A prospective study of changes in the quality of life of patients following mitral valve repair and replacement.

OBJECTIVE: The primary aim of medical care and surgery for mitral valve disease is to improve the overall functional capacity and health of patients. AIM: To assess whether there was an actual improvement in quality of life (QOL) of patients 3 months following primary mitral valve repair (MRr) or mitral valve replacement (MVR). METHODS: Prospective study of 61 consecutive patients (34 males, mean age 64+/-12) who underwent primary, isolated mitral valve repair (MRr, n=40) or mitral valve replacement (MVR, n = 21) from April 1997 to October 1998. QOL parameters using the validated short form 36 (SF-36) questionnaire were determined before and at 3 months after surgery and analysed using the Wilcoxon matched pairs rank test. RESULTS: Mean QOL scores (scale 0-100) for all patients following mitral valve surgery showed clinical and statistically significant improvement in seven of eight QOL parameters, namely (i) physical function (post, 60+/-31 vs. pre, 44+/-29; P = 0.0001); (ii) role limitation due to physical function (50+/-42 vs. 23+/-36; P = 0.0002); (iii) social function (76+/-31 vs. 59+/-36; P = 0.0006); (iv) role limitation due to emotional problems (65+/-42 vs. 44+/-45; P = 0.003); (v) energy (57+/-24 vs. 40+/-24; P < 0.0001); (vi) mental health (73+/-20 vs. 66+/-21; P = 0.007); and (vii) general health perception (68+/-19 v 56+/-22; P = 0.0001); but not pain (73+/-29 v 71+/-30; P = 0.4). Following MRr there was significant improvement in seven of eight QOL parameters and following MVR there was significant improvement in three of eight QOL parameters. Whilst patients with ejection fraction > or = 50% showed significant improvement in seven of eight QOL parameters, there was no significant improvement in any QOL parameters in patients with impaired left ventricular (LV) function. Similarly, patients with mitral regurgitation with end-systolic dimensions of > or = 45 mm showed no significant improvement in any QOL parameters at 3 months follow-up. CONCLUSIONS: Our study suggests that following mitral valve surgery there was significant improvement in the QOL of patients especially in those patients requiring mitral valve repair. However, patients with impaired LV function and those with MR with end-systolic dimensions > or = 45 mm were unlikely to demonstrate a significant improvement in QOL at 3 months follow-up.

Midterm evaluation of the Tissuemed (Aspire) porcine bioprosthesis: 493 patients, 506 bioprostheses.

BACKGROUND: Valve durability has been a major concern with bioprostheses, and the Tissuemed (Aspire) porcine bioprosthesis was designed to provide a solution to structural valve failure. Because bioprostheses tend to fail by 8 years, the aim of our study was to determine its midterm durability and performance. METHODS: We reviewed 506 prostheses that were implanted in 493 patients (287 men; mean age 73 +/- 6 years) between 1991 and 1999. Preoperatively 316 (68%) patients were in New York Heart Association class III or IV. There were 417 (85%) aortic, 61 (12%) mitral, 13 (2.6%) aortic and mitral, and two (0.4%) tricuspid procedures. Concomitant procedures were performed in 163 (33%) patients. Follow-up was complete in 488 (98.9%) patients with a total cumulative follow-up of 1,402 patient-years. RESULTS: The 30-day mortality in this elderly population was 10% (95% confidence interval, 8 to 13), with no early valve-related deaths. Patients' survival at 8 years was 46% +/- 7%. This was influenced by the following factors: (1) the patient's age, being worse for those 70 years or older (p = 0.005); (2) those in New York Heart Association functional class III and IV (p = 0.004); (3) those in atrial fibrillation before the operation (p = 0.006); (4) those with poor left ventricular function (p = 0.009); and (5) those who had a previous cardiac operation (p = 0.003). Valve-related complications (expressed as percent per patient-year) were thromboembolism at 0.9%/patient-year; major hemorrhage at 1.4%/patient-year; bacterial endocarditis at 0.4%/patient-year; nonstructural dysfunction at 0.2%/patient-year, and reoperation at 0.2%/patient-year. At 8 years, freedom from thromboembolism was 93% +/- 7%, major hemorrhage, 90% +/- 4%, nonstructural dysfunction, 99% +/- 1%, structural valve failure, 100%, and reoperation, 99% +/- 1%. At follow-up, 98% of survivors were in New York Heart Association class I or II. CONCLUSIONS: Our study suggests that at 8 years, the Tissuemed (Aspire) porcine bioprosthesis is durable and has satisfactory performance with low complication rates.

