Eur J Cardiothorac Surg 2000;18:565-569
© 2000 Elsevier Science NL
Tricuspid valve replacement with the St. Jude Medical valve: 19 years of experience
Hiroshi Kawano,
Takeshi Oda,
Shuji Fukunaga,
Eiki Tayama,
Takemi Kawara,
Atsushige Oryoji,
Shigeaki Aoyagi
Department of Surgery, Kurume University School of Medicine, Kurume, Japan
Received 12 May 2000;
received in revised form 2 August 2000;
accepted 5 September 2000.
Corresponding author. National Kyushu Medical Center Hospital, 1-8-1 Jigyouhama, Chuoku, Fukuoka, 810-8563 Japan, Tel.: +81-92-852-0700; fax: +81-92-846-8485
e-mail: hkawano{at}qmed.hosp.go.jp
 |
Abstract
|
|---|
Objective: The choice of the valve substitute in the tricuspid position remains controversial. A St. Jude Medical valve is a choice of valve substitute and its lower thrombogenicity and excellent hemodynamic performance have been reported even in the tricuspid position. However, little is known of the long-term durability of the St. Jude Medical valve in the tricuspid position. Our long-term experience of tricuspid valve replacement showed the higher thrombogenicity than we had expected, therefore, this study was done to reconsider our strategy for valve choice. Methods: This study reviewed 23 patient who underwent 25 tricuspid valve replacements with the St. Jude Medical valves from 1980 to 1997. The mean age was 40 years. Eleven patients (48%) were men. There were four in-hospital deaths (17%). The remaining 19 patients were all alive and followed from 2.2 to 19.0 years (mean 11.8 years). Results: The overall survival, including hospital mortality, was 83%, 10 and 15 years after surgery. Valve thrombosis occurred in six patients. Freedom from valve thrombosis was 78 and 70%, 10 and 15 years after surgery, respectively. The linearized rate of the valve thrombosis was 2.9%/patient-years. Six patients required reoperation. The mean interval to reoperation was 9.5 years. Freedom from reoperation was 83% and 75%, 10 and 15 years after surgery, respectively. The linearized rate of the reoperation was 2.8%/patient-years. No structural valve deterioration was found. Echocardiographic study showed that the function of the St. Jude Medical valve without valve-related complications was well maintained. Conclusions: The higher thrombogenicity of the St. Jude Medical valve in the tricuspid position altered our choice of valve substitutes from the St. Jude Medical valve to a bioprosthesis which is lack of need for anticoagulant therapy except for juvenile patients who are able to maintain potent anticoagulant therapy.
Key Words: Tricuspid valve replacement • St. Jude Medical • Tricuspid valve replacement
|
1. Introduction
|
|---|
The choice of the valve substitute in the tricuspid position remains controversial [1–4]. Although the higher incidence of tricuspid valve thrombosis in old mechanical valves has been well reported [5,6], a St. Jude Medical (SJM) (St. Jude Medical, Inc, St. Paul, MN) valve is a choice of valve substitutes. The SJM valve is a bileaflet low-profile mechanical valve and its excellent long-term results have been well reported, especially in both aortic and mitral positions [7,8]. Although, even in the tricuspid position, both lower thrombogenicity [1,3,9,10] and excellent hemodynamic performance [11] of the SJM valve have been reported, little is known of the long-term durability of the SJM valve in the tricuspid position. As noted by others [1,3,9,10], our mid-term results of the SJM valve in the tricuspid position were also satisfactory [12]. However, our further experience of tricuspid valve replacement (TVR) showed the higher thrombogenicity than we had expected, therefore, we reviewed our series to reconsider our strategy for valve choice.
|
2. Patients and methods
|
|---|
From May 1980 to April 1997, 25 SJM valves were implanted in the tricuspid position in 23 patients at Kurume University Hospital. The mean age was 40±15 years (range, 5–65 years). Eleven patients (48%) were men. The clinical data of the patients at the time of the first TVR using the SJM valve are summarized in Table 1.
First TVR was done using the SJM valve for tricuspid regurgitation in 15 patients and for a combination of stenosis and regurgitation in seven patients. Only one patient with traumatic tricuspid regurgitation had previously experienced TVR twice due to old mechanical valve dysfunction before the third TVR with the SJM valve was done. Preoperative diagnosis was confirmed at the time of operation. Eight patients had undergone one previous cardiac surgery and four patients had undergone two, as shown in Table 2.
