ORIGINAL ARTICLE
Heart, Lung and Circulation (2014) 23, 1175–1178 1443-9506/04/$36.00 http://dx.doi.org/10.1016/j.hlc.2014.05.015
Long Term Results Comparing Mechanical and Biological Prostheses in the Tricuspid Valve Position Which valve types are better - mechanical or biological prostheses? C. Murat Songur *, Erdal Simsek, Anıl Ozen, Sabit Kocabeyoglu, Tugba Avcı Donmez Department of Cardiovascular Surgery, Turkey Yuksek Ihtisas Hospital Ankara, Turkey Received 17 February 2014; received in revised form 14 May 2014; accepted 20 May 2014; online published-ahead-of-print 20 June 2014
Objectives
The aim of this study was to evaluate the clinical outcome of patients who underwent TVR focusing on longterm survival- and valve-related complications.
Methods
Between January 1993 and June 2011, 132 patients underwent tricuspid valve replacement in our centre. Sixty-eight bioprosthetic valves (52%) and 64 mechanical valves (48%) were implanted for tricuspid position. For 51 patients (39%) this was a first-time tricuspid valve operation.
Results
Nineteen patients died during hospitalisation, yielding a hospital mortality rate of 14%. The hospital mortality and morbidity were not statistically significantly different between the two groups. Sixteen patients (14,1%) died after discharge from the hospital. Twelve-year actuarial survival after mechanical and bioprosthetic TVR was 72,1 5,9 and 61.6 6,6%, respectively. No statistically significant difference was detected between mechanical and bioprosthetic valves in regard to event-free survival.
Conclusion
The choice between mechanical or biological prostheses in the tricuspid position should be individualised according to the clinical judgment, even though absence of any difference in the survival data supports the opinion that there is no ‘‘gold standard’’ for prosthetic tricuspid valve replacement.
Keywords
Biologic Prosthesis Mechanical Prosthesis Survival Tricuspid valve Tricuspid valve replacement Valve thrombosis
Introduction Tricuspid valve surgery has always been a challenging problem. Most cardiac surgeons perform 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. 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. When a decision is made to replace the tricuspid valve, the choice of prosthesis remains controversial. The lower pressures and flows in the right side of the heart predispose mechanical prostheses to a high rate of
*Corresponding author at: Yas¸amkent mah.3222/1 sok.Park Armoni sitesi, C blok daire:9 Yenimahalle/Ankara, Turkey. Tel.: +90 505 376 21 00; fax: +90 312 312 41 20., Email: [email protected] © 2014 Australian and New Zealand Society of Cardiac and Thoracic Surgeons (ANZSCTS) and the Cardiac Society of Australia and New Zealand (CSANZ). Published by Elsevier Inc. All rights reserved.
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valve thrombosis [1,2]. Furthermore, tricuspid prostheses are frequently combined with left heart valve prostheses, either in the same operation or on reoperation. The aim of this study was to evaluate the clinical outcome of patients, who underwent TVR, focussing on long-term survival- and valve-related complications.
Material and Methods Between January 1993 and June 2011, 132 patients underwent tricuspid valve replacement in our centre. Sixty-eight bioprosthetic valves (52%) and 64 mechanical valves (48%) were implanted. All of the mechanical prosthesis was bileaflet mechanical prosthesis. Porcine bioprosthesis was used in 62 patients, and in six patients pericardial bioprosthesis was used. Brand name of valves were not written on the operation notes in the previous periods. Therefore, we could not reach reliable data on the valve brands. In addition, we did not specify the data about valve numbers in our article because it is missing. For 51 patients (39%) this was a firsttime tricuspid valve operation, rheumatic heart disease was the most frequent cause and was present in 25 patients (49%). Ebstein’s anomaly occurred in one (2%), endocarditis in four (8%), and in the remaining 21 patients (41%) the disease process was considered to be functional. Eighty-one patients had resternotomy for previous valve replacement. Eightyfive (64.3%) underwent TVR only, 37 (28%) had TVR and mitral valve replacement (MVR), seven (5.3%) had TVR and aortic valve replacement (AVR), and three (2.4%) had triple valve replacement (Table 1). All patients underwent median sternotomy or resternotomy. Intraoperative myocardial protection was provided by systemic hypothermia to 28 8C to 32 8C, and cold crystalloid potassium-rich cardioplegic solution and isotermic blood cardioplegic solution infused in an antegrade fashion under pressure either into the aortic root, directly into the coronary ostia (aortic valve operation) or retrograd fashion into the coronary sinuse. The mean size of the valve prosthesis implanted was 31 6.3 mm. Anticoagulation therapy with warfarin (Coumadin) was started on the first postoperative day and continued life-long in patients with mechanical valves. Follow-up data were obtained from patient’s follow up visits and by telephone interview with the patient or their
Table 1 Operative Procedures Combined With Tricuspid Valve Replacement. Bioprosthesis (n = 68)
Mechanic prosthesis (n = 64)
families. Valve-related complications were reported according to the American Association for Thoracic Surgery Guidelines for reporting morbidity and mortality after cardiac valvular operations [3]. Anticoagulation therapy was adjusted during outpatient visits at three-month intervals to achieve a target international normalised ratio (INR) of 2.0–3.0. Patients with inadequate INR values were evaluated weekly or monthly until the target INR was achieved.
