Should the tricuspid valve be replaced with a mechanical or biological valve?

Transcription

1 doi: /icvts Interactive CardioVascular and Thoracic Surgery 6 (2007) Best evidence topic - Valves Should the tricuspid valve be replaced with a mechanical or biological valve? a a b a, Babu Kunadian, Kunadian Vijayalakshmi, Sankar Balasubramanian, Joel Dunning * a Department of Cardiothoracic Surgery, James Cook University Hospital, Middlesbrough, UK b Department of Cardiothoracic Surgery, Blackpool Victoria Hospital, Blackpool, UK Received 8 May 2007; accepted 9 May Summary A best evidence topic in cardiac surgery was written according to a structured protocol. The question addressed was whether patients requiring tricuspid replacement should have a mechanical or a biological valve. Using the reported search, 561 papers were identified. Thirteen papers represented the best evidence on the subject. The author,, date and country of publication, patient group studied, study type, relevant outcomes, weaknesses, results and study comments were tabulated. We conclude that there are no major differences between the insertion of a mechanical or biological tricuspid valve. Aggregating the available data it is found that the reoperation rate is similar with bioprosthetic degeneration rate being equivalent to the mechanical thrombosis rate. Conversely up to 95% of patients with a bioprosthesis still receive anticoagulation. Survival in over 1000 prostheses pooled by meta-analysis was equivalent between biological and mechanical valves Published by European Association for Cardio-Thoracic Surgery. All rights reserved. Keywords: Tricuspid valve; Artificial valve; Thoracic surgery; Tricuspid valve replacement 1. Introduction A best evidence topic was constructed according to a structured protocol. This protocol is fully described in the ICVTS w1x. 2. Clinical scenario You are about to operate on a 32-year-old i.v. drug abuser who has been under the care of your cardiologists for eight weeks with tricuspid valve endocarditis. She has successfully undergone six weeks of antibiotic therapy and three blood cultures off antibiotics have all been negative. However, she has severe tricuspid regurgitation with hepatic congestion and peripheral oedema and requires tricuspid replacement. You wonder whether to use a biological or mechanical valve. 3. Three-part question In patients requiring a wtricuspid valve replacementx is a wmechanical valve or a biological valvex better for wlongterm survival and lower morbidityx. 4. Search strategy Medline 1950 April 2007 using the OVID interface. wexp Tricuspid ValveyOR tricuspid valve.mpx AND wexp Heart Valve ProsthesisyOR valve replacement.mp. OR exp *Corresponding author. Tel.yfax: q address: joeldunning@doctors.org.uk (J. Dunning) Published by European Association for Cardio-Thoracic Surgery Heart Valve Prosthesis Implantationyx AND wsurvival.mp OR outcome.mp OR.mpx LIMIT to Humanyenglish. 5. Search outcome A total of 561 papers were found of which thirteen papers were relevant (Table 1). 6. Results The published series are few and are limited by small sample size, often spanning from the 1960s through 1990s. We identified thirteen papers which have compared both biological and mechanical valves in the tricuspid position including a meta-analysis. The meta-analysis by Rizzoli et al. w2x comparing 646 biological and 514 mechanical prostheses from 11 studies did not find a difference in the early and late survival, or reoperations. The meta-analysis included series starting in the 1960s and included patients with first-generation valve prostheses. Among 391 patients discharged with mechanical prostheses, the pooled 1-, 5-, 10-, and 15-year survival of the hospital-discharged patients was 86.9%, 73.5%, 60.2%, and 47.8%, respectively; among 477 patients discharged with tricuspid bioprostheses, survival was 86.5%, 73.6%, 62%, and 46.7%, respectively. Five-year survival was identical. Differences were trivial, favouring mechanical prostheses at 1-year and at 15-year, favouring biological prostheses at 10-year.

2 552 B. Kunadian et al. / Interactive CardioVascular and Thoracic Surgery 6 (2007) Table 1 Summary of best evidence papers Rizzoli et al Survival (Bio worx vs. Mec worx, Differences were trivial (2004), Ann ns1258; mean Hazard ratio P-value) Thorac ages49.3 OR 1.07 (95% CI, Favoured mechanical at Surg, Italy, w2x Biologicals , Ps0.60) 1 and 15 years; Mechanicals514 biological at 10 years Meta-analysis (Level 1a) Isolated TVR ratio Freedom from OR 1.24 (95% CI, Methodological (0.36) re-operation , Ps0.50) limitations due to inclusion of observational Survival free OR 0.86 (95% CI, studies; results are less Re-operation ratio re-operation , Ps0.14) reliable (0.53) Thrombosis incidence 0.87% Valve degeneration incidence 1.02% Chang et al Survival at 15 years Biological Similar long-term (2006), Ann ns138; mean ages "10 outcomes Thorac Surg, Biologicals35 Mechanical Korea, w11x Mechanicals103 66"19, Ps0.18 Need to prevent thrombosis in early post- Single centre (Bio w%x vs. Mec w%x) Freedom from Biological period in mechanical re-operation at 15 years 55.1"13.8 valves Cohort Study (Level 2b) Isolated TVR Mechanical 86"6.2 (46 vs. 24) Greater chance of Survival free re-operation in Re-operation re-operation biological prostheses (40 vs. 63) 5 years Bio vs. Mech 10 years 91"0.6 vs. 98"0.8, Ps0.4, 15 years 85"0.9 vs. 92"1.0 heterogeneity of patients 84"0.9 vs. 92"1.4 and surgical techniques Thrombosis incidence (overall; valve) Both (1.41%; 1.28%) Mechanical (2.11%; 1.92%) Valve degeneration Both 0.84% incidence Bio-prostheses 2.68% late Preoperative ascites and peripheral oedema Filsoufi et al Survival (Bio w%x vs. Mec w%x, No superiority (2005), Ann ns81; mean ages years P-value) Overall high Thorac Surg, Biologicals34 5 years 80 vs. 84 USA, w8x Mechanicals47 10 years 60 vs. 69 Heart failure common In-hospital 45 vs. 59 cause of early and late Single centre Isolated TVR (31%) 15 vs. 32, Ps0.06 Cohort Study Re-operation (63%) Thrombosis (Bio w%x vs. Mec w%x), small (Level 2b) 0% vs. 8% sample size, heterogeneity of patients and surgical Valve degeneration (Bio w%x vs. Mec w%x) techniques 4% vs. 0% late Organic aetiology Rizzoli et al. ns101, mean age 46 Survival (Bio worx vs. Mec worx,, small (1998), Ann Biologicals78 Hazard ratio P-value) sample size, Thorac Surg, Mechanicals23 1 year (0.87 vs. 0.93) heterogeneity of patients Italy, w12x 5 years (0.73 vs. 0.79) and surgical techniques (Bio w%x vs. Mec 10 years (0.39 vs. 0.56) Single centre w%x) 15 years (0.28 vs. 0.45) (Continued on next page)

3 B. Kunadian et al. / Interactive CardioVascular and Thoracic Surgery 6 (2007) Table 1 (Continued) Cohort Study Isolated TVR ratio Freedom from (Level 2b) (0.23 vs. 0.26) re-operation 1 year (0.96 vs. 1) Re-operation ratio 5 years (0.96 vs ) (0.73) 10 years (0.84 vs. 0.84) 15 years (0.53 vs. 0.62) Survival free re-operation 1 year (0.85 vs. 0.93) 5 years (0.71 vs. 0.72) 10 years (0.45 vs. 0.46) 15 years (0.23 vs. 0.28) Thrombosis incidence 2.22% Valve degeneration incidence 1.96% Carrier et al Survival (Bio w%x vs. Mec w%x, Favoured bio prostheses (2003), Ann ns97; mean ages52 30 days P-value) life expectancy Thorac Surg, Biologicals82 1 year 17 vs. 20, Ps0.7 unrelated to the type of Canada, w6x Mechanicals15 5 years 67"5 vs. 60"13, Ps0.9 prostheses used at 56"6 vs. 60"13 long-term follow-up Single centre (Bio w%x vs. Mec w%x) Freedom from, small Cohort Study Isolated TVR (38 vs. re-operation sample size, heterogeneity (Level 2b) 73, Ps0.01) 1 year 100"3 vs. 91"9, Ps0.2 of patients and surgical 5 years 97"3 vs. 91"9 techniques Re-operation (78 vs. Survival free 80, Ps0.8) re-operation 1 year 66"5 vs. 53"13, Ps0.8 5 years 52"6 vs. 53"13 Thrombosis incidence 4.55% Valve degeneration 5.45% incidence Age, CPBT