Ira Goldsmith

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 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.

Indexes of hypercoagulability measured in peripheral blood reflect levels in intracardiac blood in patients with atrial fibrillation secondary to mitral stenosis

Systemic thromboembolism is a major complication in patients with mitral stenosis, especially in those who have atrial fibrillation (AF). It has been suggested that there may be increased regional left atrial coagulation activity in such patients, despite normal systemic coagulation activity on peripheral blood sampling. Our aim was to investigate whether there were significant differences between intracardiac versus peripheral indexes of hypercoagulability in 25 patients (5 men; mean age 60 years) with mitral stenosis who were undergoing percutaneous balloon mitral valvuloplasty and who were all in chronic AF. Two days after halting warfarin therapy, intracardiac (right and left atria) and peripheral (venous and arterial) blood samples from patients were obtained and compared with levels in matched healthy controls in sinus rhythm. Thrombogenicity was assessed by levels of fibrin D-dimer, fibrinogen, indexes of platelet activation (soluble P-selectin and beta thromboglobulin [betaTG]) and indexes of endothelial dysfunction (soluble thrombomodulin [sTM] and von Willebrand factor [vWF]). There were no statistically significant differences in the various markers between the femoral vein and artery, left and right atria, and between the femoral vein and both atria (all p = NS). Plasma fibrinogen, vWf (both p <0.005), and D-dimer (p = 0.011) were significantly higher and levels of sP-selectin and sTM were lower (both p <0.005) in patients when compared with controls. There was no significant difference in plasma betaTG levels. Our results suggest that there is no significant variation in indexes of thrombogenesis, platelet activation, and endothelial dysfunction between left atrium, right atrium, and the peripheral artery or vein. Peripheral samples therefore do reflect atrial coagulation, platelet, and endothelial activities.

Valvar heart disease and prosthetic heart valves

Thromboembolism and anticoagulant related bleeding are major life threatening complications in patients with valvar heart disease and those with prosthetic heart valves. In these patients effective and safe antithrombotic therapy is indicated to reduce the risks of thromboembolism while keeping bleeding complications to a minimum. ![][1] Valve thrombosis of a bileaflet prosthetic mitral valve Risk factors that increase the incidence of systemic embolism must be considered when defining the need for starting antithrombotic therapy in patients with cardiac valvar disease and prosthetic heart valves. These factors include age, smoking, hypertension, diabetes, hyperlipidaemia, type and severity of valve lesion, presence of atrial fibrillation, heart failure or low cardiac output, size of the left atrium (over 50 mm on echocardiography), previous thromboembolism, and abnormalities of the coagulation system including hepatic failure. Secondly, the type, number, and location of prostheses implanted must be considered. For example, mechanical prostheses are more thrombogenic than bioprostheses or homografts, and hence patients with mechanical valves require lifelong anticoagulant therapy. However, the intensity of treatment varies according to the type of mechanical prosthesis implanted. First generation mechanical valves, namely the Starr-Edwards caged ball valve and Bjork-Shiley standard valves, have a high thromboembolic risk; single tilting disc valves have an intermediate thromboembolic risk; and the newer (second and third generation) bileaflet valves have low thromboembolic risks. #### Considerations for antithrombotic therapy in patients with valve disease In patients with a bioprosthesis in sinus rhythm, antithrombotic therapy with an … [1]: /embed/graphic-1.gif

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.

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.

Hyperlipidaemia Management after Primary Coronary Artery Bypass Surgery: A Survey of Patients and General Practitioners