Statistical Analyses The patients’ characteristics were compared between the groups by using the chi-square and t-tests. The survival rates were analysed by Kaplan-Meier test and Log-rank test was used for the comparison in between the groups. P value less than 0.05 was considered statistically significant (p < 0.05). All values reported are mean SEM.
Results Patients’ demographics are presented Table 2. There were not any differences between the two groups. Nineteen patients died during hospitalisation, yielding a hospital mortality rate of 14%. Cardiac failure was responsible in nine patients (47%), multiple organ failure in five (26%), respiratory insufficiency in two (11%), sepsis in three (16%). Two patients in the bioprosthetic group and one patient in the mechanical group required insertion of a dual-chamber pacing type (DDD) pacemaker because of complete atrioventricular conduction block. The hospital mortality and morbidity were not statistically significantly different between the patients undergoing biologic tricuspid valve replacement and those in whom mechanical valves were implanted. Sixteen patients (14.1%) died after discharge from the hospital (mechanical, seven vs. bioprosthetic, nine). Ten patients
Table 2 Patients’ Characteristics. Characteristics
Bioprosthesis
Mechanic
(n = 68)
prosthesis
P
(n = 64) Age
61,6 10,4
62,3 9,8
0,8
Female
53 (78%)
45 (70%)
0,7
Male
15 (22%)
19 (30%)
0,4
HT
10 (15%)
6 (9%)
0,2
DM
6 (9%)
5 (8%)
0,6
AF
44 (65%)
42 (66%)
0,8
EF History of previous
52 45 (66%)
54 36 (56%)
0,2
cardiac surgery NYHA Class IV
18 (26%)
15 (23%)
0,8
TVR
45 (66%)
40 (62,5%)
Ascites
14 (21%)
11 (17%)
0,4
TVR + MVR
17 (25%)
20 (31%)
Peripheral Oedema
22 (32%)
19 (30%)
0,7
6 (9%)
5 (8%)
0,7
12 (18%)
10 (16%)
0,6
TVR + TVR + MVR + AVR
4 (6%) 2 (3%)
3 (4,5%) 1 (2%)
Hepatomegaly Prolonged intubation
1177
Figure 1 Overall survival curves in the mechanical tricuspid valve replacement group and the bioprosthetic valve group.
died from cardiac causes and others from non-cardiac causes. With regard to overall mortality (in-hospital and follow-up), 12-year actuarial survival after mechanical and bioprosthetic TVR was 72.1 5.9 and 61.6 6.6%, respectively (p = 0.1; Fig. 1). Hepatomegaly, ascites, NYHA class IV, prolonged entubation were independent factors for mortality. Eleven patients (8.3%) underwent reoperation (mechanical 5 vs bioprosthesis 6). While mean time from the first operation and second operation for mechanic prosthesis was 44.2 months, bioprosthesis was 92.3 months. Valve thrombosis was observed in six patients. Of these patients, five were in mechanical TVR group, and other one in MVR (mechanical prosthesis) + TVR (bioprosthesis) group. In the mechanical prosthesis group, tricuspid mechanical prosthetic valve thrombosis in four patients was identified and were all redone TVR. In one patient both mitral and tricuspid valve thrombosis was detected, and MVR + TVR was redone. In bioprosthesis group, mitral mechanical valve thrombosis and tricuspid bioprosthesis degeneration was detected and redo MVR + TVR (porcine bioprosthesis) was performed. In all patients with valve thrombosis, varying degrees of warfarin misuse was detected as a etiologic factor. Overall 24 patients, 16 after mechanical TVR and eight after bioprosthetic TVR, experienced a thromboembolic (mechanical, 4 vs. bioprosthetic, 1) or bleeding event (mechanical, 11 vs. bioprosthetic, 7). Freedom from thromboembolism or bleeding 12 years after mechanical TVR and bioprosthetic TVR was 74.3 8.4% and 81.2 6.3%, respectively (p = 0.3).