Kaplan et al Survival (Bio w%x vs. Mec w%x, No difference (2002), ns129, mean ages36 Hazard ratio P-value) Ann Thorac Biologicals32 OR (95% CI, Recommend modern Surg, w9x Mechanicals , Ps0.238) bi-leaflet mechanical valve (Bio w%x vs. Mec w%x) Early Single centre Mid-term 31.2% vs. 20.6%, Isolated TVR ratio 9% vs. 9% heterogeneity of patients Cohort Study (0.31 vs. 0.21) and surgical techniques (Level 2b) Survival free OR (95% CI, Re-operation ratio re-operation , Ps0.440) (0.79) Re-operation 9% vs. 6.5% Thrombosis incidence 1.28% Valve degeneration 1.74% incidence Do et al Survival Included only isolated (2000), ns32, mean age 48 5 years 63% TVR Can J Biologicals26 10 years 47% Cardiology, Mechanicals6 improves NYHA class France, w5x Thrombosis incidence 3.33% (Bio w%x vs. Mec w%x), small Single centre sample size, heterogeneity Isolated TVR ratio Valve degeneration 2.27% of patients and surgical (Continued on next page)

4 554 B. Kunadian et al. / Interactive CardioVascular and Thoracic Surgery 6 (2007) Table 1 (Continued) Cohort Study (1 vs. 1) incidence techniques (Level 2b) Re-operation ratio (0.84) Dalrymple Survival (Bio worx vs. Mec worx, Bio prothesis initial et al. (1998), ns32; mean ages59 Hazard ratio P-value) durability and low J Heart Valve Biologicals52 OR (95% CI, operation rate Disease, UK, Mechanicals , Ps0.827) w10x Freedom from, small (Bio w%x vs. Mec w%x) re-operation sample size, heterogeneity 5 years 97"2.5 vs. 86"7.4, of patients and surgical Single centre Isolated TVR ratio 10 years 89"6.3 vs. 74"9.9 techniques 15 years 70"12 vs. 68"11 Cohort Study (0.31 vs. 0.09) Ps0.2 (Level 2b) Thrombosis incidence 1.76% Re-operation ratio (0.52) Valve degeneration 0.709% incidence Advanced NYHA functional class, CPBT Ratnatunga Survival (Bio w%x vs. Mec w%x, No superiority et al. (1998), ns425, mean ages57 30 days P-value) Ann Thorac Biologicals225 5 years 18.8 vs. 15.6, Ps0.52 Registry retrospective Surg, UK, w3x Mechanicals years 70.5 vs years 61.5 vs Isolated TVR ratio 47.7 vs Cohort Study (0.38) (Level 2b) Freedom from Re-operation ratio re-operation (0.04) 1 year 99.3 vs years 97.7 vs (Ps0.59) Survival free re-operation 1 year 70 vs years 46.7 vs (Ps0.55) Thrombosis incidence 0.134% Valve degeneration 0.119% incidence Year of operation, age, number of valves implanted Hayashi et al Survival (Bio worx vs. Mec worx, Both similar; suggested (1996), Thorac ns29, mean ages40 Hazard ratio P-value) patient specific selection Cardiovasc Biologicals14 OR 1.40 (95% CI, of the prothesis Surg, Japan, Mechanicals , Ps0.628) w13x Isolated TVR ratio Thrombosis incidence 1%, small Single centre (0.347) sample size, heterogeneity of patients and surgical Cohort Study Valve degeneration techniques (Level 2b) incidence 3.19% Re-operation ratio Functional class, baseline (0.35) diseases Farinas Mortality 30 days 23.6%, small et al. (1996), ns55, mean ages49 sample size, heterogeneity Annales de Biologicals47 Thrombosis incidence 0 of patients and surgical (Continued on next page)

5 B. Kunadian et al. / Interactive CardioVascular and Thoracic Surgery 6 (2007) Table 1 (Continued) Chirurgie, Mechanicals8 techniques France, w4x Isolated TVR ratio Valve degeneration 0.674% Single centre (0.27) incidence Cohort Study High systolic pulmonary (Level 2b) operative pressure, bypass time, abnormal ejection fraction Munro et al Survival (Bio w%x vs. Mec w%x, Favoured bio-prostheses (1995), ns97, mean ages55 Early P-value) low rate of structural Ann Thorac Biologicals83 Late 14.4 vs. 14.5, PsNS valve deterioration and Surg, Canada, Mechanicals14 9.2% patientyyear (isolated avoidance of thrombosis w7x TVR 12.2% vs. 7.9% TVR Isolated TVR ratio q others), small Single centre (0.31) sample size, heterogeneity