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J Thorac Cardiovasc Surg 1995;110:672-0679
© 1995 Mosby, Inc.

SURGERY FOR ACQUIRED HEART DISEASE

Tricuspid valve replacement: Postoperative and long-term results

Guido J. Van Nooten, MDa, Frank Caes, MDa, Yves Taeymans, MDb, Yves Van Belleghem, MDa, Katrien François, MDa, Dirk De Bacquer, MScb, Frank E. Deuvaert, MDc, Francis Wellens, MDc, Georges Primo, MDc

Ghent and Brussels, Belgium

Received for publication August 12, 1994. Accepted for publication Dec. 29, 1994. Address for reprints: Guido J. Van Nooten, MD, Cardiac Surgery Department, University Hospital Ghent, De Pintelaan 185, 9000 Ghent, Belgium.

Abstract

A series of 146 consecutive patients who underwent tricuspid valve replacement at the University Brugmann Hospital between 1967 and 1987 was reviewed. Mean age at operation was 51.4 years (±12.1 years). Different types of prostheses were implanted including porcine and bovine pericardial bioprostheses and older and bileaflet mechanical valves. Most patients were severely disabled by their cardiac disease before operation, with 30.1% in New York Heart Association functional class III and 69.9% in class IV. Operative mortality and hospital mortality rates (30 days) were high (16.4%). Incremental risk factors for hospital death included icterus (p<0.005), preoperative hepatomegaly (p= 0.012), and New York Heart Association functional class IV (p= 0.013). Multivariate analysis only selected preoperative icterus (p<0.01) as being independently significantly related to hospital mortality. The hospital survivors were followed up for a median of 94 months. A complete follow-up was available for all patients except two for 30 months or more. At 30 months the only two significant parameters were the type of myocardial protection (p= 0.024) and the year of operation (before 1977 or after [precardioplegia era or after], p= 0.011). There were 70 late deaths during the entire follow-up period. The univariate (log-rank statistics) incremental risk factor for late death was the type of tricuspid prosthesis (Smeloff-Cutter and Kay-Shiley versus St. Jude Medical versus bioprosthesis) (p= 0.04). A trend was observed for the type of operative myocardial protection (normothermia and coronary perfusion) (p= 0.06) and preoperative New York Heart Association functional class IV (p= 0.055). Actuarial survival was 74% at 60 months and 23.4% at 180 months. Cumulative follow-up added up to 1015 patient-years. In a more detailed analysis of the effect on survival of the type of tricuspid prosthesis, a significant difference was observed between the bioprostheses and some older mechanical prostheses (Smeloff-Cutter and Kay-Shiley) (p= 0.04) but not between the bioprostheses and the bileaflet valves (p= 0.15). When the follow-up period was stratified according to less than 7 years and more than 7 years of follow-up, no difference was observed for the first period, but for the late follow-up the new mechanical prostheses did better than the bioprostheses (p= 0.05), suggesting a degradation of the bioprostheses after 7 years and favoring mechanical prostheses for those patients with a good long-term prognosis. (J THORACCARDIOVASCSURG1995;110:672-9)

Since the start of tricuspid valve replacements in the early 1960s, nearly all types of prostheses have been used in the tricuspid position, with different results. In the absence of severe structural damage of the native valve, repair or annuloplasty should always be attempted.Go 1 During the period of our study 173 tricuspid valve reconstructions were done at the same hospital. Nevertheless, nearly 45% of our patients with tricuspid valve disease required valve replacement, more frequently in the early years. We reviewed and analyzed the results in our 146 patients with valve replacement to establish a strategy toward the optimal valve choice. As described by McGrath and colleagues,Go 2 bioprostheses in the tricuspid position perform well up to 10 years after implantation, but can show some structural deterioration, and this finding was even more pronounced in younger patients in other series.Go 3 Good long-term results with bileaflet mechanical valves could alter our policy of using preferentially a large bioprosthesis in the tricuspid position.

