Mid-term hemodynamic and clinical results of the stented porcine medtronic mosaic valve in aortic position.

BACKGROUND: Our study aim was to evaluate the hemodynamic and clinical performance of the Mosaic bioprosthesis in aortic position. METHODS: The stented porcine bioprosthesis combines zero pressure glutaraldehyde fixation and amino oleic acid antimineralization treatment for improved hemodynamics and durability. Between 2/1994 and 5/1999, 100 patients underwent aortic valve replacement. Mean age at implant was 73.4 years. Patients were followed up within thirty days after intervention, after six months and then annually. Mean follow-up was 4.8 years (range 0.1-8.8 years), totaling 483.4 patient-years. RESULTS: Mortality within 30 days was 3.0 %; late mortality was 4.6%/patient-year, including 0.4 %/patient-year prosthesis-related mortality. Freedom from event rates at 8.5 years were 96.8% for thromboembolism, 97.7% for thrombosed bioprosthesis, 97.4% for structural deterioration, 98.7% for nonstructural dysfunction, 95.9 % for hemorrhage, 98.9% for endocarditis and 95.1 % for reoperation and explant. Mean pressure gradients were 15.2 mm Hg (21), 14.5 mm Hg (23), 12.7 mm Hg (25) and 13.0 mm Hg (27) after one year; effective orifice areas 1.36 cm2 (21), 1.68 cm2 (23), 1.76 cm2 (25) and 2.57 cm2 (27). CONCLUSIONS: Clinical and hemodynamic performance of the Mosaic bioprosthesis was highly satisfactory during the first 8.5 years after clinical introduction

Hemodynamic performance and incidence of patient-prosthesis mismatch of the complete supraannular perimount magna bioprosthesis in the aortic position.

BACKGROUND: Complete supraannular placement and smaller stent design allow the implantation of a Perimount Magna bioprosthesis with a larger inner diameter than that of a standard Perimount. This study compares the hemodynamic performance and the incidence of patient-prosthesis mismatch (PPM) of both prostheses. METHODS: 128 patients underwent aortic valve replacement, receiving either a Magna (n = 57) or a standard (n = 71) prosthesis. Inner aortic annulus diameter was measured intraoperatively by a hegar dilator to match echocardiographically obtained results to the annulus diameter instead of matching them to labelled valve size. RESULTS: The Magna was significantly superior with respect to mean pressure gradient and effective orifice area in patients with an annulus diameter of 22-23 mm. In patients with an annulus diameter 23 mm, there was a non-significant trend towards superior hemodynamics in the Magna group. Severe PPM (effective orifice area index 23 mm in both groups. CONCLUSIONS: The Perimount Magna had a significantly reduced incidence of patient-prosthesis mismatch and superior hemodynamics compared to the standard Perimount

[Clinical and hemodynamic results of the mosaic bioprosthesis in aortic position]

