Randomized (CO)mparison of (TRI)fecta and (P)erimount Magna Ease Supraannular Aortic Xenografts—CO.TRI.P Study

2018 ◽  
Vol 67 (04) ◽  
pp. 266-273
Author(s):  
Arnaud Van Linden ◽  
Mani Arsalan ◽  
Thore Körschgen ◽  
Johannes Blumenstein ◽  
Jörg Kempfert ◽  
...  
Keyword(s):  
Aortic Valve ◽  
Effective Orifice Area ◽  
Exercise Echocardiography ◽  
Obese Patients ◽  
Special Design ◽  
Orifice Area ◽  
Mean Pressure ◽  
Hemodynamic Performance ◽  
Annulus Diameter

Background Modern supraannular aortic xenografts offer a special design, thus providing maximized opening area for improved hemodynamics. The aim of this study was a prospectively randomized comparison of the Trifecta and the Perimount Magna Ease valves based on metric annulus sizing. Methods A total of 100 patients with aortic stenosis undergoing aortic valve replacement (AVR) with or without concomitant procedures were prospectively included. After decalcification of the annulus, stratified intraoperative randomization was performed. The diameter of the aortic annulus was measured using metric Hegar dilators and randomization was based on this metric annulus diameter. Exercise echocardiography was performed at 10-month follow-up. Results Mean age was 69 years, with 36% female. Predominant implanted valve sizes were 23 mm (39%) and 25 mm (32%). Unadjusted mean pressure gradient was significantly lower and effective orifice area larger for the Trifecta group (10.8 ± 5 vs. 13.2 ± 4 mm Hg, p = 0.02 and 1.93 ± 0.39 vs. 1.70 ± 0.30 cm2, p = 0.002) at discharge. In patients with small annuli, based on the metric annulus size there were no significant differences in gradients or the orifice area. At exercise echocardiography follow-up, there were no significant hemodynamic differences between both prostheses. Conclusions The Trifecta and the Perimount Magna Ease prostheses both show excellent hemodynamic performance after AVR. In patients with larger annuli, the Trifecta valve seems to be even superior to the Magna Ease, which may be advantageous in obese patients.

scholarly journals The Usefulness of [18F]F-Fluorodeoxyglucose and [18F]F-Sodium Fluoride Positron Emission Tomography Imaging in the Assessment of Early-Stage Aortic Valve Degeneration after Transcatheter Aortic Valve Implantation (TAVI)—Protocol Description and Preliminary Results

2021 ◽  
Vol 10 (3) ◽  
pp. 431
Author(s):  
Danuta Sorysz ◽  
Rafał Januszek ◽  
Anna Sowa-Staszczak ◽  
Anna Grochowska ◽  
Marta Opalińska ◽  
...  
Keyword(s):  
Aortic Valve ◽  
Emission Tomography ◽  
Effective Orifice Area ◽  
Orifice Area ◽  
Transcatheter Aortic Valve ◽  
Positron Emission ◽  
Pet Ct ◽  
Transvalvular Gradient ◽  
Valve Implantation

