Brief Title
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
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.
Study Type
Observational
Primary Outcome
Changes in cognitive impairment evaluation using minimental state examination (MMSE)
Secondary Outcome
Quality of Life
Condition
Mitral Valve Insufficiency
Intervention
geriatric assessment
Study Arms / Comparison Groups
patients before and after TAVI/MitraClip
Description: geriatric assessment of patients before and after TAVI/Mitraclip
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Diagnostic Test
Estimated Enrollment
100
Start Date
June 1, 2017
Completion Date
October 30, 2020
Primary Completion Date
May 30, 2020
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.
Gender
All
Ages
65 Years - 90 Years
Accepts Healthy Volunteers
No
Contacts
Gianfranco Piccirillo, MD, PhD, +393356759046, [email protected]
Location Countries
Italy
Location Countries
Italy
Administrative Informations
NCT ID
NCT03145376
Organization ID
TaMi01
Responsible Party
Principal Investigator
Study Sponsor
University of Roma La Sapienza
Study Sponsor
Gianfranco Piccirillo, MD, PhD, Principal Investigator, Sapienza
Verification Date
October 2017