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Next generation surgical aortic biological prostheses : ..

aortic stenosis include high blood pressure and cholesterol, diabetes mellitus, and smoking.3,18

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prosthesis currently available: A - 3f Enable valve ..

In our experience with MIAVR using SU bioprostheses the hospital mortality was very low considering the class of risk as the major postoperative complications. The minimally invasive approach to AVR has advantages of decreased ICU and hospital stay, which may be attributed to the reduced surgical trauma. No wound infections occurred in minithoracotomy and ministernotomy but in minithoracotomy, above all, this benefits may be translated from the smaller incision, sternum preservation, and integrity of the costal cartilages. Despite MIAVR has only recently gained acceptance in the surgical community and requires a significant learning curve we found SU valves very easy to implant and we did not have any issue comparing to traditional bioprostheses. We operated patients with isolated severe aortic stenosis with a medium to high operative risk assessed by Euro SCORE 1. Considering our experience in minimally invasive AVR, which in our Departments currently accounts for up to 80% of all AVR, we were mostly interested in implanting SU valves in MICS procedures through RAMT or MS access. CCT and ECC time resulted relatively low but not significantly lower than in AVR performed with conventional bioprostheses. This can be explained considering the learning curve to become confident with the device, in the last quartile of implants performed, in fact, the mean CCT resulted less than 40 min.

The 3f Enable sutureless bioprosthesis: Early results, safeguards, ..

Left ventricular hypertrophy in aortic stenosis is considered a compensatory response for the maintenance of systolic function but a risk factor for cardiac morbidity and death. We investigated the degree of left ventricular mass regression after implantation of the sutureless Medtronic 3f Enable® Aortic Bioprosthesis.

3F-Enable aortic valve prosthesis.

Conclusions: The sutureless valve implantation technique is feasible and safe with the ATS 3f Enable Bioprosthesis.

This study shows a significant regression in LV mass at the 6-month follow-up after sutureless bioprosthesis implantation in 19 patients undergoing isolated AVR. We showed that implantation of the 3f Enable bioprosthesis in high-risk patients is a safe and feasible procedure associated with low morbidity and mortality rates and with excellent hemodynamic performance at short-term follow-up. This is confirmed by several previous reports. Santarpino and colleagues described LV mass regression at a mean 13.5 ± 7.3 months' follow-up after the implantation of a Perceval S sutureless bioprosthesis (S Group; Saluggia, Italy). However, the impact of the 3f Enable bioprosthesis on LV mass at short-term follow-up has never before been analyzed.

Paravalvular aortic regurgitation (PAR) is relatively common after transcatheter aortic valve replacement (TAVR). In a recent meta-analysis, the incidence of moderate or severe PAR was 11.7%, although it is apparently less frequent with the Edwards SAPIEN valve (Edwards Lifesciences; Irvine, CA, USA) than with the CoreValve (Medtronic; Tolochenaz, Switzerland) (9.1% vs. 16.0%, respectively; p=0.005). The PARTNER study reported severe PAR in 6.8% of cases, compared to 1.6% found in the meta-analysis by Athapan et al., while moderate PAR occurred in 10.5% of cases in both studies. Minimal PAR was observed in 46% according to the meta-analysis. Three factors have been identified as predictors of PAR after TAVR: prosthetic valve undersizing, improper implantation depth and aortic valve calcification. The importance of this issue is that moderate or severe regurgitation has been associated with increased mortality at both 30 days and one year; mild regurgitation has been linked to higher mortality, although this is only a tendency in some studies. On the basis of current data, some reports have emphasized the importance of selecting the most appropriate prosthesis size using imaging techniques such as computed tomography.

ATS 3f Enable(tm) Aortic Bioprosthesis, Model 6000

Overall, these data confirm the safety and clinical utility of the Enable® Bioprosthesis for aortic valve replacement.

As previously mentioned, SU valves were initially indicated as offering, in high-risk patients, the benefit of CCT and ECC time savings, but as their use has spread many other benefits have emerged, such as the excellent hemodynamic performance in small aortic annulus and sizes, and the “no need for sutures” has been reported to be crucial in cases of heavily calcified aortic annulus and aortic roots, as in degenerated homo grafts and stent less prostheses. Recently Vola et al. [11] reported the first four - successful - cases of totally endoscopic aortic valve replacement: this important innovation opens up a new scenario for possible future applications of SU valves. Initial reports about SU valves are positive and encouraging and our initial experience confirms this, but the limited number of case series published, as well as the lack of prospective randomized trials and long-term follow-up, does not allow any definitive conclusion to be drawn regarding the effective clinical advantages of these bioprostheses. They currently represent an important additional option for special conditions, but as they are demonstrating the same safety, at least in the short- and mid-term, as conventional tissue valves, their use may become a valid option for all patients eligible for biological AVR.