Transcatheter aortic valve implantation (TAVI) is now a well-established treatment for severe aortic stenosis. As the number of procedures and indications increase, the age of patients decreases. However, their durability and factors accelerating the process of degeneration are not well-known. The aim of the study was to verify the possibility of using [18F]F-sodium fluoride ([18F]F-NaF) and [18F]F-fluorodeoxyglucose ([18F]F-FDG) positron emission tomography/computed tomography (PET/CT) in assessing the intensity of TAVI valve degenerative processes. In 73 TAVI patients, transthoracic echocardiography (TTE) at initial (before TAVI), baseline (after TAVI), and during follow-up, as well as transesophageal echocardiography (TEE) and PET/CT, were performed using [18F]F-NaF and [18F]F-FDG at the six-month follow-up (FU) visit as a part of a two-year FU period. The morphology of TAVI valve leaflets were assessed in TEE, transvalvular gradients and effective orifice area (EOA) in TTE. Calcium scores and PET tracer activity were counted. We assessed the relationship between [18F]F-NaF and [18F]F-FDG PET/CT uptake at the 6 = month FU with selected indices e.g.,: transvalvular gradient, valve type, EOA and insufficiency grade at following time points after the TAVI procedure. We present the preliminary PET/CT ([18F]F-NaF, [18F]F-FDG) results at the six-month follow-up period as are part of an ongoing study, which will last two years FU. We enrolled 73 TAVI patients with the mean age of 82.49 ± 7.11 years. A significant decrease in transvalvular gradient and increase of effective orifice area and left ventricle ejection fraction were observed. At six months, FU valve thrombosis was diagnosed in four patients, while 7.6% of patients refused planned controls due to the COVID-19 pandemic. We noticed significant correlations between valve types, EOA and transaortic valve gradients, as well as [18F]F-NaF and [18F]F-FDG uptake in PET/CT. PET/CT imaging with the use of [18F]F-FDG and [18F]F-NaF is intended to be feasible, and it practically allows the standardized uptake value (SUV) to differentiate the area containing the TAVI leaflets from the SUV directly adjacent to the ring calcifications and the calcified native leaflets. This could become the seed for future detection and evaluation capabilities regarding the progression of even early degenerative lesions to the TAVI valve, expressed as local leaflet inflammation and microcalcifications.

Abstract 17870: Hemodynamic Performance of Transcatheter Prosthetic Valve is Superior to that of Surgical Prosthetic Valve for Aortic Valve Stenosis with Small Aortic Root

Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
Koichi Maeda ◽  
Toru Kuratani ◽  
Kei Torikai ◽  
Isamu Mizote ◽  
Yasuhiro Ichibori ◽  
...  
Keyword(s):  
Aortic Valve ◽  
Aortic Valve Replacement ◽  
Predictive Factor ◽  
Aortic Root ◽  
Prosthetic Valve ◽  
The Other ◽  
Effective Orifice Area ◽  
Orifice Area ◽  
Small Aortic Root ◽  
Hemodynamic Performance

Introduction: Surgical aortic valve replacement (SAVR) in a small aortic root is still challenging with regard to the surgical technique and prosthesis size selection, which often causes patient-prosthesis mismatch (PPM). On the other hand, because a prosthetic valve of transcatheter aortic valve replacement (TAVR) is tightly implanted inside a native valve, larger effective orifice area (EOA) may be gained. The aim of this study is to prove that hemodynamic performance after TAVR is superior to that after SAVR. Methods: 160 patients, who underwent SAVR (n=36; age 75.1±5.6 years) and TAVR (n=124; age 82.4±6.8 years) for aortic valve stenosis, were enrolled. Preoperative ECG-gated multi-slice CT (MSCT) and echocardiography immediately before a discharge were performed in all patients. PPM was defined as the effective orifice area index ≤0.85cm2/m2 and we compared and examined hemodynamic performance after TAVR and SAVR. Results: Although the mean body size was significantly smaller (p<.05) in TAVR than that in SAVR (1.44±0.15 vs 1.51±0.20 m2), there were no significant differences in the diameters of annulus (23.2±1.6 vs 23.3±2.8 mm), valsalva sinus (29.8±2.6 vs 29.9±4.4 mm), and ST junction (25.2±2.8 vs 24.8±3.5 mm) on preoperative MSCT findings. Postoperative echocardiography revealed significantly less Vmax (2.2±0.4 vs 2.5±0.5 m/s, p<.0001), less mean pressure gradient (10.1±3.6 vs 14.5±5.0 mmHg, p<.0001), and larger EOA (1.62±0.29 vs 1.45±0.36 cm2, p<.005) in TAVR compared to SAVR, respectively. Consequently, PPM was more frequently in SAVR compared to TAVR (33.3 vs 8.9%; p<.0007). In multivariate analysis in SAVR identified small ST junction with only predictive factor of PPM (odds ratio [OR], 2.08; 95% CI, 1.23-4.36; p<.005; area under the receiver-operating characteristic curve [AUC], 0.84). On the other hand, regarding TAVR, large BSA was only predictive factor of PPM (p<.05). Conclusions: The hemodynamic performance of transcatheter prosthetic valve is superior to that of surgical prosthetic valve in a patient with small aortic root, in particular, small ST junction. TAVR should be considered in patients with anticipated PPM if the surgical risk is similar to TAVR.

