до внедрения модели, и 2019–2022 гг. – период использования модели. Применены методы: контент-анализа, статистический, математический, аналитический, сравнительный, экспертный. Для оценки достоверности использован критерий t-Уайта. Различия сравниваемых показателей считали достоверными при р<0,05.Результаты. Разработанная модель врача-специалиста на этапе ПМСП включала компоненты пациентоориентированности; время первичной и повторной амбулаторной консультации; компетенции и навыки; приверженность хирургической помощи и длительному непрерывному клиническому управлению; информатизацию, автоматизацию и систематизацию процесса ПМСП; междисциплинарную интеграцию; реализацию алгоритма ПМСП и оценку эффективности. Полученная результативность модели подтверждена достоверными различиями сравниваемых показателей за периоды 2016–2017 и 2018–2022 гг.: ростом доступности хирургической рентгенэндоваскулярной помощи для пациентов с распространенным атеросклерозом артерий с 7 до 100% и приверженности сердечно-сосудистых врачей хирургической помощи и длительному непрерывному клиническому управлению на основе совершенствования и интеграции навыков и компетенций владения хирургической и рентгенэндоваскулярной технологиями лечения (с 25 до 100%); снижением частоты повторных госпитализаций больных в стационар с 33 до 13% (p<0,05) и вызовов скорой помощи с 9 до 0,13% (р<0,05), частоты развития острых ССЗ – первичного острого инфаркта миокарда с 12 до 0% (p<0,05), рецидива критической ишемии нижних конечностей с 36 до 0,1% (р<0,05). Трехлетняя выживаемость пациентов составила 96%.Заключение. Разработанная модель врача-специалиста на этапе ПМСП при заболеваниях сердца и сосудов способствует росту выживаемости пациентов пожилого и старческого возраста в течение 3 лет наблюдения (96%)

Информационное управление качеством диспансерного наблюдения при ишемической болезни сердца

Highlights. Using the big data databases of provided medical services belonging to the Territorial Compulsory Medical Insurance Fund and the Unified State Healthcare Information System (USHIS), clinical and statistical analysis of ambulatory follow-up of patients with coronary artery disease was carried out, an algorithm was developed and the effectiveness of the presented information management technology was determined.Aim. To assess and justify the developed information management technology for the quality management of ambulatory follow-up of patients with coronary artery disease (CAD) based on monitoring and analyzing electronic personified data on medical services.Methods. In 2018 the Territorial Compulsory Medical Insurance Fund (TCMIF), the Medical Information and Analytical Center (MIAC) and healthcare organizations of the Orenburg Region implemented information management technology to assess the quality of ambulatory follow-up in patients with CAD, which is based on big data analysis of medical services and information integration “emergency medical services (EMS), hospital-TCMIF + MIAC-polyclinic”. To assess the effectiveness of the technology, the proportion of patients with myocardial infarction (MI), death from coronary artery disease, emergency hospitalizations and emergency calls for angina pectoris were compared. The study involved   two groups of patients: 13 208 ambulatory patients with angina pectoris and 4017 patients without follow-up, according to  the  TCMIF  reports  in  2017.  Out of the 13,208 patients with angina pectoris in 2019, 10,205 patients with continued follow-up presented with the same clinical endpoints. Patients with these unfavorable outcomes in proportion to the total number of patients in each group in 2017 and 2019 were compared as well.Results. The developed and implemented information management technology led to an increase in the number of ambulatory patients with angina pectoris from 63 to 69%, with MI from 78 to 87%, and a reduction of emergency calls and emergency hospitalizations of patients with angina pectoris in the region in 2017 and 2019.Conclusion. Information quality management of ambulatory follow-up of patients with coronary artery disease using electronic personalized data on medical services increases the number of ambulatory patients with angina pectoris and myocardial infarction, and decreases the number of unfavorable outcomes of patients with angina pectoris.Основные положения. По базам больших электронных данных о медицинских услугах – территориального фонда обязательного медицинского страхования и Единой государственной информационной системы в сфере здравоохранения – проведен клинико-статистический анализ диспансерного наблюдения при ишемической болезни сердца, построен алгоритм и определена результативность разработанной технологии информационного управления качеством такого наблюдения.Цель. Оценить и обосновать разработанную технологию информационного управления качеством диспансерного наблюдения при ишемической болезни сердца (ИБС) на основе мониторинга и анализа электронных персонифицированных данных о медицинских услугах.Материалы и методы. В 2018 г. в работу территориального фонда обязательного медицинского страхования (ТФОМС), медицинского информационно-аналитического центра (МИАЦ) и медицинских организаций Оренбургской области начато внедрение информационного управления качеством диспансерного наблюдения при ИБС. Технология такого управления разработана на основе анализа больших данных о медицинских услугах и информационной интеграции «скорая медицинская помощь (СМП), стационар-ТФОМС + МИАЦ-поликлиника». Для оценки эффективности разработанной технологии в двух группах пациентов со стенокардией из 13 208 больных с диспансерным наблюдением и 4 017 больных без него за 2017 г. по реестрам счетов ТФОМС сравнили доли больных инфарктом миокарда (ИМ), с летальным исходом от ИБС, экстренными госпитализациями и вызовами СМП по поводу стенокардии. Из 13 208 больных стенокардией в 2019 г. у 10 205 пациентов, находящихся по-прежнему на диспансерном наблюдении, определили такие же конечные клинические точки. Больных с данными неблагоприятными исходами в долях от общего числа каждой группы за 2017 и 2019 гг. сравнили между собой.Результаты. Результатом внедрения разработанной технологии информационного управления стало увеличение в регионе за 2017 и 2019 гг. доли пациентов с диспансерным наблюдением при стенокардии с 63 до 69%, при ИМ – с 78 до 87%, а также достоверное снижение доли больных стенокардией с вызовами СМП и экстренными госпитализациями среди пациентов, состоящих на диспансерном наблюдении.Заключение. Информационное управления качеством диспансерного наблюдения при ИБС по электронным персонифицированным данным о медицинских услугах приводит к увеличению доли больных с диспансерным наблюдением при стенокардии и ИМ и снижению неблагоприятных исходов стенокардии

