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Ann Thorac Surg 1998;66:443-448
© 1998 The Society of Thoracic Surgeons

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Original articles: cardiovascular

Up to eight years’ follow-up of 997 patients receiving the CarboMedics prosthetic heart valve

^a Department of Surgery A, Rikshospitalet, University of Oslo, Oslo, Norway

Accepted for publication March 15, 1998.

Address reprint requests to Dr Fiane, Department of Surgery A, Rikshospitalet, Pilestredet 32, 0027 Oslo, Norway

	Abstract

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Background. The aim of the study was to evaluate our clinical experience with the CarboMedics Heart Valve Prosthesis.

Methods. Nine hundred ninety-seven consecutive patients underwent mechanical valve implantation (aortic, 771; mitral, 169; double, 52; tricuspid, 5) with this prosthesis from September 1987 through December 1993. The mean age was 62.3 ± 13.7 years (range, 0.4 to 84 years); 56.6% (564 patients) were men. Four hundred seventy patients (47.1%) underwent additional surgical procedures. Mean follow-up was 4.1 ± 2.2 years (range, 0 to 8.3 years) with a total of 4,040 patient-years.

Results. Early mortality was 5.0% (50/997; aortic, 4.4%; mitral, 6.4%; double, 9.6%). Late mortality was 14.8% (140/947). Survival at 7 years was 75.9% ± 1.8% (aortic, 78.4% ± 2%; mitral, 70.7% ± 4.5%; double, 60.8% ± 7.4%). When matched for sex and age and compared with the normal Norwegian population, our patients had an increased standard mortality ratio in both men (1.9 ± 0.4) and women (2.9 ± 0.6). The linearized rate of major thromboembolism was 0.9% per patient-year, valve thrombosis 0.2% per patient-year, major bleeding event 0.6% per patient-year, paravalvular leak needing reoperation 0.5% per patient-year, prosthetic valve endocarditis 0.1% per patient-year, and of all reoperations 0.6% per patient-year.

Conclusions. The CarboMedics Heart Valve Prosthesis has incidences of morbid events comparable with or better than reported for other mechanical valves.

	Introduction

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In 1995 we reported the first results from 569 patients who had received a CarboMedics prosthetic heart valve (CPHV) (CarboMedics Inc, Austin, TX) at Rikshospitalet [1]. At that time this study represented the largest single-center experience, except for the multicenter study [2]. The aim of the present study was to analyze and present midterm results for a total of 997 consecutive patients who received the CPHV in our institution from September 1987 through December 1993.

	Material and methods

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Patient population
A total of 997 patients received 1,049 valves. There were 771 (77.3%) aortic (AVR), 169 (17%) mitral (MVR), 52 (5.2%) double (DVR), and 5 (0.5%) tricuspid valve replacements (TVR). Preoperative characteristics of the study population are shown in Table 1. The mean age was 62.3 ± 13.7 years (range, 0.4 to 84 years), with the largest age group in the sixth decade of life (Fig 1). Sixteen patients were younger than 20 years, and 22 were older than 80 years. Three hundred thirty-seven (33.7%) patients were older than 70 years at operation. The mean age of patients having aortic valve size less than or equal to 21 mm (67.0 ± 13.3 years; range, 4 to 84 years) was significantly higher (p < 0.001) than patients having aortic valve size greater than or equal to 23 mm (60.7 ± 13.4 years; range, 8 to 83 years). Preoperatively, 78.7% (n = 785) of the patients were in New York Heart Association (NYHA) functional class III or IV.

View larger version (16K): [in this window] [in a new window]   Fig 1. Age at operation in years shown by decade.

Procedure
Standard techniques for cardiopulmonary bypass were used with membrane oxygenators and moderate hemodilution. Moderate systemic hypothermia (27° to 32°C), topical cooling, and cold St. Thomas crystalloid solution provided myocardial protection. Mean total bypass time was 109 ± 37 minutes (range, 46 to 405 minutes). Mean cross-clamp time was 68 ± 22 minutes (range, 26 to 184 minutes).

After sizing the aortic root, the valve was sewn in using mattressed sutures. Pledgets were used whenever deemed necessary by the operating surgeon. Eight patients (0.8%) underwent aortic root enlargement. In general, the CPHV axis was implanted or rotated perpendicular to the septum in AVR, parallel to the septum in MVR, and perpendicular to the septal leaflet in TVR. Concomitant procedures were performed in 470 patients (47.1%), 351 (35.2%) of these being coronary artery bypass grafts. Ninety-one procedures (9.1%) were urgent. The most frequently used aortic valve sizes were 23 and 25 mm. For the mitral position, the most frequently used sizes were 29 and 31 mm. A total of 255 patients (25.6%) (women, 216/255, 94.7%; men, 39/255, 15.3%) received small (size 19 and 21 mm) aortic valves; 80 (8.0%) received size 19 mm, and 175 (17.6%) received size 21 mm (Fig 2).

