Hemodynamic Results and Mid-term Follow-up of 850 19 to 23 mm Perimount Magna Ease Valves

Anselmi, Amédéo; Ruggieri, Vito Giovanni; Soulami, Réda Belhaj; Flécher, Erwan; Langanay, Thierry; Leguerrier, Alain; Verhoye, Jean‐Philippe

doi:10.1055/s-0038-1660517

Cited by 23 publications

(20 citation statements)

References 28 publications

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“…Moderate and severe PPM was seen in 32% and 11%, respectively. This is similar to rates of PPM reported elsewhere: In the retrospective investigation by Anselmi et al, moderate and severe PPM is described to occur in 30% and 7%, respectively, which is comparable to the data in our study (10). Deutsch and colleagues reported comparable numbers of moderate and severe PPM (24% and 4%) with the supraannular St Jude Medical Trifecta prosthesis (bovine pericardial, St Jude Medical, Inc., St Paul, MN, USA) (20).…”

Section: Discussionsupporting

confidence: 92%

“…In the present investigation overall survival at 10 years was 77%. This compares favorably to Anselmi et al who report a survival rate of 74% seven years after PME implantation (10). Other reported survival rates 10 years after SAVR with various stented bioprosthetic valves range from 32% to 95%, depending on the age of the patient population as well as the rate of concomitant procedures (4,(13)(14)(15).…”

Section: Discussionsupporting

confidence: 70%

“…For the proper assessment of SVD, a close and complete serial echocardiographic follow-up is mandatory (6)(7)(8). Currently, only data on early and mid-term hemodynamic and clinical performance of the Carpentier-Edwards Perimount Magna Ease prosthesis (PME) (Edwards Lifesciences, Irvine, CA, USA) are available (9,10). Specific characteristics of this stented bovine pericardial aortic valve are its cobaltchromium alloy stent, the low profile, the low stent base, and sleek commissure posts.…”

Section: Introductionmentioning

confidence: 99%

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Serial echocardiographic evaluation of the Perimount Magna Ease prosthesis

et al. 2021

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Background: The Carpentier-Edwards Perimount Magna Ease prosthesis (PME) represents the latest generation of stented bioprostheses used for surgical aortic valve replacement (SAVR). The aim of our study was to evaluate the long-term clinical outcome and hemodynamic performance of the prosthesis with a focus on the incidence and course of structural valve deterioration (SVD) by serial echocardiographic examinations. Methods: SAVR with the PME was performed in 58 consecutive patients between 2007 and 2008.Transthoracic echocardiography was performed preoperatively, at discharge and annually during a 10-year follow-up at the German Heart Center Munich. Results: Mean age at surgery was 62±14 years. At discharge (n=57), the overall mean pressure gradient (MPG) and effective orifice area (EOA) were 15.8±4.1 mmHg and 1.8±0.4 cm 2 , respectively. Moderate patient-prosthesis mismatch (PPM) was present in 18 patients (32%) and severe PPM in 6 patients (11%) at discharge. Ten years following SAVR (n=33), the overall MPG was 16.6±7.3 mmHg and EOA was 1.3±0.4 cm 2 .Thirty-day and late mortality was 2% (n=1) and 21% (n=12), respectively. Survival at 1, 5, and 10 years was 94.7%±3.3%, 91.1%±4.1%, and 77.3%±5.9%, respectively. Freedom from reoperation at 10 years was 88.8%±4.7%. Ten years after PME implantation the cumulative incidence of any SVD, severe SVD, and bioprosthetic valve failure (BVF) was 25%±6%, 14%±5%, and 16%±5%, respectively. Conclusions:The PME shows an excellent hemodynamic performance over the course of 10 years with development of clinically relevant SVD as late as 6 years post implant, and a 10-year incidence of severe SVD of 14%.

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Section: Discussionsupporting

confidence: 92%

Section: Discussionsupporting

confidence: 70%

Section: Introductionmentioning

confidence: 99%

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Serial echocardiographic evaluation of the Perimount Magna Ease prosthesis

et al. 2021

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“…It is recognized that PPM is not an uncommon issue following AVR and has been reported with an incidence of as high as 70% [14]. A study examining the incidence of PPM following implantation of the CEPME prosthesis reported an overall incidence of severe PPM of 6.5% similar to our experience, however as expected they observed that this was strongly correlated with prosthesis size -21.5% experienced PPM with a 19 mm prosthesis [15]. Reassuringly, it is worth noting that they concluded that there was no association between PPM and adverse clinical outcomes in the early-to mid-termboth mortality and functional status deterioration.…”

Section: Discussionsupporting

confidence: 83%

Mid-term follow-up after aortic valve replacement with the Carpentier Edwards Magna Ease prosthesis

