Patient-year For Mitral Valve Replacement Research Articles

CardiaMed mechanical valve: mid-term results of a multicenter clinical trial

Prosthesis choice is a major concern in valvular surgery. A multicenter clinical trial was performed to assess the efficacy and safety of the CardiaMed prosthetic heart valve. The study enrolled 420 patients who underwent mitral (209) or aortic (211) valve replacement from 2003 to 2004 at 7 institutions in Russia, and who were followed up from 2006 to 2011. The mean age was 52.2 ± 10.2 years (range, 12-78 years), 47.4% were female, and 99.05% completed the study. The maximum observation term was 7.5 years (2188.5 patient-years); 1081.6 patient-years for aortic and 1106.9 patient-years for mitral valve replacement. The overall 7-year survival rate was 85.1% ± 3.7%; 86.1% ± 4.8% and 84.4% ± 5.4% for aortic and mitral valve replacement, respectively. The 7-year freedom from valve-related death was 93.9% ± 3.7% and 94.5% ± 3.2% for aortic and mitral valve replacement, respectively. When early mortality (<30 days) was excluded, these rates were 94.8% ± 3.1% and 93.8% ± 3.82%, respectively. Linearized valve-dependent complication rates were determined for structural valve failure (0%/patient-year overall), thrombosis (0.63%/patient-year, all for mitral valve replacement), thromboembolic complications including transient neurologic deficits (0.13%/patient-year overall, 0.5%/patient-year for aortic valve replacement, 0.8%/patient-year for mitral valve replacement), hemorrhagic bleeding (0.64%/patient-year overall, 0.55%/patient-year for aortic valve replacement, 0.09%/patient-year for mitral valve replacement), prosthetic endocarditis (0.28%/patient-year overall, 0.28%/patient-year for aortic valve replacement, 0%/patient-year for mitral valve replacement), and hemolysis (0%/patient-year overall). The CardiaMed mechanical heart valve prostheses meets world standards of safety and efficacy.

St Jude Medical Epic porcine bioprosthesis: Results of the regulatory evaluation

The St Jude Medical Epic heart valve (St Jude Medical, Inc, St Paul, Minn) is a tricomposite glutaraldehyde-preserved porcine bioprosthesis. The St Jude Medical Biocor porcine bioprosthesis is the precursor valve to the St Jude Medical Epic valve. The Epic valve is identical to the Biocor valve except that it is treated with Linx AC ethanol-based calcium mitigation therapy. The St Jude Medical Epic valve was implanted in 761 patients (mean age 73.9 ± 9.2 years) between 2003 and 2006 in the US Food and Drug Administration regulatory study in 22 investigational centers. The position distribution was 557 aortic valve replacements, 175 mitral valve replacements, and 29 double valve replacements. Concomitant coronary artery bypass grafting was performed in 50.8% of patients undergoing aortic valve replacement and 36.6% of those undergoing mitral valve replacement. The early mortality was 3.6% in aortic and 2.3% in mitral valve replacement. The follow-up was 1675.5 patient-years with a mean of 2.2 ± 1.2 years/patient. Late mortality was 5.2%/patient-year in aortic and 6.6%/patient-year in mitral valve replacement. The late major thromboembolism rate was 0.98%/patient-year for aortic and 2.6%/patient-year for mitral valve replacement. There were 19 reoperations, including 2 for structural valve deterioration, 1 for thrombosis, 9 for nonstructural dysfunction, and 7 for prosthetic valve endocarditis. The actuarial freedom from reoperation owing to structural valve deterioration for aortic valve replacement at 4 years for age 60 years or less was 93.3% ± 6.4%; for ages 61 to 70 years, 98.1% ± 1.9%; and for older than 70 years, 100% (P = .0006 > 70 vs ≤ 60 years). There were no events of structural deterioration with mitral valve replacement. The actuarial freedom from major thromboembolism for all patients at 4 years was 93.6% ± 1.0%. The 2 cases of structural valve deterioration occurred in aortic valves that became perforated without calcification causing aortic regurgitation. The performance of the St Jude Medical Epic porcine bioprosthesis is satisfactory at 4 years for both aortic and mitral valve replacement. This study establishes the early clinical performance including durability of this porcine bioprosthesis.

Medtronic Mosaic porcine bioprosthesis: Assessment of 12-year performance

The Mosaic porcine bioprosthesis (Medtronic, Inc, Minneapolis, Minn) was approved in 2000 by the US Food and Drug Administration. Clinical performance was evaluated in 6 centers. From 1994 to 2000, 797 patients (mean age 69 years) had aortic valve replacement (AVR) and 232 (mean 67 years) had mitral valve replacement (MVR). Concomitant coronary artery bypass grafting was performed with aortic valve replacement (45.4%) and mitral valve replacement (43.5%). Mean follow-ups were 7.5 years for aortic position and 7.3 years for mitral position. Early mortalities were 2.8% for AVR and 3.0% for MVR. Late mortalities were 4.2%/patient-year for AVR and 5.1%/patient-year for MVR. Overall 12-year survivals were 55.8% ± 3.7% for AVR and 43.9% ± 7.4% for MVR. Twelve-year freedoms from valve-related mortality were 87.1% ± 3.1% for AVR and 82.5% ± 7.7% for MVR. Twelve-year freedoms from reoperation were 84.0% ± 3.3% for AVR and 82.5% ± 7.5% for MVR. Freedoms from structural valve deterioration (SVD) by explant reoperation at 12 years for AVR were 93.3% ± 2.6% for patients at least 60 years old and 75.9% ± 9.3% for patients younger than 60 years. Freedoms from SVD by explant reoperation at 10 years for MVR were 95.3% ± 7.8% for patients at least 70 years old and 84.0% ± 9.3% for patients younger than 70 years. Hemodynamic performance data at 1 year for AVR (sizes 21-27 mm) were mean systolic gradient range 13.7 ± 4.8 to 10.3 ± 3.2 mm Hg and effective orifice area range 1.5 ± 0.3 to 2.5 ± 0.4 cm(2). For MVR (sizes 25-31 mm), data were mean diastolic gradient range 6.7 ± 1.7 to 3.7 ± 0.9 mm Hg and effective orifice area range 1.9 ± 0.3 to 2.4 ± 0.6 cm(2). Overall performance of Mosaic porcine bioprosthesis to 12 years is satisfactory. Freedoms from SVD by explant reoperation were most satisfactory for aortic position in patients at least 60 years old and mitral position in patients at least 70 years old. Overall actuarial freedom from SVD by explant reoperation is encouraging for patients with MVR.

Influence of the On-X mechanical prosthesis on intermediate-term major thromboembolism and hemorrhage: A prospective multicenter study

Long-term thromboembolic and hemorrhagic outcomes after mechanical valve replacement have been well described; however, few studies have described these outcomes after valve replacement with the On-X mechanical prosthesis (On-X Life Technologies, Inc, Austin, Tex). Between 2003 and 2008, 737 patients underwent either aortic valve replacement (n=400), mitral valve replacement (n=282), or double-valve replacement (n=55). Longitudinal performance, freedom evaluation, and risk analysis were assessed with regard to major thromboembolism and hemorrhage. Risk modeling was performed with 16 variables inclusive of age, atrial fibrillation, concomitant coronary artery bypass grafting, New York Heart Association class, and ventricular dysfunction. Early mortality was 2.5% (n=10) for aortic valve replacement and 3.2% (n=9) for mitral valve replacement. Late mortality for aortic valve replacement was 4.8% per patient-year and 6.0% per patient-year for mitral valve replacement. Five-year freedom from major thromboembolism was 96.5%± 1.2% for aortic valve replacement and 97.7%± 0.9% for mitral valve replacement. Five-year freedom from hemorrhage was 93.6%± 1.8% for aortic valve replacement and 95.7%± 1.5% for mitral valve replacement. Concomitant coronary artery bypass grafting was predictive of major thromboembolism after aortic valve replacement (hazard ratio, 5.3; P=.02) and antithrombotic hemorrhage after mitral valve replacement (hazard ratio, 4.7; P=.03). No other independent predictors of major thromboembolism or hemorrhage were identified. One thrombosed mitral prosthesis was observed after deliberate discontinuation of anticoagulation. The major thromboembolic events occurred with variation of international normalized ratio levels inclusive of subtherapeutic levels. The majority of hemorrhagic events occurred with high international normalized ratio levels. The On-X mechanical prosthesis provides favorable intermediate-term results with regard to major thromboembolism and hemorrhage.

Mosaic valve international clinical trial: early performance results

Background. A new third generation porcine bioprosthesis was developed in an attempt to improve on hemodynamic performance and durability of current prostheses.Methods. One thousand, two hundred, sixty patients underwent aortic valve replacement and 366 patients underwent mitral valve replacement between February 1994 and September 2000. The cumulative follow-up was 3,696.3 patient-years for aortic valve replacement and 880.1 patient-years for mitral valve replacement. Follow-up was complete for 95.5% of aortic valve replacement patients and 97.5% of mitral valve replacement patients.Results. For aortic valve replacement, freedom from valve-related adverse events at 1 year was 96.5% ± 0.5% for antithromboembolic-related hemorrhage and 100% for structural valve deterioration. Freedom from valve-related adverse events at 5 years was 93.8% ± 2.6% for antithromboembolic-related hemorrhage and 99.3% ± 0.9% for structural valve deterioration. For mitral valve replacement, freedom from valve-related adverse events at 1 year was 96.0% ± 1.1% for antithromboembolic-related hemorrhage and 100% for structural valve deterioration. Freedom from valve-related adverse events at 4 years was 92.1% ± 3.7% for antithromboembolic-related hemorrhage and 100% for structural valve deterioration.Conclusions. These results support the claim that the Mosaic bioprosthetic valve is efficacious and safe, but continued follow-up is mandatory to determine mid- and long-term performance.