TVR was done with the use of standard cardiopulmonary bypass and moderate hypothermia. Cold crystalloid cardioplegia was employed before 1995. More recently, cold blood cardioplegia has been used. The SJM valve was sewn into the tricuspid position by means of interrupted mattress sutures. The direction of the pivot was perpendicular to the ventricular septum in all except the initial three patients. The annular size of the SJM valve was 31 mm in 13 patients, 29 mm in nine and 27 mm in three. Concomitant cardiac procedures were necessary in 13 patients.
Warfarin anticoagulation was started as soon as oral administration was possible and maintained in all patients to keep the thrombotest value around 20%, which is equivalent to from 1.5 to 2.0 times control in the prothrombin time International Normalized Ratio (INR).
Of all surviving patients, 15 patients (79%) were examined by cardiovascular surgeons in our hospital and the remaining four patients were interviewed by telephone. The post-operative follow-up was 100% complete and ended in September 1999 with a closing period of 7 months. The mean follow-up was 11.8±5.1 years (2.2–19.0 years) and giving a total follow-up of 223.6 patient-years.
Kaplan–Meier survival curves were used for presentation of the estimates of survival, valve-related events and reoperations. Kaplan–Meier estimator was presented as the mean±standard error and other results were presented as mean±SD. The incidences of valve thrombosis and reoperation were expressed by linearized rates with the 70% confidence limits (CL) (corresponding to 1 SD). The analysis and reporting of results of the TVR followed the guidelines published in this journal in 1996 [13].
|
3. Results
|
|---|
3.1. Mortality
There were four in-hospital deaths (17%) and three of four patients died within 30 days after surgery. The causes were the results of low cardiac output syndrome in two patients, multi-organ failure in one and both cerebral and renal emboli resulting from prosthetic valve endocarditis in the aortic position in one. These deaths were all cardiac deaths but not valve-related deaths. There were no cases of late death among the remaining 19 patients who were discharged from the hospital. Sixteen patients were in New York Heart Association functional class I and three were in class II, postoperatively. The overall survival, including hospital mortality, was 83±8%, 10 and 15 years after surgery (Fig. 1)
.
View larger version (10K):
[in this window]
[in a new window]
|
Fig. 1. The overall survival curve including hospital deaths. Numbers above the horizontal axis represent the numbers at risk at each interval. SE, standard error.
|
|
3.2. Valve thrombosis
Valve thrombosis occurred in six patients, 40 days, 3.1, 4.7, 8.4, 10.7 and 17.1 years after surgery, respectively. Valve thrombosis is thought to have occurred due to inadequate anticoagulant therapy in three patients. One patient had to discontinue warfarin for 5 months due to repeated gastrointestinal hemorrhage necessitating transfusion. One patient intermittently missed taking warfarin before manifesting exertional dyspnea and a syncope attack. The other patient required re-TVR due to pannus ingrowth and a new SJM valve was implanted. However, valve thrombosis occurred twice in this new SJM valve 4.7 years and 1 more years after surgery. First was when a permanent pace maker wire cord was exchanged and second was when a tooth was pulled. During these perioperative periods, the anticoagulant therapy was maintained by administrating heparin instead of warfarin. The thrombolytic therapy was effective twice in this case. However, the remaining three patients had been taking adequate oral anticoagulation when a diagnosis of valve thrombosis was made. Thrombolytic therapy with urokinase successfully restored normal leaflet motion in two patients. Freedom from valve thrombosis was 78±10% and 70±12%, 10 and 15 years after surgery, respectively, (Fig. 2)
. The linearized rate of the valve thrombosis was 2.9%/patient-years (CL 2–12%).
View larger version (12K):
[in this window]
[in a new window]
|
Fig. 2. Freedom from valve thrombosis (left panel) and reoperation (right panel) for 21 cases including two re-tricuspid valve replacements with the St. Jude Medical valve. Numbers above the horizontal axis represent the numbers at risk at each interval. SE, standard error.
|
|
3.3. Non-structural dysfunction
Two cases of the entrapment of one leaflet by pannus were confirmed at the time of reoperation performed 2 months and 17.2 years after surgery. These entrapped SJM valves were replaced with a new SJM valve and a pericardial bioprosthesis, respectively. Freedom from non-structural dysfunction was 95±5%, 10 and 15 years after surgery, respectively.
