Single center experience with the Sorin Bicarbon prosthesis: A 17-year clinical follow-up

Celiento, Michele; Filaferro, Luca; Milano, Aldo Domenico; Anastasio, Gerardo; Ferrari, Gabriele; Bortolotti, Uberto

doi:10.1016/j.jtcvs.2013.11.015

Cited by 13 publications

(12 citation statements)

References 31 publications

(51 reference statements)

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“…This prosthesis has been in clinical use since 1990 and has shown remarkable long-term results 14 . As reported by Celiento and co-workers in their 17-year follow-up study “a low incidence of embolic events was observed with a linearized rate of 0.39% ± 0.09%/patient-years after AVR” 15 . These outcomes are consistent with those disclosed by Azarnoush et al .…”

Section: Discussionmentioning

confidence: 71%

Low-dose anticoagulation after isolated mechanical aortic valve replacement with Liva Nova Bicarbon prosthesis: A post hoc analysis of LOWERING-IT Trial

Torella

Aquila

Chiodini

et al. 2018

Sci Rep

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Thromboembolic complications after cardiac valve replacement are due to a complex interplay between patients’ characteristics, device features and anticoagulation intensity. Subtle design and material differences in available prostheses may thrombosis. We conducted a post-hoc sub-analysis of the LOWERING-IT database to test the safety and feasibility of a low-level oral anticoagulant regime in low-risk patients with aortic LivaNova prosthetic valve replacement. The study population included 148 patients randomized to a low INR target (1.5–2.5; LOW-INR group), and 144 patients to the standard INR (2.0–3.0; CONVENTIONAL-INR group). The non-inferiority of thromboembolic events between LOW-INR and CONVENTIONAL-INR groups was tested. Cumulative follow-up reached 1,545 patient/years. The mean INR was 1.91 ± 0.23 in the LOW-INR group, and 2.59 ± 0.26 in the CONVENTIONAL-INR group (P < 0.001). There were 3 thromboembolic events, all in the CONVENTIONAL-INR group. Comparison of thromboembolic events was not significant. The 1-sided 97.5% exact CI for the difference in primary event proportion was 0.54%, satisfying criteria non-inferiority. Bleeding events were significantly different: 6.61 per 1,000 patient-year in LOW-INR group vs 18.65 per 1,000 patient-year in CONVENTIONAL-INR group (p < 0.045, RR 0.37). In conclusions these data suggest that low-dose anticoagulation is safe in selected patients after aortic LivaNova Bicarbon prosthesis implantation.

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Section: Discussionmentioning

confidence: 71%

Low-dose anticoagulation after isolated mechanical aortic valve replacement with Liva Nova Bicarbon prosthesis: A post hoc analysis of LOWERING-IT Trial

Torella

Aquila

Chiodini

et al. 2018

Sci Rep

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“…A group in Italy recently published 17 year follow-up from a cohort of 507 patients with Sorin mechanical valves. 17 This study found that only five patients required re-operation, which accounted to 0.08% patient-years, and there were a total of 15 valve related deaths in the subset of patients who had an aortic valve replacement. 17 Another study from Spain demonstrated that that patients with Sorin Bicarbon used for their aortic valve had over a 93% event free survival at 24 months.…”

Section: Mechanical Heart Valvesmentioning

confidence: 71%

“…17 This study found that only five patients required re-operation, which accounted to 0.08% patient-years, and there were a total of 15 valve related deaths in the subset of patients who had an aortic valve replacement. 17 Another study from Spain demonstrated that that patients with Sorin Bicarbon used for their aortic valve had over a 93% event free survival at 24 months. 67 Overall, Sorin mechanical valves have been consistently shown to have excellent in vitro functionality and favorable clinical outcomes.…”

Section: Mechanical Heart Valvesmentioning

confidence: 71%

Emerging Trends in Heart Valve Engineering: Part II. Novel and Standard Technologies for Aortic Valve Replacement

et al. 2014

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Abstract-The engineering of technologies for heart valve replacement (i.e., heart valve engineering) is an exciting and evolving field. Since the first valve replacement, technology has progressed by leaps and bounds. Innovations emerge frequently and supply patients and physicians with new, increasingly efficacious and less invasive treatment options. As much as any other field in medicine the treatment of heart valve disease has experienced a renaissance in the last 10 years. Here we review the currently available technologies and future options in the surgical and transcatheter treatment of aortic valve disease. Different valves from major manufacturers are described in details with their applications.