Background It is well established that, in patients with increased cholesterol concentrations and vascular disease, decreasing the cholesterol concentration significantly reduces the risk of coronary events. After coronary artery bypass graft surgery (CABG), the risk of further coronary events is likely to be reduced if there is effective control of cholesterol concentrations. The aim of the survey was to review awareness among general practitioners and patients of the need for maintenance of serum cholesterol values, frequency of serum cholesterol checks, dietary advice and lipid-decreasing medication in patients after CABG. Methods Hospital notes of 200 patients who underwent primary, coronary artery bypass surgery from January 1994 to 1996 were examined and postal questionnaires sent to patients and their general practitioners inquiring whether they had had their serum cholesterol tested in the past 3 years; whether dietary advice had been given if cholesterol concentrations were increased to more than 5.2 mmol/l; whether a repeat serum cholesterol test was performed 3 months later if values were greater than 5.2 mmol/l; and (for those with serum cholesterol values greater than 5.2 mmol/l), whether they were on lipid-decreasing medication. Results We considered 146 (76%) replies to be complete. Hospital and general practitioner records of these patients showed, that in the previous 3 years, after CABG, only 63% (n = 92) had their serum lipid profile checked and, of these, 74% (n = 68) had increased serum cholesterol concentrations of more than 5.2 mmol/l. Only 46% (n = 31) received dietary advice alone. After dietary advice had been given, serum cholesterol was rechecked in 26% (n = 8) of patients and only 3% (n = 1) had a decrease in serum cholesterol to less than 5.2 mmol/l. Among the patients with increased serum cholesterol, 50% (n = 34) received lipid-decreasing medication, but serum cholesterol was rechecked in only 52% (n = 17) of patients. In 9% (n = 3) of these, serum cholesterol concentrations had decreased to less than 5.2 mmol/l. Among the 146 complete replies from patients, 95% (n = 139) indicated that control of serum cholesterol was important, 82% (n = 120) had received dietary advice and 39% (n = 57) were on lipid-decreasing medication. Conclusion General practitioners and patients were generally aware of cholesterol control after CABG. However, a relatively low proportion of patients underwent serum cholesterol checks and received documented dietary advice, lipid-decreasing medication, or both. Dietary advice alone may be inadequate in controlling lipid concentrations and, in many cases, needed to be supplemented with adequate lipid-decreasing therapy.

Early clinical experience with the tissuemed porcine bioprosthesis

BACKGROUND Tissuemed (Leeds, England) porcine bioprostheses are freshly mounted and dilated for correct functional sizing and commissural alignment, then fixed under low pressure. These valves closely approximate the natural leaflet geometry, reduce opening commissural bending stresses, and may provide a solution to structural valve failure from calcification and tears. To evaluate the performance of the bioprosthesis 207 Tissuemed bioprostheses were implanted in 203 patients, 114 men and 89 women (mean age 73 years; range 56 to 94 years), between 1991 and 1996. Preoperatively 66% of the patients were in New York Heart Association functional class III or IV. There were 175 aortic, 22 mitral, 2 tricuspid, and 4 multiple replacements. Concomitant procedures were performed in 26.1% (53 of 203) of patients. Follow-up was 99.5% (total cumulative follow-up 447.5 patient-years). RESULTS The 30 day mortality, influenced by age and valve position, was 11.8% with no early valve-related deaths. Patient survival at 5 years was 76% (standard error 3.3%). Valve-related complication rates (expressed as percent per patient-year and number of events) were thromboembolism 1.1% (5), hemorrhage 0.7% (3), bacterial endocarditis 0.2% (1), nonstructural valve failure 0.2% (1), and reoperation 0.5% (2). At 5 years freedom from valve-related events were as follows: thromboembolism 92.9% (standard error 2.7%), hemorrhage 96.1% (standard error 1.9%), endocarditis 98.1% (standard error 1.8%), nonstructural valve failure 99.2% (standard error 0.7%), structural valve dysfunction 100% (standard error 0.0%), and reoperation 98.1% (standard error 1.8%). At follow-up 73.8% of the patients were in New York Heart Association functional class I or II. CONCLUSIONS There were no early valve-related deaths, no episodes of structural valve failure, and valve-related complications compared favorably with other porcine series. There was overall clinical improvement in patient symptoms. Our experience suggests that the Tissuemed porcine bioprosthesis is a safe and reliable heart valve providing good clinical improvement in patient symptoms. Long-term clinical follow-up is, however, essential to complete the evaluation.

Re: A prospective randomised study to assess the efficacy of a surgical sealant to treat air leaks in lung surgery

I congratulate the authors for a randomised trial demonstrating the effectiveness of Coseal in reducing intra-operative air leak following lung resection [1] .T he second aim of the study was to assess if Coseal reduced the number of patients with air leaks at 24 and 48 h following surgery. The study data showed that following the application of Coseal, the rate of air leaks increased at 24 and 48 h since the number of patients with air leaks increased from 15% (intra-operative air leaks) to 24% at 48 h in the Coseal group compared with 1% increase in the control group. Hence, the statement that the application of the sealant allowed significant reduction in the number of patients with air leaks assessed at 24 and 48 h after surgery is misleading. Moreover, this may also explain why there was no significant difference in the duration of hospital stay between the two groups instead of medical and surgical factors, as suggested by the authors, since randomisation should account for these factors otherwise the groups are different.