1. Trans-Apical Aortic Valve Implant:
Current Results of Inovare™ Registry,
First Brazilian Made
Transcatheter Aortic Valve Prosthesis
Valter C. Lima, MD, PhD, FSCAI
Director, Interventional Cardiology
São Francisco Hospital, Santa Casa Medical Center
Porto Alegre, RS

2. Trans-Apical Aortic Valve Implant:
Current Results of Inovare™ Registry,
First Brazilian Made
Transcatheter Aortic Valve Prosthesis
Lucchese, FA; Lima VC; Sales, M; Leães, PE;
Gaia, D; Palma, JH; Buffolo, E
Santa Casa de Porto Alegre Medical Center
São Paulo Hospital – UNIFESP

3. Disclosure Writting group member Employment Research grant
Consultant/Advisory board
Fernando A. Lucchese
São Francisco Hospital / ISCMPA
Biotronik
Medtronic
Braile Biomédica
Valter C. Lima
Boston Scientific
Diego Gaia
EPM/UNIFESP -
José Honório Palma
Enio Buffolo

4. Background
Up to a 20%-25% of severe aortic stenosis have been considered too high risk or inoperable.
Transcatheter aortic valve implantation (TAVR), either transfemoral or trans-apical, has emerged as an alternative.
Braile Biomedical:
Established medical device company in Brazil
Strong market share on heart valve surgical prosthesis

5. Inovare™ Aortic Valve Prosthesis
Bovine pericardium
Cobalt chrome metal frame
Anti-leak polyester coating
Tantalum radiopaque markers
Sizes (mm):
20/22/24/26
Delivering apical sheath: 22F

6. Inovare™ Prosthesis International Standards • ANSI/AAMI/ISO 5840
Cardiovascular implants—Cardiacvalveprostheses
• ANSI/AAMI/ISO
Cardiovascular implants—Endovasculardevices— Part1: Endovascularprostheses
• ISO/DIS
Cardiovascular implants --Cardiac valve prostheses -- Part 3: Heart valve substitutes implanted by minimally invasive techniques -DRAFT

7. Objectives
The aim of this study was to assess safety and efficacy of Inovare™ - the first Brazilian made transcatheter valve prosthesis.

8. Methods: Patient Selection Inclusion Criteria Exclusion Criteria
Symptomatic severe AS
Bioprosthesis Dysfunction
Euro Score >15 and/or STS >10
Informed consent
AMI
Intracardiac Mass
Limited Life Expectancy
Bicuspid Valves

9. Patients N: 93 Age: 77 yo (34-88) Mean logistic Euro SCORE: 39
STS Score: 31
Valve in valve: 10 patients
eGFR < 50: 76%
PARTNER criteria
A (High risk): 76%
B (Inoperable): 24%

10. Procedural Success Definition
Uncomplicated successful valve prosthesis implant over annulus.
Residual echo mean gradient < 20 mm Hg.
Aortic regurgitation <2+

11. Results (1) Procedural success: 87 (93.5%)
Conversion to standard surgery: 3 (3.3%)
ECHO mean gradient: 43.1 to 11.1 mm Hg
Mortality:
Procedural: 3 (3.3%)
30-day: 16 (17.2%)
Permanent Pacemaker: 2 (2.2%)
Stroke: 1 (1.07%)

12. Results (2): Procedural Data
Procedural duration; (min)
Fluoroscopy; (min)
164 ± 75
12.1 ± 5.9
Contrast Dye; (mL) 28
OR/Cath lab extubation; n (%)
78 (80)

13. Results (3): ECHO LV EF Mean Gradient * n = 33
Gradient (mmHg)
Ejection Fraction (%)
Time (Days)
PRE POST
PRE POST
n = 33
TIME
Rev Bras Cir Cardiovasc. 2011;26(3): Gaia, DF, et al.

14. Results (4): Late Survival
n = 79
Time (months)
Kaplan-Mayer Curve
Survival

15. Inovare™ Clinical Registry Results Medical Practice Effect
This registry was the basis for ANVISA (Brazilian Drugs and Medical Devices Regulatory Agency) to approve the Inovare™ for clinical use in November 2011.

16. Conclusion
Trans-apical TAVR with Inovare™ is both, safe and associated with acceptable midterm results.
Longer term follow-up is mandatory in order to assess sustained late clinical results (quality of life and survival).

17. Thank you very much for your attention !!!
Valter C. Lima, MD, PhD, FSCAI
Director, Interventional Cardiology
São Francisco Hospital
Santa Casa Medical Center
Porto Alegre, RS, Brazil

18. Brazilian Population Aging & Aortic Stenosis18 18