Twenty-year clinical experience with porcine bioprostheses

Fann, James I.; Miller, D. Craig; Moore, Kathleen A.; Mitchell, R. Scott; Oyer, Philip E.; Stinson, Edward B.; Robbins, Robert C.; Reitz, Bruce A.; Shumway, Norman E.

doi:10.1016/0003-4975(96)00629-7

Cited by 121 publications

(69 citation statements)

References 26 publications

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“…12 Hazard ratios of 8.0, 3.6, 1.5, 1.1, and 1.0 were found adequate for the background mortality in men aged 35, 45, 55, 65, and 75 years, respectively.…”

Section: Model Calibrationmentioning

confidence: 80%

“…19 -21 Therefore, hazard ratios were applied to the age-specific survival rates of the Dutch population to calibrate the model outputs with the age-specific survival curves obtained from the literature. 12 Operative mortality was estimated as 1.5% for a 40-year-old man, increasing with odds ratios of 1.022 for age (per year) and 1.7 for every reoperation. 18,21 …”

Section: Parameters In the Modelmentioning

confidence: 95%

“…The shape parameter of the Weibull model was estimated from the average freedom-from-SVD curve, which was pooled from 4 reports. 7,8,12,13 The age effect was incorporated in the scale parameter of the Weibull model, based on 1 study. 12 …”

Section: Data Extraction and Analysismentioning

confidence: 99%

“…The model output was validated against the pooled survival curve, as obtained from 3 reports. 8,10,12 …”

Section: Evaluation and Validationmentioning

confidence: 99%

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Prognosis After Aortic Valve Replacement With a Bioprosthesis

et al. 2001

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Background-Bioprostheses are widely used as an aortic valve substitute, but knowledge about prognosis is still incomplete. The purpose of this study was to provide insight into the age-related life expectancy and actual risks of reoperation and valve-related events of patients after aortic valve replacement with a porcine bioprosthesis. Methods and Results-We conducted a meta-analysis of 9 selected reports on stented porcine bioprostheses, including 5837 patients with a total follow-up of 31 874 patient-years. The annual rates of valve thrombosis, thromboembolism, hemorrhage, and nonstructural dysfunction were 0.03%, 0.87%, 0.38%, and 0.38%, respectively. The annual rate of endocarditis was estimated at 0.68% for Ͼ6 months of implantation and was 5 times as high during the first 6 months. Structural valve deterioration was described with a Weibull model that incorporated lower risks for older patients. These estimates were used to parameterize, calibrate, and validate a mathematical microsimulation model. The model was used to predict life expectancy and actual risks of reoperation and valve-related events after implantation for patients of different ages. For a 65-year-old male, these figures were 11.3 years, 28%, and 47%, respectively. Conclusions-The combination of meta-analysis with microsimulation enabled a detailed insight into the prognosis after aortic valve replacement with a bioprosthesis for patients of different ages. This information will be useful for patient counseling and clinical decision making. It also could serve as a baseline for the evaluation of newer valve types. Key Words: heart diseases Ⅲ surgery Ⅲ valves Ⅲ meta-analysis Ⅲ prognosis Ⅲ survival N early 40 years after the pioneering efforts of Starr and Edwards in heart valve replacement, a wide variety of mechanical, bioprosthetic, and human tissue prostheses are now available for clinical use. Mechanical valves have a greater durability and consequently lower reoperation rates than other valve types. However, they are associated with a greater risk of thromboembolism, which necessitates regular anticoagulation with the concomitant risk of hemorrhage. In contrast, bioprostheses have a low thrombogeneity, which in most patients obviates the need for regular anticoagulation and consequently reduces hemorrhagic accidents. However, the main factor limiting their use is the propensity to undergo tissue degeneration, often necessitating reoperation. Human tissue valves have a relatively low rate of thromboembolism and endocarditis. However, the long-term incidence of structural valve deterioration (SVD) of these valves is uncertain, and human valves are scarce. [1][2][3] With the aging of the general population, the number of elderly patients requiring aortic valve replacement has increased rapidly during recent years. Hence, the choice and long-term performance of a valve prosthesis becomes of paramount importance. Currently, bioprostheses are recommended for elderly patients who do not have risk factors for thromboembolism. These valves may ...

