Asian Cardiovasc Thorac Ann 2004;12:143-148
© 2004 Asia Publishing EXchange Ltd
Tricuspid Valve Replacement: Bioprosthetic or Mechanical Valve?
Neville A G Solomon, MCh,
Remy C H Lim, MB,
Parma Nand, FRACS,
Kenneth J Graham, FRACS
Department of Cardiothoracic Surgery, Green Lane Hospital, Auckland, New Zealand
For reprint information contact: Neville A G Solomon, MCh Tel: 64 21 030 3488 Fax: 64 9 630 9873 Email: nev_sheeba{at}yahoo.com 2/7, King George Ave, Epsom, Auckland, New Zealand.
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ABSTRACT
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Significant morbidity and mortality is associated with tricuspid valve replacement, and controversy still exists as to the ideal prosthesis in this position. This study aimed to identify the risk factors for low cardiac output and mortality, and whether bioprosthetic or mechanical valves perform better in the tricuspid position. Results of 121 tricuspid valve replacements in 104 patients between January 1966 and December 2002 were reviewed. Most patients were in New York Heart Association functional class III or IV. Perioperative mortality was 19%. On multivariate analysis, age and preoperative jaundice were significant predictors of low cardiac output; age, jaundice, atrial fibrillation, and bypass time were significant predictors of mortality. Mechanical valves were significantly more prone to thromboembolism, whereas bioprostheses suffered structural valve deterioration. There were no significant differences in anticoagulation or bleeding episodes between the two groups, nor in valve-related events, deaths, and long term survival. There was no significant difference in performance so as to recommend one type over the other, but bioprosthetic valves may be more favorable as they fail predictably.
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INTRODUCTION
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Tricuspid valve replacement (TVR) is a procedure associated with significant morbidity and mortality.1–10 There has been much debate as to the ideal prosthesis in the tricuspid position.1–3,6,10–12 At Green Lane Hospital, the preferred tricuspid prosthesis has changed periodically. This study aimed to analyze the results of TVR at this institution and determine the ideal prosthesis for the tricuspid position.
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PATIENTS AND METHODS
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During the period January 1, 1966 to December 31, 2002, there were 669 tricuspid valve repairs performed at Green Lane Hospital. Excluding patients who had tricuspid valve replacement (TVR) with a stented homograft and cases of corrected transposition of the great arteries, there were 121 TVR operations carried out in 104 patients with a mean age of 40.9 ± 16.1 years (range, 7 to 73 years) at surgery. Demographic data are shown in Table 1
. The study period was divided into 3 eras (1966–78, 1979–90, and 1991–2002) to determine whether there were any changes in results over time. In 74% of patients, there was clinically evident hepatomegaly, and 52.1% had jaundice (defined as preoperative serum bilirubin > 20 mmol·L–1). 61 patients (50.4%)hadgrosscardiomegaly(cardiothoracicratio>0.65), and 70 of 107 patients (65.4%) whose left ventricular ejection fraction was recorded on angiography or echocardiography had normal function (ejection fraction > 60%). A previous open heart operation had been carried out in 83 patients (68.6%). Concomitant procedures were undertaken in 88 patients (72.7%): 43 had mitral valve procedures, 25 had mitral and aortic valve surgery, 8 had aortic valve replacement, 6 had pulmonary valve replacement, 3 had coronary artery bypass grafting, 2 had mitral valve surgery and ventricular septal defect closure, and 1 had pulmonary valve replacement and ventricular septal defect closure. The operation was performed electively in 107 patients (88%).
A median sternotomy was performed in 116 patients and 5 underwent a right thoracotomy. The procedure was accomplished under standard cardiopulmonary bypass (CPB) with mild systemic hypothermia (28°C–32°C). Myocardial protection varied depending on the era of operation: 29 procedures were carried out with continuous coronary infusion, either beating heart or direct cannulation of the coronary ostia; intermittent fibrillation and crossclamping was used in 6; cold crystalloid cardioplegia was used in 47; and cold blood cardioplegia was used in 39, either antegrade or retrograde depending upon the surgeon’s preference. The valve implantation technique was based on the surgeon’s preference and included continuous suturing, simple interrupted sutures, and horizontal pledgetted interrupted sutures. The choice of prosthesis was also at the discretion of the surgeon. The bioprosthetic valves utilized included 36 Intact (Medtronic, Inc., Minneapolis, MN, USA), 17 Hancock (Medtronic, Inc., Irvine, CA, USA), 16 Mosaic (Medtronic, Inc., Minneapolis, MN, USA), 7 Carpentier-Edwards porcine and 5 Perimount valves (Baxter-Edwards, Inc., Irvine, CA, USA). Mechanical valves included 14 St. Jude Medical (St. Jude Medical, Inc., Minneapolis, MN, USA), 11 Starr-Edwards (Baxter Healthcare Corp., Edwards Division, Santa Ana, CA, USA), 9 Medtronic-Hall (Medtronic, Inc., Minneapolis, MN, USA), 4 Bjork-Shiley (Sorin Biomedica, Saluggia, Italy) and 1 each of Braunwald-Cutter (Cutter Laboratories) and ATS valves (ATS Medical, Minneapolis, MN, USA).
