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Ann Thorac Surg 1998;66:1940-1947
© 1998 The Society of Thoracic Surgeons

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Original Articles

Tricuspid valve replacement: UK heart valve registry mid-term results comparing mechanical and biological prostheses

^a United Kingdom Heart Valve Registry, Department of Cardiothoracic Surgery, Hammersmith Hospital, London, England, UK
^b Department of Medical Statistics and Evaluation, Imperial College School of Medicine, London, England, UK

Address reprint requests to Dr Ratnatunga, Department of Cardiothoracic Surgery, Hammersmith Hospital, Du Cane Road, London W12 0HS, England

Presented at the Thirty-fourth Annual Meeting of The Society of Thoracic Surgeons, New Orleans, LA, Jan 26–28, 1998.

	Abstract

Top Abstract Introduction Patients and methods Results Comment Acknowledgments References

 
Background. Little is known of time-related outcome and comparative performance of biological and mechanical prostheses following tricuspid valve replacement (TVR).

Methods. A retrospective UK Heart Valve Registry study (Jan 1, 1986 to June 30, 1997) identified 425 patients who underwent TVR. Two-hundred twenty-five (52.9%) received biological and 200 (47.1%) received mechanical valves. One-hundred sixty (38%), 158, and 76 had isolated, double, and triple valve replacements, respectively. The follow-up was 96% complete with a total of 1,585 patient-years.

Results. Thirty-day mortality for TVR was 17.3% (73 deaths). One-, 5-, and 10-year survival rates were 72.2%, 59.9%, and 42.9%, respectively. Year of operation (p = 0.04), age (p = 0.04), and number of valves implanted (p = 0.03) predicted overall mortality. Age (p < 0.001) and year of operation (p = 0.002) predicted overall survival. Thirty-day mortality for biological and mechanical prostheses was 18.8% and 15.6%, respectively. One-, 5-, and 10-year survival rates were 70.5%, 61.5%, and 47.7% for biological and 74.0%, 57.9%, and 33.9% for mechanical prostheses, respectively. Freedom from reoperation at 1 and 10 years was 98.7% and 97.4%. Freedom from death or reoperation was 71.2% at 1 year and 41.9% at 10 years. None of the above outcomes was significantly different between the type of valve prostheses.

Conclusions. TVR carries a high 30-day mortality and a poor longer term survival. No superiority could be identified for biological or mechanical prostheses in the tricuspid position for either survival or reoperation.

	Introduction

Top Abstract Introduction Patients and methods Results Comment Acknowledgments References

 
Most cardiac surgeons undertake tricuspid valve surgery infrequently and usually perform tricuspid valve repair. It is only in the rare instance of a severely functionally or organically diseased tricuspid valve that tricuspid valve replacement (TVR) is undertaken. This is reflected in the United Kingdom Heart Valve Registry (UKHVR) databank, where, in nearly 63,000 heart valve replacements, only 425 were TVRs (Fig 1). Most cardiac surgeons, therefore, have very limited experience in TVR. Tricuspid valve surgery has, furthermore, not evolved as a subspeciality undertaken by a selected few. Instead, it is usually in the repertoire of every cardiac surgeon as a rare procedure, making it difficult to assess the outcome of such low-volume procedures. There is an identified need, therefore, for a benchmark for outcome in TVR so that surgeons and their institutions can advise patients of risk preoperatively and monitor their own performance postoperatively. This benchmark must represent the whole spectrum of cardiac surgery.

View larger version (26K): [in this window] [in a new window]   Fig 1. Annual incidence of all valve and tricuspid valve implants registered in the UK Heart Valve Registry 1986 to 1996.

	Patients and methods

Top Abstract Introduction Patients and methods Results Comment Acknowledgments References

 
All TVRs registered in UKHVR between January 1, 1986, and June 30, 1997, were analyzed. The UKHVR, funded by the Medical Devices Agency, an agency of the UK Department of Health, has a computerized database continuing certain patient, surgeon, and hospital identification data together with implant and selected follow-up data for all registered patients undergoing valve replacement. Patients are now recruited from the majority of the United Kingdom cardiac units (currently 51 centers), although it has taken several years to achieve this figure. Established in January 1986 it now holds data on around 56,000 patients and 63,000 implanted valves. The Registry is based in the Cardiac Surgical Unit, Hammersmith Hospital, London.