Discussion TVR is rarely required and it is performed in less than 2% of all valve operations [4]. It is generally agreed that tricuspid annuloplasty is the preferred treatment for moderate to severe tricuspid insufficiency. Tricuspid valve replacement is usually reserved for those patients with significant organic
tricuspid valve disease that is unlikely to improve if more conservative measures are taken [5–8]. The choice of valve prosthesis for TVR is a subject of ongoing debate and is based on the durability of bioprosthetic valves and on the probability of anticoagulation related complications with mechanical valves. Some authors [9–11] have advocated the use of bioprostheses in the tricuspid position, based on the concept that low pressure and low stress in the right heart seem to provide a higher valve durability, compared to those located in the systemic circulation. However, the use of bioprostheses in the tricuspid position leads to an increased rate of reoperation after 7–10 years [12]. Our early mortality rate of 14% compares well with most series published in the literature. A high operative mortality rate has been consistently reported, ranging from 12% to 26% in the most recent series [13,14]. Almost half of our early deaths were caused by cardiac failure related to severe depression of myocardial function. In a comparison of the hospital mortality and postoperative morbidity between patients who were undergoing biologic or mechanical prosthetic tricuspid replacement, we found no difference. Although others have noted a higher hospital mortality with the use of mechanical prostheses, [15] other things being equal, it is logical that there would be no difference. The long-term survival after TVR is generally unsatisfactory, ranging between 33% and 68% at 10 years [12,16,17] with a notable exception of that from Sung et al. [18] that revealed a 79% survival at eight years. Our study indicated that 74% of patients (mechanical, 73.5% and bioprosthetic, 73.6%) were alive 12 years after TVR. Some studies declared that preoperative functional class [7,8], presence of hepatic dysfunction [7], elevated mean pulmonary artery pressure [1], sex [7], and bypass time [7] as predictors of 30-day mortality following TVR. We found hepatomegaly, ascites, NYHA class IV, prolonged entubation have been associated with high early mortality rates. Regarding the durability of the bioprosthesis in the tricuspid position, several authors have reported excellent longterm results. Munro and associates compared clinical performance of TVR with bioprostheses and mechanical valve prosthesis [19]. Bioprostheses were used in 83 operations. The freedom from structural valve deterioration was 97.1% at seven years for bioprostheses. Our studies showed that freedom from death or reoperation was analysed, there was similarly no difference between biological and mechanical valves implanted at the tricuspid position but while mean reoperation time was 44.2 months for mechanic prosthesis, it was 92.3 months for bioprosthesis. Thrombosis occurs at random but it is most probable in the early postoperative periods because of difficulties in rapidly reaching a good anticoagulation control. Conversely, degeneration of biological prostheses requires time to develop so that its real occurrence depends on follow-up time. The higher prevalence of tricuspid valve thrombosis in older mechanical valves has been confirmed by several authors [20–22]. Likewise, a low prevalence of valve-related thromboembolism with the St. Jude Medical valve in patients
1178
with correctly regulated anticoagulation therapy has been reported [23]. Similarly our five patients with mechanic prosthesis thrombosis were older generation prostheses. One of the major differences between mechanical and bioprosthetic valves is the use of anticoagulation therapy. The patients who underwent bioprosthetic TVR do not need anticoagulation therapy. However, many of these patients require anticoagulation therapy for other reasons such as atrial fibrillation, presence of other prosthetic valves, and atrial size or thrombus, thus losing the potential advantage of tissue valves. In our series there were no significant differences in anticoagulated, thromboembolic or bleeding complications for both groups. In conclusion, the choice between mechanical or biological prostheses in the tricuspid position should be individualised according to the clinical judgment, even though absence of any difference in the survival data supports the opinion that there is no ‘‘gold standard’’ for prosthetic tricuspid valve replacement.
Study Limitations Our study is necessarily limited by its retrospective nature, relatively small sample size, and heterogeneity of patients and surgical techniques. The diversity in concomitant procedures is also likely to influence the study.
C.M. Songur et al.
[5] [6]
[7]
[8]
[9]
[10]
[11]
[12]
[13]
[14]
[15]
[16]
Declaration of Conflict of Interest
[17]
The author(s) declared no potential conflict of interest with respect to the research, authorship, and/or publication of this article.
[18]
[19]
References [1] Bourdillon PDW, Sharratt GP. Malfunction of Bjork-Shiley valve prosthesis in tricuspid position. Br Heart J 1976;38:1149. [2] Boskovic D, Elezovic I, Boskovic D, Simin N, Rolovic Z, Josipovic V. Late thrombosis of the Bjork-Shiley tilting disc valve in the tricuspid position. J Thorac Cardıovasc Surg 1986;91:1–8. [3] Edmunds Jr LH, Clark RE, Cohn LH, Grunkemeier GL, Miller DC, Weisel RD. Guidelines for reporting morbidity and mortality after cardiac valvular operations. Ad Hoc Liaison Committee for Standardizing Definitions of Prosthetic Heart Valve Morbidity of the American Association for Thoracic Surgery and the Society of Thoracic Surgeons. J Thorac Cardiovasc Surg 1996;112:708–11. [4] Rizzoli G, Schiavon L, Bellini P. Does the use of bilateral internal mammary artery (IMA) grafts provide incremental benefit relative to the use
[20]
[21] [22]
[23]
of a single IMA graft? A metaanalysis approach. Eur J Cardiothorac Surg 2002;22:781–6. Kaul TK, Mercer JL. Tricuspid valve replacement: factors influencing early and late mortality. Thorac Cardiovasc Surg 1990;38:229–35. Hauck JA, Freeman DP, Ackerman DM, Danielson GK, Edwards WD. Surgical pathology of the tricuspid valve: a study of 363 cases spanning 25 years. Mayo Clin Proc 1988;63:851–63. Pluth JR, Ellis Jr FH. Tricuspid insufficiency in patients undergoing mitral valve replacement: conservative management, annuloplasty or replacement. J Thorac Cardıovasc Surg 1969;58:484–91. Kay LG, Morita S, Mendez MA, Zubiate P, Kay HJ. Tricuspid regurgitation associated with mitral valve disease: repair and replacement. Ann Thorac Surg 1989;48:593–5. Kawano H, Oda T, Fukunaga S, Tayama E, Kawara T, Oryoji A, et al. Tricuspid valve replacement with the St. Jude Medical valve: 19 Years of experience. Eur J Cardiothorac Surg 2000;18:565–9. Carrier M, He´bert Y, Pellerin M, Bouchard D, Perrault LP, Cartier R, et al. Tricuspid valve replacement: An analysis of 25 years of experience at a single center. Ann Thorac Surg 2003;75:47–50. Ohata T, Kiqawa I, Tohda E, Wanibuchi Y. Comparison of durability of bioprostheses in tricuspid and mitral positions. Ann Thorac Surg 2001;71: S240–3. Van Nooten GJ, Caes FL, Franc¸ois KJ, Taeymans Y, Primo G, Wellens F, et al. The valve choice in tricuspid valve replacement: 25 Years of experience. Eur J Cardiothorac Surg 1995;9:441–6. discussion 446–447. Filsoufi F, Anyanwu AC, Salzberg SP, Frankel T, Cohn LH, Adams DH. Long-term outcomes of tricuspid valve replacement in the current era. Ann Thorac Surg 2005;80:845–50. Rizzoli G, Vendramin I, Nesseris G, Bottio T, Guglielmi C, Schiavon L. Biological or mechanical prostheses in tricuspid position? A metaanalysis of intra-institutional results. Ann Thorac Surg 2004;77:1607–14. Jegaden O, Perinetti M, Barthelet M, Vedrinne C, Delahaye F, Montagna P. Long-term results of porcine bioprosthesis in the tricuspid position. Eur J Cardiothorac Surg 1992;6:256–60. Dalrymple-Hay MJ, Leung Y, Ohri SK, Haw MP, Ross JK, Livesey SA, et al. Tricuspid valve replacement: Bioprostheses are preferable. J Heart Valve Dis 1999;8:644–8. Nakano K, Ishibashi-Ueda H, Kobayashi J, Sasako Y, Yagihara T. Tricuspid valve replacement with bioprostheses: Long-term results and causes of valve dysfunction. Ann Thorac Surg 2001;71:105–9. Sung K, Park PW, Park KH, Jun TG, Lee YT, Yang JH, et al. Is tricuspid valve replacement a catastrophic operation? Eur J Cardiothorac Surg 2009;36:825–9. Munro AI, Jamieson WRE, Tyers GFO, Germann E. Tricuspid valve replacement: porcine bioprostheses and mechanical prostheses. Ann Thorac Surg 1995;59:S470–4. Sanfelippo PM, Giuliani ER, Danielson GK, Wallace RB, Pluth JR, McGoon DC. Tricuspid valve prosthetic replacement: early and late results with the Starr-Edwards prosthesis. J Thorac Cardıovasc Surg 1976;71:441–5. Wellens F, Goldstein J. Tricuspid valve replacement. Cardiovasc Clin 1987;17:111–5. Thorburn CW, Morgan JJ, Shanahan MX, Chang VP. Long-term results of tricuspid valve replacement and the problem of prosthetic valve thrombosis. Am J Cardiol 1983;51:1128–32. Singh AK, Christian FD, Williams DO, Georas CS, Riley RR, Nanian KB, et al. Follow-up assessment of the St. Jude Medical prosthetic valve in the tricuspid position: clinical and hemodynamic results. Ann Thorac Surg 1984;37:324–7.
