Hemodynamic stability during 17 years of the Carpentier-Edwards aortic pericardial bioprosthesis

BACKGROUND: Long-term stability of the hemodynamic performance of commercially available Carpentier-Edwards stented bovine pericardial aortic bioprostheses (Perimount RSR) is unknown. To anticipate the fate of this bioprosthesis, we examined its hemodynamic performance up to 17 years using echocardiographic studies in a Premarket Approval cohort. METHODS: Of 267 patients at four institutions in the Premarket Approval cohort, 85 had a total of 168 echocardiographic studies during a 17-year period of yearly follow-up examinations. These were reviewed and quantified in a core echocardiographic facility. Longitudinal data analysis was used to account for repeated, censored data. RESULTS: Mean transvalvular gradient was inversely related to prosthesis size (p = 0.01), and possibly (p = 0.06) increased somewhat during the first 10 years of follow-up, then stabilized. Effective orifice area was larger in larger valve sizes (p = 0.01), declined somewhat during the first 10 years, and then began to increase again. Ejection fraction declined minimally (p = 0.2). In contrast to the rather stable hemodynamics, aortic regurgitation steadily increased from none to 1 to 2+ (p = 0.005), but rarely (< 10% at 17 years) progressed to 3+ or 4+. CONCLUSIONS: The Carpentier-Edwards aortic pericardial bioprosthesis can be anticipated to have an acceptable long-term transvalvular gradient and effective orifice size that will change trivially up to 17 years after implantation. Mild aortic regurgitation will develop progressively. This anticipated hemodynamic resilience supports continued clinical use of the Perimount Carpentier-Edwards bovine pericardial stented bioprosthesis.     

Immediate structural valve deterioration of 27-mm Carpentier-Edwards aortic pericardial bioprosthesis

We describe two cases of immediate structural valve deterioration of the 27-mm Carpentier-Edwards pericardial valve. Tissue characteristics of bovine pericardium and the possible mechanism of failure are discussed.     

Mass regression in aortic stenosis after valve replacement with small size pericardial bioprosthesis

BACKGROUND: The aim of the study was to determine whether left ventricular mass regression is influenced by valve size after the implantation of a Carpentier-Edwards Perimount (CEP) pericardial bioprosthesis for pure aortic stenosis. METHODS: Patients receiving 19-mm, 21-mm, and 23-mm CEP aortic valves underwent echocardiography preoperatively and at least 1 year after surgery (mean, 2.3 +/- 1 years) and the echocardiograms were compared within and between groups. RESULTS: The study involved a total of 88 patients: 34 receiving 19-mm CEPs, 29 receiving 21-mm CEPs, and 25 receiving 23-mm CEPs. The mean postoperative prosthetic gradients were respectively 20.6 +/- 6.6 mm Hg, 17.9 +/- 5.8 mm Hg, and 13.2 +/- 4.1 mm Hg (p = 0.0001); the mean postoperative valve areas were respectively 1.24 +/- 0.16 cm(2), 1.45 +/- 0.2 cm(2), and 1.63 +/- 0.21 cm(2) (p = 0.0001). In comparison with the preoperative echocardiographic measurements absolute left ventricular mass significantly decreased by -54.1 +/- 48.8 g, -54.1 +/- 55.1 g, and -74.4 +/- 57.4 g respectively with no statistically significant between-group difference (analysis of variance) but ventricular septum and posterior wall thickness significantly decreased in each group (p < 0.05). CONCLUSIONS: The implantation of 19-mm, 21-mm, and 23-mm CEP aortic prostheses significantly reduces left ventricular mass without any size-related differences.     

Unusual 25-year durability of an Ionescu-Shiley pericardial bioprosthesis

Ionescu-Shiley valve was withdrawn from clinical use in 1987 for its early structural failure after implantation. This was due to valve design rather than the natural properties of bovine pericardium itself. We describe the unexpected 25-year survival of an Ionescu-Shiley bioprosthesis in the mitral and tricuspid positions, implanted to treat endomyocardial fibrosis. This report makes 2 important points: (1) pannus overgrowth may be a favorable determinant of the durability of xenografts, and (2) bovine pericardial valves may have excellent hemodynamic performance and tissue durability for more than 20 years in the mitral position even in young patients.     

Thromboembolic events after aortic valve replacement in elderly patients with a Carpentier-Edwards Perimount pericardial bioprosthesis

