Trans-Apical Aortic Valve Implant:

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Presentation transcript:

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 vlima@uol.com.br valter.lima@santacasa.tche.br

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 www.fernandolucchese.com.br lucchese@santacasa.tche.br

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

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

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

Inovare™ Prosthesis International Standards • ANSI/AAMI/ISO 5840 Cardiovascular implants—Cardiacvalveprostheses • ANSI/AAMI/ISO 25539-1 Cardiovascular implants—Endovasculardevices— Part1: Endovascularprostheses • ISO/DIS 5840-3 Cardiovascular implants --Cardiac valve prostheses -- Part 3: Heart valve substitutes implanted by minimally invasive techniques -DRAFT

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

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

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%

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

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%)

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)

Results (3): ECHO LV EF Mean Gradient * n = 33 Gradient (mmHg) Ejection Fraction (%) Time (Days) PRE POST 7 30 180 360 PRE POST 7 30 180 360 n = 33 TIME Rev Bras Cir Cardiovasc. 2011;26(3):338-47. Gaia, DF, et al.

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

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.

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).

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 vlima@uol.com.br valter.lima@santacasa.tche.br

Brazilian Population Aging & Aortic Stenosis 18 18