implante de válvula transcateter. inovare - braile via femoral

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Estenose Artica e Disfuno ventricular esquerda. O que fazer?

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Prof. Dr. Jose Carlos Dorsa Vieira Pontes

Universidade Federal de Mato Grosso do SuL

TRANSCATHETER AORTIC VALVE REPLACEMENT. INOVARE EXPERIENCE.1

Good afternoon everyone.First of all I would like to thank the opportunity to be in this important event organized by Professor Kostadinos Plestis and porfessor doctor Otoni Moreira Gomes.We will present the experience of pioneering transcater aortic valve implantation by femoral route using Inovare - prosthesis produced by braille biomedica . This prosthesis was designed initially for transapical implants1

Aortic Stenosis Is The Most Prevalent Form Of Cardiovascular Disease In The World After Hypertension And Coronary Artery Disease

Mayo Clin Proc. 2010;85(5):483-500

Aortic Stenosis Is The Most Prevalent Form Of Cardiovascular Disease In The World After Hypertension And Coronary Artery Disease2

aortic valve disease:

the acquired aortic valve disease is present in 4.5% of the population

In young individuals stand out rheumatic and congenital bicuspid and in elderly senile calcific aortic disease, which is associated with traditional risk factors for atherosclerosis (dyslipidemia, smoking and arterial hypertension).Ha also increased in patients with valvular heart disease with severe comorbidities, with limited evaluation and indication of interventional treatment, such as those with cancer in radiotherapy and / or chemotherapy, among others.the acquired aortic valve disease is present in 4.5% of the population 3

Diretriz Brasileira de Valvopatias SBC 2011 I Diretriz Interamericana de Valvopatias SIAC 2011 pacientes cuja estenose valvar seja responsavel pela sobrecarga pressorica e disfuncao ventricular, a cirurgia, mesmo que com riscos imediatos mais elevados e sobrevida tardia mais limitada, apresenta resultados superiores aos do tratamento clinico. Mesmo alguns pacientes sem reserva contratil podem se beneficiar da CVAo, mas as decisoes em pacientes de alto risco devem ser individualizadas.

Brazil is undergoing to a demographic shift, where there was a decrease in fertility and increase in life expectancy in recent years4

Aortic Stenosis- Increases with Age -

5With the change in population profile we expect an increasing number of elderly in the coming years 5

Only the presence of severe aortic stenosis, even asymptomatic presents a malignant natural history. Surgical treatment provides significant increase in patient survival.6

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When there are symptoms the natual history of aortic disease is changed drastically shortening the long survival of patients: two years for heart fail, 3 years syncope and 5 years for angina.7

31.8% did not undergo intervention, despite NYHA class III/IV symptoms

Do patients with valvular heart disease receive treatment according to established guidelines?

5,001 patients from April-July, 2001 92 hospitals from 25 countriesNO !

8because of comorbidities.

The aortic valve surgery (CVAo) is still the only effective therapeutic to long-term relief of left ventricular hypertrophy in patients with severe Aortic Stenoses

Due to the risk of operative and immediate and late complications of valvular prosthesis, the optimal time for surgery is often controversial.

Adequate knowledge of the natural history of disease along with clinical evaluation and complete data for specific exams enables tracing rational treatment guidelines.

Although randomized clinical trials comparing surgery and clinical treatment continued not been conducted, observational studies show that the corrective surgery of aortic stenosis and almost always followed by symptomatic improvement and a significant increase in survival.9

Cribier , 1996 - valvoplastia artica alternativa a pacientes inoperaveis65% de mortalidade em 1 ano.Davies , 1965 - primeira descrio de implante valvar atravs de cateter. Andersen et al. 1992 - implante experimental de uma estrutura metlica sobre a qual eram montadas cspides.Cribier et al. 2002 primeiro implante em humanos em um caso de extrema gravidade. O resultado imediato foi bastante satisfatrio, com reduo expressiva do gradiente transvalvar, melhora da frao de ejeo e do estado clnico de choque cardiognico.

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Estudos com prottipos em 2003 e 2004:

I-REVIVE (Initial Registry of Endovascular Implantation of Valves in Europe)RECAST (Registry of Endovascular Critical AorticStenosis Treatment). sucesso 75%, com elevao da rea valvar de 0,6 cm2 para 1,6 cm2, reduo do gradiente transvalvar mdio de 37 para 9 mmHg e melhora da frao de ejeo de 45% para 53%. A mortalidade em 30 dias foi de 23%

A experincia inicial encorajadora motivou diversos estudos multicntricos:

REVIVAL II (Transcatheter EndoVascular Implantation of Valves II)REVIVE II (Registry of Endovascular Implantation of Valves in Europe II).PARTNER (Placement of Aortic Transcatheter).

