Long-term Outcomes of Isolated Tricuspid Valve Surgery According to Preoperative Clinical and Functional Staging
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 172
- 试验地点
- 1
- 主要终点
- Mortality
研究概览
简要总结
Tricuspid regurgitation (TR) was identified as an independent prognostic factor associated with excess mortality and morbidity, independent of left ventricular (LV) function and pulmonary hypertension. Isolated tricuspid surgery has been performed for a long time in a few selected cases, however in recent years several studies have underlined how the poor outcomes described for isolated tricuspid valve surgery seem to be related to the baseline characteristics of the patients and to late referral for surgical treatment rather than the intervention itself. To facilitate patient screening, a new clinical and functional TR staging system has recently been proposed. This classification, which evaluates the progression of morphological variations of the tricuspid valve and right ventricle (RV) in association with the onset of symptoms, identifies several parameters and factors that can be useful for a better stratification of surgical risk. Rather than simply assessing the degree of TR, this new staging mechanism also focuses on symptoms, RV remodeling and function, medical therapy, and right heart failure hospitalizations.
Investigators previously focused on the short-term (mainly hospital) outcomes of patients undergoing isolated surgery for severe TR, who were classified at baseline according to this clinical and functional staging system. Results showed that a more comprehensive classification reflects the population and hospital outcomes of surgically treated patients with isolated TR.
The purpose of this study is to ultimately evaluate long-term outcomes of this patients population and estimate the impact of baseline staging on long-term outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •Adult patients
- •Affected by severe tricuspid regurgitation (TR), both of degenerative and functional etiology and;
- •Patients underwent isolated surgery, either repair or replacement, of the tricuspid valve
- •Patients operated on at theCardiac Surgery Department of San Raffaele Hospital from May 2004 to May 2020.
排除标准
- •Patients with non-isolated tricuspid valve surgery (concomitant surgery on other valves).
结局指标
主要结局
Mortality
时间窗: Up to 17 years
Right heart failure hospitalization incidence
时间窗: Up to 17 years
Reoperation for TR recurrency
时间窗: Up to 17 years
次要结局
未报告次要终点
研究者
Michele De Bonis
Chief of Cardiac Surgery of Advanced and Research Therapies
Ospedale San Raffaele
