Key result
Temporary Direct Flow Medical PAV implantation yields ~88% procedural success in severe aortic stenosis.
Why the study?
The technical feasibility of using the Direct Flow Medical percutaneous aortic valve to treat severe aortic stenosis was not established.
Does the Direct Flow Medical percutaneous aortic valve improve transaortic gradient and demonstrate technical feasibility in patients with severe aortic stenosis?
Observational (n=8)
Does the Direct Flow Medical percutaneous aortic valve improve transaortic gradient and demonstrate technical feasibility in patients with severe aortic stenosis?
The Direct Flow Medical percutaneous aortic valve demonstrated proof-of-concept technical feasibility and significant transaortic gradient reduction in patients with severe aortic stenosis.
Supports feasibility of temporary percutaneous aortic valve use in severe AS; leaves open need for larger trials to assess safety and durability.
AIMS: This paper reports the technical feasibility of using the Direct Flow Medical percutaneous aortic valve (PAV) to treat patients with severe aortic stenosis (AS). METHODS AND RESULTS: Eight patients with critical AS underwent temporary implantation of the PAV. Two patients received open surgical implantation of the device while six patients underwent percutaneous implantation. The mean age of these eight patients was 58.1 years, mean pre-procedural aortic valve area was <0.65 cm2 and pre-procedural gradient was 87.6 +/- 12.4 mmHg. Procedural success was achieved in seven out of eight patients, with a mean post-implantation gradient of 17.9 +/- 9.1 mmHg. There was one death related to inferior hypogastric artery dissection. All other patients subsequently received open surgical explantation of the PAV and aortic valve replacement with a mechanical valve. CONCLUSIONS: The Direct Flow Medical PAV is technically feasible and safe to deploy in humans with severe AS and results in a significant transaortic gradient reduction.
No takes yet. Share an insight, caveat, or question.
Low et al. (2008) conducted an observational in Severe aortic stenosis (n=8). Direct Flow Medical percutaneous aortic valve (PAV) was evaluated on Procedural success. Temporary implantation of the Direct Flow Medical percutaneous aortic valve achieved procedural success in 7 of 8 patients with severe aortic stenosis, reducing the mean gradient to 17.9 mmHg.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: