The Italian Society of Invasive Cardiology Registry on Percutaneous Aortic Valve
The Italian Society of Invasive Cardiology Registry on Percutaneous Aortic Valve
The Italian Society of Invasive Cardiology Registry on Percutaneous Aortic Valve is a
 prospective Italian registry including several centers performing TAVI, collecting baseline,
 procedural and outcome data.
Aortic valve stenosis is the most common degenerative valve disease in the elderly, the
 prevalence is about 1-2% in the age group> 65 years and 4% in patients aged> 85. The natural
 history is characterized by a poor prognosis with a survival rate of 62% at 1 year, 32% at 5
 years and 18% at 10 years from symptom onset. Predictors of death were age> of 75 years, poor
 left ventricular ejection fraction, congestive heart failure, chronic obstructive pulmonary
 disease, severe mitral regurgitation and pulmonary hypertension.

 The gold standard therapy, with improved survival, for severe aortic stenosis is the surgical
 aortic valve replacement with mechanical or biological prosthesis. Cardiac surgery is therapy
 of choice for patients with severe aortic valve stenosis with left ventricular dysfunction or
 when symptomatic for lipothymia or syncope, angina pectoris, heart failure.

 Criteria for high surgical risk are: left ventricular failure, coronary artery disease,
 previous cardiac surgery for coronary artery bypass , chronic obstructive pulmonary disease,
 and/or advanced age and comorbidity , which can be a contraindication to intervention.
 Frequently cardiac surgery is not performed in elderly patients for the high surgery risk. In
 the Euro Heart Survey up to 33% of patients with single valve disease, New York Heart
 Association class III or IV, were not operated for concomitant disease or reduced life
 expectancy.

 The need to provide a therapeutic option for patients considered at high surgery risk, has
 stimulated the development of prosthetic valve implantable with a percutaneous transcatheter
 techniques. The percutaneous treatment of valvular aortic stenosis has potential advantages
 in terms of reduction of hospitalization of elderly patients with high risk of peri-operative
 mortality and morbidity, as well as avoiding treatment with oral anticoagulants. The
 experience up to now is very positive, with immediate favorable results in terms of
 hemodynamic and clinical improvement. Since the procedure is at initial stage of clinical
 application, it becomes necessary a uniform and standardized data collection to assess the
 effectiveness of the procedure, the incidence of acute and late complications, and the
 performance of the biological valve prosthesis.

 The investigators propose the establishment of an observational registry of percutaneous
 aortic valve replacement performed in the Italian Interventional Cardiology Laboratory.

 The objectives are:

 -  Record the clinical criteria used to asses indication for percutaneous aortic valve
 replacement in different centers

 -  Record the anatomical and morphological criteria of vascular access and thoraco
 abdominal aorta, evaluated with noninvasive and invasive diagnostic tests
 (echocardiography, multislice angiographic computed tomography, aortography) in
 particular calcification and tortuosity of aorto-iliac-femoral axis, degree of
 calcifications of the aortic valve and thoracic aortic wall calcifications.

 -  Record the types of devices used for percutaneous aortic valve replacement

 -  Observe different way of procedure (type of access, anesthetic protocols, procedural
 delay, aortic valvuloplasty, and so forth)

 -  Follow the procedure-related complications and / or of prosthesis implantation.

 -  Acute complications:

 -  Cerebral ischemia

 -  Arrhythmias

 -  Pericardial effusion / cardiac tamponade

 -  Aortic valve insufficiency

 -  Periprosthesis insufficiency

 -  Myocardial ischemia

 -  Kidney diseases

 -  Conversion to cardiac surgery

 -  Complications related to arterial vascular access

 -  Late complications

 -  Residual aortic valve insufficiency

 -  Arrhythmias with need of pacemaker

 -  Coronary Ischemia

 -  Kidney diseases

 -  Endocarditis

 -  Post Procedure hospital stay

 -  Evaluate the results at 30 days, 6, 12, 18 and 24 months of follow up:

 -  echocardiographic mean transvalvular aortic gradient

 -  valvular and/or periprosthesis insufficiency

 -  left ventricular ejection fraction

 -  Evaluate the clinical outcomes at 30 days, 6, 12, 18 and 24 months of follow up

 -  New York Heart Association functional class

 -  Medical therapy for heart failure

 -  Number of hospitalization for heart failure

 Information obtained will be analyzed and used to standardize and make more appropriate
 indications for percutaneous aortic valve replacement to improve and standardize the
 protocols of procedure, to assess the immediate and long-term effectiveness of the technique,
 to monitor acute and late complications related and especially to verify the performance of
 tissue valves in the medium to long term.

 The hemodynamics centers wishing to join the register will send a completed form to the
 steering committee. Once registered they will receive an identification code and pass word
 for recording data.

 Registration of patients that underwent percutaneous aortic valve replacement with prosthetic
 heart valves with the CE mark, consecutively enrolled during period of 24 months.

 Use of paper and electronic case report forms, divided into 4 parts:

 I. Personal details, medical history, clinical assessment / Instrumental II. procedure III.
 Post-procedure hospital stay (24 hours, 48 hours, discharge) IV. Follow up to 30 days, 6
 months, 12 months, 18 months, 24 months

 The data will be compiled and analyzed on a quarterly basis and discussed with the
 participating centers with semi-annual meetings

 Primary end-points will be:

 1. Feasibility of the procedure (functioning of the device, procedural success)

 2. Access through the stenotic native aortic valve

 3. Effectiveness of the positioning of the valve

 4. Removal of the transport system

 5. Procedural success will be determined by the efficacy of the valve system with a
 reduction of the gradient, and no hemodynamically significant valvular regurgitation, as
 assessed by angiography and color Doppler echocardiography

 6. Major intraprocedural adverse events at 30 days, 3, 6, 12, 18 and 24 months

 1. Major arrhythmias

 2. Myocardial infarction,

 3. Cardiac tamponade

 4. Malfunctioning valve

 5. Emergency surgical aortic valve replacement

 6. Emergency aorto-coronary bypass or percutaneous coronary angioplasty

 7. Cardiogenic shock

 8. Infective endocarditis

 9. Stroke or transient ischemic attacks

 10. Aortic dissection

 11. Dissection of the peripheral vessel

 12. Vascular perforation

 13. Acute occlusion of the artery access

 14. Major bleeding

 15. Death

 7. New York Heart Association functional class at 30 days, 6, 12, 18 and 24 months

 8. Left ventricle ejection fraction measured by echocardiography at 30 days, 6, 12, 18 and
 24 months

 9. Valve functioning: valve area, residual mean gradient, aortic regurgitation assessed
 with color Doppler echocardiography at 30 days, 6, 12, 18 and 24 months

 10. Incidence of paravalvular regurgitation at 30 days, 6, 12, 18 and 24 months

 11. Incidence of infective endocarditis at 30 days, 6, 12, 18 and 24 months

 12. Incidence of vascular complications needs surgery
Inclusion Criteria:

 -  Patients in whom transcatheter aortic valve implantation is attempted at participating
 center.

 Exclusion Criteria:

 -  None except failure to obtain informed consent.