scholarly journals St. Jude Trifecta Versus Carpentier-Edwards Perimount Magna valves for the treatment of aortic stenosis: comparison of early Doppler-Echocardiography and hemodynamic performance

2015 ◽  
Vol 80 (3) ◽  
Author(s):  
Giovanni Minardi ◽  
Amedeo Pergolini ◽  
Giordano Zampi ◽  
Giovanni Pulignano ◽  
Gaetano Pero ◽  
...  
Keyword(s):  
Aortic Valve ◽  
Aortic Stenosis ◽  
Doppler Echocardiography ◽  
Bioprosthetic Valve ◽  
Effective Orifice Area ◽  
Orifice Area ◽  
Hemodynamic Profile ◽  
Hemodynamic Performance

Objective. Aim of this study was to compare the hemodynamic profiles of 2 aortic valve bioprostheses: the Carpentier Edwards Perimount Magna (CEPM) valve and the Trifecta valve. Methods. 100 patients who underwent AVR for severe symptomatic AS between September 2011 and October 2012 were analyzed by means of standard trans-thoracic Doppler-echocardiography. Results. Mean and peak gradients were significantly lower for the 21 mm Trifecta vs CEPM (11 ± 4 vs 15 ± 4 mmHg, and 20 ± 6 vs 26 ± 7 mmHg, respectively; all p &lt; 0.05) and the 23 mm Trifecta vs CEPM (8 ± 2 vs 14 ± 4 mmHg, and 17 ± 6 vs 25 ± 9 mmHg; all p &lt; 0.05). Effective orifice area tended to be slightly higher for the Trifecta valve. Conclusion. The new bioprosthetic valve Trifecta has an excellent hemodynamic profile, and lower trans-prosthesic gradients when compared to CEPM valve.

Stentless versus Stented Bioprosthetic Aortic Valves

2009 ◽  
Vol 4 (2) ◽  
pp. 61-73 ◽  
Author(s):  
Davy Cheng ◽  
John Pepper ◽  
Janet Martin ◽  
Rex Stanbridge ◽  
Francis D. Ferdinand ◽  
...  
Keyword(s):  
Aortic Valve ◽  
Controlled Trial ◽  
Meta Analysis ◽  
Effective Orifice Area ◽  
Aortic Valves ◽  
Area Index ◽  
Orifice Area ◽  
Mean Differences ◽  
Bioprosthetic Valves

Objective This meta-analysis sought to determine whether stentless bioprosthetic valves improve clinical and resource outcomes compared with stented valves in patients undergoing aortic valve replacement. Methods A comprehensive search was undertaken to identify all randomized and nonrandomized controlled trials comparing stentless to stented bioprosthetic valves in patients undergoing aortic valve replacement available up to March 2008. The primary outcomes were clinical and resource outcomes in randomized controlled trial (RCT). Secondary outcomes clinical and resource outcomes in nonrandomized controlled trial (non-RCT). Odds ratios (OR), weighted mean differences (WMD), or standardized mean differences and their 95% confidence intervals (CI) were analyzed as appropriate. Results Seventeen RCTs published in 23 articles involving 1317 patients, and 14 non-RCTs published in 18 articles involving 2485 patients were included in the meta-analysis. For the primary analysis of randomized trials, mortality for stentless versus stented valve groups did not differ at 30 days (OR 1.36, 95% CI 0.68–2.72), 1 year (OR 1.01, 95% CI 0.55–1.85), or 2 to 10 years follow-up (OR 0.82, 95% CI 0.50–1.33). Aggregate event rates for all-cause mortality at 30 days were 3.7% versus 2.9%, at 1 year were 5.5% versus 5.9% and at 2 to 10 years were 17% versus 19% for stentless versus stented valve groups, respectively. Stroke or neurologic complications did not differ between stentless (3.6%) and stented (4.0%) valve groups. Risk of prosthesis-patient mismatch was numerically lower in the stentless group (11.0% vs. 31.3%, OR 0.30, 95% CI 0.05–1.66), but this parameter was reported in few trials and did not reach statistical significance. Effective orifice area index was significantly greater for stentless aortic valve compared with stented valves at 30 days (WMD 0.12 cm2/m2), at 2 to 6 months (WMD 0.15 cm2/m2), and at 1 year (WMD 0.26 cm2/m2). Mean gradient at 1 month was significantly lower in the stentless valve group (WMD −6 mm Hg), at 2 to 6 month follow-up (WMD −4 mm Hg,), at 1 year follow-up (WMD −3 mm Hg) and up to 3 year follow-up (WMD −3 mm Hg) compared with the stented valve group. Although the left ventricular mass index was generally lower in the stentless group versus the stented valve group, the aggregate estimates of mean difference did not reach significance during any time period of follow-up (1 month, 2–6 months, 1 year, and 8 years). Conclusions Evidence from randomized trials shows that subcoronary stentless aortic valves improve hemodynamic parameters of effective orifice area index, mean gradient, and peak gradient over the short and long term. These improvements have not led to proven impact on patient morbidity, mortality, and resource-related outcomes; however, few trials reported on clinical outcomes beyond 1 year and definitive conclusions are not possible until sufficient evidence addresses longer-term effects.