Freedom from of patients and surgical Cohort Study re-operation techniques (Level 2b) 5 years 97"2.9 vs. 87"12, 10 years 82.3"11 vs. 86.7"12.4 PsNS Thrombosis incidence 1.92% Valve degeneration 0.325% incidence Scully et al Survival (Bio w%x vs. Mec w%x, Both equally effective (1995), J Thorac ns60, mean ages50 All patients P-value) Cardiovasc Biologicals28 Hospital 38"15 vs. 38"11, PsNS, small Surg, w14x Mechanicals32 survivors sample size, heterogeneity (Bio w%x vs. Mec w%x) 50"12 vs. 56"20, PsNS of patients and surgical techniques Single centre Isolated TVR (25 vs. 44) Cohort Study (Level 2b) Re-operation ratio Re-operation 3 had re-operation (2 Bio (0.75) and 1 Mec) Thrombosis incidence 0.50% Valve degeneration 1.71% incidence Nooten et al Survival (Bio w%x vs. Mec w%x, Bio prothesis better than (1995), J Thorac ns146, mean ages51 Hazard ratio P-value) old mechanical prothesis Cardiovasc Biologicals69 OR (95% CI, (Ps0.04) Surg, Mechanicals , Ps0.903) Belgium, w15x When follow-up period Survival free OR (95% CI, was split Single centre re-operation , Ps0.163) -7 years no difference. Cohort Study Isolated TVR ratio Thrombosis incidence 0.748% But )7 years new (Level 2b) (0.16) mechanical prothesis better than bio prothesis, Re-operation ratio Valve degeneration 0.417% Ps0.05) (0.45) incidence Presence of icterus The median incidence of mechanical tricuspid valve thrombosis reported in the meta-analysis was 1.28% patient-years. There was a large variability in the incidence of thrombosis reported in these series. The series of Ratnatunga w3x and Farinas w4x report the lowest incidence; Do w5x and Carrier w6x report the highest. The series of Ratnatunga w3x, Farinas w4x, and Munro w7x reported lower incidence of structural valve deterioration;

6 556 B. Kunadian et al. / Interactive CardioVascular and Thoracic Surgery 6 (2007) Do w5x and Carrier w6x reported the highest. Overall, 21 mechanical valve thromboses and 37 deterioration episodes were reported in the meta-analysis. The incidence rate of thrombosis was 0.87% patientyyear (in comparison to MVR: 0.54%ypatient-year and AVR: 0.33%ypatient-year) and the incidence of valve deterioration was 1.02% patientyyear. The difference was not significant (Ps0.25). The risk of reoperation reported was 4.7%ypatient-year for bioprostheses and 2.2%ypatient-year for mechanical prostheses. Filsoufi w8x reported 81 cases of tricuspid valve replacement of which 34 were biological and 47 were mechanical, (25 isolated). They had an overall of 22%. The common cause of death was heart failure in both early and late death. Survival at 2.5, 5 and 10 years for biological prostheses were 80%, 60% and 45%, and 84%, 69% and 59% for mechanical prostheses. There was no clear superiority of one prosthesis over another. Carrier et al. w6x reported 97 patients with tricuspid valve replacement, of which 82 were biological and 15 were mechanical. Mortality in the biological group was 17% and 20% in the mechanical group. Congestive heart failure was the most significant cause of long-term death. One- and 5- year survival rates were 67"5% and 56"6% with bioprostheses and 60"13% and 60"13% in the mechanical group. They favoured biological prostheses. Kaplan et al. w9x reported 122 patients with tricuspid valve replacement, which included biological prostheses in 32 patients and mechanical prostheses in 97 patients. Early was 24.5% and 9.7% late. Mean survival time was 159"19 months for mechanical prostheses and 85.7"12.1 months for biological prostheses. They recommend mechanical valve prostheses. Dalrymple et al. w10x reported 87 patients with tricuspid valve replacement of which 53 were biological and 35 were mechanical. They reported an early of 10.3% which is the