Medtronic intact porcine bioprosthesis experience to twelve years

Background. The Medtronic Intact porcine bioprosthesis was further evaluated to determine the influence of zero-pressure glutaraldehyde fixation on structural valve deterioration (SVD).Methods. From 1986 through 1996, at three Canadian centers, 1,272 patients had 1,296 procedures: 836 aortic valve replacement (AVR), 332 mitral valve replacement (MVR), 14 tricuspid valve replacement, 3 pulmonary valve replacement, and 111 multiple valve replacements. The mean age of the patient population was 67 years (range 9 to 91 years). The total follow-up was 8,011 patient-years (mean 6.2 years).Results. The late mortality (overall) was 4.8% and 6.7% per patient-year for AVR with or without concomitant procedures, respectively; and 4.7% and 10.4% per patient-year for MVR, respectively. There were 51 cases of SVD (AVR 22 of 836; MVR 23 of 332; pulmonary valve replacement 1 of 3; and multiple valve replacement 5 of 111). The actuarial freedom from SVD at 12 years for AVR was 94.3% ± 3.3% for patients aged 61 to 70 years and 97.7% ± 1.1% for those more than 70 years; for MVR actuarial freedom from SVD at 12 years was 93.7% ± 3.9% for patients more than 70 years. The actual freedom at 12 years from SVD for AVR was 92.4% ± 3.1% for patients aged 51 to 60 years, 96.1% ± 2.1% for those 61 to 70 years, and 98.4% ± 0.7% for those older than 70 years; for MVR actual freedom from SVD at 12 years was 89.6% ± 3.2% for patients 61 to 70 years and 96.6% ± 3.4% for those more than 70 years.Conclusions. The Medtronic Intact porcine bioprosthesis, formulated with tissue preservation at zero-pressure fixation, has encouraging freedom from structural failure.

Heart valve replacement with the Sorin tilting-disc prosthesis

From 1978 to 1988, 697 patients with a mean age of 48 +/- 11 years (range 5 to 75 years) received a Sorin tilting-disc prosthesis; 358 had had aortic valve replacement, 247 mitral valve replacement, and 92 mitral and aortic valve replacement. Operative mortality rates were 7.8%, 11.3%, and 10.8%, respectively, in the three groups. Cumulative duration of follow-up is 1650 patient-years for aortic valve replacement (maximum follow-up 11.4 years), 963 patient-years for mitral valve replacement (maximum follow-up 9.9 years) and 328 patient-years for mitral and aortic valve replacement (maximum follow-up 9.4 years). Actuarial survival at 9 years is 72% +/- 4% after mitral valve replacement, 70% +/- 3% after aortic valve replacement, and 50% +/- 12% after mitral and aortic valve replacement, and actuarial freedom from valve-related deaths is 97% +/- 2% after mitral valve replacement, 92% +/- 2% after aortic valve replacement, and 62% +/- 15% after mitral and aortic valve replacement. Thromboembolic events occurred in 21 patients with aortic valve replacement (1.3% +/- 0.2%/pt-yr), in 12 with mitral valve replacement (1.2% +/- 0.3% pt-yr), and in seven with mitral and aortic valve replacement (2.1% +/- 0.8%), with one case of prosthetic thrombosis in each group; actuarial freedom from thromboembolism at 9 years is 92% +/- 3% after mitral valve replacement, 91% +/- 3% after aortic valve replacement, and 74% +/- 16% after mitral and aortic valve replacement. Anticoagulant-related hemorrhage was observed in 15 patients after aortic valve replacement (0.9% +/- 0.2%/pt-yr), in 9 after mitral valve replacement (0.9% +/- 0.3%/pt-yr), and in 6 with mitral and aortic valve replacement (0.9% +/- 0.5%/pt-yr); actuarial freedom from this complication at 9 years is 94% +/- 2% after aortic valve replacement, 91% +/- 4% after mitral valve replacement, and 68% +/- 16% after mitral and aortic valve replacement. Actuarial freedom from reoperation at 9 years is 97% +/- 2% after mitral and aortic valve replacement, 92% +/- 4% after mitral valve replacement, and 89% +/- 3% after aortic valve replacement, with no cases of mechanical fracture. The Sorin valve has shown a satisfactory long-term overall performance, comparable with other mechanical prostheses, and an excellent durability that renders it a reliable heart valve substitute for the mitral and aortic positions.