Various risk factors (Appendix 1) were analyzed to identify predictors of low cardiac output (LCO) and perioperative mortality. Low cardiac output was defined as the need for inotropics for more than 24 hours. Perioperative mortality was defined as death within 30 days of operation or within the same hospital stay. The incidences of other complications were analyzed, including prolonged ventilation (> 48 hours) and renal failure (requiring dialysis). The patients were divided into two groups: the 71 who received a bioprosthetic valve in the tricuspid position, and the 33 who had a mechanical valve. Various preoperative and operative factors were analyzed to ensure that the two groups were comparable. Follow-up was by review of letters from the patient’s cardiologist and questionnaires completed by their general practitioner. These data were analyzed to identify differences between the 2 groups with regard to postoperative complications including thromboembolism, structural valve deterioration, reoperation, bleeding episodes, anticoagulation, valve-related events, valve-related deaths, and long term survival using Kaplan-Meier curves. All definitions for these endpoints were taken from the guidelines for reporting morbidity and mortality.13 Continuous variables were reported as mean ± standard deviation, and discrete variables as absolute values with percentages. The chi-squared test was used for statistical analysis of discrete variables. Continuous variables were compared by a simple t test. All variables were entered into a logistic regression model and multivariate analysis was undertaken. A p-value < 0.05 was considered statistically significant. Analyses were performed using SAS version 9 software (SAS Institute, Cary, NC, USA).
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RESULTS
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The mean CPB time was 151 ± 64 min, and crossclamp time was 84 ± 56 min. There was a high incidence of LCO (65/121, 53.7%) and mortality (23/121, 19%), 14.4% of patients required reexploration for bleeding, 33.9% required prolonged ventilation, and 15.8% had dialysis for renal failure. Triple valve procedures had a mortality of 19.2% (5/26). Mortality for isolated TVR was 28.6% (2/7) in patients undergoing open heart surgery for the first time, and 15.4% (4/26) in those who had experienced a previous cardiac operation. Men had a higher incidence of LCO (68% vs. 49%) and slightly higher mortality (21.4% vs. 18.3%). Maoris (58%), Pacific Islanders (55%) and others including Caucasians (49%) had similar incidences of LCO, but the Pacific Islanders had the highest perioperative mortality (31% vs. 11.6% in Maoris and 18.4% in the rest). The second era (1979–90) had the highest incidence of LCO (corresponding to the use of crystalloid cardioplegia) compared to the first and third eras (64.3% vs. 44.6% and 46%) but mortality was similar (19% vs. 22% and 18%). Patients presenting in NYHA class IV had a higher incidence of LCO (64% vs. 45%) and higher mortality (25% vs. 13.9%) than those in lower NYHA classes. Elective procedures had a lower incidence of LCO (51%) and mortality (18.7%) than non-elective procedures (71% and 21%, respectively). Hepatomegaly (LCO 57.3% vs. 43%; mortality 22.5% vs. 10%) and jaundice (LCO 64.5% vs. 42%; mortality 25.8% vs. 12.3%) appear to be risk factors. The occurrence of tricuspid regurgitation as the predominant lesion appears to predispose to LCO (57.3% vs. 42%) and mortality (22.2% vs. 9.7%). Myocardial protection with crystalloid cardioplegia had the highest incidence of LCO (68% vs. 41% in blood cardioplegia and 48% in continuous perfusion) but mortality was highest in those who had continuous perfusion (27.6% vs. blood cardioplegia 17.9% and crystalloid cardioplegia 17%). The CPB time was longer in patients with LCO (163 ± 69 vs. 137 ± 54 min) and in those who died (176 ± 88 vs. 145 ± 56 min). Low cardiac output was obviously predictive of mortality as all but 2 of the 23 patients who died had postoperative LCO. Patients with LCO had a mortality of 32.3% (21/65). Table 2 summarizes the univariate analysis of various risk factors for LCO and mortality. Preoperative NYHA class IV ( p = 0.03) and jaundice ( p = 0.01) predisposed to LCO. No single factor was found to be predictive of mortality; jaundice came closest to statistical significance ( p = 0.06). Multivariate analysis showed age ( p = 0.02) and jaundice ( p = 0.02) to be significant predictors of LCO, while age ( p = 0.009), jaundice ( p = 0.03), preoperative atrial fibrillation ( p = 0.04), and CPB time ( p = 0.02) predicted perioperative mortality.
