Outcome Comparison of Different Surgical Strategies for the Management of Severe Aortic Valve Stenosis: Study Protocol of a Prospective Multicentre European Registry (E-AVR Registry)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 8,000
- 试验地点
- 1
- 主要终点
- 5-year all-cause mortality
研究概览
简要总结
Traditional and transcatheter surgical treatments of severe aortic valve stenosis (SAVS) are increasing in parallel with the improved life-expectancy. Recent randomized trials (RCTs) reported comparable or non-inferior mortality with transcatheter treatments compared to traditional surgery. However, RCTs have the limitation of being a mirror of the predefined inclusion/exclusion criteria, without reflecting the "real clinical world".
Technological improvements have recently allowed the development of minimally invasive surgical accesses and the use of sutureless valves, but their impact on the clinical scenario is difficult to assess because of the monocentric design of published studies and limited sample-size. A prospective multicentre registry including all patients referred for a surgical treatment of SAVS (traditional, through full-sternotomy; minimally-invasive; or transcatheter; with both "sutured" and "sutureless" valves) will provide a "real-world" picture of available results of current surgical options, and will help to clarify the "grey zones" of current guidelines.
E-AVR is a prospective observational open registry designed to collect all data from patients admitted for SAVS, with or without coronary artery disease, in 16 cardiac surgery Centres located in six countries (France, Germany, Italy, Spain, Switzerland, and United Kingdom). Patients will be enrolled over a 2-year period and followed-up for a minimum of 5 years to a maximum of 10 years after enrolment. Outcome definitions are concordant with VARC-2 criteria and established guidelines. Primary outcome is 5-year all-cause mortality. Secondary outcomes aim at establishing "early" 30-day all-cause and cardiovascular mortality, as well as major morbidity, and "late" cardio-vascular mortality, major morbidity, structural and non-structural valve complications, quality of life and echocardiographic results.
The study protocol is approved by Local Ethics Committees. Any formal presentation or publication of data will be considered as a joint publication by the participating physician(s) and will follow the recommendations of the International Committee of Medical Journal Editors (ICMJE) for authorship.
详细描述
Robust early and follow-up data on the safety and efficacy of surgical TAVR, last-generation sutureless surgical valves, and minimally-invasive approaches compared with standard SAVR, with or without a contemporary (surgical or interventional) treatment of concurrent CAD, are still lacking for a real-world large population of patients at variable surgical risk. Such data is urgently required for the correct allocation of therapy in daily surgical practice. Furthermore, data on quality of life and functional echocardiographic results with different surgical alternatives might similarly help physicians in decision-making in local "Heart Teams". Data from a multicentre, real-world, open registry enrolling all patients with SAVS±CAD consecutively referred to several Centres at different European latitudes should help to answer some of these open questions.
The main strength of a prospective clinical open registry is the high external validity, given that data are collected in the settings of standard clinical practice. Moreover, large sample size enables a better estimation of event rates, and allows the investigation of hard endpoints and outcomes, by means of a wide population of patients from different institutions and with extremely limited exclusion criteria.
Importantly, clinical registries may provide data on long-term outcomes occurring after the study period of a trial. They are more practical than randomized controlled trials, require fewer resources, and have less stringent inclusion and exclusion criteria for patient enrolment. Finally, clinical findings from registries have even more significance when patient-populations derive from different geographic areas, with heterogeneous referral pathways, baseline clinical characteristics, and perioperative treatment strategies. All these features substantiate the concept of "a real world practice" underlying any "registry-study".
Therefore, the rationale of this European multicenter observational open registry is to prospectively collect data on baseline characteristics, treatment options, perioperative management and postoperative outcome of all patients consecutively undergoing surgical treatment of SAVS (regardless of gradients, AVA or AVAi)±CAD or aortic prosthetic dysfunction±CAD at 16 European university or non-university tertiary hospitals located in six European countries (France, Germany, Italy, Spain, Switzerland, and United Kingdom).
The primary aim of the study is a 5-year comparison between SAVR and surgical TAVR: we hypothesize to report a 10% superiority in terms of all-cause mortality in favor of SAVR vs TAVR. For the purpose of this study, patients will be consecutively enrolled for a 2-year period, and will be followed-up for a minimum of 5 years after the index surgical treatment. Maximum follow-up length will be 10 years after surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
5-year all-cause mortality
时间窗: The outcome measure will be assessed at 5 years after surgery
Any death occurring after surgery
次要结局
- Blood losses(Participants will be followed 12 hours after surgery)
- Cardiovascular mortality(The outcome measure will be assessed at time point (30 days, 1 year, and yearly up to 10 years after surgery)
- Intra-aortic balloon pump(Participants will be followed for the duration of hospital stay (expected: 10 days))
- Follow-up all-cause mortality(The outcome measure will be assessed at time point (30 days, and yearly from 1 to 4 years after surgery, then from 6 to 10 years))
- Stroke(The outcome measure will be assessed at time point (30 days, 1 year, and yearly thereafter up to 10 years after surgery)
- Use of blood products(Participants will be followed for the duration of hospital stay (expected: 10 days))
- Acute kidney injury(Participants will be followed for the duration of hospital stay (expected: 10 days))
- Repeat revascularization(The outcome measure will be assessed at time point (30 days, 1 year, and yearly thereafter up to 10 years after surgery)
- Surgical site infection(Participants will be followed up to 3 months after surgery)
- Nadir hematocrit(Participants will be followed up to 24 hours after the operation)
- Nadir hemoglobin(Participants will be followed up to 24 hours after the operation)
- Permanent pace-maker(The outcome measure will be assessed at time point (30 days, 1 year, and yearly thereafter up to 10 years after surgery)
- Length of stay in the intensive care unit(Participants will be followed for the duration of hospital stay (expected: 10 days))
- Length of in-hospital stay(Participants will be followed for the duration of hospital stay (expected: 10 days))
- Post procedural aortic prostheses performance(The outcome measure will be assessed at time point (30 days, 1 year and yearly thereafter up to 10 years after surgery)
- Acute myocardial infarction(The outcome measure will be assessed at time point (30 days, 1 year, and yearly thereafter up to 10 years after surgery)
- Prolonged use of inotropes(Participants will be followed up to 72 hours after surgery)
- Cardiac conduction disturbances(Participants will be followed for the duration of hospital stay (expected: 10 days))
- Re-intervention on the aortic valve(The outcome measure will be assessed at time point (30 days, 1 year and yearly thereafter up to 10 years after surgery)
- Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)(The outcome measure will be assessed at time point (30 days, 1 year, and yearly thereafter up to 10 years after surgery)
- Extra-corporeal membrane oxygenator (ECMO)(Participants will be followed for the duration of hospital stay (expected: 10 days))
- Resternotomy for bleeding(Participants will be followed for the duration of hospital stay (expected: 10 days))
- Atrial fibrillation(Participants will be followed for the duration of hospital stay (expected: 10 days))
- Pericardial effusion(Participants will be followed up to 3 months after surgery)
- Early repeat surgery(Participants will be followed up to discharge to home or to rehabilitation clinic (expected: 10 days))
- Aortic valve -related adverse events(The outcome measure will be assessed at time point (30 days, 1 year, and yearly thereafter up to 10 years after surgery)
- Cardioverter-defibrillator implantation(The outcome measure will be assessed at time point (30 days, 1 year, and yearly thereafter up to 10 years after surgery)
研究者
Francesco Onorati, MD, PhD
Associate Professor of Cardiac Surgery
Universita di Verona