Fifteen-year experience with the mitral Carpentier-Edwards PERIMOUNT pericardial bioprosthesis.

BACKGROUND: This multicenter study concerning the mitral PERIMOUNT valve previously reported clinical results at 12 years; this report updates the performance to 15 years postoperatively. METHODS: The 435 patients (mean age 60.7+/-11.6 years; 41.1% male) underwent implantation with the PERIMOUNT valve between 1984 and 1989 at seven institutions. Follow-up was complete for 96.1% of the cohort. The mean follow-up was 8.1+/-4.4 years (range 0 to 15.4 years) for a total of 3492 patient-years. RESULTS: There were 34 (7.8%) operative deaths, one (0.2%) valve related. The late mortality rate was 5.3%/patient-year (2.2%/patient-year valve related). At 14 years, the overall actuarial survival rate was 37.1%+/-3.3% (63.1%+/-4.4% valve related). Actuarial freedom from complications at 14 years was as follows: thromboembolism, 83.8%+/-3.2% (1.1%/patient-year); hemorrhage, 86.6%+/-3.2% (1.1%/patient-year); and explant due to structural valve deterioration (SVD), 68.8%+/-4.7%. Actual freedom from explant due to SVD was 83.4%+/-2.3%. Rates of structural failure decreased with increasing age at implant. CONCLUSIONS: The Carpentier-Edwards PERIMOUNT Pericardial Bioprosthesis is a reliable choice for a tissue valve in the mitral position, especially in patients more than 60 years of age.

A prospective study of changes in patients' quality of life after aortic valve replacement.

BACKGROUND AND AIM OF THE STUDY: After aortic valve replacement (AVR), 90% of survivors are in NYHA class I or II, and most return to work after three months. It is unclear, however, whether at that time patients have an improved quality of life (QOL), are able to perform physical and social activities, and live independently. METHODS: To assess this situation, 62 patients (39 males, 23 females; mean age 68.5 +/- 10 years) who underwent primary AVR completed the validated Short Form 36 (SF-36) questionnaire. QOL parameters were determined before and three months after surgery prospectively, and analyzed using the Wilcoxon matched pairs rank test. RESULTS: All patients showed significant improvement in all eight QOL parameters (score 0-100): (i) physical function (67 +/- 26 versus 37 +/- 28; p <0.00001); (ii) role limitation due to physical function (52 +/- 43 versus 20 +/- 37; p <0.0001); (iii) social function (80 +/- 25 versus 59 +/- 30; p <0.0001); (iv) role limitation due to emotional problems (64 +/- 41 versus 41 +/- 46; p = 0.01); (v) energy (62 +/- 22 versus 42 +/- 23; p <0.00001); (vi) mental health (78 +/- 19 versus 63 +/- 22; p <0.00001); (vii) pain (78 +/- 27 versus 67 +/- 32; p = 0.02); and (viii) general health perception (72 +/- 20 versus 58 +/- 21; p <0.00001). Significant improvements in QOL parameters were: (i) after mechanical and bioprosthetic AVR, seven of eight QOL parameters were improved; (ii) patients aged < 70 years had pronounced improvement in six of seven parameters, while those aged > or = 70 years had limited improvement in five of eight parameters; (iii) patients with valve sizes 19 and 21 mm improved in five of eight parameters, while those with > or = 23 mm implants improved in all eight parameters, regardless of post-AVR peak gradient of < 20 or > or = 20 mmHg; and (iv) patients with left ventricular end-diastolic dimension (LVEDD) < 55 mm improved in all eight parameters while those with LVEDD > or = 55 mm improved in only five parameters. CONCLUSION: There was significant improvement in patients' QOL at three months after AVR, regardless of the type of aortic implant used; improvement was greatest in those aged < 70 years. The results also suggest that patients with smaller implants (who were older) and those with LVEDD > or = 55 mm were less likely to show significant improvement in all QOL parameters at three months after AVR.