lowest of all the papers documented. Six mechanical valves needed re-operation, five for prosthetic valve thrombosis and one for mechanical failure secondary to pannus formation. Five biological prostheses needed reoperation, two for prosthetic valve endocarditis and three for prosthetic valve degeneration. They recommend the use of biological prostheses because of its initial durability and low re-operation rate. Ratnatunga et al. w3x from the United Kingdom did a retrospective UK Heart Valve registry study of all the valves done between 1986 to 1997 and reported 425 patients with tricuspid valve replacement (225 biological and 200 mechanical). Early was 17.3% and for biological was 18.6% and 15.6% for mechanical prostheses. One-, 5- and 10-year survival was 70.5%, 61.5% and 47.7% for biological prostheses and 74%, 57.9% and 33.9% for mechanical prostheses. The remaining studies which were tabulated, didn t find any difference between the prostheses. In summary, two series recommend biological prostheses and one series recommends mechanical prostheses. The overall for TVR ranged from 10.3% to 27%. Most of these studies did not find any superiority between the prostheses used. Rizzoli et al. w2x made the following observations after their meta-analysis. (1) Tricuspid position is no exception to the rule that patients more than years obtain the largest advantage from bioprostheses and younger patients from mechanical prostheses. (2) The extent and the severity of cardiac disease might suggest, in some cases, a limited expectation of life and, therefore, might favour the use of biological prostheses in younger patients, as concluded by Carrier et al. w6x. On the other hand, concomitant use of left-sided mechanical prostheses favours the same valve for the right heart. (3) Small-size patients with small right ventricles may benefit from the superior haemodynamics of the low profile bileaflet valve as opposed to the largest bioprostheses, which is prone to develop mural cusp pannus and thrombosis. (4) Rizzoli et al. w2x, in their study found that 97% of living patients with biological tricuspid prostheses receive anticoagulant treatment, making the need for anticoagulation an unreliable choice of valve type. 7. Clinical bottom line There are no major differences between the insertion of a mechanical or biological tricuspid valve. Aggregating the available data it is found that the reoperation rate is similar with bioprosthetic degeneration rate being equivalent to the mechanical thrombosis rate. Conversely up to 95% of patients with a bioprosthesis still receive anticoagulation. Survival in over 1000 prostheses pooled by metaanalysis was equivalent between biological and mechanical valves. References w1x Dunning J, Prendergast B, Mackway-Jones K. Towards evidence-based medicine in cardiothoracic surgery: best BETS. Interactive Cardiovasc Thorac Surg 2003;2: w2x 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: w3x Ratnatunga CP, Edwards MB, Dore CJ, Taylor KM. Tricuspid valve replacement: UK heart valve registry mid-term results comparing mechanical and biological prostheses.wsee commentx. Ann Thorac Surg 1998;66: w4x Farinas JM, Leclerc Y, Antchouey AM, Mercier LA. wtricuspid valve replacement: long-term clinical and echocardiographic follow-upx. wfrenchx. Annales de Chirurgie 1996;50: w5x Do QB, Pellerin M, Carrier M, Cartier R, Hebert Y, Page P, Perrault LP, Pelletier LC. Clinical outcome after isolated tricuspid valve replacement: 20-year experience. Can J Cardio 2000;16: w6x Carrier M, Hebert Y, Pellerin M, Bouchard D, Perrault LP, Cartier R, Basmajian A, Page P, Poirier NC. Tricuspid valve replacement: an analysis of 25 years of experience at a single centre. Ann Thorac Surg 2003;75: w7x