Clinical and Geriatric Assessment in Elderly Patients Before and After TAVI or MitraClip Positioning

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Insertable Cardiac Monitoring Device Reactive Oxygen Species Following Aortic Valve Replacement Biological Factors Associated With Subclinical Valvular Thrombosis Hemodynamic Comparison of Tissue Aortic Valves Volume Challenge Added to DSE in the Diagnosis of Severe LFLGAS Impact of Perioperative Treatment With Intravenous Glutamine on Myocardial Protection in Cardiac Surgery Patients With Aortic Stenosis The Effects of High Spinal Anesthesia on Heart Function, Stress Response and Pain Control in Aortic Valve Surgery A Clinical Trial of Transcatheter Aortic Valves in Dialysis Patients (Japan) Erythropoietin + Iron Therapy for Anemic Patients Undergoing Aortic Valve Replacement A Study Evaluating the Effects of Ataciguat (HMR1766) on Aortic Valve Calcification Efficacy of Angiotensin Receptor Blocker Following aortIc Valve Intervention for Aortic STenOsis: a Randomized mulTi-cEntric Double-blind Phase II Study Prehabilitation to Improve Functional and Clinical Outcomes in Patients With 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Evaluated Via Modern Ballistocardiography and Seismocardiography Study of Platelet Activation by Severe Aortic Stenosis and Its Correction by Transcatheter Aortic Valve Implantation Sizing-sTrategy of Bicuspid AoRtic Valve Stenosis With Transcatheter Self-expandable Valve The Plasma Serotonin and Aortic Stenosis: a Pilot Study. 18F-NaF Uptake and Aortic Stenosis Progression Cardiovascular Rehabilitation in Patients With Severe Aortic Stenosis Submitted to Valvar Correction Aortic Stenosis and PhosphodiEsterase Type 5 iNhibition (ASPEN): A Pilot Study Clinical Outcome of Patients With Low-gradient Severe Aortic Stenosis Ultrasonic Markers for Myocardial Fibrosis and Prognosis in Aortic Stenosis Fetal Intervention for Aortic Stenosis and Evolving Hypoplastic Left Heart Syndrome The PARTNER 3 – Trial – The Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis Ventricular Remodeling In Patients With Aortic Stenosis Assessed Echocardiography Podocan and Wnt Pathway in Left Ventricular Remodeling of Aortic Stenosis Preoperative Assessment of Aortic Valve Stenosis and Coronary Artery Disease Statin Therapy in Asymptomatic Aortic Stenosis Validation of the “TASQ” in Patients Undergoing SAVR or TF-TAVI Analysis and Comparative Evaluation of Aortic Calcium by Computed Tomography and Histopathology in Patients With Aortic Stenosis Improving Echo Measurements in the Diagnosis of Aortic Stenosis accuRate Evaluation of Benefit With Optimal Medical Treatment With or With-Out Transcatheter Valve Repair of PARADOXical Low Flow Low Gradient Aortic Stenosis – REBOOT-PARADOX Aortic Stenosis: Determinants and Prognostic Value of Preoperative Left Ventricular Remodeling After Valvular Replacement Randomized Study for the Optimal Treatment of Symptomatic Patients With Low Gradient Severe Aortic Valve Stenosis and Preserved Left Ventricular Ejection Fraction Microvascular Dysfunction in Aortic Stenosis Percutaneous Aortic 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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