Heart, Lung and Circulation (2014) 23, 1175–1178 1443-9506/04/$36.00 http://dx.doi.org/10.1016/j.hlc.2014.05.015
Long Term Results Comparing Mechanical and Biological Prostheses in the Tricuspid Valve Position Which valve types are better - mechanical or biological prostheses? C. Murat Songur *, Erdal Simsek, Anıl Ozen, Sabit Kocabeyoglu, Tugba Avcı Donmez Department of Cardiovascular Surgery, Turkey Yuksek Ihtisas Hospital Ankara, Turkey Received 17 February 2014; received in revised form 14 May 2014; accepted 20 May 2014; online published-ahead-of-print 20 June 2014
Objectives
The aim of this study was to evaluate the clinical outcome of patients who underwent TVR focusing on longterm survival- and valve-related complications.
Methods
Between January 1993 and June 2011, 132 patients underwent tricuspid valve replacement in our centre. Sixty-eight bioprosthetic valves (52%) and 64 mechanical valves (48%) were implanted for tricuspid position. For 51 patients (39%) this was a first-time tricuspid valve operation.
Results
Nineteen patients died during hospitalisation, yielding a hospital mortality rate of 14%. The hospital mortality and morbidity were not statistically significantly different between the two groups. Sixteen patients (14,1%) died after discharge from the hospital. Twelve-year actuarial survival after mechanical and bioprosthetic TVR was 72,1 5,9 and 61.6 6,6%, respectively. No statistically significant difference was detected between mechanical and bioprosthetic valves in regard to event-free survival.
Conclusion
The choice between mechanical or biological prostheses in the tricuspid position should be individualised according to the clinical judgment, even though absence of any difference in the survival data supports the opinion that there is no ‘‘gold standard’’ for prosthetic tricuspid valve replacement.
Keywords
Biologic Prosthesis Mechanical Prosthesis Survival Tricuspid valve Tricuspid valve replacement Valve thrombosis
Introduction Tricuspid valve surgery has always been a challenging problem. Most cardiac surgeons perform 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. 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. When a decision is made to replace the tricuspid valve, the choice of prosthesis remains controversial. The lower pressures and flows in the right side of the heart predispose mechanical prostheses to a high rate of
*Corresponding author at: Yas¸amkent mah.3222/1 sok.Park Armoni sitesi, C blok daire:9 Yenimahalle/Ankara, Turkey. Tel.: +90 505 376 21 00; fax: +90 312 312 41 20., Email: [email protected] © 2014 Australian and New Zealand Society of Cardiac and Thoracic Surgeons (ANZSCTS) and the Cardiac Society of Australia and New Zealand (CSANZ). Published by Elsevier Inc. All rights reserved.
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C.M. Songur et al.
valve thrombosis [1,2]. Furthermore, tricuspid prostheses are frequently combined with left heart valve prostheses, either in the same operation or on reoperation. The aim of this study was to evaluate the clinical outcome of patients, who underwent TVR, focussing on long-term survival- and valve-related complications.
Material and Methods Between January 1993 and June 2011, 132 patients underwent tricuspid valve replacement in our centre. Sixty-eight bioprosthetic valves (52%) and 64 mechanical valves (48%) were implanted. All of the mechanical prosthesis was bileaflet mechanical prosthesis. Porcine bioprosthesis was used in 62 patients, and in six patients pericardial bioprosthesis was used. Brand name of valves were not written on the operation notes in the previous periods. Therefore, we could not reach reliable data on the valve brands. In addition, we did not specify the data about valve numbers in our article because it is missing. For 51 patients (39%) this was a firsttime tricuspid valve operation, rheumatic heart disease was the most frequent cause and was present in 25 patients (49%). Ebstein’s anomaly occurred in one (2%), endocarditis in four (8%), and in the remaining 21 patients (41%) the disease process was considered to be functional. Eighty-one patients had resternotomy for previous valve replacement. Eightyfive (64.3%) underwent TVR only, 37 (28%) had TVR and mitral valve replacement (MVR), seven (5.3%) had TVR and aortic valve replacement (AVR), and three (2.4%) had triple valve replacement (Table 1). All patients underwent median sternotomy or resternotomy. Intraoperative myocardial protection was provided by systemic hypothermia to 28 8C to 32 8C, and cold crystalloid potassium-rich cardioplegic solution and isotermic blood cardioplegic solution infused in an antegrade fashion under pressure either into the aortic root, directly into the coronary ostia (aortic valve operation) or retrograd fashion into the coronary sinuse. The mean size of the valve prosthesis implanted was 31 6.3 mm. Anticoagulation therapy with warfarin (Coumadin) was started on the first postoperative day and continued life-long in patients with mechanical valves. Follow-up data were obtained from patient’s follow up visits and by telephone interview with the patient or their
Table 1 Operative Procedures Combined With Tricuspid Valve Replacement. Bioprosthesis (n = 68)
Mechanic prosthesis (n = 64)
families. Valve-related complications were reported according to the American Association for Thoracic Surgery Guidelines for reporting morbidity and mortality after cardiac valvular operations [3]. Anticoagulation therapy was adjusted during outpatient visits at three-month intervals to achieve a target international normalised ratio (INR) of 2.0–3.0. Patients with inadequate INR values were evaluated weekly or monthly until the target INR was achieved.
Statistical Analyses The patients’ characteristics were compared between the groups by using the chi-square and t-tests. The survival rates were analysed by Kaplan-Meier test and Log-rank test was used for the comparison in between the groups. P value less than 0.05 was considered statistically significant (p < 0.05). All values reported are mean SEM.
Results Patients’ demographics are presented Table 2. There were not any differences between the two groups. Nineteen patients died during hospitalisation, yielding a hospital mortality rate of 14%. Cardiac failure was responsible in nine patients (47%), multiple organ failure in five (26%), respiratory insufficiency in two (11%), sepsis in three (16%). Two patients in the bioprosthetic group and one patient in the mechanical group required insertion of a dual-chamber pacing type (DDD) pacemaker because of complete atrioventricular conduction block. The hospital mortality and morbidity were not statistically significantly different between the patients undergoing biologic tricuspid valve replacement and those in whom mechanical valves were implanted. Sixteen patients (14.1%) died after discharge from the hospital (mechanical, seven vs. bioprosthetic, nine). Ten patients
Table 2 Patients’ Characteristics. Characteristics
Bioprosthesis
Mechanic
(n = 68)
prosthesis
P
(n = 64) Age
61,6 10,4
62,3 9,8
0,8
Female
53 (78%)
45 (70%)
0,7
Male
15 (22%)
19 (30%)
0,4
HT
10 (15%)
6 (9%)
0,2
DM
6 (9%)
5 (8%)
0,6
AF
44 (65%)
42 (66%)
0,8
EF History of previous
52 45 (66%)
54 36 (56%)
0,2
cardiac surgery NYHA Class IV
18 (26%)
15 (23%)
0,8
TVR
45 (66%)
40 (62,5%)
Ascites
14 (21%)
11 (17%)
0,4
TVR + MVR
17 (25%)
20 (31%)
Peripheral Oedema
22 (32%)
19 (30%)
0,7
6 (9%)
5 (8%)
0,7
12 (18%)
10 (16%)
0,6
TVR + TVR + MVR + AVR
4 (6%) 2 (3%)
3 (4,5%) 1 (2%)
Hepatomegaly Prolonged intubation
1177
Figure 1 Overall survival curves in the mechanical tricuspid valve replacement group and the bioprosthetic valve group.
died from cardiac causes and others from non-cardiac causes. With regard to overall mortality (in-hospital and follow-up), 12-year actuarial survival after mechanical and bioprosthetic TVR was 72.1 5.9 and 61.6 6.6%, respectively (p = 0.1; Fig. 1). Hepatomegaly, ascites, NYHA class IV, prolonged entubation were independent factors for mortality. Eleven patients (8.3%) underwent reoperation (mechanical 5 vs bioprosthesis 6). While mean time from the first operation and second operation for mechanic prosthesis was 44.2 months, bioprosthesis was 92.3 months. Valve thrombosis was observed in six patients. Of these patients, five were in mechanical TVR group, and other one in MVR (mechanical prosthesis) + TVR (bioprosthesis) group. In the mechanical prosthesis group, tricuspid mechanical prosthetic valve thrombosis in four patients was identified and were all redone TVR. In one patient both mitral and tricuspid valve thrombosis was detected, and MVR + TVR was redone. In bioprosthesis group, mitral mechanical valve thrombosis and tricuspid bioprosthesis degeneration was detected and redo MVR + TVR (porcine bioprosthesis) was performed. In all patients with valve thrombosis, varying degrees of warfarin misuse was detected as a etiologic factor. Overall 24 patients, 16 after mechanical TVR and eight after bioprosthetic TVR, experienced a thromboembolic (mechanical, 4 vs. bioprosthetic, 1) or bleeding event (mechanical, 11 vs. bioprosthetic, 7). Freedom from thromboembolism or bleeding 12 years after mechanical TVR and bioprosthetic TVR was 74.3 8.4% and 81.2 6.3%, respectively (p = 0.3).
