Durability of a bovine pericardial aortic bioprosthesis based on Valve Academic Research Consortium-3 echocardiographic criteria.

Objectives: The Carpentier-Edwards Perimount Magna Ease (Edwards Lifesciences) pericardial bioprosthesis has demonstrated satisfying hemodynamics at midterm follow-up, but its durability remains unclear. We report our 10-year experience with this third-generation valve implanted in the aortic position, with particular attention to structural valve deterioration. Methods: From 2007 to 2016 at our center, 338 patients underwent aortic valve replacement using the Perimount Magna Ease pericardial bioprosthesis. Patients were prospectively followed (mean 6.6 ± 2.6 years) with clinical evaluation and yearly echocardiography. Follow-up was 98% complete (7 patients lost) for a total of 2238 valve-years. Bioprosthesis structural valve deterioration was determined by strict echocardiographic assessment based on the Valve Academic Research Consortium 3 criteria. Results: Overall operative mortality was 1.2%. Actuarial survival including early deaths averaged 80.9% ± 2.2% and 66.7% ± 4.4% after 5 and 10 years of follow-up, respectively. Actuarial freedom from explantation due to structural valve deterioration at 5 and 10 years was 99.6% ± 0.4% and 88.8% ± 5.0%, respectively, and actuarial freedom of structural valve deterioration at 5 and 10 years was 98.5% ± 0.7% and 44.0% ± 6.4%, respectively. More precisely, actuarial freedom of structural valve deterioration stage 3 was 99.6% ± 0.4% at 5 years and 88.3% ± 5.0% at 10 years, whereas freedom of structural valve deterioration stage 2/3 was 98.5% ± 0.7% and 60.9% ± 7.0%, respectively. Conclusions: With a low rate of explantation due to structural valve deterioration events at 10 years, and particularly a low rate of moderate or severe structural valve deterioration based on echocardiographic Valve Academic Research Consortium 3 criteria, the Carpentier-Edwards Perimount Magna Ease pericardial bioprosthesis remains a reliable choice for a tissue valve in the aortic position.

Comparison of Implantability, Early Post-Operative Valve Function and Structural Valve Deterioration between the Carpentier-Edward Perimount Magna Valve and St. Jude Medical Trifecta Valve / 日本心臓血管外科学会雑誌

Purpose : Easy and safe implantability, good post-operative valve function and good long-term durability are required for any bioprosthetic valve implanted in aortic position. The Carpentier Edwards Perimount Magna valve (Magna) was introduced in 2009 and the St. Jude Medical Trifecta valve (Trifecta) was introduced in 2012 to our institution. In this study, we compared implantability, early post-operative valve function and structural valve deterioration (SVD) between these two valves. Patients and Methods : Between January 2009 and December 2019, Magna or Trifecta were electively implanted for 254 patients (Magna 151 patients and Trifecta 103 patients) and these patients were included in this study. Implantability was evaluated by occurrence of intraoperative valve dysfunction. Early post-operative valve function was evaluated by mean pressure gradient (m-PG) and indexed aortic valve area (AVAI) by ultrasonography performed 10 days after surgery. The relationship between indexed bioprosthetic valve orifice area calculated from internal diameter (GOAI) and AVAI was evaluated. If there was a significant relationship between GOAI and AVAI, maximum body surface area (BSA) to obtain AVAI≥0.85 cm2/m2 was estimated from 99% reliable interval of regression line. Results : Age, gender, and BSA did not differ between the two groups. There was no intraoperative valve dysfunction in Magna ; however we experienced one patient with severe aortic regurgitation due to stent distortion by the aortic wall during surgery with the 25 mm Trifecta valve. For this patient, Trifecta was replaced with Magna intra-operatively. In the 19 mm valve, AVAI was significantly larger (1.12±0.27 cm2/m2 vs. 0.88±0.21 cm2/m2, p<0.001) and m-PG was significantly lower (8.7±2.7 mmHg vs. 17.2±6.3 mmHg, p<0.001) in Trifecta. The frequency of AVAI<0.85 cm2/m2 (24% vs. 49%, p=0.036) and the frequency of m-PG≥20 mmHg (0% vs. 26%, p=0.006) were significantly less in Trifecta. There was significant relationship between GOAI and AVAI in both valves. Maximum BSA to obtain AVAI ≥0.85 cm2/m2 was estimated as 1.35 m2 in Magna and 1.50 m2 in Trifecta. In the 21 mm valve, AVAI was significantly larger (1.14±0.23 cm2/m2 vs. 0.92±0.22 cm2/m2, p<0.001) and m-PG was significantly lower (7.8±3.2 mmHg vs. 14.6±4.7 mmHg, p<0.001) in Trifecta. The frequency of AVAI<0.85 cm2/m2 was significantly less in Trifecta (11% vs. 42%, p=0.002) ; however, the frequency of m-PG≥20 mmHg did not differ significantly. There was a significant relationship between GOAI and AVAI in Magna and Trifecta. Maximum BSA to obtain AVAI ≥0.85 cm2/m2 was estimated as 1.49 m2 in Magna and 1.70 m2 in Trifecta. In the 23 and 25 mm valves, AVAI was significantly larger and m-PG was significantly lower in Trifecta. However neither the frequency of AVAI<0.85 cm2/m2 nor m-PG≥20 mmHg differed between the two valves. There was one early (27 months after surgery) SVD due to leaflet tear in Trifecta and two SVDs due to leaflet calcification more than 10 years after surgery in Magna. Conclusion : For Trifecta implantation, valve size selection seemed to be important and larger valves should be avoided with narrow ST junctions. Selection of 19 and 21 mm Magna valves should be limited for the patient with a BSA less than 1.35 and 1.49 m2 respectively. In Trifecta, early SVD might occur and careful follow-up is necessary.