Standard 19mm St Jude aortic valves in patients with body surface less than 1.7m2

2001 ◽  
Vol 24 (4) ◽  
pp. 229-234
Author(s):  
A. Renzulli ◽  
M. De Feo ◽  
L.S. De Santo ◽  
A. Della Corte ◽  
G. Dialetto ◽  
...  
Keyword(s):  
Body Surface ◽  
Effective Orifice Area ◽  
Long Term Effects ◽  
Aortic Valves ◽  
Actuarial Survival ◽  
Orifice Area ◽  
Hemodynamic Performance ◽  
Peak Gradient

Although new models of bileaflet valves with improved orifice have been devised, aortic valve replacement with 19mm prostheses still raises concerns about long term effects of residual transprosthetic gradient. We reviewed our experience with 19 mm standard model St Jude prostheses in 68 patients operated on between January 1983 and December 1995. Clinical late assessment was performed to evaluate the incidence of valve related complications. Postoperative echocardiography was performed to evaluate hemodynamic performance of the prostheses. Mean body surface area was 1.66±0.14m2. Late postoperative peak gradient was 53.85±7.16 mmHg; mean gradient was 34.80±5.55 mm Hg; effective orifice area was 1.93±0.05 cm2. Thirteen-year actuarial survival has been 90.89 ± 0.6%; thirteen-year freedom from embolism 89.41 ± 0.7% and freedom from hemorrhage 98.25 ± 0.02%. No case of prosthetic endocarditis, thrombosis, or reoperation was observed during follow-up.

scholarly journals Effective orifice area and hemodynamic performance of the transcatheter Edwards Sapien 3 prosthesis: short-term and 1-year follow-up

2017 ◽  
Vol 19 (1) ◽  
pp. 23-30 ◽  
Author(s):  
Mischa Külling ◽  
Jeremy Külling ◽  
Christophe Wyss ◽  
David Hürlimann ◽  
Ivano Reho ◽  
...  
Keyword(s):  
Effective Orifice Area ◽  
Short Term ◽  
Orifice Area ◽  
Edwards Sapien ◽  
Sapien 3 ◽  
Hemodynamic Performance

Early Outcomes of Isolated Aortic Valve Replacement Through Right Anterior Minithoracotomy Using the Latest-Generation Biological Prosthesis

2020 ◽  
pp. 155698452097588
Author(s):  
Hossein Amirjamshidi ◽  
Courtney Vidovich ◽  
Ariana Goodman ◽  
Peter A. Knight
Keyword(s):  
Aortic Valve ◽  
Aortic Valve Replacement ◽  
Minimally Invasive ◽  
Valve Replacement ◽  
Effective Orifice Area ◽  
Term Survival ◽  
Invasive Approach ◽  
Intermediate Outcomes ◽  
Hemodynamic Performance