3.4. Bleeding event
Gastrointestinal hemorrhage necessitating transfusion occurred in one patient. Anticoagulant therapy was discontinued to control the bleeding as above-mentioned. The valve thrombosis occurred 10.7 years after surgery and the reoperation was necessary. Freedom from bleeding event was 92±8%, 10 and 15 years after surgery, respectively.
No episodes of structural deterioration, embolic event and operated valvular endocarditis occurred in our series. Moreover, the prostheses used in the left side of the heart were all normally functioning SJM valves.
3.5. Reoperation
Six patients required re-TVR due to valve thrombosis in four and pannus ingrowth in two. The reoperations were done with a new SJM valve in two patients, a porcine bioprosthesis in one and a pericardial bioprosthesis in three. One patient required mitral valve replacement at the time of re-TVR due to progression of mitral stenosis 16.6 years after open mitral commissurotomy. This was the only procedure performed concomitantly at the time of re-TVR. The mean interval to reoperation was 9.5±7.0 years (range 0.2–17.2 years). Freedom from reoperation was 83±9% and 75±11%, 10 and 15 years after surgery, respectively, (Fig. 2). The linearized rate of the reoperation was 2.8%/patient-years (CL 2–12%).
|
4. Discussion
|
|---|
Although our series showed the higher hospital mortality rate of 17% which falls within the 7.7–37% range of in-hospital mortalities reported elsewhere [1–4,9,10,14–17], no late deaths occurred. However, background of patients who require TVR is various. The preoperative variables such as etiology and the younger age are assumed to influence our excellent survival.
The major problem we were faced with was the durability of the implanted valves. The thrombogenicity in our series was higher than we had expected. We continued to favor the use of the SJM valve in the tricuspid position because of its lower rate of valve thrombosis [1,3,9,10] and its excellent hemodynamic performance [11]. However, valve thrombosis occurred in six patients from 40 days to 17 years after surgery and four of six patients (67%) required re-TVR due to unsuccessful thrombolytic therapy. Inadequate control of the anticoagulant therapy was obviously the reason for the valve thrombosis in three patients. However, valve thrombosis also occurred in the other three patients who maintained adequate anticoagulant therapy. Moreover, considering the fact that no valve thrombosis was found in the left side of the heart, the optimal level of INR for patients with a SJM valve in the tricuspid position is thought to be higher than that in the left side of the heart. Although bioprostheses have been reported more durable in a low-pressure chamber than in the systemic circulation [15,17], this lower pressure may predispose SJM valves in the tricuspid position to the higher thrombogenicity.
Valve substitute should be chosen in the light of the durability of each valve substitute to avoid valve-related complications. Although a number of papers concerning the TVR have been published, there are not many large series that make definitive statements. In our series, the linearized rates of the valve thrombosis and reoperation deemed to be higher than those of the bioprostheses in the tricuspid position reported elsewhere [4,14,17]. SJM valves in the tricuspid position must be given more potent anticoagulant therapy than we have tried. The effective range of INR for TVR may be narrow and thus subtle changes of INR may cause valve thrombosis easily. If so, it would be difficult to keep the effective range of INR for life, especially, for the older patients who have higher chances of bleeding events. Therefore, we have changed our choice of the valve substitute in the tricuspid position from a SJM valve to a bioprosthesis, which is lack of need for anticoagulant therapy. Also, even when one or two mechanical prostheses are implanted in the left side of the heart, a bioprosthesis should be employed to reduce the possibility of reoperation due to valve thrombosis in the tricuspid position.
However, the function of the bioprostheses tend to be worse gradually due to degenerative changes of the cusps after years [4], especially in children [18]. Nakano et al. [14] have reported that subclinical prosthetic dysfunction was found in 35% of patients who were followed up for longer than 5 years by echocardiography. On the other hand, the function of the SJM valve without valve-related complications was well maintained. Hayashi et al. [4] also reported that echocardiography performed 10±5 years after surgery showed no hemodynamic abnormality in all patients with a SJM valve. As considering these facts, a SJM valve is recommended for juvenile patients who are able to maintain potent anticoagulant therapy, with the expectation of a long-term durability.