Discussion TVR is rarely required and it is performed in less than 2% of all valve operations [4]. It is generally agreed that tricuspid annuloplasty is the preferred treatment for moderate to severe tricuspid insufficiency. Tricuspid valve replacement is usually reserved for those patients with significant organic
tricuspid valve disease that is unlikely to improve if more conservative measures are taken [5–8]. The choice of valve prosthesis for TVR is a subject of ongoing debate and is based on the durability of bioprosthetic valves and on the probability of anticoagulation related complications with mechanical valves. Some authors [9–11] have advocated the use of bioprostheses in the tricuspid position, based on the concept that low pressure and low stress in the right heart seem to provide a higher valve durability, compared to those located in the systemic circulation. However, the use of bioprostheses in the tricuspid position leads to an increased rate of reoperation after 7–10 years [12]. Our early mortality rate of 14% compares well with most series published in the literature. A high operative mortality rate has been consistently reported, ranging from 12% to 26% in the most recent series [13,14]. Almost half of our early deaths were caused by cardiac failure related to severe depression of myocardial function. In a comparison of the hospital mortality and postoperative morbidity between patients who were undergoing biologic or mechanical prosthetic tricuspid replacement, we found no difference. Although others have noted a higher hospital mortality with the use of mechanical prostheses, [15] other things being equal, it is logical that there would be no difference. The long-term survival after TVR is generally unsatisfactory, ranging between 33% and 68% at 10 years [12,16,17] with a notable exception of that from Sung et al. [18] that revealed a 79% survival at eight years. Our study indicated that 74% of patients (mechanical, 73.5% and bioprosthetic, 73.6%) were alive 12 years after TVR. Some studies declared that preoperative functional class [7,8], presence of hepatic dysfunction [7], elevated mean pulmonary artery pressure [1], sex [7], and bypass time [7] as predictors of 30-day mortality following TVR. We found hepatomegaly, ascites, NYHA class IV, prolonged entubation have been associated with high early mortality rates. Regarding the durability of the bioprosthesis in the tricuspid position, several authors have reported excellent longterm results. Munro and associates compared clinical performance of TVR with bioprostheses and mechanical valve prosthesis [19]. Bioprostheses were used in 83 operations. The freedom from structural valve deterioration was 97.1% at seven years for bioprostheses. Our studies showed that freedom from death or reoperation was analysed, there was similarly no difference between biological and mechanical valves implanted at the tricuspid position but while mean reoperation time was 44.2 months for mechanic prosthesis, it was 92.3 months for bioprosthesis. Thrombosis occurs at random but it is most probable in the early postoperative periods because of difficulties in rapidly reaching a good anticoagulation control. Conversely, degeneration of biological prostheses requires time to develop so that its real occurrence depends on follow-up time. The higher prevalence of tricuspid valve thrombosis in older mechanical valves has been confirmed by several authors [20–22]. Likewise, a low prevalence of valve-related thromboembolism with the St. Jude Medical valve in patients
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with correctly regulated anticoagulation therapy has been reported [23]. Similarly our five patients with mechanic prosthesis thrombosis were older generation prostheses. One of the major differences between mechanical and bioprosthetic valves is the use of anticoagulation therapy. The patients who underwent bioprosthetic TVR do not need anticoagulation therapy. However, many of these patients require anticoagulation therapy for other reasons such as atrial fibrillation, presence of other prosthetic valves, and atrial size or thrombus, thus losing the potential advantage of tissue valves. In our series there were no significant differences in anticoagulated, thromboembolic or bleeding complications for both groups. In conclusion, the choice between mechanical or biological prostheses in the tricuspid position should be individualised according to the clinical judgment, even though absence of any difference in the survival data supports the opinion that there is no ‘‘gold standard’’ for prosthetic tricuspid valve replacement.
Study Limitations Our study is necessarily limited by its retrospective nature, relatively small sample size, and heterogeneity of patients and surgical techniques. The diversity in concomitant procedures is also likely to influence the study.
C.M. Songur et al.
[5] [6]
[7]
[8]
[9]
[10]
[11]
[12]
[13]
[14]
[15]
[16]
Declaration of Conflict of Interest
[17]
The author(s) declared no potential conflict of interest with respect to the research, authorship, and/or publication of this article.