View larger version (24K): [in this window] [in a new window]   Fig 2. Valve sizes (in mm) implanted.

Postoperative follow-up
All patients were readmitted for follow-up 1 year after implantation. Thereafter follow-up was performed by questionnaires and, whenever necessary, direct contact with patients or their physicians. Death dates and causes were received from the National Bureau of Statistics. The time required to complete current follow-up was 2 months. Follow-up was 100% complete with a closing date of January 1, 1996. Mean follow-up was 4.1 ± 2.2 years (range, 0 to 8.3 years) with a total of 4,040 patient-years. Follow-up for AVR was 3,176 patient-years, MVR follow-up was 677 patient-years, DVR follow-up was 167 patient-years, and TVR follow-up was 19 patient-years. Follow-up of more than 5 years was achieved in 331 patients (33.2%). No patient was lost to follow-up.

Epidemiologic and statistical methods
Definitions provided in the revised guidelines published in 1996 by Edmunds and associates [3] were used in categorizing morbid events. Late mortality was estimated by actuarial analysis [4, 5]. Late morbidity was also expressed as actuarial percentages and as linearized rates (% per patient-year) [3, 5]. The total population survival tables were taken from the National Bureau of Statistics. The method of standard mortality ratio analysis was used [6]. Values of p less than 0.05 were considered significant.

	Results

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Early results
Thirty-four patients (3.4%) needed mechanical assistance (intraaortic balloon pump or ventricular assist device) postoperatively. Early (30-day) mortality was 5.0% (50/997); in women, it was 4.9% (21/432), in men 5.1% (29/565), with AVR 4.4% (34/771), with MVR 6.4% (11/169), and with DVR 9.6% (5/52). In 43.4% of all deaths an autopsy was performed. Causes of early death were mostly related to poor ventricular function (Table 2). Thirty-five (3.5%) patients died of cardiac failure, arrhythmia, or myocardial infarction, which was not related to the prosthesis. Valve-related causes of early mortality included major neurologic event (1/997, 0.1%); major bleeding events (2/997, 0.2%), endocarditis (3/997, 0.3%), and sudden or unexplained events (2/997, 0.2%).

View larger version (28K): [in this window] [in a new window]   Fig 3. Survival of patients receiving prosthetic valve implants (n = 997). (AVR = aortic valve replacement; DVR = double valve replacement; MVR = mitral valve replacement.)

View larger version (25K): [in this window] [in a new window]   Fig 4. Freedom from paravalvular leak requiring reoperation. (AVR = aortic valve replacement; DVR = double valve replacement; MVR = mitral valve replacement.)

Reoperation
The linearized rate of reoperation for all causes was 0.6% per patient-year (Table 4). Actuarial percentages of freedom from reoperation at 5 years were 98.7% ± 0.5% for AVR, 97.9% ± 1.2% for MVR, and 100% for DVR. Five of the reoperations were because of endocarditis, 19 were because of perivalvular leak, 2 were because of valve thrombosis; 80% of these valves were explanted. All explants were replaced with CPHV of the same size. Two of 26 (7.4%) patients died early after reoperation because of cardiac failure. The risk of reoperation was not significantly different from primary replacement.

Structural valve deterioration
No structural failure was observed.

All events including mortality
Actuarial percentages of freedom from all events including mortality at 5 years were 92% ± 1.1% for AVR, 88.8% ± 2.7% for MVR, and 84.2% ± 5.2% for DVR; total 89.9% ± 1.1% (Fig 5).

View larger version (27K): [in this window] [in a new window]   Fig 5. Freedom from all events including mortality. (AVR = aortic valve replacement; DVR = double valve replacement; MVR = mitral valve replacement; NS = not significant.)

	Comment

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At Rikshospitalet, the first CPHV was implanted in 1987. The first 120 cases were included in the material used to support approval of this device in the United States. As the CPHV has remained the preferred mechanical valve in our institution, we have one of the longest clinical follow-ups and largest numbers implanted of any institution to date [1, 2, 7–9]. The follow-up is 100% complete. More than one third of the patients were older than 69 years, half had coronary artery disease, and one third had small valves implanted, indicating a large number of high-risk patients in our patient population.

Controversy regarding the superior heart valve prosthesis continues to be debated. The patient characteristics vary from center to center, and nonrandomized, single-center observations do not allow meaningful comparisons of mortality and morbidity rates and are therefore inappropriate to show superiority of one device over another [10]. However, in multiinstitutional studies, local biases may be present that do not appear in single-center studies. Our report describing different factors influencing patients operated on with a single heart valve prosthesis may therefore be of value. We do include the postoperative period in our analyses, although this may give a higher complication rate with a systemic bias of the results [11].