In conclusion, the thrombogenicity of the SJM valve in the tricuspid position was higher than that reported elsewhere. Although the SJM valve would be expected its long-term durability and its excellent hemodynamic performance, the higher level of anticoagulant therapy must be given for life. Therefore, a bioprosthesis, which is lack of need for anticoagulant therapy, should be the first choice of valve substitute in the tricuspid position except for juvenile patients who are able to receive long-term oral anticoagulants sufficient to prolong the higher level of INR.
|
References
|
|---|
- Van Nooten G.J., Caes F.L., Francois K.J., Taeymans Y., Primo G., Wellens F., Leclerq J.L., Deuvaert F.E. The valve choice in tricuspid valve replacement: 25 years of experience. Eur J Cardio-thorac Surg 1995;9(8):441-446.[Abstract]
- Ratnatunga C.P., Edwards M.B., Dore C.J., Taylor K.M. Tricuspid valve replacement: UK Heart Valve Registry mid-term results comparing mechanical and biological prostheses. Ann Thorac Surg 1998;66(6):1940-1947.[Abstract/Free Full Text]
- Scully H.E., Armstrong C.S. Tricuspid valve replacement. Fifteen years of experience with mechanical prostheses and bioprostheses. J Thorac Cardiovasc Surg 1995;109(6):1035-1041.
- Hayashi J., Saito A., Yamamoto K., Watanabe H., Ohzeki H., Eguchi S. Is a bioprosthesis preferable in tricuspid valve replacement?. J Thorac Cardiovasc Surg 1996;44(5):230-233.
- Thorburn C.W., Morgan J.J., Shanahan M.X., Chang V.P. Long-term results of tricuspid valve replacement and the problem of prosthetic valve thrombosis. Am J Cardiol 1983;51(7):1128-1132.[Medline]
- Boskovic D., Elezovic I., Simin N., Rolovic Z., Josipovic V. Late thrombosis of the Bjork-Shiley tilting disc valve in the tricuspid position. Thrombolytic treatment with streptokinase. J Thorac Cardiovasc Surg 1986;91(1):1-8.[Abstract]
- Aoyagi S., Oryoji A., Nishi Y., Tanaka K., Kosuga K., Oishi K. Long-term results of valve replacement with the St. Jude Medical valve. J Thorac Cardiovasc Surg 1994;108(6):1021-1029.[Abstract/Free Full Text]
- Baudet E.M., Puel V., McBride J.T., Grimaud J.P., Roques F., Clerc F., Roques X., Laborde N. Long-term results of valve replacement with the St. Jude Medical prosthesis. J Thorac Cardiovasc Surg 1995;109(5):858-870.[Abstract]
- Nakano K., Koyanagi H., Hashimoto A., Ohtsuka G., Nojiri C. Tricuspid valve replacement with the bileaflet St. Jude Medical valve prosthesis. J Thorac Cardiovasc Surg 1994;108(5):888-892.[Abstract/Free Full Text]
- Singh A.K., Feng W.C., Sanofsky S.J. Long-term results of St. Jude Medical valve in the tricuspid position. Ann Thorac Surg 1992;54(3):538-540.[Abstract]
- Singh A.K., Christian F.D., Williams D.O., Georas C.S., Riley R.R., Nanian K.B., Karlson K.E. Follow-up assessment of St. Jude Medical prosthetic valve in the tricuspid position: clinical and hemodynamic results. Ann Thorac Surg 1984;37(4):324-327.[Abstract]
- Aoyagi S., Nishi Y., Kawara T., Oryoji A., Hara H., Kosuga K., Ohishi K. Tricuspid valve replacement with the St. Jude Medical valve. Surg Today 1994;24(1):6-12.[Medline]
- Edmunds L.H., Jr, Clark R.E., Cohn L.H., Grunkemeier G.L., Miller D.C., Weisel R.D. Guidelines for reporting morbidity and mortality after cardiac valvular operations. Eur J Cardio-thorac Surg 1996;10(9):812-816.[Abstract]
- Nakano K., Eishi K., Kosakai Y., Isobe F., Sasako Y., Nagata S., Ueda H., Kito Y., Kawashima Y. Ten-year experience with the Carpentier–Edwards pericardial xenograft in the tricuspid position. J Thorac Cardiovasc Surg 1996;111(3):605-612.[Abstract/Free Full Text]
