Key result
Transcatheter aortic valve implantation using the Inovare prosthesis via femoral or iliac access significantly reduced the mean gradient by 70.46% (P=0.002) with no intraoperative or hospital deaths.
Why the study?
Is transcatheter aortic valve implantation using the Inovare prosthesis via femoral or iliac artery feasible and effective in reducing mean gradient?
Observational (n=6)
Is transcatheter aortic valve implantation using the Inovare prosthesis via femoral or iliac artery feasible and effective in reducing mean gradient?
Effect estimate: 70.46% reduction
p-value: p=0.002
Transcatheter aortic valve implantation using the Inovare prosthesis via the femoral or iliac artery is feasible and significantly reduces the mean transvalvular gradient in a small initial series.
Supports early feasibility of Inovare TAVI via femoral/iliac access; leaves open need for larger prospective trials before broader adoption.
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.
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Pontes et al. (2013) conducted an observational in aortic valve stenosis (n=6). Inovare prosthesis implantation was evaluated on mean gradient (70.46% reduction, p=0.002). Transcatheter aortic valve implantation using the Inovare prosthesis via femoral or iliac access significantly reduced the mean gradient by 70.46% (P=0.002) with no intraoperative or hospital deaths.
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