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Ann Thorac Surg 2001;71:1164-1171
© 2001 The Society of Thoracic Surgeons
a Department of Cardiovascular and Thoracic Surgery, Stanford University School of Medicine, Stanford, California, USA
Accepted for publication November 6, 2000.
Address reprint requests to Dr Miller, Department of Cardiovascular and Thoracic Surgery, Falk Cardiovascular Research Center, 300 Pasteur Dr, Stanford University School of Medicine, Stanford, CA 94305-5247
e-mail: dcm{at}leland.stanford.edu
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Abstract |
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Methods. Between 1964 and 1995, 306 patients underwent valve replacement for left-sided native (209 patients) or prosthetic (97 patients) valve endocarditis. Mechanical valves were implanted in 65 patients, bioprostheses in 221 patients, and homografts in 20 patients.
Results. Operative mortality was 18 ± 2% and was independent of replacement valve type (p > 0.74). Long-term survival was superior for patients with native valve endocarditis (44 ± 5% at 20 years) compared with those with prosthetic valve endocarditis (16 ± 7% at 20 years) (p < 0.003). Survival was independent of valve type (p > 0.27). The long-term freedom from reoperation for patients who received a biologic valve who were younger than 60 years of age was low (51 ± 5% at 10 years, 19 ± 6% at 15 years). For patients older than 60 years, however, freedom from reoperation with a biological valve (84 ± 7% at 15 years) was similar to that for all patients with mechanical valves (74 ± 9% at 15 years) (p > 0.64).
Conclusions. Mechanical valves are most suitable for younger patients with native valve endocarditis; however, tissue valves are acceptable for patients greater than 60 years of age with native or prosthetic valve infections and for selected younger patients with prosthetic valve infections because of their limited life expectancy.
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Introduction |
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TopAbstractIntroductionMaterial and methodsResultsCommentReferences |
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Material and methods |
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TopAbstractIntroductionMaterial and methodsResultsCommentReferences |
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The diagnosis of endocarditis was based on generally accepted clinical criteria, including appropriate combinations of fever, new or altered cardiac murmurs, systemic emboli, positive blood cultures, and echocardiographic findings. Characteristic valvular changes were confirmed both at operation and histopathologically. Endocarditis was defined as active (211 patients) versus healed (95 patients) based on whether a planned, standard course of antibiotic therapy had been completed before operation. Although this arbitrary distinction is not a direct index of the activity of the infectious process per se, it correlates with both the operative risk and pathological findings at operation [8, 9]. The time from symptoms to treatment averaged 35 ± 60 days, while the time from initiation of medical treatment to operation was 51 ± 69 days. Topical and systemic hypothermia alone was used for myocardial protection in 107 (35%) patients, cold crystalloid cardioplegia was added in 158 (52%) patients, and cold blood cardioplegia in 41 (13%) patients. Cardiopulmonary bypass time was 118 ± 71 minutes, and aortic clamp time averaged 74 ± 41 minutes. Isolated aortic valve replacement (AVR) was performed in 190 (62%) patients, isolated mitral valve replacement (MVR) in 89 (29%) patients, and combined AVR and MVR in 27 (9%) patients. Before 1976, Starr-Edwards mechanical caged-ball valves were implanted most often (61% mechanical, 27% bioprosthetic, 12% homograft); between 1976 and 1986, porcine bioprosthetic valves were implanted almost exclusively (98% bioprosthetic, 2% homograft); from 1987 to 1995, valve choice varied (25% mechanical, 65% bioprosthetic, 10% homograft) according to the judgment of the attending surgeon. The use of specific valve types is summarized in Table 1. Concomitant coronary artery bypass grafting was performed in 28 (9%) patients. Thirty-one patients (14% of those who underwent AVR) required aortic root replacement for extensive annular or aortic wall involvement. Seventeen of these patients underwent homograft root replacement, while 2 patients underwent mechanical and 12 patients underwent bioprosthetic composite valve-graft replacement. The responsible organisms for all patients are listed in Table 2. Streptococcal infections were common in both NVE and PVE; however, while Staphylococcus aureus was more common in NVE, S epidermidis predominated in PVE cases. Postoperative antibiotics were continued for 26 ± 23 days.
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Continuous data are reported as mean ± 1 SD, and clinically important ratios with 70% confidence limits. Actuarial life-table survival estimates were calculated using the Cutler-Ederer method and compared using the Gehan technique (SPSS, Chicago, IL). Variability of the actuarial estimates was expressed as ±1 SEM. Freedom from reoperation estimates were also determined using the actual, or cumulative incidence, method of analysis, which takes into account the competing hazard risk of death when calculating the probability of reoperation [10, 11]. Univariate and multivariate regression analysis (Cox proportional hazard model) was used to determine the preoperative and intraoperative risk factors that were significant, independent predictors of operative mortality and the development of a late complication. Thirty variables (see Table 4) were examined, including intraoperative factors (for example, myocardial protection with topical and systemic hypothermia alone vs cold crystalloid or blood cardioplegia) and complications related to visceral organ dysfunction, cardiac dysfunction, underlying comorbid disease, persistent sepsis, and the extent of the infection.