Munro AI, Jamieson WR, Tyers GF, Germann E. Tricuspid valve replacement: porcine bioprostheses and mechanical prostheses. Ann Thorac Surg 60:S ; discussion 1995;S w8x 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: w9x Kaplan M, Kut MS, Demirtas MM, Cimen S, Ozler A. Prosthetic replacement of tricuspid valve: bioprosthetic or mechanical. Ann Thorac Surg 2002;73: w10x Dalrymple-Hay MJ, Leung Y, Ohri SK, Haw MP, Ross JK, Livesey SA, Monro JL. Tricuspid valve replacement: bioprostheses are preferable. J Heart Valve Dis 1999;8: w11x Chang BC, Lim SH, Yi G, Hong YS, Lee S, Yoo KJ, Kang MS, Cho BK. Long-term clinical results of tricuspid valve replacement. Ann Thorac Surg 81: , discussion 2006;

7 B. Kunadian et al. / Interactive CardioVascular and Thoracic Surgery 6 (2007) w12x Rizzoli G, De PL, Bottio T, Minutolo G, Thiene G, Casarotto D. Prosthetic replacement of the tricuspid valve: biological or mechanical? Ann Thorac Surg 1998;66:S w13x Hayashi J, Saito A, Yamamoto K, Watanabe H, Ohzeki H, Eguchi S. Is a bioprosthesis preferable in tricuspid valve replacement? Thorac Cardiovasc Surg 1996;44: w14x Scully HE, Armstrong CS. Tricuspid valve replacement. Fifteen years of experience with mechanical prostheses and bioprostheses. J Thorac Cardiovasc Surg 1995;109: w15x Van Nooten GJ, Caes F, Taeymans Y, Van BY, Francois K, De BD, Deuvaert FE, Wellens F, Primo G. Tricuspid valve replacement: postoperative and long-term results. J Thorac Cardiovasc Surg 1995;110: ICVTS on-line discussion A Title: Anticoagulation in biologic valves in tricuspid position Authors: Domingo Braile, Rio Preto Statate Medical School/AV J.K.1505 São Jose do Rio Preto/ /Brazil; Valeria Braile, Joao Carlos Leal doi: /icvts a ecomment: I congratulate the authors for the effort in developing this very important meta-analysis w1x. It has always been a challenge to make the choice of a prosthesis when operating patients with tricuspid valve diseases. In our experience, considering the difficulty in maintaining the patients in correct anticoagulation, we use in all cases biologic valves (pericardial valves) without anticoagulation. Our results are similar to the ones presented in the papers presented in the article. I don t know the reason to anticoagulate the patients with Biologic Valves in the tricuspid, mitral or aortic position, except if they have atrial fibrillation. Can the author explain the reason for that behavior? Reference w1x Kunadian B, Vijayalakshmi K, Balasubramanian S, Dunning J. Should the tricuspid valve be replaced with a mechanical or biological valve? Interact CardioVasc Thorac Surg 2007;6: ICVTS on-line discussion B Title: Which prosthesis in tricuspid position? Author: Domenico Scalia, via L.Configliachi 2, Padova, Italy doi: /icvts b ecomment: First of all, I would like to congratulate the authors for their research w1x. In my opinion the choice for tricuspid replacement, after a methodical attempt of valve repairing, is dependent on the prosthesis used in the left side of the heart. In the exceptional cases of isolated tricuspid valve malfunction which needs valve replacement the choice is dependent, as usual, on the age, heart dimension, risk bleeding, and reliable aptitude to anticoagulation. Finally, with regard to patients treated with anticoagulants by some cardiologists even if they have bioprosthetic tricuspid valve, I guess that, more than atrial fibrillation, the reduced blood pressure on the right side of the heart and the dilated right ventricle can be the reason to justify long term anticoagulation. Reference w1x Kunadian B, Vijayalakshmi K, Balasubramanian S, Dunning J. Should the tricuspid valve be replaced with a mechanical or biological valve? Interact CardioVasc Thorac Surg 2007;6: