Patient-prosthesis mismatch can be predicted at the time of operation.

BACKGROUND: Patient-prosthesis mismatch is a frequent cause of high postoperative gradients in normally functioning prostheses. The objective of this study was to determine whether mismatch can be predicted at the time of operation. METHODS: Indices used to predict mismatch were valve size, indexed internal geometric area, and projected indexed effective orifice area (EOA) calculated at the time of operation, and results were compared with indexed EOA and mean gradients measured by Doppler echocardiography after operation in 396 patients. RESULTS: The sensitivity and specificity of these indices to detect mismatch, defined as a postoperative indexed EOA of 0.85 cm2/m2 or less, were respectively: 35% and 84% for valve size, 46% and 85% for indexed internal geometric area, and 73% and 80% for projected indexed EOA. Projected indexed EOA also correlated best with resting (r = 0.67) and exercise (r = 0.77) postoperative gradients. CONCLUSIONS: The projected indexed EOA calculated at the time of operation accurately predicts mismatch as well as resting and exercise postoperative gradients, whereas valve size and indexed internal geometric area cannot be used for this purpose.

Clinical and hemodynamic performance of the Freestyle aortic root bioprosthesis.

BACKGROUND: The objective of this study is to assess the clinical and hemodynamic performance of a stentless porcine bioprosthesis, the Freestyle aortic root bioprosthesis. METHODS: Consenting patients requiring isolated aortic valve or aortic root replacement received the Freestyle bioprosthesis. Clinical follow-up and echocardiographic data were obtained at discharge, 3 to 6 months, 1 year, and annually thereafter. RESULTS: Two hundred seventy-six patients received a Freestyle aortic root bioprosthesis between January 1993 and July 1997. The mean age was 67.7 years. Preoperatively, 86.3% were either New York Heart Association class III or IV. Two hundred thirty-eight patients underwent valve (subcoronary) replacement, 36 underwent aortic root replacement, and 2 underwent valve replacement using the root-inclusion technique. The early mortality was 5.4%, with 3.3% mortality for the subcoronary technique and 19.4% mortality for aortic root replacement. The mean gradient decreased significantly between discharge and the 3- to 6-month follow-up and stabilized thereafter. The effective orifice area increased significantly from discharge to 3 to 6 months' follow-up. At 3 years, 84.4% of the patients had either no or trivial regurgitation. CONCLUSIONS: The Freestyle bioprosthesis has good clinical performance and good short-term hemodynamic performance. The majority of the regurgitation identified is not clinically significant.

Aortic valve replacement with pulmonary autograft in children and adults.

Aortic valve replacement with a conventional prosthesis is still flawed with complications, especially in children and young adults. Complex aortic root enlargement (Konno) is often needed because of small aortic diameter. The poor compliance with anticoagulation by teenagers and the risks associated with this made us look at alternative techniques. From November 1990 to June 1994, 70 patients were considered for pulmonary autografts in our institution; 64 underwent the procedure with one death and one failure to implant. Short-term results are excellent, with minimal gradient in 90% and minimal regurgitation in 96% of the patients. The long-term follow-up, hopefully, will confirm the superiority of this procedure over more conventional replacement.

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.

Medtronic intact porcine bioprosthesis: 10 years' experience.

BACKGROUND: The Medtronic Intact porcine bioprosthesis experience was evaluated over a period of 10 years to determine the influence of structural valve deterioration by valve position in various age groupings. METHODS: From 1986 to 1996 inclusive, at three centers, 1,272 patients had the prosthesis implanted in 1,296 procedures. The mean age of the population was 67 years (range, 9 to 91 years). There were 836 aortic valve replacements (AVR) (64.5%), 333 mitral valve replacements (MVR) (25.7%), and 110 multiple valve replacements (MR) (8.5%). RESULTS: The early mortality was 7.3% (94 of 1,296 procedures). The early mortality with concomitant procedures (primarily coronary artery bypass grafting) was 9.8% (52 of 528) and without, 5.5% (42 of 768). The late mortality was 4.25%/patient-year. The linearized rate of major thromboembolism was 0.86%/patient-year. The rate of reoperation was 1.19%/patient-year and valve-related mortality, 1.06%/patient-year. There were 36 cases of structural valve deterioration for aortic valve replacement (16), mitral valve replacement (15), tricuspid valve replacement (2), and multiple valve replacement (3). The freedom from structural valve deterioration for aortic valve replacement was in patients 21 to 40 years, 62.5%+/-25.8% at 7 years; 41 to 50 years, 75.0%+/-15.3% at 7 years; 51 to 60 years, 91.0%+/-4.5% at 8 years; 61 to 70 years, 98.7%+/-0.7% at 10 years; and older than 70 years, 98.3%+/-1.0% at 10 years (p < 0.05). The freedom from structural valve deterioration for mitral valve replacement was for patients 41 to 50 years, 91.7%+/-8.0% at 7 years; 51 to 60 years, 85.9%+/-9.9% at 8 years; 61 to 70 years, 86.3%+/-6.8% at 8 years; and older than 70 years, 93.9%+/-4.8% at 8 years (not significant). CONCLUSIONS: The Medtronic Intact porcine bioprosthesis has acceptable freedom from structural valve deterioration in both the aortic and mitral positions approaching 10 years of evaluation.

Hemodynamic features of the freestyle aortic bioprosthesis compared with stented bioprosthesis.

BACKGROUND: The Freestyle prosthesis is a new stentless aortic bioprosthesis. Anticipated benefits are improved hemodynamics and increased longevity. METHODS: Doppler echocardiograms were performed early and at 3 to 6 months, 1 year, and 2 years after operation in 157 patients (69 men, 88 women, aged 48 to 85 years) with this prosthesis, and results were compared with hemodynamic data in patients with Intact and Mosaic stented bioprostheses. RESULTS: Distinctive features of the prosthesis compared with stented prostheses are (1) an increase in effective orifice area (+0.15+/-0.26 cm2; p < 0.05) and a decrease in mean gradient (-3.5+/-4.0 mm Hg; p < 0.001) during the first 3 to 6 months postoperatively and stabilization thereafter; (2) a markedly lower mean gradient at 1 year after operation (average, 6+/-4 mm Hg) than in stented prostheses (Intact, 22+/-8 mm Hg; Mosaic, 12+/-6 mm Hg); (3) in contrast to stented prostheses, in vivo effective orifice areas much lower (-0.91+/-0.35 cm2) than those calculated in vitro; (4) as in stented prostheses, the indexed effective orifice area (cm2/m2) is the best predictor (r = 0.77 at 1 year) of the mean gradient after operation; and (5) similar incidence of aortic regurgitation (trivial or mild, 34% versus 29% in Intact). CONCLUSIONS: The hemodynamics of the Freestyle are very satisfactory and represent a marked improvement in comparison to stented prosthesis.

Medtronic Intact porcine bioprosthesis: clinical performance to seven years.

The clinical performance of the Medtronic Intact porcine bioprosthesis was evaluated in 1,084 patients (mean age 66.4 years, range 9 to 91 years) who had a total of 1,099 implantations between 1985 and 1992, inclusive. There were 709 aortic valve replacements, 297 mitral valve replacements, and 80 multiple valve replacements. Concomitant procedures were performed in 432 (39.3%). The age group distribution (years) was 35 or younger in 20 patients, 36 to 50 in 64, 51 to 64 in 274, 65 to 69 in 225, 70 or older in 500. The total follow-up time was 2,741 patient-years (mean, 2.5 years) and was 97.5% complete. The early mortality rate was 7.1% and late mortality was 3.9% per patient-year. The overall patient survival at 7 years was 70% +/- 3%. The freedom from major thromboembolism was 94% +/- 1% at 7 years (p = not significant for valve positions). The freedom from reoperation at 7 years was 93% +/- 1%; freedom from valve-related mortality was 89% +/- 2%. The freedom from structural valve deterioration at 7 years was 97% +/- 1% (aortic valve replacement 97% +/- 1%; mitral valve replacement 97% +/- 2%). The freedom from structural valve deterioration among age groups was not different for the overall population, aortic valve replacement, or mitral valve replacement. Hemodynamic assessment revealed obstructive properties for aortic valve replacement sizes of 21 and 23 mm and for mitral valve replacement sizes of 25 and 27 mm.(ABSTRACT TRUNCATED AT 250 WORDS)