The early mortality rate of 5% in our patient cohort is lower than in some other studies on mechanical heart valves: CPHV reports [2, 8], St. Jude reports [12, 13], and Medtronic-Hall studies [14–16]. Our overall 7-year survival rate of 79.5% compares with the international CPHV study [2], St. Jude reports [12, 13], and Medtronic-Hall study [14]. Valve-related mortality describes the likelihood of a patient dying secondary to any valve-related complication, including sudden, unexplained early and late deaths. Unfortunately, only 43.4% of our patients had autopsies performed, making the analysis of cause of death less convincing. However, our study showed, not surprisingly, that the incidence of cardiac-related death with poor ventricular function and pump failure was the most common cause of death. One fourth of the patients received size 19 or 21 mm aortic prostheses. We did not find significantly different survival in small prostheses compared with larger ones, even though there was a significant difference in mean age at implantation.

When we compared our cohort of patients receiving heart prostheses with the total Norwegian population, the standard mortality ratios were high in both sexes, but in particular in women, suggesting a more aggressive course of heart disease in women receiving heart prostheses than in men. However, the standard mortality ratio method of adjustment does not completely take account of differences in population composition. Therefore, when more than two populations are to be compared, each may be compared to the standard population, but not directly to the others [17]. At the latest follow-up 19.4% of the patients were in NYHA class III or IV. This should be expected as our cohort incorporated a high percentage of older patients with significant heart failure before the operation or a high rate of coronary artery disease.

The major concern with mechanical heart valve prostheses remains their thrombogenic potential and the need for anticoagulation. The goal is currently to avoid thrombosis and find the balance between the lowest level of thromboembolic events and the bleeding complications. The pivot of CPHV has been designed to give greater regurgitate washing, which more than likely contributes to the valve’s low thrombosis rate in the aortic position [1, 7–9] and overall low rates of major thromboembolic events. Major bleeding events occurred rarely, but more commonly in the patients with AVR than in the other groups. The ability to visualize the leaflets on chest radiographs was of particular advantage whenever thrombosis was suspected. The frequency of thrombosis in our material (0.2% per patient-year) is at the same level as reported in the literature [2, 12, 16].

The reported background incidence for spontaneous (that is, without anticoagulation treatment) bleedings in patients 64 years or older is approximately 0.8% per year, and for transient plus nontransient cerebral ischemic attacks the rate is approximately 1.3% per year if unselected men aged 65 to 74 years are taken into account [18]. Horstkotte [19] suggests that all complications reporting less than 2.0% thromboembolic plus bleeding complications per year are lacking proper follow-up techniques, as not even the background incidence of such complications in the general population is detected. We do not know the background incidence of thromboembolic and bleeding complications in a matched Norwegian population. Despite the complete and thorough follow-up of our patients the incidences of thromboembolic and bleeding events in our material are less than the anticipated background incidence, which also includes minor thromboembolic and bleeding events. We do, however, believe that the quality of the anticoagulation management in Norway is good because of a well-developed primary health care system. An analysis of the independent CarboMedics Scientific Committee has in an extensive review concluded that there was no evidence of significant differences in relative frequency of thromboembolic and bleeding events or valve thrombosis in CPHV, Medtronic-Hall, and St. Jude prostheses [20]. Our results certainly support this conclusion.

Aksnes and colleagues [21] have shown that preoperative endocarditis is a significant risk factor of early mortality in valve replacement. An incidence of postoperative endocarditis of 0.1% in our patient population is low compared with other CPHV [2, 8], Medtronic-Hall, and St. Jude studies [12–15]. The incidence of paravalvular leak requiring reoperation equals that of other reports of CPHV, Medtronic-Hall, and St. Jude implantation [2, 12, 15], and significant paravalvular leak remains the most common indication for reoperation. The cuff in the mitral position provides a generous surface area and bulkiness, which is thought to be needed to prevent reoperation. Still, the reoperation estimate was greatest in the patients with MVR, as in other reports [2, 12]. Why mechanical valve prosthesis implantation in the mitral position is more susceptible to reoperation is unclear, although the strain of left ventricular pressure and the fact that the implantation of MVR sometimes is technically demanding, especially in severely calcified annuli, may be of importance.

The orifice of the CPHV valve is prevented from distortion because of the presence of the titanium stiffening ring. This virtually eliminates anecdotal and published reports of failure of mechanical heart valve prosthesis because of leaflet escape. In our experience we did not see any case of mechanical failure such as breakdown, leaflet escape, and lockup as reported for other valves [22–25].

In conclusion, our present analysis of 997 patients receiving CPHV valves in one institution, with a mean follow-up time of 4.1 ± 2.2 years (range, 0 to 8.3 years), confirms our first impression that CPHV is a reliable and safe mechanical prosthesis even in older age groups and that it may provide improved functional status and extend survival in the majority of patients. The added features of rotation, radiographic visibility, and resistance to distortion of the orifice make it an advanced design of the current bileaflet valve.

	References

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This Article Abstract Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Add to Personal Folders Download to citation manager Author home page(s): Arnt E. Fiane Odd R. Geiran Jan L. Svennevig Permission Requests Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Fiane, A. E. Articles by Svennevig, J. L. Search for Related Content PubMed PubMed Citation Articles by Fiane, A. E. Articles by Svennevig, J. L.