From the very outset, in order to maintain simplicity and completeness of data collection and to achieve maximum cooperation from participating centers, the Registry has been deliberately selective about the data it collects. The variables collected by the Registry are age, sex, size of prosthesis, site of valve surgery, number of implanted valves, type of implanted valve, previous sternotomy for valve replacement, and year of operation and reoperation. The only sequential follow-up data collected by the Registry are the occurrence of death or reoperation and the cause of these two outcomes. All patients entered in the UKHVR are tracked by The Office of National Statistics (in England, Scotland, and Wales) and the Central Services Agency (in Northern Ireland), who notify the Registry of the place, date, and certified cause of death together with relevant available postmortem information on all deceased patients. The Registry is thus in the unique position of being able to collect accurate time-related data on mortality after valve replacement. Similarly, the Registry database is reliable with regard to re-replacement of tricuspid valve prostheses. It is possible, however, that some underreporting of reoperation for other causes such as tricuspid thrombectomy or repair of paravalvular leak may occur. The Registry does not currently collect data for other endpoints that do not result in death or re-replacement, such as thrombosis or hemorrhage.

Between January 1, 1986, and June 30, 1997, 425 patients undergoing TVR were recruited to the UKHVR. Three-hundred thirty-four (78.6%) were women and 91 (21.4%) were men (Table 1). Their mean age was 57.1 ± 12.3 years with a range of 18.5 to 81 years. When the patients were subdivided by decade of age the modal decade was 60 to 70 years, suggesting that the data represent a middle-age and older population. This is clearly illustrated in Figure 2, where the majority of patients are found at the older end of the age spectrum.

View larger version (13K): [in this window] [in a new window]   Fig 2. Thirty-day mortality for tricuspid valve replacement by number of valves implanted at operation.

Seventeen patients were lost to follow-up resulting in a completeness of follow up of 96%. The mean follow up was 3.7 ± 3.6 patient-years, ranging from 0 to 11.8 years and giving a total follow-up of 1,585 patient-years.

All data reported as mean ± standard deviation unless otherwise recorded. Certain data are also accompanied by 95% confidence intervals. The Registry has accurate 30-day and time-related mortality data because of the death certification information provided by The Office for National Statistic and The Central Services Agency. All deaths more than 30 days after operation were classified as late deaths.

All variables were entered into a Cox proportional hazards univariate regression analysis to identify significant determinants of 30-day mortality, overall survival, and freedom from reoperation using the Stata Release 5 statistical software package (Stata Corporation, College Station, TX). The variables were similarly used in a stepwise Cox proportional hazards multiple regression analysis to identify determinants of 30-day mortality, overall survival, and reoperation. Kaplan-Meier survival curves were constructed for presentation of survival and freedom from reoperation. Statistical significance was defined as a p value less than 0.05.

	Results

Top Abstract Introduction Patients and methods Results Comment Acknowledgments References

 
There were 73, or 17.3%, 30-day deaths for TVR (Table 2). Of these early (<30-day) deaths, 3 were valve-related deaths, including an intrinsic valve failure, and 70 were non–valve-related deaths, with the vast majority being due to cardiac failure (43, 59%), cerebrovascular event (7, 10%), and infection (5, 7%). There were 106 late deaths, giving 1-, 5-, and 10-year survival rates of 72.2%, 59.9%, and 42.9%, respectively (see Table 2). There were 17 (16%) valve-related late deaths, 8 (8%) of which were accounted for by cerebrovascular events. There were 89 non–valve-related deaths; 49 (46%) were due to cardiac failure, 11 (10%) to cancer, 9 (8%) to pneumonia, and 9 (8%) to myocardial infarction.

View larger version (11K): [in this window] [in a new window]   Fig 3. Survival after tricuspid valve replacement according to age.

View larger version (10K): [in this window] [in a new window]   Fig 4. Survival after tricuspid valve replacement according to type of prosthesis.

Mean freedom from death or reoperation following TVR at 1 and 10 years was worse than the above at 71.2% (range, 66.5% to 75.3%) and 41.9% (range, 34.3% to 49.3%), respectively, for the study population. No variable was identified as a predictor for reoperation. Age (>40 years) was shown to determine freedom from death or reoperation univariately (p < 0.000, HR = 4.0), as was year of operation (p = 0.005, HR = 0.92; 0.88 to 0.98). After type of prosthesis at a given site was excluded, multivariate analysis identified age at operation (p < 0.001, HR = 1.02; 1.01 to 1.04) and year of operation (p = 0.001, HR = 0.92; 0.87 to 0.97) as determinants of freedom from death or reoperation.