Rajab

Ali

Hernández-Sánchez

et al. 2020

J Cardiothorac Surg

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Background: Approximately 250,000 heart valve operations are performed annually worldwide. An intensive research and development effort has led to progressively more advanced heart valve prostheses. The Carpentier-Edwards Perimount Magna Ease (CEPME) prosthesis represents the latest iteration of the Edwards Perimount series of aortic tissue valves. The current study aims to evaluate the midterm performance of this bioprosthesis. Methods: Five hundred and eighteen patients with aortic stenosis underwent aortic valve replacement with the CEPME valve at Papworth Hospital between August 2008 and November 2011. After a minimum of 3 years from the index operation, eligible patients were retrospectively and consecutively recruited to participate. Recruitment was closed after 100 eligible patients had completed all study assessments. Investigations at follow-up included echocardiography, and NYHA status. Primary endpoints included valve performance measures. Results: The mean age was 72 years, 64% were male and median follow-up was 5.1 years. NYHA status had improved in 66% of patients. The average postoperative peak and mean pressure gradients decreased by 51.2 mmHg (64.5%) and 31.8 mmHg (59.4%), with a significant improvement in NYHA status. The frequency of moderate aortic regurgitation was 3%. There was no evidence for structural valve deterioration. Conclusions: The CEPME has excellent mid-term durability. Its use effectively improves haemodynamics and functional capacity.

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“…However, as also underlined by many authors (12,14,(38)(39)(40), to evaluate as excellent the hemodynamic performance of the Trifecta valve, and to understand if the freedom from deterioration is equal or higher than other biological aortic valve prostheses, a long-term follow-up, i.e., at 10 years, is necessary.…”

Section: Hemodynamic Performancementioning

confidence: 99%

Clinical outcome and hemodynamic performance of St. Jude Trifecta aortic prosthesis: short-term follow-up and risk factors analysis

et al. 2019

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Background: We retrospectively analysed the short-term outcome of the third-generation St. Jude Trifecta aortic prosthesis. Methods: Between December 2014 and December 2017, 177 patients (mean age 75.1±6.8 years, 95 males, 82 females) underwent aortic valve replacement with a St. Jude Trifecta aortic prosthesis and were followed up to 27±9 months. Preoperatively 92 patients (52.0%) were in NYHA class III-IV, EuroSCORE II was 3.2%±2.1%. Results: Trifecta sizes implanted were 19 mm (n=46) (26%), 21 mm (n=69) (39%), 23 mm (n=46) (26%), 25 mm (n=16) (9%). Concomitant coronary artery bypass grafting was performed in 60 patients (34.0%).Operative mortality was 3.4% (1.7% for isolated aortic valve replacement versus 6.7% for combined aortic valve replacement and coronary artery bypass grafting) (P=0.084). The only independent predictor of mortality was the need for the mechanical ventilation greater than 24 hours (P=0.037); recently occurring myocardial infarction was risk factor for mortality at the univariate analysis only (P=0.013). Three-year survival was 84%±6%, freedom from cardiac death 98%±1%, freedom from prosthetic endocarditis 97%±1%. No thromboembolisms or structural valve degeneration were observed. Patient-prosthesis mismatch (PPM) was absent in 126 patients (71.2%), mild-to-moderate in 32 (18.1%), moderate in 19 (10.7%), severe in no any patient. Follow-up echocardiography showed an average mean and peak transaortic valve gradients reduction more than 70% in comparison with preoperative value (P<0.0001), and a significant regression of left ventricular hypertrophy (P<0.0001). Moderate PPM did not negatively affect survival. Concomitant severe coronary artery disease was found as an independent predictor of reduced survival (72%±12% versus 86%±6%) (P=0.015). Conclusions: Trifecta aortic prosthesis seems to provide very favourable clinical outcome and hemodynamic performance. At three years, survival was negatively affected by severe coronary artery disease detected at the time of operation. During short-term follow-up, no early structural valve degeneration was been observed. Due to low incidence of PPM and low peak and mean trans-prosthetic aortic valve gradients, third generation Trifecta aortic prosthesis should be considered as one of the best options in the setting of the aortic valve replacement surgery. However, a long-term follow-up is mandatory to confirm the early promising data.

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Hemodynamic Results and Mid-term Follow-up of 850 19 to 23 mm Perimount Magna Ease Valves

Cited by 23 publications

References 28 publications

Serial echocardiographic evaluation of the Perimount Magna Ease prosthesis

Serial echocardiographic evaluation of the Perimount Magna Ease prosthesis

Mid-term follow-up after aortic valve replacement with the Carpentier Edwards Magna Ease prosthesis

Clinical outcome and hemodynamic performance of St. Jude Trifecta aortic prosthesis: short-term follow-up and risk factors analysis

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