A Non-Invasive Material Characterization Framework for Bioprosthetic Heart Valves.

Computational modeling and simulation has become more common in design and development of bioprosthetic heart valves. To have a reliable computational model, considering accurate mechanical properties of biological soft tissue is one of the most important steps. The goal of this study was to present a non-invasive material characterization framework to determine mechanical propertied of soft tissue employed in bioprosthetic heart valves. Using integrated experimental methods (i.e., digital image correlation measurements and hemodynamic testing in a pulse duplicator system) and numerical methods (i.e., finite element modeling and optimization), three-dimensional anisotropic mechanical properties of leaflets used in two commercially available transcatheter aortic valves (i.e., Edwards SAPIEN 3 and Medtronic CoreValve) were characterized and compared to that of a commonly used and well-examined surgical bioprosthesis (i.e., Carpentier-Edwards PERIMOUNT Magna aortic heart valve). The results of the simulations showed that the highest stress value during one cardiac cycle was at the peak of systole in the three bioprostheses. In addition, in the diastole, the peak of maximum in-plane principal stress was 0.98, 0.96, and 2.95 MPa for the PERIMOUNT Magna, CoreValve, and SAPIEN 3, respectively. Considering leaflet stress distributions, there might be a difference in the long-term durability of different TAV models.

Cuff leakage, not paravalvular leakage, in the Carpentier Edwards PERIMOUNT Magna Ease aortic bioprosthesis.

Though the Carpentier Edwards PERIMOUNT Magna Ease valve is a bioprosthesis with documented excellent haemodynamics and easy implantability, this valve has a gap between the cobalt-chromium-nickel alloy stent and silicone sewing ring. This gap, which is widest just below each of the three commissural struts, lacks silicone and leaves the two-layer polytetrafluoroethylene fabric unsupported and unprotected. If the needle of a valve suture is placed in this structurally weak area of the sewing ring, the resultant fabric tear may result in a true cuff leakage, not the usual paravalvular leakage. We describe this pitfall in the context of a recent operation to alert surgeons everywhere that suture placement too close to the stent (missing the silicone sewing ring) can result in postoperative cuff leakage. We need to be very careful to include the silicone ring in each stitch to prevent injury to the valve cuff of this prosthesis and to avoid cuff leakage.

Primary echocardiographic results of the Carpentier-Edwards Perimount Magna.

PURPOSE: The aim of this study was to investigate the primary echocardiographic results of aortic valve replacement using 21- and 19-mm Carpentier-Edwards Perimount Magna bioprosthesis aortic xenografts in patients with small aortic annulus. METHODS: Twenty patients (mean body surface area 1.63 ± 0.16 m(2)) underwent aortic valve replacement between June 2008 and December 2009. Eight and 12 patients received 21- and 19-mm Magna bioprostheses, respectively. After 12 months, hemodynamic data were obtained by echocardiography to estimate the prosthesis-patient mismatch. RESULTS: At follow-up, significant decreases in peak and mean left ventricular aortic pressure gradients were observed in the 12 patients with aortic stenosis (P < 0.05). Regression of the left ventricular mass was observed in all the patients (P < 0.05). The mean measured effective orifice area (EOA) and EOA index (EOAI) were 1.61 ± 0.28 cm(2) and 0.99 ± 0.16 cm(2)/m(2), respectively. Prosthesis-patient mismatch (EOAI ≤0.85) was documented in three patients. CONCLUSION: The primary echocardiographic findings suggested that the hemodynamic performance of the 19- and 21-mm Carpentier-Edwards Perimount Magna bioprostheses was satisfactory in the patients with a small aortic annulus.

A Case of Left Main Trunk (LMT) Obstruction after Aortic Valve Replacement (AVR) Using Carpentier-Edwards PERIMOUNT MAGNA / 日本心臓血管外科学会雑誌

We reported a 74-year-old female complicated by ostial obstruction of the left main trunk after aortic valve replacement for severe aortic stenosis. At surgery, the length from the orifice of the left main trunk to the aortic annulus was 3 mm. After a 19 mm Carpentier-Edwards PERIMOUNT MAGNA was implanted in supra-annular position, the orifice of left main trunk was concealed by a sewing cuff of the bioprosthesis. Before aortic declamping, saphenous vein graft was bypassed to the left anterior descending artery. The postoperative course was uneventful. Computed tomography demonstrated the ostial obstruction of the left main trunk by the bioprosthesis.