Impact of Targeted Preoperative Dental Screening on Post-procedural Risk of Infective Endocarditis in Patients Undergoing Transcatheter Aortic Valve Implantation: a Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Number of Participants with Infectious Endocarditis
研究概览
简要总结
In Odense University Hospital preoperative dental screening (PDS) protocol for patients treated with Transcatheter Aortic Valve Implantation (TAVI) was changed from mandatory to targeted PDS to between June 2023 to october 2023. The investigators will therefore compare the risk of IE before june 2023 and after october 2023.
详细描述
Infective endocarditis (IE), a condition linked with significant mortality and morbidity rates, is particularly concerning for patients with prosthetic left-sided valves.
These patients face an elevated IE risk, estimated at about 1% annually in tertiary care settings, cumulatively impacting around one in every 20 patients over a decade.
In line with this, both the American Heart Association (AHA) and the European Society of Cardiology (ESC) strongly advocate for the elimination of potential dental sepsis sources at least two weeks before prosthetic valve implantation, except in urgent cases.
These guidelines, while not grounded in randomized trials, largely draw upon registry data detailing IE incidence among surgical aortic valve replacement (SAVR) patients.
In a recent study the investigators found no difference in risk of IE when comparing mandatory preoperative dental screening (MPDS) with no preoperative dental screening (NPDS).
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
- •Patients undergoing TAVI
排除标准
- 未提供
结局指标
主要结局
Number of Participants with Infectious Endocarditis
时间窗: Through study completion, an average of 1 year
Infectious endocarditis diagnosed by healthcare professionals
次要结局
- Number of Participants undergoing Oral surgical procedure at dental screening(Through study completion, an average of 1 year)
- Number of Participants undergoing Tooth extraction at dental screening(Through study completion, an average of 1 year)
- The different Bacteria types causing the infectious endocarditis assessed by blood culture(Through study completion, an average of 1 year)
- Number of Participants with IE caused by bacteria from oral foci(Through study completion, an average of 1 year)
- Number patients with Bacteremia assessed by positive blood culture(Through study completion, an average of 1 year)
- Number of Participants with Cardiac implantable electronic device risk of IE(Through study completion, an average of 1 year)
研究者
Jordi Dahl
Associate Professor, Chief physician in charge of cardiology imaging
Odense University Hospital