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a Klinik für Herzchirurgie, Universität Leipzig, Herzzentrum, Leipzig, Germany
c Klinik für Kardiologie, Universität Leipzig, Herzzentrum, Leipzig, Germany
b Chaim Sheba Medical Center, Tel Hashomer, Israel
Accepted for publication December 1, 2008.
* Address correspondence to Dr Falk, Universität Leipzig, Herzzentrum, Klinik für Herzchirurgie, Strümpellstr 39, Leipzig, 04289, Germany (Email: falv{at}medizin.uni-leipzig.de).
| Dr Schwammenthal discloses that he has a financial relationship with Ventor Technologies.
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Abstract |
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Since the introduction of transcatheter aortic valve implantation [1–3], transapical and transfemoral implantation techniques both have yielded similar results for early outcomes. Self-expanding designs based on the nitinol stent, such as the CorValve (CoreValve Inc, Irvine, CA) as well as balloon-expandable steel stent valves such as the Edwards Sapien valve (Carpentier-Edwards Lifesciences, Irvine, CA), rely solely on radial forces to anchor the valve within the aortic root. Both of these currently available valves have a symmetric shape that enables placement within in the aortic annulus, but suboptimal implantation can occur in both the subannular or supraannular position.
The Ventor Embracer valve (Ventor Technogies, Netanya, Israel) used in this initial clinical case may overcome this potential shortcoming by combining a self-expanding nitinol stent with 3 support arms that are anchored in the aortic sinuses to provide a self-centering mechanism upon deployment. Furthermore, it allows for exact anatomic orientation of the implanted prosthesis by anatomically aligning the commissures and provides bidirectional axial forces for fixation in addition to radial forces. The Embracer is a flexible heart valve prosthesis composed of 3 leaflets that are cut from tissue-fixed bovine pericardium, sewn to a polyester sleeve, and mounted on a compressible and self-expandable nitinol frame (stent assembly). The stent assembly consists of a main frame and a support frame that are coupled to form the commissural posts for the valve (Fig 1). Here we report the successful transapical human implant of this new valve.
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The operation was performed in a surgical hybrid suite. Femoral arterial and venous wires were inserted percutaneously to provide immediate access in case cardiopulmonary bypass was required. Intravenous heparin (100 IU/kg) was given to allow angiography in a left anterior oblique projection with mild cranial tilt for visualization of the left and right coronary sinus and the commissure in between. A pigtail catheter was introduced through the arterial sheath to allow fluoroscopic visualization of the aortic root.
A 5-cm anterolateral minithoracotomy was performed in the fifth left intercostal space, and after limited pericardiotomy, two felt pledgeted purse-string sutures were placed at the left ventricular apex. A temporary pacing wire was placed at the left ventricle to allow for rapid ventricular pacing. The apex was punctured with a needle, and a soft guidewire was inserted antegrade across the stenotic aortic valve. A 14F (30-cm-long) soft tipped sheath was placed across the aortic valve, followed by a superstiff 260-cm Amplatzer guidewire (AGA Medical Corp, Plymouth, MN) across the aortic arch into the descending aorta with the help of a right Judkins catheter.
A 20-mm Z-MED balloon (NuMED Inc, Hopkinton, NY) filled with 1:4 diluted contrast was used for balloon valvuloplasty of the aortic valve, which was performed under a brief episode of rapid ventricular pacing at a rate of 180/min. The 14F sheath was exchanged for a 27F delivery sheath. The delivery catheter was then inserted into the overtube and advanced until the distal end of the commissural posts reached the end of the overtube with the support arms still in it (Fig 2a).
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Fluoroscopy and transesophageal echocardiography revealed perfect positioning of the valve, with only minimal paravalvular leakage. The peak-to-peak pressure gradient was measured to be 5 mm Hg. All catheters were withdrawn, and the wound was closed in a standard fashion.
The operation lasted 80 minutes. The patient was discharged after an uneventful recovery on postoperative day 19 in good health. A discharge echocardiogram revealed excellent valve function, with a mean pressure gradient of 4 mm Hg, a peak gradient of 8 mm Hg, and only a minimal paravalvular leak (aortic insufficiency < grade I).
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Comment |
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TopAbstractIntroductionCommentReferences |
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We successfully implanted this new transapical valve in our patient. The valve features a distinct design iteration compared with the currently implanted valves by providing 3 support arms to facilitate correct anatomic positioning and safe anchoring within the aortic sinuses; thus, it does not rely purely only on radial forces for fixation within the aortic annulus, but provides axial forces for fixation at both sides of the annulus. The valve designed incorporates the Venturi tube principle to minimize pressure loss at the inlet and maximize pressure recovery at the outlet portion. The outlet portion provides commissural posts for attachment of the pericardial leaflets that are therefore not encompassed by a stent, and can therefore interact with the naturally occurring vortices in the aortic sinuses.
Care must be taken in the positioning of the commissural posts. If the commissural post only projects itself onto the CRL, but actually faces the noncoronary sinus—away from the x-ray detector—release of the arms will potentially bring the arms on top of the commissures. In this instance, the system needs to be rotated by 60 degrees in any direction to fall in place.
The minimally invasive approach and the good hemodynamic outcome led to an uneventful recovery in this patient and warrant further clinical evaluation.
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