Durability and Low Thrombogenicity of the St. Jude Medical Valve at 5-Year Follow-up

Between November, 1978, and December, 1983, 736 patients had valve replacement with the St. Jude Medical valve prosthesis. There were 478 patients with aortic valve replacement (AVR), 188 with mitral valve replacement (MVR), 63 with double valve replacement, and 7 with tricuspid valve replacement (they were not included in this study). The mean age at the time of operation was 46.7 years for patients having AVR and 48.6 years for those having MVR and AVR + MVR. Follow-up totaled 1,116 patient-years (range, 4 to 82 months). Early (30-day) mortality was lowest for isolated MVR (2.3%) and AVR (3.7%), and increased with reoperation or when associated procedures were combined with valve replacement. Patients undergoing reoperation or having associated procedures made up 49% of the AVR and 54% of the MVR groups. All patients were advised of the need for long-term anticoagulation with warfarin sodium. Nine patients (7 with AVR, 1 with MVR, 1 with AVR + MVR) had suspected or confirmed episodes of systemic thromboembolism, a linearized incidence of 0.99% per patient-year for AVR, 0.36% per patient-year for MVR, and 0.98% per patient-year for AVR + MVR. Eight patients with AVR underwent reoperation for prosthetic valve endocarditis (5 of the 8 patients had endocarditis prior to initial valve replacement). There were no instances of structural valve failure. There were 37 late deaths. Actuarial survival at 5 years (excluding early mortality, 95% confidence limits) was 89.8% for AVR, 84.8% for MVR, and 95.2% for AVR + MVR. At 5-year follow-up the St. Jude Medical prosthetic valve has a low incidence of valve-related complications, which makes it a suitable choice in patients requiring valve replacement.

Five- to eight-year follow-up of patients with the Hancock cardiac bioprosthesis

All patients undergoing a heart valve replacement with a glutaraldehyde-preserved Hancock xenograft from June, 1974, through June, 1977, were reviewed. This analysis included 403 patients: 202 having mitral valve replacement (MVR), 131 having aortic valve replacement (AVR), and 70 having mitral and aortic valve replacement (M/AVR). The hospital mortality was 9.9% (40/403): 10.8% (22/202) for MVR, 4.5% (6/131) for AVR, and 17.1% (12/70) for M/AVR. Of 363 patients discharged from the hospital, six were lost to follow-up at 24 and 37 months and they are excluded from the figures. There were 41 late deaths, which represents an incidence of 1.47% per patient-year for MVR (16/177), 1.95% per patient-year for AVR (14/122), and 3.35% per patient-year for the M/AVR (11/58). There were 37 thromboembolic events in 32 patients. This represents a linearized incidence of 1.93%, 0.97%, and 2.74% per patient-year for MVR, AVR, and M/AVR, respectively. None of the accidents was fatal, and four of the 32 patients were on a regimen of controlled anticoagulation at the time of embolism. Primary tissue failure was observed in 34 patients (231 MVR, eight AVR, and five MAVR). The probability of being free from primary tissue failure at 8 years is 85.3% +/- 3.7% for MVR, 85% +/- 11.6% for AVR, and 81% +/- 8.9% for M/AVR. These current results indicate that the Hancock xenograft valve can be considered as a valid alternative in heart valve replacement.

Clinical experience with the Carpentier-Edwards porcine bioprosthesis: short-term results (from 2 to 4.5 years).

All patients undergoing a heart valve replacement with a glutaraldehyde Carpentier-Edwards xenograft from April 1978 through December 1980 were reviewed. This analysis included 189 patients: 117 having a mitral valve replacement (MVR), 45 having an aortic valve replacement (AVR), and 27 having mitral and aortic valve replacements (MAVR). Out of 174 patients discharged from the hospital, one was lost to follow-up and is excluded from the analysis. There were 11 late deaths, which represent an incidence of 1.89% per patient-year for the MVR (6/106), 0.83% per patient-year for the AVR (1/41), and 5.83% per patient-year for the MAVR (4/26). There were 6 instances of infective endocarditis (4 MVR, 2 MAVR), which represent a linearized incidence o 1.26% and 2.91% per patient-year for the MVR and MAVR respectively. All were successfully treated with medication. There were 10 thromboembolic events in 7 patients (6 MVR had 9 events and 1 AVR had 1 event). This represents a linearized incidence of 2.84% and 0.83% per patient-year for MVR and AVR, respectively. Primary tissue failure was observed in 3 patients (2 MVR, 1 MAVR), who required reoperation for explantation of the mitral valves. This represents an overall linearized incidence of mitral failures of 0.78% per patient-year. The probability of being free from primary tissue failure is 95.9 +/- 4.9% for all mitral prostheses at 4.5 years of follow-up. These current results indicate that the Carpentier-Edwards porcine xenograft valve can be considered as a valid alternative for heart valve replacement.