Effect of aortic valve replacement on plasma soluble P-selectin, von Willebrand factor, and fibrinogen.

We measured indexes of platelet activation (soluble P-selectin), endothelial dysfunction (von Willebrand factor), and fibrinogen in 54 patients who underwent aortic valve replacement (AVR): after mechanical AVR implantation, there was a significant increase in plasma levels of soluble P-selectin and von Willebrand factor levels 3 months after surgery, with no change in mean plasma fibrinogen levels. No significant changes in measured indexes were noted in patients undergoing biologic AVR, suggesting that mechanical AVR results in abnormal endothelial damage and/or dysfunction and platelet activation, which is not apparent among patients undergoing this procedure.

Increased platelet activation and endothelial dysfunction in patients with atrial fibrillation immediately following percutaneous balloon mitral valvuloplasty.

BACKGROUND: Immediately following percutaneous balloon mitral valvuloplasty (PBMVP), patients have a 3% risk of systemic thromboembolism. HYPOTHESIS: We hypothesized that this may in part be due to an increase in hypercoagulability (as indicated by abnormal coagulation, platelet activation, and endothelial dysfunction) in such patients. METHODS: We measured indices of platelet activation [soluble P-selectin (sPsel), ELISA], endothelial dysfunction [von Willebrand factor (vWf), ELISA], and coagulation (fibrinogen, modified Clauss) in 16 patients (15 women, mean age 59 +/- 10 years) with chronic atrial fibrillation admitted for PBMVP, and 16 healthy age- and gender-matched controls. Blood samples were obtained as follows: (1) peripheral venous samples prior to PBMVP, immediately following PBMVP, and 24 h after PBMVP; and (2) arterial samples prior to and immediately following PBMVP. RESULTS: Patients with mitral stenosis and chronic atrial fibrillation demonstrated significantly higher mean levels of vWf [148 (SD 24) vs. 102 (SD 37); t-test, p < 0.001] and plasma fibrinogen [4.2 (SD 0.8) vs. 3.3 (SD 0.8); p = 0.003] at baseline than matched healthy controls. There was a nonsignificant trend toward lower median sP-sel levels in patients with mitral stenosis [64 (inter quartile range 47-91) vs. 109 (46-128); Mann-Whitney test, p = 0.08]. Following PBMVP, there was a significant increase in venous sP-sel levels immediately post procedure (paired Wilcoxon test, p = 0.03) and at 24 h afterward (p = 0.01). Arterial s-Psel levels correspondingly increased immediately post procedure (p = 0.008). There was a significant increase in mean venous (at 24 h) but not arterial vWf levels post PBMVP. There were no significant changes in mean venous or arterial plasma fibrinogen levels following PBMVP. CONCLUSION: Patients with mitral stenosis and chronic atrial fibrillation have increased plasma levels of vWf and fibrinogen levels compared with healthy controls, suggesting increased endothelial dysfunction and coagulation at baseline in these patients. The increased levels of sP-sel immediately post procedure and at 24 h, in association with increased vWf levels at 24 h after PBMVP, are in keeping with an increase in platelet activation and endothelial dysfunction following PBMVP. These changes may contribute to the increased risk of thromboembolism following PBMVP and suggest the need for adequate antithrombotic therapy following PBMVP.

von Willebrand factor, fibrinogen, and soluble P-selectin levels after mitral valve replacement versus mitral valve repair.

