Published Online
on September 3, 2008

A more recent version of this article appeared on October 1, 2008

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Original Article

Retrograde Transarterial Implantation of a Nonmetallic Aortic Valve Prosthesis in High-Surgical-Risk Patients with Severe Aortic Stenosis. A First-in-Man Feasibility and Safety Study

Joachim Schofer¹; Michael Schlüter^1,5; Hendrik Treede²; Olaf W. Franzen²; Thilo Tübler¹; Andrea Pascotto¹; Reginald I. Low³; Steven F. Bolling⁴; Thomas Meinertz² and Hermann Reichenspurner²

¹ Hamburg University Cardiovascular Center;
² University Heart Center Hamburg;
³ University of California, Davis Medical Center;
⁴ University of Michigan Cardiovascular Center, Ann Arbor

⁵ E-mail: schlueter{at}herz-hh.de

Background—To assess the feasibility and safety of retrograde transarterial implantation of a novel nonmetallic aortic valve prosthesis (Direct Flow Medical, Inc.), a prospective single-center study was performed in patients with severe aortic stenosis at high risk for open-heart surgery.

Methods and Results—Fifteen patients (intention-to-treat cohort) with an aortic valve area 0.8 cm², a 35 mmHg mean transvalvular pressure gradient, and a logistic EuroSCORE 20% were enrolled. Percutaneous aortic valve replacement was performed with the patient in general anesthesia. Hemodynamic parameters were assessed pre and post implantation by transesophageal echocardiography. Clinical follow-up and transthoracic echocardiographic assessment were obtained at 30 days. Procedural success was achieved in 12 patients (80%). Surgical conversion became necessary at day 2 in 1 patient, thus 11 patients (73%) were discharged with a permanent implant. In these patients, implantation resulted acutely in a significant increase in aortic valve area (median 1.64 [IQR, 1.27 - 1.74] vs. 0.60 [0.46 - 0.69] cm²; P = 0.0033) and a concomitant reduction in the mean pressure gradient (14.0 [13.2 - 16.5] vs. 54.0 [43.2 - 59.8] mmHg; P = 0.0033). At 30 days, 1 cardiac death (6.7%; 95% CI, 0.2%-32.0%) and 1 major stroke were observed. The 10 surviving patients with a permanent implant showed marked hemodynamic and clinical improvement at this time point.

Conclusions—In this small series of patients, percutaneous implantation of the Direct Flow Medical aortic valve prosthesis in high-surgical-risk patients was feasible and associated with a reasonably low safety profile.

Key Words: aorta • catheterization • prosthesis • stenosis • valves

Related Article

Retrograde Transarterial Implantation of a Nonmetallic Aortic Valve Prosthesis in High–Surgical-Risk Patients With Severe Aortic Stenosis: A First-in-Man Feasibility and Safety Study

Joachim Schofer, Michael Schlüter, Hendrik Treede, Olaf W. Franzen, Thilo Tübler, Andrea Pascotto, Reginald I. Low, Steven F. Bolling, Thomas Meinertz, and Hermann Reichenspurner
Circ Cardiovasc Interv 2008 1: 126-133. [Abstract] [Full Text] [PDF]

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