INTRODUCTION: Aim of the study was to evaluate the hemodynamic and clinical performance of the Mosaic bioprosthesis in the aortic position. PATIENTS AND METHODS: The Mosaic bioprosthesis is a stented porcine heart valve for implantation in the aortic and mitral position, which combines zero pressure and root pressure fixation with glutaraldehyde, antimineralization treatment with alpha amino oleic acid (AOA) and a low profile stent, to optimize hemodynamic function and to minimize mechanical wear and thus to achieve longer tissue durability. Included in a multicenter study, 100 patients (49 females) underwent isolated aortic valve replacement with the Mosaic bioprosthesis between February 1994 and May 1999. Average age at implant was 73.4 +/- 7.3 years (range 31.3-86.8 years). Preoperative and operative clinical data are shown in Tables 1 and 2. Patients were followed-up within the first 30 postoperative days, after six months and at annual intervals, including transthoracic echocardiography and documentation of any adverse events. Mean follow-up was 3.8 years (range 0.1-7.1 years), total 383.1 patient-years. Follow-up is 100% complete. RESULTS: One year after implantation of the bioprosthesis, mean systolic pressure gradient was 15.3 +/- 6.7 mmHg (21), 14.5 +/- 5.7 mmHg (23), 12.7 +/- 4.1 mmHg (25) and 13.0 +/- 4.8 mmHg (27); effective orifice area (EOA) was 1.4 +/- 0.4 cm2 (21), 1.7 +/- 0.4 cm2 (23), 1.8 +/- 0.4 cm2 (25) and 2.6 +/- 0.4 cm2 (27) (Table 3). One year postoperative, nine patients (10.8%) showed mild aortic regurgitation and one patient (1.2%) moderate. Left ventricular mass index decreased significantly for all sizes within the first postoperative year from 159.7 +/- 56.8 g/m2 to 137.3 +/- 40.8 g/m2. Separating the patients with regard to valve size, only the 21-group (154.1 +/- 51.2 g/m2 to 129.1 +/- 34.6 g/m2) and the 27-group (237.7 +/- 59.2 g/m2 to 146.7 +/- 20.6 g/m2) showed significant results. Freedom from event rates at seven years were 96.8 +/- 1.8% for thromboembolic events, 97.2 +/- 2.0% for thrombosed bioprosthesis, 96.6 +/- 2.6% for structural valve deterioration, 98.2% +/- 1.8% for nonstructural dysfunction, 95.9% +/- 2.0% for antithromboembolic hemorrhage, 98.9 +/- 1.1% for endocarditis and 93.9 +/- 3.2% for reoperation and explant (see Table 4). Early mortality (within 30 days) was 3.0%; late mortality was 4.6%/patient-year, including a valve-related mortality of 0.6%/patient-year. Of the patients, 96.5% showed an improvement of at least one NYHA class when comparing preoperative and one year status. DISCUSSION: The hemodynamic performance and the frequency of adverse events of the Mosaic bioprosthesis in the aortic position were very satisfactory within the first seven postoperative years with excellent results, comparable to studies about other established bioprostheses and similar to the findings in other Mosaic series. Only the number of cases of antithromboembolic hemorrhage was noticeably high. One reason might be the high percentage of patients under continuous anti-coagulant therapy: Six months postoperative, still 52.2% of the patients received phenprocoumon, 6.7% acetylsalicylic acid. Concerning hemodynamics, patient-prosthesis mismatch appeared to be a common problem, especially in small valve sizes. Separating the sample in groups with EOA index 0.75 cm2/m2 after one year, 51.6% in the 21-group had an EOA index < or = 0.75 cm2/m2, whereas it was 19.4% (23), 18.8% (25) and 0% (27) in the larger size groups. Generally, further data have to be collected to determine durability of the biological tissue, as the critical period has just started with the seventh year of the clinical trial. CONCLUSION: The Mosaic bioprosthesis proved to be a reliable and well-functioning device for aortic valve replacement, especially in larger sizes

Hemodynamic comparison of Bioprostheses for complete supra-annular position in patients with small aortic annulus

OBJECTIVES The present study evaluates complete supra-annular bioprostheses in patients with an aortic annulus of 18 to 23 mm in diameter. BACKGROUND Aortic valve replacement in patients with small aortic annulus using stented bioprostheses is often associated with unsatisfactory hemodynamic results and high incidence of patient-prosthesis mismatch. METHODS Between February 2000 and January 2004, 156 patients with aortic valve disease and an aortic annulus of 18 to 23 mm in diameter received the stented bovine Soprano (Sorin Biomedica Cardio, Saluggia, Italy) (n = 18), Perimount (Edwards Lifesciences, Irvine, California) (n = 52), Perimount Magna (Edwards Lifesciences) (n = 42), or the stented porcine Mosaic (Medtronic Inc., Minneapolis, Minnesota) (n = 44) bioprostheses. Intraoperatively, the surgeon measured the aortic annulus diameter by inserting a hegar dilator. Thus, postoperative hemodynamic results could be referred to the patient's aortic annulus diameter instead of referring the results to the labeled valve size. This allows for objective comparisons between different valve types. RESULTS There was no significant difference in hemodynamic results between the different valve types in patients with an aortic annulus 18 to 20 mm. In patients with an annulus 21 to 23 mm, the Magna was significantly superior to the other investigated devices in mean pressure gradient, effective orifice area, and incidence of patient-prosthesis mismatch. There was no significant difference between the complete supra-annular bioprostheses Mosaic and Soprano and the intra-supra-annular Perimount valve. CONCLUSIONS In patients with an aortic annulus of 18 to 20 mm in diameter, hemodynamic performance is independent of the implanted stented valve type and the annular position. Root enlargement or stentless valves may be beneficial alternatives. Patients with annulus diameter 21 to 23 mm benefit from the Magna in complete supra-annular position leading to superior hemodynamic results. (c) 2005 by the American College of Cardiology Foundation