When the data were again divided by type of prosthesis used for TVR, mean freedom from reoperation at 1 and 10 years was 99.3% (range, 95.1% to 99.9%) and 97.7% (range, 93.1% to 99.3%), respectively, for biological prosthesis and 98.0 (range, 94.0% to 99.4%) and 97.1% (range, 92.4% to 98.9%), respectively, for mechanical valves (p = 0.59).

There was similarly no difference between biological and mechanical prostheses when freedom from death or reoperation was analyzed; at 1 and 10 years this was 70.0% (range, 63.4% to 75.7%) and 46.7% (range, 37.3% to 55.5%), respectively, for bioprostheses and 72.4% (range 65.4% to 78.2%) and 32.3% (range, 18.0% to 47.2%), respectively, for mechanical prostheses (p = 0.55).

	Comment

Top Abstract Introduction Patients and methods Results Comment Acknowledgments References

 
Tricuspid valve replacement is an uncommon procedure in contemporary cardiac surgery in Western Europe and North America. This may reflect the reduction in rheumatic heart disease and also a more aggressive approach toward conservative valve surgery. An incidence of 0.7% for TVR out of all valve replacements registered at the UKHVR is similar to but lower than the incidences reported from other institutions [1, 6]. Given its rarity as an operation in most surgeons’ repertoires, time-related survival and reoperation data cannot meaningfully be assimilated by individuals or individual institutions. There has been a call by some for a pooling of several centers’ data [1], and this is particularly important if each surgeon is to continue to perform TVR infrequently. The UKHVR, by representing a wide spectrum of cardiac surgery, can fulfill this role of benchmarking important outcomes for TVR. This is particularly relevant in these days of increased audit of outcomes for individual surgeons and institutions and is also essential if a meaningful debate on resource allocation is to be undertaken. As the largest series of TVRs published with accurate time-related mortality and reoperation data, this series needs no defending in its primary role as a provider of a benchmark for freedom from death or reoperation after TVR. It is pertinent, therefore, that the sex and age distribution, prevalence of multiple valve procedures, and mean size of tricuspid prosthesis (31 mm) described in this series is similar to that reported in other series from the West [1, 5, 6, 8, 10] and suggests that it represents a middle-age or older population with primarily acquired tricuspid disease.

The 30-day mortality for TVR was 17.3% in this series and falls within the 12% to 37% range of mortalities (operative and in-hospital) reported elsewhere [1, 6, 10, 13–15]. It is important to reaffirm, however, that the 30-day mortality reported in this study is unique because of the patient tracking system employed by the UKHVR. The UKHVR 30-day mortality for TVR compares poorly with the equivalent UKHVR 30-day mortality results [16] for MVR (7.1%) and AVR (5.1%) for the period 1986 to 1995. This increased 30-day mortality in TVR is likely to be multifactorial and probably reflects the fact that tricuspid replacement patients are generally poorer surgical candidates [5, 6, 17].

Analysis of the documented Registry variables identified age, number of valves, synchronous MVR, and the combination with mechanical MVR as univariate determinants of 30-day mortality following TVR. Glower et al [5] also reported age as a predictor of operative mortality, although the age categorization that best fitted their data was younger than 50 years and 50 years or older. In this series, division of the population by age into less than 40 and 40 years or older provided the best fit to the observed reported data. Poveda et al [15], however, did not find age to be a useful predictor of 30-day mortality but suggested that the actual elapsed time from the onset of symptoms was more important. Glower et al [5], in a series of TVR where 92% of the double valve replacements involved MVR, also identified concurrent MVR as a predictor of operative mortality and found a trend of increased operative mortality with triple valve replacement, although their numbers were too small to achieve statistical significance. The finding by multivariate analysis of a mechanical mitral valve as an important predictor of 30-day mortality in this series can only reflect the imbalance in the distribution of biological and mechanical prostheses at the mitral and aortic sites as discussed previously in the results section; mechanical tricuspids are probably never accompanied by mitral or aortic bioprostheses. The finding by multivariate analysis of the importance of the year of operation (p = 0.04) is surprising. Van Nooten et al [18] have reported the influence of the year of intervention on operative mortality, although this was thought to be in relation to cardioplegia. Although bypass and myocardial management continue to improve, it is difficult to identify any striking difference in bypass or myocardial management practices between 1986 and 1996.

