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3f Enable Aortic Bioprosthesis (model 6000) | …
In this series, the mean transvalvular gradient after the VIV procedure was 20.9 ± 5.9mmHg, and 42% of patients had a mean gradient ≥ 20mmHg. These values are higher than those commonly observed after TAVI in native valve stenosis (≤ 10mmHg). Studies show that the occurrence of severe mismatch (cm/m) after aortic VIV is 32.1%. Higher transvalvular gradients are, therefore, somewhat expected in these procedures: the VIV prosthesis is implanted in a non-distensible structure (in this case, the surgical prosthesis annulus), resulting in a smaller effective flow area. Some patients also have mismatch and high mean baseline gradient after surgical valve replacement (especially with bioprosthesis mm). This fact also contributes to the observation of higher gradients after VIV. In the current series, however, even patients with a mean gradient > 20mmHg after VIV had significant improvement in symptoms.
Clinical, echocardiographic, and procedural profiles were characterized, and the mid-term results of patients with surgical bioprosthesis dysfunction submitted to valve-in-valve implantation in the aortic position were reported.
Enable® Aortic Sutureless Bioprosthesis Evaluation - …
In this initial study, the valve-in-valve procedure was clinically effective, resulting in immediate favorable results in patients with aortic bioprosthesis dysfunction and high surgical risk. The clinical and hemodynamic benefits were maintained in the midterm follow-up. Studies with more patients and longer-term follow-up are still required to consolidate its indication, especially in individuals with lower surgical risk.
The knowledge of the fluoroscopic aspect of a particular surgical prosthesis defines the optimum position for the transcatheter bioprosthesis implantation (usually 15% below the suture annulus for the Sapien XT and from zero to 4mm for the Core Valve prosthesis) (). Currently, the smartphone application developed in 2013 by Bapat allows access to the necessary structural information of several surgical prostheses, assisting in the most appropriate choice of size and positioning of the VIV prosthesis, thus reducing the possibility of mismatch and aortic regurgitation.
The 3f Enable sutureless bioprosthesis: Early results, safeguards, ..
After median sternotomy, the CPB was instituted with aorto-atrial cannulation. The heart was arrested with retrograde normothermic blood cardioplegia and LAD was revascularized with left mammary artery. The transverse aortotomy was performed ~3 cm above the sinotubular ridge and the aortic valve was inspected. The valve was tricuspid and extremely calcified. The native aortic valve was excised, the annulus was decalcified and the valve was replaced with a 3F Enable (ATS Medical—Medtronic, Inc., Minneapolis, MN, USA) 23-mm sutureless bioprosthesis. The rising and folding processes of the prosthesis and the implantation technique have been described by Martens et al. . The aortotomy was closed with a continuous 4-0 prolene suture and the patient was weaned from the CPB uneventfully. The CPB time and aortic cross-clamp (ACC) time were 103 and 70 min, respectively. Intraoperative transoesophageal echocardiography showed a good position and normal valve function with mild perivalvular leakage.
We report the first case of successful treatment of severe stenosis of a degenerated aortic bioprosthesis using the percutaneous CoreValve prosthesis. This case illustrates the viability and safety of the procedure. Repeat surgery is associated with high morbidity and mortality rates; hence, percutaneous treatment for prosthesis dysfunction, whether for regurgitation or stenosis, may be a therapeutic alternative for a subgroup of patients.
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MDa Objective: The 3f Enable aortic bioprosthesis ..
Sutureless aortic bioprosthesis implantation is an alternative technique in high-risk patients undergoing aortic valve replacement with a possible reduction in the extracorporeal circuit time and reliable haemodynamic features. A 3F Enable (ATS Medical—Medtronic, Inc., Minneapolis, MN, USA) has shown very good results. We report the first upward displacement of 3F Enable three months post implantation.
Sutureless Medtronic 3f Enable aortic valve replacement …
Aortic valve replacement (AVR) with mechanical or biological stented valves is the standard treatment for patients with severe, symptomatic aortic stenosis . However, high-risk patients undergoing AVR may require alternative treatment options to reduce postoperative mortality and morbidity. Sutureless aortic bioprosthesis implantation is a less-invasive technique, which may shorten the cardiopulmonary bypass (CPB) time and show an excellent haemodynamic performance. Results are encouraging and this technique continues evolving. The rate of perivalvular leakage remains an important issue with this technology , but in literature there are no described cases of the sutureless dislocation requiring reintervention. We report the first case of a late upward displacement of a 3F Enable three months post implantation.
ATS Medical announced FDA approval for ATS 3f Aortic Bioprosthesis
After median sternotomy and lysis of tenacious adhesions, the CPB was instituted, the heart was arrested and the transverse aortotomy was performed as described previously. At the follow-up, a dislocation into the outflow tract was confirmed with the displacement at the level of left sinus of Valsalva. The bioprosthesis was intact and showed no degeneration. The intimal wall of the aortic root did not show injury. The 3F Enable was easily mobilized by irrigation with chilled sterile physiological saline solution to keep the Nitinol frame malleable, and then correctly repositioned and expanded with warmer saline. We fixed the bioprosthesis in the aortic annulus with four pledgeted stitches. The CPB and ACC time were 54 and 28 min, respectively. Intraoperative transoesophageal echocardiography showed a good position and normal function of the bioprosthesis without perivalvular leakage. Postoperative course was uneventful.
with implantation of the ATS 3f Aortic Bioprosthesis
To the best of our knowledge, this is the first case reported in literature of a late 3F Enable sutureless dislocation. We believe that the dislocation was not linked to the size of the bioprosthesis, but probably due to the deep decalcification determining an anatomic inexact circular aortic annulus and consequently an incorrect implantation. Realizing that the bioprosthesis was intact and the leaflets were not degenerated, we decided to re-implant the same valve. Specifically, the bioprosthesis was irrigated with chilled saline solution to make the Nitinol frame malleable and repositioned at the level of the aortic annulus. Subsequently, it was expanded with warmer saline and the bioprosthesis was fixed into the aortic annulus with some pledgeted stitches, to reduce the risk of re-migration.
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