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“…Finally, the whole study was focused on the Sorin Bicarbon Fitline Bileaflet (size 25 mm). This specific device was chosen because of its widespread use [26,27]. Yet, the MPDS in its current version could be applied only to the detection of PMVT in recipients of this specific device.…”

Section: Limitationsmentioning

confidence: 99%

A Novel Multiparametric Score for the Detection and Grading of Prosthetic Mitral Valve Obstruction in Cases With Different Disc Motion Abnormalities

Meskin

Dimasi

Votta

et al. 2019

Ultrasound in Medicine & Biology

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Prosthetic Mechanical Valves (PMV) are the elective choice in Mitral Valve (MV) replacement, because of their reliability and easiness of implantation. However, these prostheses can suffer from complications, the major one being Prosthetic Mitral Valve Thrombosis (PMVT). In these cases, Transthoracic Doppler Echocardiogram (TDE) is the standard diagnostic work-up for diagnosis of valve malfunction. The American Society of Echocardiography (ASE) indicates the possible TDE-derived indexes, which can help in identifying insurgence of MV replacement complications. Unfortunately, in some cases, it is not possible to detect PMVT based on these criteria. In these cases, we speak of Doppler Silent Thrombosis (DST) and only more accurate and invasive analyses, such as fluoroscopy, allow for a correct diagnosis. In this work, Computational Fluid Dynamic (CFD) models were implemented to simulate valve fluid dynamics in different clinical scenarios in order to improve the reliability of PMVT diagnosis based on TDE. In detail, seven mechanical valve configurations, associated to different potential thrombotic conditions (symmetric and asymmetric stenosis), were designed and tested using 5 pathological transmitral velocity profile, extracted from real TDE images; to obtain the flow rate profiles, each TDE velocity profile was scaled to yield a Mean Flow Rate (MFR) of 4, 5 and 6 l/min, respectively. As a result, 105 (7x5x3) synthetic cases, accounting for different velocity profiles, MFRs and valve configurations, were simulated. TDE-derived indexes were calculated according to the ASE guidelines were extracted. Advanced statistical methods were applied to propose a new diagnostic algorithm for detecting PMVT. Our results showed that there isn't any significant difference between symmetric and asymmetric stenosis, probe location and flow rate waveform and confirmed that the single modality diagnostic is not able to predict thrombosis in a relevant number of cases, referable to mild and mild-severe stenosis cases. To overcome the problem, a novel multi-parametric discrete score (MPDS) based on the designed diagnostic algorithm was attained and tested; the Percentage of Stenosis (POS) was predicted with an accuracy rate of 90.5%. Even more interestingly, the error rate of 9.5% is related to 4 false positive cases corresponding to mild stenosis (POS=15%) which were erroneously classified as mild-severe stenosis. No false negatives were obtained. Our results suggest that a reliable estimation must take into account the mean flow rate as well as the transmitral velocity profile in order to provide a correct diagnosis.

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Single center experience with the Sorin Bicarbon prosthesis: A 17-year clinical follow-up

Abstract: The SBP has shown excellent results in terms of clinical improvement and freedom from valve-related complications, even up to 17 years after AVR and MVR. It therefore seems to be a safe option whenever a mechanical prosthesis is needed.

Cited by 13 publications

References 31 publications

Low-dose anticoagulation after isolated mechanical aortic valve replacement with Liva Nova Bicarbon prosthesis: A post hoc analysis of LOWERING-IT Trial

Low-dose anticoagulation after isolated mechanical aortic valve replacement with Liva Nova Bicarbon prosthesis: A post hoc analysis of LOWERING-IT Trial

Emerging Trends in Heart Valve Engineering: Part II. Novel and Standard Technologies for Aortic Valve Replacement

A Novel Multiparametric Score for the Detection and Grading of Prosthetic Mitral Valve Obstruction in Cases With Different Disc Motion Abnormalities

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