OBJECTIVES: Thromboembolic events after aortic valve replacement with a bioprosthesis were the most frequently occurring complications in elderly patients. Whether this was valve related or dependent on other factors needed further exploration. METHODS: Five hundred patients with a median age of 73 years were followed retrospectively after aortic valve replacement with a pericardial prosthesis for occurrence of thromboembolism. Of these, 348 also underwent coronary artery bypass grafting. Twenty-five factors were investigated for their potential effect by using univariate and multivariate analysis. RESULTS: Univariate analysis revealed 6 significant factors: preoperative endocarditis (P =.0001), preoperative cerebrovascular accident (P =.002), use of postoperative warfarin sodium (Coumadin, DuPont Merck; P =.006), arterial hypertension (P =.023), size of valve prosthesis of 27 mm or larger (P =.023), and hospital thromboembolism (P =.040). There was a trend toward increased fatal thromboembolism in patients without medication. With a multivariate analysis, 4 factors remained significant: preoperative cerebrovascular accident (risk ratio, 4.8; P =.0016), warfarin sodium (risk ratio, 3.0; P =.0028), preoperative endocarditis (risk ratio, 5.6; P =.006), and hospital thromboembolism (risk ratio, 6.1; P =.016). Hypertension had a borderline effect. Age, sex, diabetes, 4 coronary artery factors, 3 other valvular factors, atrial fibrillation, and carotid artery disease had no significant effect. CONCLUSIONS: Some emboli seemed triggered by the valve prosthesis. A proper anticoagulant protocol but also a treatment of hypertension is important in the prevention of thromboembolism after aortic valve replacement with a bioprosthesis. We did not find a significant role of atrial fibrillation and carotid artery disease.     

Undiagnosed mitroflow bioprosthesis deformation causing early structural valve deterioration

Bioprosthesis are commonly used in the elderly population. Structural valve deterioration affects the long-term durability. We report an early deterioration of a Mitroflow valve caused by ring deformation and prosthetic leaflet rupture. The 69-years-old patient underwent successful redo surgery with excision of the bioprosthesis and placement of a mechanical valve.     

Transatrial transcatheter tricuspid valve-in-valve implantation of balloon expandable bioprosthesis

Transcatheter valve-in-valve implantation into failing mitral and aortic bioprosthetic valves have been reported. This strategy avoids performing high-risk repeat cardiac surgery in elderly patients with multiple comorbidities. Tricuspid valve-in-valve implantation has not been described. We report a case of failing bioprosthetic tricuspid valve in a 48-year-old woman with carcinoid syndrome. We attempted a transatrial transcatheter approach and we successfully deployed a 26-mm Edwards Sapien balloon expandable bioprosthesis (Edwards Lifesciences, Irvine, CA) into a severely stenotic tricuspid bioprosthesis. This case demonstrates the technical feasibility and safety of this approach. Therefore, tricuspid valve-in-valve implantation may be a viable treatment alternative in carefully selected patients.     

Eight-year results after aortic valve replacement with the Freestyle stentless bioprosthesis

OBJECTIVES: We sought to describe the hemodynamic and clinical outcomes for the Freestyle aortic root bioprosthesis (Medtronic, Inc, Minneapolis, Minn) in a large multicenter cohort prospectively followed for 8 years. METHODS: A total of 700 patients (651 [93%] >60 years of age) at 8 centers in North America were followed prospectively after aortic valve replacement with the Freestyle stentless bioprosthesis; the implant technique was subcoronary in 500, total root in 162, and root inclusion in 38. Follow-up was 3395 patient-years (4.9 +/- 2.3 years per patient). Clinical and echocardiographic follow-up was prospectively obtained at yearly intervals. RESULTS: For the subcoronary, total root, and root inclusion groups, actuarial freedom from valve-related death was 96.8% (SE 3.0%), 92.3% (SE 7.7%), and 90.9% (SE 11.2%), respectively, and freedom from structural deterioration was 98.6% (SE 2.0%), 100.0% (SE 0.0%), and 100.0% (SE 0.0%), respectively. Hemodynamics remained excellent at 6 years. Freedom from moderate or more aortic regurgitation was 86.0% (SE 5.1%), 98.7% (SE 3.9%), and 97.3% (SE 6.6%), respectively. Gradients were slightly lower (P =.0009), and the effective orifice area (P =.02) and freedom from aortic regurgitation were slightly higher (P =.03) with total root than subcoronary implantation. CONCLUSIONS: The Freestyle stentless aortic root bioprosthesis is a versatile option for aortic valve replacement. Measures of clinical outcomes and prosthesis durability remain excellent in multicenter follow-up through 8 years in a population predominantly older than 60 years at the time of the operation.     

Perforation of the Valsalva sinus after implantation of Medtronic Freestyle aortic bioprosthesis

We report on structural valve deterioration in patients with the Medtronic Freestyle aortic bioprosthesis (Medtronic, Inc, Minneapolis, MN), including spontaneous perforation of the Valsalva sinus. These occurred in four prosthesis in 3 patients using the modified subcoronary method or full root technique. One patient died of ruptured pseudoaneurysm and the others survived reoperation well. Careful follow-up is required after Freestyle bioprosthesis implantation.     

Early structural deterioration with the mitroflow pericardial xenograft in the mitral position.

Early structural deterioration with the mitral Mitroflow pericardial valve requiring reoperation occurred in 6 patients. Clinical diagnosis of prosthetic failure was made 5 to 58 months after valve implantation (mean, 38 months). Re-replacement was carried out 22 to 80 months (mean, 55 months) after the initial operation. Mode of failures were cuspal tear without calcification in three valves and massive calcifications in the remaining bioprostheses. High incidence of early structural deterioration of the Mitroflow pericardial valve makes this new prosthesis an unsatisfactory alternative as a substitute in the mitral position.