Others have identified preoperative functional class [10, 12], presence of hepatic dysfunction [10], elevated mean pulmonary artery pressure [15], sex [10], and bypass time [10] as predictors of 30-day mortality following TVR. In our much larger series there was no difference in 30-day mortality between women and men. As from the outset, to ensure maximum cooperation and completeness of collection the Registry restricted itself to the collection of a limited data set, we cannot comment on the role of other reported predictors of 30-day mortality. It is hoped, nevertheless, that with greater appreciation by cardiac surgeons of the value and power of a registry, such as in providing a benchmarking service for less common procedures, they will recognize the need to cooperate in the collection of greater detailed preoperative, perioperative, and postoperative data for the registry of their choice.

The longer-term survival reported in this series of 72.2% at 1 year and 42.9% at 10 years also lies within the survival rates reported in the literature. Scully and Armstrong [1] in a series involving biological and mechanical valves reported a 15-year actuarial survival of 37%, and Van Nooten et al [18], in a series of both biological and mechanical prosthesis, reported 5- and 15-year survival rates of 74% and 23.4%, respectively. The 10-year survival after TVR compares poorly with equivalent survival figures from the UKHVR [16] for AVR (62.7%) and MVR (56.8%). This poorer longer term survival probably reflects the same factors that were postulated to lead to a higher 30-day mortality with TVR discussed previously. The majority of tricuspid disease that necessitates TVR is likely to be secondary to valve dysfunction at another site reflecting a greater extent of ventricular (both left and right) and other organ dysfunction.

Age and the year of operation were predictors of overall survival identified in the Registry data both univariately and multivariately. Glower et al [5] also found age to be an independent predictor of decreased survival together with functional class. The categorization of age that best fitted their data was the division into two groups at the age of 60 years. The Registry analysis, however, suggested that the observed variance was fitted best by an age division at 40 years. The same authors [5] identified previous sternotomy as a predictor of decreased survival in those discharged from hospital. The Registry data did not find any predictive value in previous sternotomy for valve replacement, but it is acknowledged that the Registry population is likely to contain many more unidentified patients who had undergone previous sternotomy for valve repair or other cardiac procedures, as suggested by the greater preponderance of previous sternotomy in other series [10, 13, 14]. Others [18] have reported type of tricuspid prosthesis (first-generation mechanical) as a predictor of survival; the finding here of the importance of year of operation may have been thought to support this, but the Registry with a larger series of mechanical prostheses showed no survival difference between ball-cage older mechanical valves and the newer mechanical prostheses.

It is recognized that a debate exists over the choice of valve prosthesis in the tricuspid position [19]. The early first-generation mechanical valves [4, 20, 21] were followed by bioprostheses [5, 6], which in turn are being challenged by modern bileaflet and tilting-disc mechanical valves [7, 8]. Many researchers [2, 5, 11, 14, 22] have advocated the use of a bioprosthesis in the tricuspid position irrespective of the type of valve prosthesis used at other sites, although others have warned against bioprosthetic dysfunction [13, 23]. Recent comparative studies [6, 10, 18] have failed to show any difference in time-related survival between biological and mechanical valves in the tricuspid position. Furthermore, although some authors have shown some increase in thrombosis, with mechanical valves [6], others have failed to demonstrate any difference in valve-related complications between the two types of valves [1]. A less dogmatic approach to the choice of prosthesis at the tricuspid site may, therefore, be emerging [1, 10, 19]. It is appropriate, therefore, that the Registry data are used to address this issue.

