Clinical trial NCT03145376: Clinical and Geriatric Assessment in Elderly Patients Before and After TAVI or MitraClip Positioning
Official title: Clinical Evaluation and Geriatric Assessment in Elderly Patients Before and After Percutaneous Aortic Valve Implantation (TAVI) or MitraClip Positioning
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mitral Valve Insufficiency
Aortic Stenosis Senile
Keywords: TAVI
MitraClip
geriatric assessment
heart rate variability
elderly
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2017-05-09
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: elderly patients with severe aortic stenosis eligible for TAVI or affected by mitral valve severe insufficiency treatable by MitraClip positioning.

Brief summary: 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.

Detailed description: 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.

A clinical evaluation and multidimensional geriatric assessment are indispensable to ensure a correct diagnosis of the patient, estimating the risk of periprocedural mortality and morbidity and evaluate the actual possibility of intervention benefit on the patient's overall health.

MitraClip

The severe mitral regurgitation is a clear indication to intervention of mitral repair which has advantages compared to traditional surgery, preserving the contractile function of the left ventricle, reducing the incidence of adverse events related to the system of the prosthesis, by reducing the hospital mortality, morbidity and hospitalization, improving the long-term survival. The surgical risk of mitral plastic surgery presents a percentage lower than 2.5% in the centers that perform no less than 140 operations per year. However, an ejection fraction (FE) of the left ventricle lower than 55% is a negative prognostic index. In addition, the mitral plastic surgery has a long and difficult learning curves, but also the indisputable advantage of less invasiveness than traditional surgery, which allows its use even in patients deemed to be at higher operative risk. The placement of a MitraClip is the evolution of conventional surgery (Alfieri's speech): percutaneous, trans-septal puncture, placing clips on the mitral leaflets to create a dual orifice and therefore decrease or completely abolish the valve insufficiency . The EVEREST II study has shown that this procedure is less effective than surgery in reducing the degree of mitral regurgitation, but the percutaneous repair of mitral regurgitation is more secure and has shown improved clinical outcomes, comparable to cardiac surgery. At a post-hoc analysis, patients who benefit most from the MitraClip patients are elderly with low ejection fraction and functional mitral insufficiency. Considering that the prevalence of mitral insufficiency in the elderly is 30-50%, it is comprehensible how the MitraClip will have certain evolution in numerical terms.

The MitraClip is, therefore, a valid therapeutic option in case of functional mitral regurgitation, since the surgery in these patients is burdened with high mortality, by high recurrence of mitral regurgitation and a long hospital stay.

The MitraClip is to be used in a small number of properly selected patients. The procedural success depends on the ability to choose an individualized therapy for each patient depending on valvular anatomy, valve functionality, on comorbidities and on patient's life expectation, performing an estimation of the risk-benefit of the two percutaneous techniques and surgical intervention.

This estimate and evaluation of the patient must be operated in the geriatric multidisciplinary field, to ensure a comprehensive risk assessment of patients and their best selection.

Aim of the study

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* altered cognitive abilities such as to impair the evaluation;
* hemodynamically unstable patient;
* Inability or unwillingness to sign informed consent.

Primary outcomes:
measure: Changes in cognitive impairment evaluation using minimental state examination (MMSE)
timeFrame: Baseline evaluation and a new one after 6 months to evaluate possible changes
Secondary outcomes:
measure: Quality of Life
timeFrame: Baseline evaluation and a new one after 6 months
measure: polypathology status evaluation with CIRS scale
timeFrame: Baseline evaluation and a new one after 6 months
measure: ADL: Activities of Daily Living
timeFrame: Baseline evaluation and a new one after 6 months
measure: IADL:InstrumentalActivities of Daily Living
timeFrame: Baseline evaluation and a new one after 6 months
measure: MNA:Mini Nutritional Assessment
timeFrame: Baseline evaluation and a new one after 6 months
measure: mortality
timeFrame: phone call after 6 months from baseline evaluation
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Gianfranco Piccirillo
city: Rome
country: Italy
facility: Policlinico Umberto I
Study officials:
affiliation: Sapienza
name: Gianfranco Piccirillo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Piccirillo G, Moscucci F, Mastropietri F, Di Iorio C, Mariani MV, Fabietti M, Stricchiola GM, Parrotta I, Sardella G, Mancone M, Magri D. Possible predictive role of electrical risk score on transcatheter aortic valve replacement outcomes in older patients: preliminary data. Clin Interv Aging. 2018 Sep 11;13:1657-1667. doi: 10.2147/CIA.S170226. eCollection 2018.