Advanced results of Fortelyzin® use in the FRIDOM1 study and real clinical practice

Aim. To study the effectiveness of Fortelyzin® in subgroups with different body weights in patients with ST-segment elevation acute myocardial infarction (STEMI) in the FRIDOM1 study and real clinical practice.Material and methods. Fortelyzin® was administered in a single-bolus dose of 15 mg over 10 seconds, regardless of the body weight of patients. Metalyse® was administered in a single-bolus dose of 30-50 mg over 10 seconds, depending on body weight. The one-year results of the FRIDOM1 study were evaluated by the clinical centers using telephone contact. Monitoring of Fortelyzin® use was carried out by inpatient physicians, emergency doctors and paramedics by filling out a monitoring sheet in the period from June 2013 to December 2021 in 19243 patients with STEMI.Results. In the FRIDOM1 study, the distribution of patients depending on body weight in the Fortelyzin® (n=190) and Metalyse® (n=191) drug groups was as follows: up to 60 kg — 4 people each (p=1,00); from 60 to 70 kg — 21 and 23 (p=0,87); from 70 to 80 kg — 39 and 43 (p=0,71), from 80 to 90 kg — 63 and 47 (p=0,07); from 90 to 100 kg — 30 and 41 (p=0,19); over 100 kg — 33 people (p=1,00) in each group. The effectiveness of thrombolysis according to electrocardiographic (ECG) data in the Fortelyzin® and Metalyse® groups was as follows: up to 60 kg — 75% each (p=1,00); from 60 to 70 kg — 76% vs 83% (p=0,72); from 70 to 80 kg — 82% vs 86% (p=0,76); from 80 to 90 kg — 81% vs 77% (p=0,64); from 90 to 100 kg — 80% vs 81% (p=1,00); over 100 kg — 79% vs 76% (p=1,00); in total — 80% vs 80% (p=0,87). The effectiveness of thrombolysis according to coronary angiography (CAG) (TIMI 2-3) in the Fortelyzin® and Metalyse® groups was as follows: up to 60 kg — 100% vs 50% (p=0,43); from 60 to 70 kg — 81% vs 67% (p=0,48); from 70 to 80 kg — 74% vs 84% (p=0,41); from 80 to 90 kg — 70% vs 72% (p=1,00); from 90 to 100 kg — 67% vs 66% (p=1,00); over 100 kg — 58% vs 64% (p=0,80); in total — 70% vs 71% (p=0,76). The one-year survival rate in the FRIDOM1 study in the Fortelyzin® and Metalyse® groups was 94% (p=0,91). The administration of Fortelyzin® in patients with STEMI caused blood flow restoration according to ECG data in 14624 of 19243 patients (76%), while according to CAG (TIMI 2-3) — in 3422 of 4805 patients (71%). Inhospital mortality was 5% (n=962), while intracranial hemorrhage developed in 0,5% (n=92).Conclusion. The use of Fortelyzin® in the FRIDOM1 study and in real clinical practice in a single-bolus (10 sec) dose of 15 mg in patients with STEMI with any body weight showed its high efficacy and safety, including at the prehospital stage

Combined Endovascular Treatment of Acute Coronary Syndrome with Bioresorbable Scaffolds and Angioplasty in Patient with Critical Lower Limb Ischemia – Hybrid Treatment in Multidisciplinary Hospital

The key to successful treatment in patients with acute coronary syndrome is maximally early revascularization of the coronary arteries. Treatment of multifocal atherosclerosis with lesions of the coronary and peripheral arteries requires coordinated work of the multidisciplinary team of doctors. Critical ischemia of the lower limbs requires urgent revascularization in order to prevent limb amputation. However, it is not always possible to perform revascularization using specialists of the same profile – endovascular or surgical. The use of hybrid methods of treatment (surgical and endovascular) allows to significantly improve the prognosis in saving the limb. The article presents a clinical observation of successful multistep treatment of a patient with acute coronary syndrome in combination with critical ischemia of the lower limb. The first stage was performed by multiple stenting of the coronary arteries with bioabsorptive scaffolds; the second stage was the hybrid treatment – femoral-tibial bypass with simultaneous recanalization and angioplasty of the lower leg arteries with good postoperative and long-term outcome