Objective The aim of this study is to evaluate early and intermediate outcomes and hemodynamics of the latest-generation Trifecta valve implanted using right anterior minithoracotomy. Methods We performed a single-center, retrospective, observational study including 175 individuals who underwent isolated minimally invasive aortic valve replacement with the latest-generation Trifecta valves through a right anterior minithoracotomy between January 2016 and January 2019. Exclusion criteria for follow-up echocardiographic study included concomitant procedures, conversion to median sternotomy, and nonsurvival during the index admission. Analyses addressed implantation safety, 30-day and intermediate-term survival and hemodynamic performance of the valves. Results Overall, patients were followed with duration ranging from 0.5 to 3 years. Early (<30 days) mortality occurred in 2 patients (1.1%), and there were 9 (5.1%) late (>30 days) deaths. Early thromboembolic events and postoperative bleeding requiring reoperation occurred at a rate of 4.0% ( n = 7) and 6.2% ( n = 11), respectively. Overall in 175 patients who met inclusion criteria for the follow-up echocardiography study, mean gradients across all valve sizes were 41.3 ± 14.9 (standard deviation) mm Hg preoperatively and remained low at 7.2 ± 3.9 mm Hg with mean effective orifice area of 1.8 ± 0.5 cm2 on the last follow-up echo. There was 1 case of infective prosthetic endocarditis, which did not require valve explant. There were no reoperations due to valve-related problems during the study period. Conclusions This is the largest series reporting on outcomes of the latest-generation Trifecta valve implanted using right anterior minithoracotomy. Our results demonstrate that this valve can be safely implanted via a minimally invasive approach with excellent early and intermediate outcomes and hemodynamic performance.

scholarly journals Two-Year Clinical Follow-Up Assessment of the Novel Cingular Surgical Bovine Pericardial Valve

2021 ◽  
Vol 8 ◽  
Author(s):  
Jinmiao Chen ◽  
Minzhi Lv ◽  
Yuntao Lu ◽  
Jiahui Fu ◽  
Yingqiang Guo ◽  
...  
Keyword(s):  
Pressure Gradient ◽  
Prosthetic Valve Endocarditis ◽  
Effective Orifice Area ◽  
Clinical Safety ◽  
Clinical Events ◽  
Structural Valve Deterioration ◽  
Mean Pressure ◽  
The Mean ◽  
Hemodynamic Performance

Objectives: To evaluate the 2-year clinical safety and hemodynamic outcomes of the Cingular bovine pericardial bioprosthesis.Methods: A prospective, multicenter, single-arm trial was conducted in patients who required aortic or mitral valve replacement. From March 2016 to October 2017, 197 patients were implanted with the Cingular bovine pericardial valve at five sites in China. The clinical outcomes and hemodynamic performance were assessed through a 2-year follow-up. Clinical safety events were reviewed by an independent clinical events committee, and echocardiographic data were assessed by an independent core laboratory.Results: The mean age was 66.9 ± 4.9 years. The 2-year survival rate was 96.4%. A complete 2-year clinical follow-up was achieved in 189 of 190 survivors. No case of structural valve deterioration, major perivalvular leak, prosthetic valve endocarditis, or valve-related reoperation was seen. For the aortic valve, the mean pressure gradient observed was 12.5 ± 4.0 mm Hg, and the effective orifice area (EOA) was 2.0 ± 0.3 cm2. For the smaller size aortic valves, 19 mm and 21 mm, respective mean EOA values of 1.7 ± 0.2 cm2 and 1.8 ± 0.2 cm2 were found. The values for mean pressure gradient and mean EOA for mitral bioprostheses were 4.0 ± 1.4 mm Hg and 2.2 ± 0.3 cm2, respectively. There was no significant change between 1-year and 2-year hemodynamic performance.Conclusions: The Cingular bovine pericardial valve showed favorable clinical safety and hemodynamic outcomes over a 2-year follow-up. Further follow-up is required to validate the long-term durability.