[18]
[19]
References [1] Bourdillon PDW, Sharratt GP. Malfunction of Bjork-Shiley valve prosthesis in tricuspid position. Br Heart J 1976;38:1149. [2] Boskovic D, Elezovic I, Boskovic D, Simin N, Rolovic Z, Josipovic V. Late thrombosis of the Bjork-Shiley tilting disc valve in the tricuspid position. J Thorac Cardıovasc Surg 1986;91:1–8. [3] Edmunds Jr LH, Clark RE, Cohn LH, Grunkemeier GL, Miller DC, Weisel RD. Guidelines for reporting morbidity and mortality after cardiac valvular operations. Ad Hoc Liaison Committee for Standardizing Definitions of Prosthetic Heart Valve Morbidity of the American Association for Thoracic Surgery and the Society of Thoracic Surgeons. J Thorac Cardiovasc Surg 1996;112:708–11. [4] Rizzoli G, Schiavon L, Bellini P. Does the use of bilateral internal mammary artery (IMA) grafts provide incremental benefit relative to the use
[20]
[21] [22]
[23]
of a single IMA graft? A metaanalysis approach. Eur J Cardiothorac Surg 2002;22:781–6. Kaul TK, Mercer JL. Tricuspid valve replacement: factors influencing early and late mortality. Thorac Cardiovasc Surg 1990;38:229–35. Hauck JA, Freeman DP, Ackerman DM, Danielson GK, Edwards WD. Surgical pathology of the tricuspid valve: a study of 363 cases spanning 25 years. Mayo Clin Proc 1988;63:851–63. Pluth JR, Ellis Jr FH. Tricuspid insufficiency in patients undergoing mitral valve replacement: conservative management, annuloplasty or replacement. J Thorac Cardıovasc Surg 1969;58:484–91. Kay LG, Morita S, Mendez MA, Zubiate P, Kay HJ. Tricuspid regurgitation associated with mitral valve disease: repair and replacement. Ann Thorac Surg 1989;48:593–5. Kawano H, Oda T, Fukunaga S, Tayama E, Kawara T, Oryoji A, et al. Tricuspid valve replacement with the St. Jude Medical valve: 19 Years of experience. Eur J Cardiothorac Surg 2000;18:565–9. Carrier M, He´bert Y, Pellerin M, Bouchard D, Perrault LP, Cartier R, et al. Tricuspid valve replacement: An analysis of 25 years of experience at a single center. Ann Thorac Surg 2003;75:47–50. Ohata T, Kiqawa I, Tohda E, Wanibuchi Y. Comparison of durability of bioprostheses in tricuspid and mitral positions. Ann Thorac Surg 2001;71: S240–3. Van Nooten GJ, Caes FL, Franc¸ois KJ, Taeymans Y, Primo G, Wellens F, et al. The valve choice in tricuspid valve replacement: 25 Years of experience. Eur J Cardiothorac Surg 1995;9:441–6. discussion 446–447. Filsoufi F, Anyanwu AC, Salzberg SP, Frankel T, Cohn LH, Adams DH. Long-term outcomes of tricuspid valve replacement in the current era. Ann Thorac Surg 2005;80:845–50. Rizzoli G, Vendramin I, Nesseris G, Bottio T, Guglielmi C, Schiavon L. Biological or mechanical prostheses in tricuspid position? A metaanalysis of intra-institutional results. Ann Thorac Surg 2004;77:1607–14. Jegaden O, Perinetti M, Barthelet M, Vedrinne C, Delahaye F, Montagna P. Long-term results of porcine bioprosthesis in the tricuspid position. Eur J Cardiothorac Surg 1992;6:256–60. Dalrymple-Hay MJ, Leung Y, Ohri SK, Haw MP, Ross JK, Livesey SA, et al. Tricuspid valve replacement: Bioprostheses are preferable. J Heart Valve Dis 1999;8:644–8. Nakano K, Ishibashi-Ueda H, Kobayashi J, Sasako Y, Yagihara T. Tricuspid valve replacement with bioprostheses: Long-term results and causes of valve dysfunction. Ann Thorac Surg 2001;71:105–9. Sung K, Park PW, Park KH, Jun TG, Lee YT, Yang JH, et al. Is tricuspid valve replacement a catastrophic operation? Eur J Cardiothorac Surg 2009;36:825–9. Munro AI, Jamieson WRE, Tyers GFO, Germann E. Tricuspid valve replacement: porcine bioprostheses and mechanical prostheses. Ann Thorac Surg 1995;59:S470–4. Sanfelippo PM, Giuliani ER, Danielson GK, Wallace RB, Pluth JR, McGoon DC. Tricuspid valve prosthetic replacement: early and late results with the Starr-Edwards prosthesis. J Thorac Cardıovasc Surg 1976;71:441–5. Wellens F, Goldstein J. Tricuspid valve replacement. Cardiovasc Clin 1987;17:111–5. Thorburn CW, Morgan JJ, Shanahan MX, Chang VP. Long-term results of tricuspid valve replacement and the problem of prosthetic valve thrombosis. Am J Cardiol 1983;51:1128–32. Singh AK, Christian FD, Williams DO, Georas CS, Riley RR, Nanian KB, et al. Follow-up assessment of the St. Jude Medical prosthetic valve in the tricuspid position: clinical and hemodynamic results. Ann Thorac Surg 1984;37:324–7.