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“…12 Hazard ratios of 8.0, 3.6, 1.5, 1.1, and 1.0 were found adequate for the background mortality in men aged 35, 45, 55, 65, and 75 years, respectively.…”

Section: Model Calibrationmentioning

confidence: 80%

Section: Parameters In the Modelmentioning

confidence: 95%

Section: Data Extraction and Analysismentioning

confidence: 99%

“…The model output was validated against the pooled survival curve, as obtained from 3 reports. 8,10,12 …”

Section: Evaluation and Validationmentioning

confidence: 99%

See 2 more Smart Citations

Prognosis After Aortic Valve Replacement With a Bioprosthesis

et al. 2001

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“…[2][3][4][5][6][7][8][9][10] Prosthetic heart valves have undergone continuous modifications to reach a good level of product quality and to provide an acceptable postoperative hemodynamic performance over the past years. However, an optimal device, possibly mimicking the native physiological valve, is neither available nor in view for AVR.…”

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confidence: 99%

Prospectively Randomized Evaluation of Stented Xenograft Hemodynamic Function in the Aortic Position

et al. 2004

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Background-Standard stented aortic xenograft valves have not yet been compared regarding their hemodynamic function using a stratified intraoperative randomization protocol. Methods and Results-100 patients were prospectively included after intraoperative metric sizing of the decalcified aortic annulus. They received Mosaic (M) or Perimount (P) aortic valve replacement. Patient age was 73Ϯ5 years, 51 were female, and New York Heart Association (NYHA) functional class was 2.8Ϯ0.5. The 21-mm annulus group consisted of 5 (M)/7 (P) patients, the 23-mm annulus group of 20 (M)/20 (P), the 25-mm annulus group of 18 (M)/19 (P), and the 27-mm annulus group of 4 (M)/7 (P) patients, respectively. Hemodynamic function was evaluated using transthoracic echocardiography before discharge and at follow-up (438Ϯ352 days). Surgery was uncomplicated in all patients. Labeled valve sizes were 0.93 (M) and 1.05 (P) mm smaller than the annulus diameters (pϭNS). In-hospital mortality was 5%, all nonvalve-related. Transvalvular blood flow velocities and transvalvular pressure gradients were significantly lower in the 25 P versus the 25 M group at baseline and in the 23 P and 25 P groups at follow-up. There was a significant regression of left ventricular mass index in all patients at follow-up. However, left ventricular mass regression was more pronounced after P aortic valve replacement. Conclusion-Labeled sizes of prosthetic heart valves implanted are smaller than the true aortic annulus. Both standard aortic xenografts compared in this prospectively randomized trial provide a sufficient hemodynamic and functional outcome.

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Mechanisms of bioprosthetic heart valve failure: Fatigue causes collagen denaturation and glycosaminoglycan loss

Vyavahare

Ogle

Schoen

et al. 1999

J. Biomed. Mater. Res.

125

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Bioprosthetic heart valve (BPHV) degeneration, characterized by extracellular matrix deterioration, remodeling, and calcification, is an important clinical problem accounting for thousands of surgeries annually. Here we report for the first time, in a series of in vitro accelerated fatigue studies (5-500 million cycles) with glutaraldehyde fixed porcine aortic valve bioprostheses, that the mechanical function of cardiac valve cusps caused progressive damage to the molecular structure of type I collagen as assessed by Fourier transform IR spectroscopy (FTIR). The cyclic fatigue caused a progressive loss of helicity of the bioprosthetic cuspal collagen, which was evident from FTIR spectral changes in the amide I carbonyl stretching region. Furthermore, cardiac valve fatigue in these studies also led to loss of glycosaminoglycans (GAGs) from the cuspal extracellular matrix. The GAG levels in glutaraldehyde crosslinked porcine aortic valve cusps were 65.2 +/- 8.66 microg uronic acid/10 mg of dry weight for control and 7.91 +/- 1.1 microg uronic acid/10 mg of dry weight for 10-300 million cycled cusps. Together, these molecular changes contribute to a significant gradual decrease in cuspal bending strength as documented in a biomechanical bending assay measuring three point deformation. We conclude that fatigue-induced damage to type I collagen and loss of GAGs are major contributing factors to material degeneration in bioprosthetic cardiac valve deterioration.

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Twenty-year clinical experience with porcine bioprostheses

Cited by 121 publications

References 26 publications

Prognosis After Aortic Valve Replacement With a Bioprosthesis

Prognosis After Aortic Valve Replacement With a Bioprosthesis

Prospectively Randomized Evaluation of Stented Xenograft Hemodynamic Function in the Aortic Position

Mechanisms of bioprosthetic heart valve failure: Fatigue causes collagen denaturation and glycosaminoglycan loss

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