Although there was an almost equal split between mechanical and biological valve totals within the series, a trend analysis identified a definite move by UK cardiac surgeons away from bioprostheses towards implanting mechanical valves in the tricuspid position during the period of 1986 to 1996 (p = 0.0001). This reflects the trends seen in valve choice for implantation at other sites, presumably because of a greater confidence with modern mechanical valves. The Registry data do not identify any survival benefit accrued by type of valve either at 30 days (18.8% for biological and 15.6% for mechanical valves) or at 1, 5, and 10 years (70.5%, 61.5% and 47.7%, respectively, for biological and 74.0%, 57.9%, and 33.9%, respectively, for mechanical valves). These results are comparable, with the 10-year survival rate of 60% [9] and the 10- and 14-year survival rates of 48% and 31%, respectively [5], reported for bioprostheses, but poorer than the 9-year survival of 75% reported with Carpentier-Edwards pericardal valves [13]; similarly, the results are comparable to the 10-year survival of 50% [7] and 14-year survival of 55% [8] with mechanical valves.

The need for reoperation, however, could potentially identify differences not present in the survival data analysis between types of prostheses used. Reoperation was infrequent in this series from the UKHVR, with only 5 of 425 (1.2%) patients having re-replacement of their tricuspid prosthesis, although it is acknowledged that the maximal follow-up was 11.8 years. It is possible that the incidence of reoperation, but not re-replacement, is higher. Others have reported rates between 6.5% and 9% [1, 5, 10] of reoperation at the tricuspid position. This is of singular importance as, if the reoperation rate is low, then the choice of a prosthesis on the basis of reducing the risk of reoperation is questionable. This low incidence of redo-TVR clearly means that the Registry could not discern any difference in freedom from reoperation by type of valve. The 10-year freedom from reoperation (for biological valves) was 97.7% for biological and 98.0% for mechanical valves and does not differ from a freedom from reoperation of 96% and 93% at 5 and 10 years, respectively, for bioprostheses [5] and 86.7% at 7 years and 10 years, respectively [6], and 100% at 10 years [9] for mechanical valves reported elsewhere. It is acknowledged, however, that these are medium-term follow-up results (up to 11 years) from the Registry, and a longer follow-up may demonstrate a difference in freedom from reoperation between the two types of prostheses.

When freedom from death or reoperation was analyzed, there was similarly no difference between biological and mechanical valves implanted at the tricuspid position. The UKHVR, therefore, found freedom from death, freedom from reoperation, and freedom from death or reoperation to be equivalent for biological and mechanical valves in the tricuspid position. There was little evidence of clinically important structural failure, although evidence does suggest that beyond 10 years the need for reoperation will increase with bioprostheses [5, 13, 17]. In contrast, mechanical valves may carry a higher incidence of thrombosis [6], and reoperation may be required for this reason. The Registry data for the comparative performance of biological and mechanical prostheses at 15 years needs, therefore, to be assessed in due course.

In summary, TVR is an uncommon cardiac surgical procedure and UK cardiac surgeons do not demonstrate a clear preference of the type of prosthesis used. TVR carries a high 30-day mortality and poorer longer term survival when compared to similar outcomes for AVR or MVR. There are no comparative benefits demonstrated between biological and mechanical valves, either in terms of time-related survival, reoperation, or survival or reoperation. From the UKHVR data with regards to mid-term outcome, therefore, the exercise of personal preference by the implanting surgeon in the choice of biological or mechanical prosthesis for the tricuspid position seems reasonable.

	Acknowledgments

Top Abstract Introduction Patients and methods Results Comment Acknowledgments References

 
We wish to thank the centers who have contributed their data to this study and who continue to support the UK Heart Valve Registry: Aberdeen Royal Infirmary, United Bristol Health Trust, Broadgreen Cardiothoracic Centre, Royal Brompton Hospital, Castle Hill Hospital, Edinburgh Royal Infirmary, Freeman Group of Hospitals, Glasgow Royal Infirmary, Glenfield General Hospital, Guy’s Hospital, Hammersmith Hospital, Harefield Hospital, Killingbeck Hospital, Kings College Hospital, Leeds General Infirmary, London Chest, Manchester Royal Infirmary, Middlesex Hospital, Northern General Hospital, North Staffordshire Royal Infirmary, Nottingham City Hospital, Queen Elizabeth Hospital, Royal Victoria Hospital, St Bartholomew’s Hospital, St George’s Hospital, St Mary’s Hospital, St Thomas’ Hospital, Southampton General Hospital, South Cleveland Hospital, Victoria Hospital, Walsgrave Hospital, Western Infirmary, Wythenshawe Hospital.

	References

Top Abstract Introduction Patients and methods Results Comment Acknowledgments References

 

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