Overview
This study will analyze patients with aortic stenosis who have undergone transcatheter valve implantation and surgical aortic valve replacement. Afterwards, the results of these two procedures will be collected to the database and compared among the Kazakhstani population.
Description
Primary Objectives
- Prevalence of aortic stenosis in Kazakhstan regions
- 12 months survival of patients after TAVI
- Intra- and postoperative complications
- Conduction disorders after TAVI
- Left ventricle function after TAVI in patients with low ejection fraction
- Comparison of aortic route dimensions by 3D-TEE and MSCT
- Comparison of TAVR with SAVR
Study Design Registry, IV phase
Subject Follow-up Schedule Maximum follow-up is approximately 4 years.
Inclusion Criteria Patients have TAVI
Exclusion Criteria Patients have not TAVI
Primary Endpoints The database contains data on mortality, intraoperative complications, post-operative complications and adverse cardiovascular events. We will perform Quality of Life analysis before TAVI and one year later, using the Short-Form 36 (SF36) instrument on 70% of our patients.
Patient Safety The NRCCS is a leading center for interventional cardiology in Kazakhstan, and in Central Asia, performing a high volume of TAVI procedures annually
Procedure / Intervention Description
- We believe our database is unique because it is the first systematically-collected, prospectively designed database in Central Asia for patients receiving TAVI.
- As known there is no data has been published regarding TAVI in Central Asia.
Secondary Endpoints
- Surgeons at NRCCS tend to use biological valves over mechanical valves because it was recognized that the requirements for long term success of mechanical valves (e.g. warfarin maintenance and compliance) were unlikely to be achieved in our patient population, many of whom live in rural areas without access to advanced cardiology care.
- Some of these patients are now returning to our center for valve in valve implantation and are being included in our registry. • Foundational work has been completed through our database development, but there is significant potential to expand our data collection to other Central Asian interventional cardiology centers.
- As technology evolves and options for trans-femoral TAVI approaches increase, the likelihood of using TAVI over SAVR will increase in Kazakhstan and Central Asia.
Statistical Method / Rationale Foundational work has been completed through our database development, but there is significant potential to expand our data collection to other Central Asian interventional cardiology centers. As technology evolves and options for trans-femoral TAVI approaches increase, the likelihood of using TAVI over SAVR will increase in Kazakhstan and Central Asia.
Eligibility
Inclusion Criteria:
- Patients has given written informed Concent for study participation prior to procedure
- Patients with Aortic Valve stenosis
- Patients has severe degenerative or congenital aortic stenosis.
- Patients has symptomatic aortic stenosis as demonstrated by NYHA II or greater
Exclusion Criteria:
- Patients has active endocarditis
- Patients has history of cerebral vascular accident or transient ischemic attack within the past 3 months