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J Thorac Cardiovasc Surg 2002;124:146-154
© 2002 The American Association for Thoracic Surgery
Surgery for Acquired Cardiovascular Disease (ACD) |
From the Division of Cardiovascular Surgery of Toronto General Hospital and the University of Toronto, Toronto, Ontario, Canada.
The Karolinska Institute and the Swedish Institute provided financial support for Dr Dellgren.
Received for publication Aug 28, 2001. Revisions requested Sept 28, 2001; revisions received Oct 22, 2001. Accepted for publication Nov 1, 2001. Address for reprints: Tirone E. David, MD, Division of Cardiovascular Surgery, Toronto General Hospital, 200 Elizabeth St, EN 13-222, Toronto, Ontario M5N 2C4 Canada (E-mail: tirone.david{at}uhn.on.ca).
| Abstract |
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| Introduction |
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| Material and methods |
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Operative survivors were followed up by telephone or questionnaire between October 1998 and January 1999. The follow-up was 100% complete. The mean follow-up was 60 ± 31 months (range 1-167 months), and 1214 patient-years of follow-up were available for analysis.
Doppler echocardiography
Transthoracic echocardiography with continuous-wave, pulsed-wave, and color flow Doppler studies were performed with a Hewlett Packard 1000, 1500, 2500, or 5500 Ultrasonoscope (Hewlett-Packard Company, Palo Alto, Calif) equipped with a 2.5-MHz transducer. Sixty-one percent of survivors (n = 109/178) had an echocardiogram performed at our hospital between December 1998 and May 1999. The mean follow-up for these studies was 67 ± 25 months (range 7-172 months). Those patients who did not undergo echocardiography either lived too far away from the hospital or were too old and in too fragile a condition to come without great difficulty.
For further details about measurements and calculations, see the Appendix. Left ventricular hypertrophy (LVH) was defined as a left ventricular mass index (LVMI) higher than 131 g/m2 for men and higher than 100 g/m2 for women.
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Definitions and statistics
This report was based on the guidelines for reporting morbidity and mortality after cardiac valvular operations.
6 Survival and time-related event analyses were performed with the Kaplan-Meier method. Multivariable analyses of risk factors for survival and time-related events were done by Cox regression methods previously described. The term actuarial survival was used to describe time-related analysis for that event and not to describe the type of analysis performed. Differences were tested for statistical significance with 1-way analysis of variance. When the F test revealed a significant difference, each pair of means was compared with the Scheffé test.
| Results |
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Complications
Thromboembolism
Thromboembolic events were observed in 17 cases (14 strokes and 3 transient ischemic attacks). The freedoms from thromboembolism at 5, 10, and 12 years were 93% ± 2%, 88% ± 3%, and 67% ± 13%, respectively. The linearized rate for thromboembolic events was 1.4% ± 0.1% events/100 patient-years. At the last follow-up 38 of 178 patients (21%) were taking warfarin sodium and 140 (79%) were taking aspirin daily. Multivariate analysis showed that age (odds ratio 1.11, 95% confidence interval 1.02-1.20, P = .01) was an independent risk factor for thromboembolism.
Structural valve dysfunction
Structural valve deterioration occurred in 4 patients, and they were reoperated on after 8, 9, 9, and 13 years of follow-up. All 4 patients had cusp tears: 2 had commissural tears and 2 had midcusp tears. In addition, 3 patients had calcification of the cusps. The actuarial freedoms from structural valve dysfunction at 5, 10, and 12 years were 100%, 86% ± 9%, and 86% ± 9%, respectively (Figure 2). The actual freedoms from structural valve dysfunction at the corresponding intervals were 100%, 92% ± 6%, and 92% ± 6%, respectively (Figure 2
). There were no valve failures in patients older than 65 years.
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Reoperations
Six patients underwent reoperation, and all survived. The indications for reoperation were structural valve deterioration in 4 cases and endocarditis in 2 cases. The actuarial freedoms from reoperation at 5, 10, and 12 years were 99% ± 1%, 83% ± 9%, and 83% ± 9%, respectively.
Other complications
Only 1 patient had a serious anticoagulant-related hemorrhage, even though 21% of the patients were receiving oral anticoagulation. Four patients needed late pacemaker implantation. Eight patients had a late acute myocardial infarction.
Late functional classification
At the latest follow-up 178 patients were alive and had the original CEP bioprosthesis in place. Seventy-two patients (41%) were in NYHA functional class I, 63 (35.5%) were in class II, 41 (23%) were in class III, and 1 (0.5%) was in class IV.
Echocardiography
Echocardiography of long-term survivors (mean 67 ± 25 months) showed that peak and mean gradients for all valve sizes were 23.2 ± 9.6 mm Hg (range 11-66 mm Hg) and 12.3 ± 4.8 mm Hg (range 5-31 mm Hg), respectively. Table 4 shows Doppler-echocardiographic data according to valve sizes at late follow-up. Smaller valves had statistically significantly higher transvalvular peak (P = .02) and mean (P = .003) gradients than did larger valves. Mean aortic valve area for all valves was 1.3 ± 0.3 (range 0.5-2.36 cm2), and area increased significantly with increasing valve size (P = .0001). Also, aortic valve areas were significantly larger in 27-, 25-, and 23-mm valves than in 19- and 21-mm valves (Table 4
). However, 22 patients (20%) had an aortic valve area smaller than 1 cm2 at late follow-up.
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| Discussion |
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In this report of clinical and hemodynamic late outcomes after AVR with the CEP bioprosthesis, we confirm previous studies indicating good results comparable to newer porcine valves.
2,3,13 Banbury and associates
2 and Neville and associates
4 reported similar 5- and 10-year survivals, although in somewhat younger patient populations than in our study, for the CEP bioprosthesis in the aortic position. Table 6 shows survivals and freedoms from structural valve degeneration in earlier reported studies of the CEP pericardial bioprosthesis. Poirier and coworkers
3 have reported excellent survival rates in a younger patient population than ours. Survivals for our patient population with the CEP bioprosthesis were lower than in our population with the Hancock II porcine bioprosthesis.
13 However, our patients with the CEP bioprosthesis were significantly older than those with the Hancock II porcine bioprosthesis (Table 6
). We have previously shown that advanced age, male sex, advanced left ventricular dysfunction, coronary artery disease, and advanced NYHA functional class are independent predictors of mortality among patients with AVR.
14 Our patient population was in general older and had more coronary artery disease than in other studies.
1-4,11,13 Considering the risk factor profile in our study, the survival must be considered satisfactory. As anticipated, the multivariate analysis from our study showed that coronary artery disease and NYHA class III or IV were risk factors for late death and for cardiac non-valve-related death.
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We found that LVH was still present at long-term follow-up in about a third of the patients. In contrast, as previously reported by our group,
16 only 8% of the patients with a Toronto SPV had LVH by echocardiography after a similar mean follow-up of 5 years. However, we have also showed that sex, hypertension, cause of valve disease, and presence of coronary artery disease,
16 as well as genetic factors,
18 influence both the preoperative degree of LVH and its regression. Thus many confounding factors exists between the previously mentioned studies, which makes it difficult to safely conclude anything regarding the degree of LVH at late follow-up. Maybe the most surprising finding of the late follow-up echocardiography was that 23% of the patients had moderate or severe mitral regurgitation. However, we were not able to show that either mitral regurgitation or preoperative aortic insufficiency was significantly more common among patients with LVH than among those without LVH.
| Limitations of the study |
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| Appendix |
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The peak (VAVmax) and mean (VAVmean) systolic flow velocities (in meters per second) across the aortic valve were recorded with continuous-wave Doppler, and those proximal to the aortic valve in the LVOT (VLVOTmax and VLVOTmean) were recorded with pulsed-wave Doppler. The average of three consecutive cardiac cycles in sinus rhythm or of 10 cardiac cycles in atrial fibrillation was used to calculate transaortic velocities and velocity time integrals (VTIAV and VTILVOT, in centimeters). Peak (PLVOTpeak and PAVpeak) and mean (PAVmean and PLVOTmean) pressure differences (in millimeters of mercury) were calculated according to the modified Bernoulli equation
1:
Ppeak = 4 x (VAVmax2 - VLVOTmax2)
Pmean = PAVmean - PLVOTmean
PAVmean - PLVOTmean = 4 x (VAVmean2 - VLVOTmean2)
The LVOT diameter (D, in centimeters) was determined in midsystole from the parasternal long-axis view. The effective orifice area (EOA, in centimeters) was calculated with the continuity equation
1:
EOA (cm2) = 3.14 x 2D/4 x VTILVOT/VTIAV
Cardiac output (CO, in liters per minute) was calculated as the product of stroke volume and heart rate (HR, in beats/min)
1:
CO = HR x (3.14 x 2D/4 x VTILVOT)/1000
Measurements of interventricular septum (IVS) and posterior wall (PW) thicknesses (in centimeters) and left ventricular end-diastolic dimension (LVEDD, in centimeters) were obtained with 2-dimensional echocardiography in a standard fashion. Left ventricular mass (LVM, in grams) was calculated from IVS and PW thicknesses and the LVEDD according to the American Society of Echocardiography cube method
2:
LVM = 0.8 x 1.04 x [(IVS + PW + LVEDD)3 - (LVEDD)3] + 0.6
The left ventricular mass index was calculated by dividing LVM by body surface area.
Aortic insufficiency was assessed with color flow Doppler and CW and PW Doppler in any view.
3 The ejection fraction was determined according to the Simpson rule and left ventricular function was classified by ejection fraction as grade 1 (>60%), grade 2 (40%-60%), grade 3 (20%-40%), or grade 4 (<20%).
1
| Acknowledgments |
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| References |
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| References |
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