Impact of Amyloidosis on TAVI Patients

Study Overview
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Brief Summary
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To analyze the prevalence and impact on the prognosis of amyloidosis due to transthyretin in patients with severe aortic stenosis who undergo percutaneous aortic valve implantation.

Detailed Description
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Type and design of the study: Multicentric, prospective cohort, observational. Number and characteristics of the patients: 321 patients to whom TAVI has been implanted due to severe degenerative AS. Duration of the study Recruitment period: All consecutive patients undergoing a non-invasive diagnostic study of amyloidosis (scintigraphy with technetium pyrophosphate99 and blood protein electrophoresis) will be recruited before discharge, in centers with proven experience, will accept non-invasive diagnosis with resonance) and have an implanted percutaneous aortic prosthesis for severe aortic stenosis. Follow-up period: clinical and echocardiographic follow-up will be carried out before discharge, in consultation at three, six, twelve and twenty-four months. Inclusion: 1 year Follow up: 2 years Data analysis: 6 months Total: 3 years and 6 months Events Main event: cardiovascular events (cardiovascular death, stroke, infarction) Secondary events: death from any cause, readmission due to heart failure, pacemaker implantation, functional class evaluation Countries and participating centers: Various Spanish and international centers will be invited to participate.

Official Title
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Impact of Cardiac Amyloidosis on Patients With Severe Aortic Stenosis Who Undergo Transcatheter Aortic

Conditions
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Valve Stenoses, Aortic, Amyloidosis Cardiac

Intervention / Treatment
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* Diagnostic Test: Diagnosis of amyloidosis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aortic valve replacement with a percutaneous prosthesis due to severe aortic stenosis after evaluation by the Heart Team. Ability to understand and sign informed consent. They do not meet any of the exclusion criteria. Exclusion Criteria: Death as a complication of the procedure during hospitalization. Associated mitral valve disease requiring intervention TAVI valve-in-valve implant. Does not sign informed consent.

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 110 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Amyloidosis<br>TAVI patients with diagnosis of amyloidosis | Diagnostic Test: Diagnosis of amyloidosis<br>* Scintigraphy and protein electrophoresis<br>|
| Non-Amyloidosis<br>TAVI patients without diagnosis of amyloidosis | Diagnostic Test: Diagnosis of amyloidosis<br>* Scintigraphy and protein electrophoresis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Survival after TAVI of patients with amyloidosis | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pacemaker requirements | Number of patients with amyloidosis who received pacemaker after TAVI. | 15 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TAVI, Aortic Stenosis, Cardiac amyloidosis