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• W2018621388 abstract "Transapical aortic valve implantation has become a routine procedure to treat high-risk patients in some centers. To facilitate optimal positioning, a new self-centering valve design with anatomic orientation of the commissures has been developed. This self-expanding nitinol stent–based valve has 3 support arms that are placed within the aortic sinuses. Here we report implantation of this new valve in a patient. The valve demonstrated excellent function with a low transvalvular gradient. Transapical aortic valve implantation has become a routine procedure to treat high-risk patients in some centers. To facilitate optimal positioning, a new self-centering valve design with anatomic orientation of the commissures has been developed. This self-expanding nitinol stent–based valve has 3 support arms that are placed within the aortic sinuses. Here we report implantation of this new valve in a patient. The valve demonstrated excellent function with a low transvalvular gradient. Dr Schwammenthal discloses that he has a financial relationship with Ventor Technologies. Dr Schwammenthal discloses that he has a financial relationship with Ventor Technologies. Since the introduction of transcatheter aortic valve implantation [1Grube E. Schuler G. Buellesfeld L. et al.Percutaneous aortic valve replacement for severe aortic stenosis in high risk patients using the second- and current third- generation self-expanding CoreValve prosthesis Device success and 30-day clinical outcome.J Am Coll Cardiol. 2007; 50: 69-76Abstract Full Text Full Text PDF PubMed Scopus (875) Google Scholar, 2Webb J.G. Chandavimol M. Thompson C.R. et al.Percutanous aortic valve implantation retrograde from the femoral artery.Circulation. 2006; 113: 842-850Crossref PubMed Scopus (787) Google Scholar, 3Walther T. Falk V. Borger M.A. et al.Minimally invasive transapical beating heart aortic valve implantation—proof of concept.Eur J Cardiothorac Surg. 2007; 31: 9-15Crossref PubMed Scopus (205) Google Scholar], 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. In June 2008, an 85-year-old woman presented with symptomatic aortic stenosis. Because of her substantial comorbidities, she had a Society of Thoracic Surgeons predicted risk score of 25.1% and was subsequently evaluated for transapical aortic valve implantation. The patient gave written informed consent to participate in the Ventor Embracer trial, which was filed with the local ethical committee. 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). The system was now rotated under fluoroscopy until one prosthetic commissure was aligned with the commissure between the left and right coronary sinus (CRL). As soon as the commissural post seen en face was aligned with the CRL—close to the x-ray detector—the support arms were released by pulling back the overtube in an anatomically perfect position without the need for any further rotational correction (Fig 2b). In this position and under constant pull and a second period of rapid ventricular pacing, the valve was gradually unsheathed and thus released (Fig 2c). 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). Transcatheter minimally invasive aortic valve implantation using the transapical or the transfemoral approach has been successfully performed in high-risk patients with native aortic valve stenosis [1Grube E. Schuler G. Buellesfeld L. et al.Percutaneous aortic valve replacement for severe aortic stenosis in high risk patients using the second- and current third- generation self-expanding CoreValve prosthesis Device success and 30-day clinical outcome.J Am Coll Cardiol. 2007; 50: 69-76Abstract Full Text Full Text PDF PubMed Scopus (875) Google Scholar, 2Webb J.G. Chandavimol M. Thompson C.R. et al.Percutanous aortic valve implantation retrograde from the femoral artery.Circulation. 2006; 113: 842-850Crossref PubMed Scopus (787) Google Scholar, 3Walther T. Falk V. Borger M.A. et al.Minimally invasive transapical beating heart aortic valve implantation—proof of concept.Eur J Cardiothorac Surg. 2007; 31: 9-15Crossref PubMed Scopus (205) Google Scholar]. Transcatheter aortic valve implantation is an emerging clinical field, and several devices will be available for clinical implantation in the future. Malpositioning of transcatheter aortic valves, however, may cause device embolization, coronary artery obstruction, annular dissection, and paravalvular leakage. Except for the latter, these events are rare and paravalvular leakages usually are only of minor, clinically nonrelevant severity. 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." @default.
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• W2018621388 date "2009-03-01" @default.
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• W2018621388 title "New Anatomically Oriented Transapical Aortic Valve Implantation" @default.
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