As with traditional aortic bioprostheses, implantation requires a cardiopulmonary bypass and aortic cross clamping that are assessed according to the surgical way of access and ascending aorta length. The diseased aortic valve leaflets are removed and the aortic annulus completely decalcified. The sutureless aortic bioprostheses were implanted according to their technique. Intraoperative transoesophageal echocardiogram (TEE) was routinely performed to verify the correct positioning of the valves and to measure the initial hemodynamic parameters.

Overall, these data confirm the safety and clinical utility of the Enable® Bioprosthesis for aortic valve replacement.
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  • 3f Enable Aortic Bioprosthesis ..

    3f Enable® aortic bioprosthesis > биопротез аорты 3f Enable®

  • ATS 3f(r) Aortic Bioprosthesis Model 1000, 19mm

    ATS 3f Enable(tm) Aortic ..

  • follow-up with the sutureless 3F-Enable aortic valve prosthesis.

    The ATS 3f Enable Aortic Bioprosthesis is targeted to be the companies' second tissue valve product to market

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27/08/2014 · ATS 3f Enable(tm) Aortic ..

(A) Aortography with mild to moderate regurgitation (arrows) through the prosthetic aortic valve; (B) aortography showing resolution of regurgitation after removal of thrombus from the right coronary artery (CA) (due to immediate improvement of left ventricular function seen on transesophageal echocardiography); (C) acute thrombotic occlusion in the mid third of the RCA; (D) RCA with TIMI 3 flow after extraction of the thrombus; (E) thrombus extracted from the RCA after aspiration with the Pronto device.


Aortic annulus diameter was 21 mm and right femoral artery diameter was 7.7 mm. The patient was scheduled for TAVR. During the implantation of a 23 mm Edwards SAPIEN X T valve, sudden severe LV dysfunction occurred with posterior-inferior akinesis and acute severe mitral regurgitation. Moderate central aortic prosthetic regurgitation was observed on aortography (appearing lighter on Doppler echocardiography) (). Emergency coronary catheterization showed an acute occlusion of the mid right coronary artery (). A thrombus was aspirated using a Pronto extraction catheter (Vascular Solutions, Minneapolis, MN, USA). Its shape suggested that it had been released from the pigtail catheter in the ascending aorta, even though heparin 100 U/kg had been administered and activated clotting time was 250 s (). As soon as the right coronary artery was opened and TIMI 3 flow was restored, LV function recovered completely and the mitral regurgitation almost disappeared, returning to baseline status (). Repeat aortography showed resolution of central prosthetic aortic valve regurgitation (). The patient progressed without problems, with minimal troponin elevation and continuing normal LV function.

of the sutureless Medtronic 3f Enable® Aortic ..

Sutureless bioprostheses present an innovative approach to surgical AVR and have been designed to enable faster implantation, reducing CPB and ACC times. This is an advantage for all patients, regardless of risk profile. Therefore, sutureless aortic valve implantation might be an alternative treatment option for patients at high risk for death and morbidity after open-heart surgery. In our experience, mean CPB and ACC times were longer than expected but similar to those reported in other studies. Our ACC time in sutureless implantation is not different from a standard AVR; this could be related to our learning curve. In the first 7 patients who underwent isolated AVR with the 3f Enable through ministernotomies, the mean ACC time was 71.8 ± 21.5 min. In the subsequent 6 patients, the ACC time was 61.2 ± 14.8 min, an improvement in operative time. Additional modifications to the polyester flange of the 3f Enable, enabling broader coaptation with the native annulus and better positioning of the valve, could further reduce procedural time. We think that greater experience of the surgeons, together with future evolution of this device, could reduce implantation time. Furthermore, we must consider that most of the bioprostheses were implanted via a minimally invasive approach, in which operative times are normally longer. As described by our study, in addition to these several advantages, the 3f Enable bioprosthesis results in excellent hemodynamic performance and a significant regression in LV mass at follow-up.

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