Abstract 2311: The Complete Supraannular Concept - In-vivo Hemodynamics of Bovine and Porcine Aortic Bioprostheses

Circulation ◽  
2008 ◽  
Vol 118 (suppl_18) ◽  
Author(s):  
Daniel J Ruzicka ◽  
Walter B Eichinger ◽  
Ina M Hettich ◽  
Andrea Hutter ◽  
Sabine Bleiziffer ◽  
...  
Keyword(s):  
High Pressure ◽  
Aortic Valve ◽  
Pressure Gradients ◽  
Valve Design ◽  
Mean Pressure ◽  
Patient Prosthesis Mismatch ◽  
Size Groups ◽  
Hemodynamic Performance ◽  
Annulus Diameter

Complete supraannular placement of an aortic bioprosthesis is one approach to optimize the hemodynamic result of an aortic valve replacement. It is achieved with the combination of a special valve design and the supraannular sewing technique with non-everted mattress sutures. We evaluated five bioprostheses designed for complete supraannular placement to assess potential hemodynamic differences due to other factors (e.g. valve material) than implantation position. In 336 patients (mean age 72.0 ± 7.1 years; 143 females) hemodynamics including mean pressure gradients (MPG), effective orifice areas (EOA), and indices (EOAi) and incidence of patient-prosthesis-mismatch (PPM) were evaluated 6 months postoperatively. Annulus diameter was measured intraoperatively. Patients received the CE Perimount Magna (Magna n = 169), Medtronic Mosaic (Mosaic n = 46), Mosaic Ultra (Ultra n = 17), SJM Epic Supra (n = 46) and the Sorin Soprano (Soprano n = 58). MPG, EOA and EOA i for all patients divided by annulus size groups are presented in table 1 . Severe PPM was observed more frequently in patients with the Mosaic (12/46; 26.1%) and Ultra (3/17; 17.6%) prostheses. Complete supraannular placement cannot prevent high pressure gradients or patient-prosthesis-mismatch thoroughly, but the choice of a bovine prosthesis can optimize hemodynamic performance.

P6482Stress echocardiography in the assessment of long-term outcomes results of aortic valve replacement with mechanical prostheses of small size

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
T G Nikityuk ◽  
L N Ivanova ◽  
V A Ivanov ◽  
E V Ivanova
Keyword(s):  
Aortic Valve ◽  
Aortic Valve Replacement ◽  
Valve Replacement ◽  
Stress Echocardiography ◽  
Effective Orifice Area ◽  
Pressure Gradients ◽  
Orifice Area ◽  
Mechanical Prostheses ◽  
Mean Pressure

Abstract Relevance Evaluation of the function of aortic mechanical prostheses of small size in the long-term period is an topical problem, due to the fact that a narrow fibrous ring occurs in 20–35% of cases of patients with aortic stenosis. Objective To study clinical and hemodynamic parameters of small size aortic prostheses using stress echocardiography in the long-term period after valve replacement Materials and methods The study included 89 patients (54 women, 35 men) who underwent aortic valve replacement with a landing diameter of 21 mm or less. The average was 48,1±11,3 years. BSA of 1,8 m2 (1.3 to 2.2). The following models of prostheses were used: On-X, ATS-AP, Carbomedics, St. Jude Medical. All patients after surgical correction in the long-term period (an average of 5,9±3,3 years from 1 to 11 years) underwent a comprehensive clinical and instrumental examination, including an ECG and stress - echocardiography with bicycle exercise. Results In the long-term period after aortic valve replacement of mechanical prostheses of small size, the ECG showed regression of hypertrophy and overload of the left ventricle. According to stress-echocardiography, there was a significant increase in load tolerance. At the peak of the load, the following were recorded: improvement of the pumping function and cardiac performance (stroke volume, cardiac output, cardiac index), improvement of myocardial work index (Tei - index), increase in speed parameters on the aortic valve prosthesis no more than 30% of the initial values. In repose, the maximum and mean pressure gradients were 26.3±9 mm Hg and 14.3±5.4 mm Hg, effective orifice area (EOA) 1,7±0,3 cm2, index effective orifice area (EOAi) 0,93±0,2 cm2/m2. When the submaximal load levels were reached, the maximum and mean pressure gradients were 33,5±6,0 mm Hg and 17,1±4,0 mm Hg, EOA - 1,5±0,4 cm2, EOAi - 0,79±0,6 cm2/m2. Conclusions The findings suggest that modern models of aortic prostheses with an increased effective orifice area provide good clinical results in the long term. Stress echocardiography is a necessary and highly informative method for assessing the parameters of mechanical aortic prostheses and heart function.

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