Initial and pioneer experience of transcatheter aortic valve implantation (Inovare) through femoral or iliac artery.

OBJECTIVE: This paper demonstrates the initial and pioneering experience implant of the Inovare prosthesis implant through transfemoral or iliac artery route. METHODS: Six patients underwent transcatheter aortic valve implantation. The access was femoral or iliac through which the delivery device, a latex balloon catheter with the crimped prosthesis, was inserted. Through the femoral introducer 24 Fr Gore® DrySeal sheath, an extra stiff guide wire with non-traumatic tip was positioned in the left ventricle by passing through the valve ring. After balloon valvuloplasty, in cases of native valve stenosis, the prosthesis implantation was performed after hypotension induced by tachycardia and controlled by temporary pacemaker. The valve positioning was guided by TEE (transesophageal ecocardiography) and fluoroscopy, aiming to position a third of the length of the prosthesis into the left ventricle cavity. RESULTS: The successful valve implantation was possible in six cases. There was no need of conversion to open surgery due to inability to access or graft migration. There were no intraoperative or hospital deaths. We observed a significant reduction in the mean gradient of 66.84115.46 mmHg to 19.74110.61 mm Hg postoperatively (P=0.002), a reduction of 70.46%. CONCLUSION: Inovare prosthesis, implanted by femoral or iliac artery was feasible, and determined adequate hemodynamic performance in the postoperative follow-up, showing no mortality in this small series.

Experiência inicial e pioneira do implante de valva aórtica transcateter (Inovare) por via femoral ou ilíaca / Initial and pioneer experience of transcatheter aortic valve implantation (Inovare) through femoral or iliac artery

OBJETIVO: O presente trabalho tem por objetivo demonstrar a experiência inicial e pioneira do implante da prótese Inovare pela via transfemoral ou ilíaca. MÉTODOS: Seis pacientes foram submetidos ao implante valvar aórtico transcateter. A via de acesso foi femoral ou ilíaca, por onde foi inserido o dispositivo de entrega, que consiste em um cateter balão de látex com a prótese "crimpada" sobre o mesmo. Com auxílio de introdutor femoral da marca Gore® DrySeal 24 Fr, posicionava-se uma guia extrarrígida com a ponta atraumática no ventrículo esquerdo, passando-se pelo anel valvar. Após valvuloplastia com cateter balão nos casos de estenose valvar nativa, implante da prótese foi realizado após hipotensão induzida por taquicardia controlada por marcapasso temporário. O posicionamento da valva foi orientado por ecocardiograma transesofágico (ETE) e radioscopia, objetivando posicionar um terço da extensão da prótese para dentro da cavidade ventricular esquerda. RESULTADOS: O implante valvar com sucesso foi possível nos 6 casos. Não houve necessidade de conversão para cirurgia convencional por impossibilidade de acesso ou migração da prótese. Não houve mortalidade intraoperatória ou hospitalar. Houve redução significativa do gradiente médio pré-operatório de 66,84115,46 mmHg para 19,74110,61 mmHg, no pós-operatório (P=0,002), significando redução de 70,46%. CONCLUSÃO: A prótese Inovare, implantada por via femoral ou ilíaca, foi factível do ponto de vista técnico, apresentando adequado desempenho hemodinâmico no seguimento pós-operatório e não apresentando mortalidade nesta pequena casuística.

OBJECTIVE: This paper demonstrates the initial and pioneering experience implant of the Inovare prosthesis implant through transfemoral or iliac artery route. METHODS: Six patients underwent transcatheter aortic valve implantation. The access was femoral or iliac through which the delivery device, a latex balloon catheter with the crimped prosthesis, was inserted. Through the femoral introducer 24 Fr Gore® DrySeal sheath, an extra stiff guide wire with non-traumatic tip was positioned in the left ventricle by passing through the valve ring. After balloon valvuloplasty, in cases of native valve stenosis, the prosthesis implantation was performed after hypotension induced by tachycardia and controlled by temporary pacemaker. The valve positioning was guided by TEE (transesophageal ecocardiography) and fluoroscopy, aiming to position a third of the length of the prosthesis into the left ventricle cavity. RESULTS: The successful valve implantation was possible in six cases. There was no need of conversion to open surgery due to inability to access or graft migration. There were no intraoperative or hospital deaths. We observed a significant reduction in the mean gradient of 66.84115.46 mmHg to 19.74110.61 mm Hg postoperatively (P=0.002), a reduction of 70.46%. CONCLUSION: Inovare prosthesis, implanted by femoral or iliac artery was feasible, and determined adequate hemodynamic performance in the postoperative follow-up, showing no mortality in this small series.

Pioneering transcatheter aortic valve Implant (Inovare®) via transfemoral.

We present a patient with severe aortic valvular bioprosthesis dysfunction implanted for 11 years, presenting with acute pulmonary edema due to severe valvular insufficiency with severe systolic dysfunction (EF <30%) and comorbid conditions that amounted operative risk (STS score > 10). We carried out the transcatheter aortic valve implantation (Inovare® - Braile Biomedica), which was implemented successfully by transfemoral access and good patient outcomes.