In 2003 and 2004 studies with prototypes showed good results, with significant improvement in hemodynamic parameters. Mortality was acceptable 23% in 30 days.

This initial experience led to other studies.In particular Partner11

This study gathered multiple centers at united states, canada and europe.Two arms: b inoperable patients and A patients at high risk for conventional surgery.12

The first results (army B) were published in the New england 2010, and demonstratedThe exchange that transcatheter aortic valve proved far superior to conventional treatments in patients with critical aortic stenosis, considered inoperable.13

699 high-risk patientsTranscatheter Replacement(348 patients)Surgical Replacement (351 patients)

PARTNER Trial InvestigatorsN Engl J Med 2011;364:2187-98.survival at 1 year.

The A arm that compared high-risk patients undergoing conventional valve replacement and transcatheter aortic valve implantatationThe results were published in June 201114

The partner A army was proved no inferiority of transcater procedure in relation to conventional aortic valve replacement15

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Until March this year the landscape of Tavi in Brazil16

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The Inovare prosthesis is a bovine pericardial prosthesis mounted in chhromium cobalt cage and ballon expandable device - inovare was developed by Professor. Braile fron Sao Jose do Rio Preto (Brazil)17

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SP = 128EPM = 108InCor/Band/Alv = 14Benef. Port. = 4SJRP = 2RJ = 4PE = 2RN = 1CE = 2AM = 1MS = 1MS =10 tfPR = 6RS = 14Inovare Transapical

In Brazil professor Buffolo and Palma has the largest experience with implant of transcatheter transapical using inovare

A multicenter study coordinated by Prof. Enio bufolo and Honorio Palma from sao paulo federal university allowed to record the Braille biomedical prosthesis in responsible sanitary organ of the Brazilian government and thus the prosthesis obtained certification to be comercilized in November 201118

Sapien

Inovare

Survival90,7%

In the Brazilian experience, Bufolo and Palma observed a survival above ninety percent, similar to the literature of the sapien valve, in a follow up of two years.19

In this beautiful scenery in the Midwest region of Brazil is located at the Federal University of Mato Grosso do Sul, where we have the immense honor of coordinating the service of cardiovascular surgery.In February 2012 the Federal University of Mato Grosso do Sul began selecting patients to implant transcatheter aortic valve.20

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Here we present a hybrid operating room UFMS university hospital, where we can observe in the same environment of an equipment hemidinamica, extracorporeal pump, etc. echotransesophageal. And also the Heart Team (surgeons, interventional cardiologists, cardiologists, echocardiographers, anesthesiologists21

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SP = 128EPM = 108InCor/Band/Alv = 14Benef. Port. = 4SJRP = 2RJ = 4PE = 2RN = 1CE = 2AM = 1MS = 1MS =10 tfPR = 6RS = 14Inovare Transfemoral

In the month of April 2012 we performed the first implant femoral prosthesis with INOVARE the Brazilian experience10 implates were performed by femoral route prosthesis with inovare in UFMS22

CASUISTIC AND METHOD10 cases EuroScore > 2503 dysfunction of prosthetic aortic01 dysfunction of prosthetic aortic valved tube (12 years after Bentall)06 pure calcified stenosisAccess route: Transfemoral or iliac23

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Transesophageal Echo in the surgical room was used to confirm the size of the valve annulus to choose the number of prostheses24

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A balloon catheter25

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the size of the prosthesis was confirmed through the transesophageal echo in the operation room26

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the prosthesis was mounted on the balloon27

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The valve was crimped on the balloon to allow its passage through the vascular introducers28

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here the prosthesis already crimped on the delivery balloon 30

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We can observe an introducer positioned in the common femoral artery31

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this video we can see the prosthesis being carried to the aortic annulus through a extra stiff guidence, previously positioned in the left ventricle 32

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This slide demontrate the correct positioning of the prosthesis, absence of valvular or paravalvar regurgitation and patency of coronary arteries33

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Another case: valve in valve. Patient underwent a previous three reoperations34

pacienteNativa/ v in vIdadeFe preanelPrtese implantadaGradiente mdio mmHgeuroescorestscoplicFe posGradient posSPNativa520,25252847 3015N4313,8BfDisfuno BP820,442224163115n4018OPCnativa740,542528812810,7n6419EBTPos Bental