Clinical Evaluation and Geriatric Assessment in Elderly Patients Before and After Percutaneous Aortic Valve Implantation (TAVI) or MitraClip Positioning
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Changes in cognitive impairment evaluation using minimental state examination (MMSE)
研究概览
简要总结
Since October of 2014, the Policlinico Umberto I Hospital has an "Heart Team", a group of selected specialists with the task of assessing and identifying eligible patients for valvular aortic transcatheter implantation (TAVI) or a placement of a MitraClip .
The specialists taking part to Heart Team are: a cardiologist, a heart surgeon, a vascular surgeon, an anesthesiologist and a geriatrician.
The Geriatrician is called to make a careful multidimensional assessment of the elderly patients who have been suggested for the interventions mentioned above. His role is to assess the degree of co-morbidity and polypathology, autonomy in the common activities of daily living, nutritional status, cognitive status and quality of life. Following this evaluation, together with the other components of Heart Team, it is expressed a collective judgment on the patient's eligibility to these interventions. So, the aim of the present study is to identify changes in the degree of cognitive decline, of autonomy in carrying out activities of daily living, quality of life, nutritional status, pre- and postoperatively (6 months after the procedure) polypathology degree in elderly patients to be undergone or undergoing TAVI or positioning MitraClip because suffering from aortic valvular stenosis or severe mitral insufficiency. The patients undergo to a battery of tests, to a 5 minutes electrocardiographic record to evaluate the Heart Rate Variability (HRV) and to a complete echocardiographic evaluation.
详细描述
Aortic stenosis (AS) is a progressive chronic valvular disease that progressively and rapidly leads to the development of heart failure. This pathology, which is typical of the elderly, is increasing together with the age of the population and it is a candidate for the development of less invasive and innovative therapies that enable the treatment of older patients with polypathology and high degree of comorbidity. According to the most recent guidelines for the treatment of valvular heart disease, the degenerative AS is the most common valve disease in Western countries especially in the group aged over 65 years. The degenerative AS, in its most severe form, is a highly debilitating chronic condition characterized by symptoms as such precordial pain suggestive of angina, transient altered state of consciousness, or syncope, dyspnea and other heart failure symptoms secondary to reduced stroke volume. A recent systematic review (2) estimated the prevalence of AS in the elderly population aged over 75 years amounted to 12.4% while the prevalence of severe AS amounted to 3.4%. The average survival after the onset of symptoms is about 2-3 years. The natural history of the disease is not modified by conservative treatment and, to date, the surgical aortic valve replacement is recommended by both the American and European guidelines for patients with severe symptomatic and asymptomatic patients with reduced ejection fraction (80 years obtain appreciable results with a less than 10% mortality and morbidity between 5 and 10%. Some conditions, such as the presence of comorbidities (chronic obstructive pulmonary disease, vasculopathy, chronic renal failure, dementia and other) and the advanced age of the patients, make the surgery too risky or impossible to achieve. Therefore, approximately one third of patients in advanced age is not currently subjected to surgery.
After the "first man" made in 2002, TAVI has been introduced in the clinic in 2007 and has quickly gained critical acclaim. Up to now, about 150,000 TAVI procedures were performed with a growing trend.
The methodical approach of the techniques involve various approaches: transfemoral, transapical, (the two most popular), transaxillary, transaortic.
The enormous diffusion of the method follows the growing demand. Conservative treatment of the SA guarantees any improvement; optimized drugs therapy is able nor to mitigate the symptomatology associated nor to resolve the underlying disease.
The surgery requires the use of extracorporeal circulation and, although conducted in the less invasive way possible, it remains an intervention in which elderly patients with polypathology and high degree of comorbidity are hardly addressed.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 90 Years(Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age higher than or equal to 65 aa;
- •the capacity to perform geriatric assessment tests;
- •sinus rhythm at the time of evaluation (for the evaluation of HRV only);
- •to sign appropriate informed consent.
排除标准
- •altered cognitive abilities such as to impair the evaluation;
- •hemodynamically unstable patient;
- •Inability or unwillingness to sign informed consent.
结局指标
主要结局
Changes in cognitive impairment evaluation using minimental state examination (MMSE)
时间窗: Baseline evaluation and a new one after 6 months to evaluate possible changes
evaluation of the pre and post-operative cognitive impairment using the same test (mini mental state examination, MMSE: tot 28-30 points no cognitive impairment, 24-27 borderline, 19-23 mild cognitive impairment, 14-18 moderate cognitive impairment, \<14 severe cognitive impairment)
次要结局
- Quality of Life(Baseline evaluation and a new one after 6 months)
- polypathology status evaluation with CIRS scale(Baseline evaluation and a new one after 6 months)
- ADL: Activities of Daily Living(Baseline evaluation and a new one after 6 months)
- IADL:InstrumentalActivities of Daily Living(Baseline evaluation and a new one after 6 months)
- MNA:Mini Nutritional Assessment(Baseline evaluation and a new one after 6 months)
- mortality(phone call after 6 months from baseline evaluation)
研究者
Gianfranco Piccirillo
associate professor
University of Roma La Sapienza