PATIENTS AND METHODS

All 146 patients who underwent tricuspid valve replacement (TVR) at the University Brugmann Hospital between 1967 and 1987 were included in the review. Our series included 32 male (21.9%) and 114 female (78.1%) patients with a mean age of 51.4 years (range 15 to 71 years, standard deviation 12.1). The clinical data of the patients in the TVR group are summarized in GoTable I. Rheumatic heart disease was the most frequent cause and was present in 102 patients (69.9%). Ebstein's anomaly occurred in 4 (2.7%), endocarditis in 3 (2.1%), and in the remaining 37 patients (25.3%) the disease process was considered to be functional. Eighty-eight (60.3%) patients had tricuspid valve regurgitation only, 4 had pure stenosis (2.7%), and 54 (37.0%) had a combination of both, as assessed clinically, echocardiographically, hemodynamically, and perioperatively. Most of our patients had an advanced stage of heart valve disease, with 44 patients (30.1%) in New York Heart Association (NYHA) functional class III and 102 patients (69.9%) in class IV or higher. Ascites was present in 21 patients (14.4%), cyanosis in 24 (16.4%), hepatomegaly in 80 (54.8%), edema in 66 (45.2%), and icterus in 31 (21.2%). Concomitant cardiac procedures were necessary in 139 patients (95.2%), as shown in GoTable II. Moreover, 59 patients(40.4%) had undergone one previous cardiac operation and 6 had undergone two (4.1%), as shown in GoTable III.


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  		Table I. Clinical features of the 146 patients undergoing TVR
 

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  		Table II. Associated cardiac procedures in 146 patients undergoing TVR
 

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  		Table III. Previous cardiac operations in 146 patients undergoing TVR
 
We used different types of prostheses in the tricuspid position: 69 bioprostheses (47.3%) and 77 mechanical valves (52.7%). During the 1960s and early 1970s, only old-style mechanical valves (27 Smeloff-Cutter,*Go 14 Kay-Shiley,{dagger}Go and 1 DeBakey{ddagger}Go) were available. Before 1977, 23 Björk-Shiley{dagger} tilting-disc valves were implanted in the tricuspid position. Since 1975, porcine xenografts (31 Carpentier-Edwards§Go and 25 Hancock||Go) have been currently used. Between 1979 and 1981, 12 St. Jude Medical¶Go mechanical valves were inserted in the tricuspid position. Finally, some bovine pericardial bioprostheses (9 Carpentier-Edwards and 4 Mitroflow) were implanted between 1978 and 1983.

All operations were done through median sternotomy with the use of standard cardiopulmonary bypass (CPB). Before 1977, normothermic CPB with coronary perfusion and mild systemic hypothermia was used, whereas more recently moderate hypothermia and cold antegrade St. Thomas' Hospital cardioplegic solution has been used. Anticoagulation therapy with warfarin (Coumadin) was started on the first postoperative day and continued life-long in patients with mechanical valves or chronic atrial fibrillation; otherwise it was stopped after 3 months. Several clinical parameters and surgical parameters were recorded retrospectively.

Statistical analysis
Continuous variables are expressed as mean and standard deviations. Variables entered into risk-factor analysis included age, gender, previous operation, rheumatic disease, tricuspid disease, NYHA functional class, ascites, cyanosis, icterus, hepatomegaly, edema, duration of aortic clamping, duration of CPBs, myocardial protection, year of operation, and type of prosthesis. For statistical power considerations the types of tricuspid prostheses were grouped into three categories: bioprostheses, old mechanical prostheses, and new mechanical prostheses. Univariate comparisons between the groups of survivors and nonsurvivors at 30 days and 30 months after operation were done by Fisher's exact test and Student's t test. A stepwise multivariate logistic regression was used to identify a subset of independent variables predictive of hospital and 30-month mortality (Systat 5.2 statistical program, Systat, Inc., Evanston, Ill.). The level for entrance to or removal from the model was set at 0.05. Univariate analysis of survival curves was done by the log-rank test.Go 4

RESULTS

Hospital mortality
Twenty-four patients died during hospitalization, yielding a hospital mortality rate of 16.4%. Cardiac failure was responsible in 11 patients (45.8%), bleeding in 3 (12.5%), arrhythmias in 3 (12.5%), multiple organ failure in 2 (8.3%), respiratory insufficiency in 1 (4.2%), sepsis in 1 (4.2%), and valvular thrombosis in 1 (4.2%); sudden death of unknown origin occurred in 2 patients (8.4%). Univariate analysis Go(Table IV) showed presence of icterus (p = 0.005), presence of hepatomegaly (p = 0.012), NYHA class IV (p = 0.013), and male gender (p = 0.04) to be associated with hospital mortality. The cause (rheumatic or not) of the tricuspid valve disease and the pathologic condition of the tricuspid valve (regurgitant or not) showed no relation with the in-hospital outcome. Among the perioperative parameters no relation was found at all with early survival Go(Table V).


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  		Table IV. Univariate analysis of clinical variables related to hospital mortality
 

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  		Table V. Univariate analysis of perioperative variables related to hospital mortality
 
Valve-related complications
Paravalvular leakage developed in 4 patients (3.3%). Twice the tricuspid prosthesis was concerned: once in a Smeloff-Cutter and once in a Björk-Shiley valve. The first patient died without surgical intervention and the latter underwent successful replacement of the affected prosthesis. Late endocarditis occurred in 3 patients (2.5%) 36, 54, and 96 months, respectively, after operation. This involved 1 Carpentier-Edwards mitral prosthesis, 1 Kay-Shiley tricuspid prosthesis, and both mitral and tricuspid St. Jude Medical prostheses in the last patient. All patients were treated medically. The first 2 patients recovered and the latter died of a cerebrovascular accident. Major anticoagulant-related hemorrhage (necessitating hospitalization and transfusion) occurred in 13 patients (10.7%). Four cases were fatal: 2 digestive, 1 cerebral, and 1 posttraumatic.

Reoperation and valve trombosis
Late tricuspid valve reoperation was required in 11 of the hospital survivors (9%) Go(Table VI). The mean interval to reoperation was 83.8 months (range 0.27 to 161 months). Three patients did not survive reoperation (27.3%); one died of cardiac failure, another of respiratory failure, and in the third patient the cause remains unknown. Prosthetic valve thrombosis occurred in 11 patients. Two cases of valve thrombosis on postoperative days 6 and 8 were fatal. Nine patients had late thrombosis from 5 to 132 months after primary TVR. The types of prosthesis involved included 4 Smeloff-Cutter valves (3 in the tricuspid and 1 in the mitral position), 3 Björk-Shiley valves (2 in the tricuspid and 1 in the mitral and tricuspid positions), and 1 St. Jude Medical valve and 1 Carpentier-Edwards valve in the tricuspid position. Of these 9 patients, 6 died before surgical intervention and the other 3 underwent successful replacement of the thrombosed prosthesis. Actuarial freedom from death and reoperation with a tricuspid valve prosthesis is shown in Fig. 1 for the different valve types.


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  		Table VI. Reoperations
 


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  		Fig. 1. Actuarial freedom from death and reoperation with tricuspid prosthesis for different valve types. Bio, Bioprosthesis.

 
Thirty-month mortality
A total of 120 hospital survivors were followed up for at least 30 months (this includes all patients except two, who were followed up for 27 and 29 months, respectively). An interim analysis at 30 months showed only a significant different survival for the type of myocardial protection (hypothermia, 8 of 68 versus normothermia, 13 of 43; p = 0.024) and the use of cardioplegia (before 1977, 18 of 65 versus after 1977, 5 of 55; p = 0.011). A trend was also shown for NYHA functional class before operation (class III, 4 of 41 versus class IV, 19 of 79; p = 005) Go(Table VII). A multivariate logistic regression at 30 months selected the absence of myocardial protection and the presence of tricuspid valve stenosis as the two factors positively and independently related to mortality (p = 0.015 and p = 0.048, respectively).


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  		Table VII. Univariate analysis of variables related to 30-month mortality
 
Late survival
Late death occurred in 70 of the 122 hospital survivors of the original TVR (57.4%). Modes included cardiac failure in 25 patients (35.7%), sudden death in 10 (14.3%), neurologic events in 5 (7.1%), valvular thrombosis in 5 (7.1%), anticoagulant-related bleeding in 4 (5.7%), valvular prosthesis dysfunction in 3 (4.3%), infective endocarditis in 2 (2.8%), arrhythmia in 1 (1.4%), noncardiac causes in 8 (11.4%), and unknown causes in 7 (10.0%). Cumulative follow-up added up to 1015 patient/years and the median survival time for hospital survivors was 116 months. Two patients were lost to follow-up (98.4% complete). The actuarial survival at 60 months remained 74.0% and decreased at 180 months to 23.4% (Fig. 2). Of the 52 long-term survivors, 11 (21.2%) are in NYHA functional class I, 32 (61.5%) in class II, 6 (11.5%) in class III, and the remaining 3 (5.8%) in class IV. Thirty-nine patients (75%) have atrial fibrillation, 7 have regular sinus rhythm (13.5%), 5 had a pacemaker implanted (9.6%), and in 1 patient the rhythm remains uncertain (1.9%). Univariate analysis (log-rank statistics) revealed the type of tricuspid prosthesis (Smeloff-Cutter and Kay-Shiley versus St. Jude Medical and bioprosthesis) (p = 0.04) as an incremental risk factor for late death. A trend was observed for the type of operative myocardial protection (normothermia and coronary perfusion) (p = 0.06) and preoperative NYHA functional class IV (p < 0.06). A more detailed analysis of the effect on survival of the type of tricuspid prosthesis showed a significant difference between the bioprosthesis and the older mechanical prostheses (Smeloff-Cutter and Kay-Shiley) (p = 0.04) but not between the bioprosthesis and the new prosthesis (p = 0.15) (Fig. 1). When the follow-up period was stratified according to less than 7 years and 7 or more years of follow-up, no significant difference was observed for the first period but for the late follow-up the new mechanical prosthesis did better than the bioprosthesis (p = 0.05). A stepwise multiple logistic regression test selected the presence of icterus as the sole independent predictor of late death (p < 0.01).



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  		Fig. 2. Actuarial survival curves according to type of prosthesis. Bio, Bioprosthesis.

 
DISCUSSION

The operative mortality rate of 16.4% in our series is comparable with those in literature reports, which range from less than 10% to more than 50% for both isolated and combined TVR.Go Go 5-19 A reduction in mortality rate in the more recent era was also observed by Livi and colleaguesGo 20 and related to improvement of perioperative myocardial protection and postoperative management. Almost half of our early deaths were caused by cardiac failure related to severe depression of myocardial function, which was especially noticed in the precardioplegia group as reported in most series.Go Go Go Go Go Go Go 6-8,11,14,16,18-21 This was also confirmed indirectly in our series by the significant relation between the year of intervention and the survival (before 1977 versus after 1977). A number of preoperative variables were identified as univariate predictors of high risk for hospital death after TVR: male gender, NYHA functional class IV, hepatomegaly, and icterus. Poor survival in men, also detected by other authors, remains unexplained.Go Go 19,22 The increased early risk for TVR in patients with advanced functional disability has beendocumented in some reports.Go Go Go Go 9,18-20,22 Preoperative hepatomegaly and icterus likely represent hepatic congestion resulting from severe failure of the right side of the heart and have been associated with high early mortality rates.Go Go 19,22

Late death occurred in 57% of the hospital survivors of the original TVR. More than one third of these patients died of cardiac failure, which suggests progression of cardiomyopathy despite successful surgical valve replacement.Go Go Go 9,17,18 Significant univariate risk factors for late death were the use of a Smeloff-Cutter or Kay-Shiley tricuspid prosthesis, myocardial protection by normothermia and coronary perfusion, and preoperative NYHA functional class IV. Intraoperative myocardial protection has been reported to influence operative mortality, but not late death.Go 21 Advanced functional disability seems to have an ominous influence not only on early but also on long-term results of TVR.Go Go Go 9,19,21 The higher prevalence of tricuspid valve thrombosis in older mechanical valves has been confirmed by several authors.Go Go Go Go Go 6,9,16,21,23 Likewise, a low prevalence of valve-related thromboembolism with the St. Jude Medical valve in patients with correctly regulated anticoagulation therapy has been reported.Go Go 24-26 The long-term results, 14 years after implantation of the bileaflet valve, equal at approximately 8 years the good score of the bioprosthesis, to improve the late results, but this requires further follow-up. On the other hand, degeneration of the bioprosthesis in the tricuspid position is exceptional during the first 10 years and becomes more pronounced more than 10 years after initial implantation, especially in children.Go Go Go Go 2,3,27,28 In our series, two cases of primary valve failure necessitated replacement, both more than 10 years after initial implantation. Other valve-related complications such as endocarditis and paravalvular leakage were rare, regardless of the type of tricuspid prosthesis.

In conclusion, TVR carries a high operative risk and low likelihood of long-term survival, both influenced by preoperative and perioperative variables. Mechanical disc or ball valves in the tricuspid position are prone to dysfunction by pannus formation or thrombosis.Go Go Go 22,29,30 Moreover, Smeloff-Cutter and Kay-Shiley prostheses are incremental risk factors for late death. Because bioprostheses in the tricuspid position have a low risk of valve-related events, we preferred a large-sized bioprosthesis when TVR was mandatory, although the confirmation of better long-term results (14 years) of the St. Jude Medical valves altered our valve choice in some particular young patients with a good long-term prognosis.

Footnotes

From the Departments of Surgerya andCardiology,b University Hospital of Ghent, Ghent, Belgium,and the Department of Surgery,c University HospitalBrugmann, Brussels, Belgium. Back

*Cutter Biological, Berkeley, Calif. Back

{dagger}Shiley, Inc., Irvine, Calif. Back

{ddagger}Surgitool, Inc., Pittsburgh, Pa. Back

§Baxter Healthcare Corp., Edwards Division, Santa Ana, Calif. Back

||Johnson & Johnson Cardiovascular, King of Prussia, Pa. Back

¶St. Jude Medical, Inc., St. Paul, Minn. Back

References

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