- Glower D.D., White W.D., Smith L.R., Young W.G., Oldham H.N., Wolfe W.G., Lowe J.E. In-hospital and long-term outcome after porcine tricuspid valve replacement. J Thorac Cardiovasc Surg 1995;109(5):877-883.[Abstract]
- Poveda J.J., Bernal J.M., Matorras P., Hernando J.P., Oliva M.J., Ochoteco A., Berrazueta J.R. Tricuspid valve replacement in rheumatic disease: preoperative predictors of hospital mortality. J Heart Valve Dis 1996;5(1):26-30.[Medline]
- Kawachi Y., Tominaga R., Hisahara M., Nakashima A., Yasui H., Tokunaga K. Excellent durability of the Hancock porcine bioprosthesis in the tricuspid position. A sixteen-year follow-up study. J Thorac Cardiovasc Surg 1992;104(6):1561-1566.[Abstract]
- Pasque M., Williams W.G., Coles J.G., Trusler G.A., Freedom R.M. Tricuspid valve replacement in children. Ann Thorac Surg 1987;44(2):164-168.[Abstract]
This article has been cited by other articles:
|
|
|
|
 
H. M. Russell, P. M. McCarthy, R. Lee, S. C. Malaisrie, and E. C. McGee Jr Jr
Tricuspid valve replacement with a bioprosthetic valve
MMCTS,
March 28, 2008;
2008(0328):
2774.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
S. Tokunaga, M. Masuda, A. Shiose, Y. Tomita, S. Morita, and R. Tominaga
Long-Term Results of Isolated Tricuspid Valve Replacement
Asian Cardiovasc Thorac Ann,
February 1, 2008;
16(1):
25 - 28.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
H. V. Schaff and R. M. Suri
Multiple Valve Disease
Card. Surg. Adult,
January 1, 2008;
3(2008):
1129 - 1158.
[Full Text]
|
|
|
|
|
|
|
Z. H. Iscan, K. M. Vural, I. Bahar, L. Mavioglu, and A. Saritas
What to expect after tricuspid valve replacement? Long-term results
Eur. J. Cardiothorac. Surg.,
August 1, 2007;
32(2):
296 - 300.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
B.-C. Chang, S.-H. Lim, G. Yi, Y. S. Hong, S. Lee, K.-J. Yoo, M. S. Kang, and B. K. Cho
Long-Term Clinical Results of Tricuspid Valve Replacement
Ann. Thorac. Surg.,
April 1, 2006;
81(4):
1317 - 1324.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
N. A G Solomon, R. C H Lim, P. Nand, and K. J Graham
Tricuspid Valve Replacement: Bioprosthetic or Mechanical Valve?
Asian Cardiovasc Thorac Ann,
June 1, 2004;
12(2):
143 - 148.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
S. Aoyagi, H. Tomoeda, H. Kawano, S. Yokose, and S. Fukunaga
Doppler Echocardiographic Evaluation of Prosthetic Valves in Tricuspid Position
Asian Cardiovasc Thorac Ann,
September 1, 2003;
11(3):
193 - 197.
[Abstract]
[Full Text]
|
|
|
|
|
|
|
M. Carrier, Y. Hebert, M. Pellerin, D. Bouchard, L. P. Perrault, R. Cartier, A. Basmajian, P. Page, and N. C. Poirier
Tricuspid valve replacement: an analysis of 25 years of experience at a single center
Ann. Thorac. Surg.,
January 1, 2003;
75(1):
47 - 50.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
H. V. Schaff and D. H. Marsh
Multiple Valve Disease
Card. Surg. Adult,
January 1, 2003;
2(2003):
1017 - 1045.
[Full Text]
|
|
|
|
|
|
|
M. Kaplan, M. S. Kut, M. M. Demirtas, S. Cimen, and A. Ozler
Prosthetic replacement of tricuspid valve: bioprosthetic or mechanical
Ann. Thorac. Surg.,
February 1, 2002;
73(2):
467 - 473.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
A. Peterffy and I. Szentkiralyi
Mechanical valves in tricuspid position: cause of thrombosis and prevention
Eur. J. Cardiothorac. Surg.,
May 1, 2001;
19(5):
735 - 735.
[Full Text]
[PDF]
|
|
|
Top
Abstract
1. Introduction