Patients with mitral valve disease undergoing surgery are at an increased risk of thromboembolism. We hypothesized that this may be due in part to abnormalities in platelet activation, endothelial damage or dysfunction, and plasma fibrinogen in such patients. To test this hypothesis, we measured indexes of platelet activation (soluble P-selectin), endothelial damage or dysfunction (von Willebrand factor [vWf], enzyme-linked immunosorbent assay) and fibrinogen (modified Clauss) in 56 consecutive patients (35 women, mean age 65 years) admitted for isolated mitral valve repair (n = 39) or replacement (using mechanical implants, n = 17). Samples were taken from a peripheral vein before and at 3 months after valve surgery. Baseline results were compared with 56 healthy age- and sex-matched controls. Compared with controls, patients with mitral valve disease had higher levels of vWf (mean +/- SD 132 +/- 28 vs 101 +/- 35 IU/dl; p <0.001), but there were no significant differences in mean fibrinogen (p = 0.418) or soluble P-selectin (p = 0.855) levels between cases and controls. There was a significant increase in plasma vWf after mitral valve replacement: 142 +/- 25 IU/dl preoperatively, increasing to 161 +/- 33 IU/dl at 3 months after surgery (p = 0.0261). However, there were no significant changes in plasma fibrinogen (p = 0.306) or soluble P-selectin levels (p = 0.191). Patients undergoing mitral valve repair did not have any significant changes in mean vWf (p = 0.25), soluble P-selectin (p = 0.77), or fibrinogen (p = 0.22). There was a significant negative correlation (Spearman, r = -0.4, p = 0.003) in postoperative plasma vWf levels and the size of valve prosthesis used. Thus, patients with mitral valve disease have increased plasma vWf levels when compared with healthy controls, suggesting endothelial damage or dysfunction, with a further increase in levels after mitral valve replacement. Conversely, patients undergoing mitral valve repair do not demonstrate any significant changes in fibrinogen, or indexes of endothelial dysfunction or platelet activation.

A survey of hospital morbidity, mortality and quality of life following coronary artery bypass surgery in a UK Indo-Asian population.

To survey the in-hospital morbidity, mortality, length of stay in the intensive therapy unit (ITU) and hospital and quality of life in patients of Indo-Asian origin following coronary artery bypass (CABG) surgery, 345 consecutive patients (mean age 58 years; SD 8.9; range 32-88 years) undergoing primary, isolated CABG were studied. Non-elective CABG was undertaken in 41% of patients. The left anterior descending artery (LAD) was grafted in 89%, although in 30% of these the internal mammary artery (IMA) was not used. Following CABG, the hospital morbidity and mortality was within the expected range, although there was a trend towards higher in-hospital mortality in the Parsonnet low risk group of patients. The length of ITU and hospital stay was not prolonged. Using the SF-36 questionnaire in postoperative patients, low quality of life scores were obtained for six of the eight modalities tested including physical functioning, bodily pain and general health perception. The low quality of life scores and IMA usage in Indo-Asians needs to be addressed.

Twelve-year experience with Carpentier-Edwards PERIMOUNT pericardial valve in the mitral position: a multicenter study.

BACKGROUND AND AIMS OF THE STUDY: The study aim was to assess the durability of the Carpentier-Edwards PERIMOUNT pericardial bioprosthesis in the mitral position. METHODS: This seven-center retrospective clinical study involved the follow up of 333 patients who underwent isolated mitral valve replacement and 102 patients who underwent double (mitral and aortic) valve replacement with the PERIMOUNT pericardial valve between 1984 and 1989. Mean patient age at implant was 60.7 +/- 11.6 years; 41.1% were males. The most common etiology was rheumatic heart disease (53.9%) and the most common mechanism mitral insufficiency. All patients but six were followed for an average of 7.2 +/- 3.6 years after surgery; total follow up was 3071.7 patient-years (pt-yr). RESULTS: The total operative mortality rate was 7.6%; this included a valve-related mortality rate of 0.2%. The late mortality rate was 5.2% per pt-yr, of which 1.4% per pt-yr was considered valve-related. At 11 years, the overall actuarial survival rate was 53.3 +/- 2.8%, and actuarial freedom from valve-related death 83.9 +/- 2.6%. At follow up, 80% of patients were in NYHA class I or II, and 74% showed improvement. Twenty-eight incidences of deterioration requiring explant were observed. At 11 years the actuarial freedom from explant due to structural failure was 84.9 +/- 3.1%. Rates of structural failure decreased with age: the actuarial freedom from explant due to structural failure was 78.1 +/- 4.8% for patients aged < or = 60 years, 89.4 +/- 4.4% for those aged 61-70 years, and 100% for those aged over 71 years. CONCLUSION: The Carpentier-Edwards PERIMOUNT pericardial bioprosthesis is a reliable choice when a tissue valve is required, especially in patients over 60 years of age.