As evidenced in Table 3, the 2 groups were evenly matched when preoperative and surgical variables were compared. Both groups had similar incidences of postoperative LCO, prolonged ventilation, and mortality. Table 4 shows that mechanical valves were prone to thromboembolism, while bioprostheses underwent structural valve deterioration. There was no statistically significant difference between the 2 groups in the rate of reoperation, bleeding, use of anticoagulants, valve-related events (Figure 1), and valve-related deaths (Figure 2). Long term survival (Figure 3) was not significantly different (p = 0.18) between the 2 groups. Of 33 patients undergoing isolated TVR, 25 received a bioprosthetic valve and 8 had a mechanical valve. In 6/7 isolated TVR patients having cardiac surgery for the first time, a bioprosthetic valve was used. Two patients with a mechanical valve required reoperation (for thromboembolism) and survived. Of the 9 patients who developed thromboembolism, 3 died, 2 developed infective endocarditis, 2 underwent reoperation, and 3 had thrombolytic treatment (one of whom had a reoperation eventually).
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DISCUSSION
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The overall demographics and mortality in this series are very similar to other large series (Table 5). Carrier and colleagues4 found that age at operation and CPB time were the only significant predictors of mortality. Kaplan and colleagues3 concluded that early mortality was significantly related to CPB time, NYHA status, previous cardiac operation, and an associated procedure. Van Nooten and colleagues5 noted that preoperative jaundice was predictive for mortality on multivariate analysis. Dalrymple-Hay and colleagues11 identified CPB time and NYHA class as risk factors for early mortality. Age and concurrent mitral valve replacement predisposed to mortality in the study by Glower and colleagues,7 whereas Rizzoli and colleagues12 found NYHA status, congenital disease, and valvuloplasty increased early mortality. Ratnatunga1 concluded that age, year of operation, and concomitant mechanical mitral valve replacement were risk factors for mortality.
Addressing the issue of the ideal prosthesis in the tricuspid position, our data confirm that there were no differences in freedom from reoperation, anticoagulation, bleeding, valve-related events or death, and long-term survival. However, mechanical valves had significantly more incidences of thromboembolism, and bioprosthetic valves had a higher rate of structural deterioration. Mechanical valves in the tricuspid position are known to suffer thromboembolism more often and repeatedly.2,5,10,11,15 Good results have been obtained with the St. Jude Medical valve in the tricuspid position, although it has not been free from thromboembolism.16,17 Kawano and colleagues9 found the St. Jude Medical valve had a high thrombogenicity with significant reoperation rates and resistance to thrombolysis. Tricuspid prosthetic obstruction is potentially dangerous; all 8 patients whose valves became obstructed in the study by McGrath and colleagues14 died, as did 8/11 in the series reported by Van Nooten and colleagues.5 Furthermore, thrombolysis carries the risk of embolism with residual pannus formation, and surgery may be preferable as the first treatment option.18 In this study, 3/9 patients with thrombosed valves died and only 3 had successful thrombolysis. There was 75% freedom from reoperation at Green Lane for bioprosthetic valves at 10 years, comparable with other large series which ranged from 75%–89%.10,11 Three other studies reported even better 10-year freedom from reoperation, ranging from 93%–100%.1,7,19 The recommendations from large series are noted in Table 5
; most favor bioprosthetic valves.
Bioprostheses are more durable in the tricuspid position compared to the mitral position, due to lower pressures in the right heart, giving good long term results.7,19,20 Bioprosthetic failure in the tricuspid position increases after 7 years.5,12 Guerra and colleagues20 reported no reoperative deaths associated with tricuspid bioprosthetic valves that failed. Reoperation was not a risk factor for mortality in our series. Interestingly, several studies report no difference in the rate of reoperation between the 2 groups.11,12 Long-term survival is not very encouraging, with 10-year survival after TVR ranging from 38% to 52%.1,2,6,7,11,12 The 10-year survival at Green Lane is 45%. As mechanical valve failure is associated with emergency surgery in a potentially moribund patient, or sudden death, bioprosthetic valves are our preferred choice as they fail slowly and predictably and can be replaced with no significant increase in mortality.
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ACKNOWLEDGMENTS
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The authors would like to express their gratitude to Alistair Stewart, Dip SC, Biostatistics Unit, Division of Community Health, Auckland University, Auckland, for doing the statistical analysis for this study.
Presented at Tongariro Cardiac Surgical Meeting, Queenstown, New Zealand, March 28–30, 2003.
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REFERENCES
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ABSTRACT
INTRODUCTION