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Results |
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Long-term survival was significantly superior for patients with NVE (54 ± 4% at 10 years, 44 ± 5% at 20 years) compared with those with PVE (41 ± 6% at 10 years, 16 ± 7% at 20 years) (p < 0.003) (Fig 1). Excluding operative deaths, long-term survival was slightly higher for patients with NVE (63 ± 4% at 10 years, 51 ± 5% at 20 years) compared with those with PVE (51 ± 5% at 10 years, 22 ± 10% at 20 years) (p = 0.10). The estimate of patients alive without complications also tended to be lower, but statistically insignificantly so, for patients with PVE (10 years: 61 ± 7% PVE vs 75 ± 4% NVE; p > 0.17). Multivariate regression analysis identified five factors to be independent predictors of developing a late complication: (1) increased age (p < 0.001); (2) PVE versus NVE (p < 0.03); (3) annular abscess (p < 0.02); (4) acute preoperative myocardial infarction (p < 0.03); and (5) emergency operation (p < 0.02). Late complications were not significantly related to the type of replacement valve (p > 0.90).
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Homograft recipients were excluded from the following analyses due to the small number of patients in each subgroup. For patients less than or equal to 60 years of age, overall long-term survival was similar in those who received a mechanical (61 ± 9% at 10 years, 50 ± 10% at 15 years) or a biologic (58 ± 4% at 10 years, 52 ± 5% at 15 years) valve (p > 0.29) (Fig 3A). For patients greater than 60 years of age, long-term survival tended to be lower in patients who received a mechanical valve (18 ± 12% at 10 years) compared with those who received a biologic valve (31 ± 6% at 10 years, 17 ± 7% at 15 years) valves (p = 0.08) (Fig 3B); however, the number of older patients receiving mechanical valves was small (15 of 87, 17%). Complication-free survival was similar with either mechanical (72 ± 8% at 10 years, 72 ± 8% at 15 years) or bioprosthetic (73 ± 4% at 10 years, 71 ± 4% at 15 years) valve replacement (p = 0.9) (Fig 4).
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Comment |
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Historically, it has been suggested that bioprosthetic valves may be less susceptible to early recurrent endocarditis than mechanical valves, but that they may be more susceptible to late endocarditis due to infection of the tissue leaflets [13, 14]. An early review of 2,184 patients reported that resistance to infection, pathologic behavior once affected by PVE, and the survival rate after PVE were similar between bioprosthetic and mechanical valves [15]. Recent reviews have substantiated these findings with current reported linearized PVE rates of less than 1.0% per patient-year for bioprosthetic and mechanical valves [5–7, 14, 16]. In the current series, the linearized rate of recurrent or residual endocarditis was 1.5 ± 0.3% per patient-year for NVE and 2.5 ± 0.7% for PVE, and did not differ significantly between mechanical (1.2 ± 0.5%) and bioprosthetic (1.8 ± 0.3%) valves. Operative mortality and complication-free survival were also similar with mechanical and bioprosthetic valves.
Infected bioprosthetic valves are, in general, more easily sterilized than mechanical valves if treatment is initiated before extension of the infection into the annulus occurs; for example, streptococcal bioprosthetic infections can be cured in 80% of patients with antibiotics as long as valvular dysfunction is not present [15, 17]. Infection of a bioprosthetic valve may, however, hasten structural valve degeneration due to injury to the bioprosthetic leaflets. This can also occur with homografts, where leaflet destruction and valvular dysfunction can occur early in the infective process, prompting surgical intervention despite the absence of annular extension [18]. Mechanical or bioprosthetic infections involving the sewing ring or annulus invariably necessitate valve re-replacement. In the current report, univariate analysis demonstrated that operative mortality was higher for patients with annular abscesses (25 ± 4% vs 13 ± 2%); while extravalvular extension was not an independent predictor of operative mortality, annular abscesses were associated with more late complications. Complete excision of all infected or necrotic tissue along with generous margins of clearly healthy tissue is the cornerstone of surgical treatment of patients with extravalvular involvement. Extensive debridement may necessitate novel, complex annular reconstructive techniques with or without homograft aortic root replacement in some cases [12, 19, 20].
Haydock and associates compared the use of freehand aortic homografts (78 patients) with mechanical or bioprosthetic valves (30 patients) in the surgical treatment of patients with active endocarditis [2]. They noted that with homografts, the hazard function for recurrent endocarditis had only a low constant phase, while with prosthetic valves, there was a high early hazard phase in addition to the low-hazard late constant phase. In the current report, only 20 homografts were implanted in highly selected patients with extensive destruction of surrounding cardiac structures, but 2 of 14 (14 ± 9%) operative survivors developed recurrent endocarditis within 5 years. In this admittedly small subset of homograft patients, there was no apparent advantage to using this technique. Looking specifically at patients with prosthetic aortic infections, Lytle and coauthors found no difference in survival or freedom from reoperation if bioprosthetic, mechanical, or homografts where used for valve re-replacement (p > 0.64) [4].
Sweeney and colleagues from the Texas Heart Institute reviewed 185 patients who underwent mechanical (97 patients) or bioprosthetic (88 patients) valve replacement for endocarditis; mean follow-up time was 20 months [1]. They noted no difference in operative mortality between the groups, but found that reoperation for recurrent endocarditis or perivalvular leak was necessary in 15 (20% of operative survivors) of patients with a bioprosthetic valve but in only 5 (6% of operative survivors) mechanical valve recipients within 3 years. In contrast, freedom from reoperation in the current series was similar between mechanical and bioprosthetic valves at 3 years (86 ± 5%, 87 ± 3%) and at 5 years (86 ± 5%, 84 ± 3%). The Texas Heart group also suggested a small, but significant, survival advantage at 4 years (excluding operative deaths) with mechanical rather than bioprosthetic valves (87% vs 79%, p < 0.05). In the current series, however, there was no difference in 4-year survival with mechanical or bioprosthetic valves (82 ± 6%, 79 ± 3%) or, more importantly, in late survival at 10 years (62 ± 9%, 61 ± 4%), 15 years (46 ± 10%, 52 ± 5%), or even 20 years (46 ± 10%, 41 ± 6%) (p > 0.50). In this context it is important to note that most of the bioprosthetic valves implanted in the Texas Heart series were Ionescu-Shiley pericardial valves; most of these were an early version with a Teflon (polytetrafluorethylene) sewing ring, which does not promote rapid tissue ingrowth as does the Dacron velour sewing rings used in later Ionescu-Shiley valves and many current valves. Furthermore, this particular type of early pericardial valve was prone to early SVD, and is no longer on the market. These factors may have played a role in the high early reinfection rate reported in their bioprosthetic recipients. In the current series, no Ionescu-Shiley valves were implanted; only stented Hancock or Carpentier-Edwards porcine valves were used.
In younger patients, the long-term reoperation rate was higher with bioprosthetic valves than with mechanical valves due to SVD, but, as patient age increased, the freedom from reoperation rates converged. Accepting that there are many different opinions among surgeons and a myriad of exceptions to the standard rule, a reasonable initial age criteria for implanting biologic prostheses for noninfectious valvular disease is 70 years of age for MVR and 65 to 70 years of age for AVR, if no comorbidities exist that would otherwise limit life expectancy. Fann and associates reported that the actuarial estimate of freedom from reoperation was very high in patients greater than 70 years of age after bioprosthetic AVR (93 ± 2% at 10 years) and MVR (84 ± 6% at 10 years), but as patient age fell below 70 years, the reoperation rates progressively rose [5]. In the current series of patients with endocarditis, freedom from reoperation appeared higher with mechanical valves in younger patients, but this risk was similar with either mechanical (100 ± 0% at 10 years) or bioprosthetic (actuarial: 84 ± 7% at 10 years, actual: 91 ± 6% at 10 years) valves for patients greater than 60 years of age. It appears that for patients with infectious valvular disease, the age threshold for selecting a bioprosthetic valve should be lower than that for patients with noninfectious valvular disease. Furthermore, long-term survival was low in all patients with PVE (31 ± 7% at 15 years, 16 ± 7% at 20 years), suggesting that bioprosthetic valves may be appropriate for selected younger patients in this subset. The competing risk of death for patients with endocarditis markedly limits life expectancy, which means that fewer patients will actually live long enough to experience SVD of a tissue valve. This high competing hazard (eg, death) exemplifies the importance of using actual methods instead of actuarial techniques to examine what the true risk of a nonfatal valve-related complication is for individual patients; this is because the actuarial freedom curves overestimate the true incidence of such an event occurring.
In summary, when valve replacement is necessary, we recommend mechanical prostheses for most patients with NVE who are less than 60 years of age, have no contraindication to long-term anticoagulation, and have a life expectancy that is otherwise not limited by other major medical problems. Bioprosthetic valves, on the other hand, are used for patients greater than 60 years of age with either NVE or PVE. Bioprosthetic valves are also acceptable for selected younger patients with PVE who have limited life expectancy, eg, coronary artery disease, left ventricular dysfunction, or end-stage renal failure. These data continue to argue strongly for early valve replacement (or repair) as the initial form of treatment for patients with congestive heart failure, in lieu of prolonged stabilization with medical therapy. Earlier surgical intervention, before the adverse multiorgan consequences of persistent infection and prolonged hemodynamic instability become manifest, may be the only way to improve the otherwise poor expected outcome in these often critically ill patients.
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