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Ann Thorac Surg 2005;80:845-850
© 2005 The Society of Thoracic Surgeons

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Original article: Cardiovascular

Long-Term Outcomes of Tricuspid Valve Replacement in the Current Era

^a Mount Sinai Hospital, New York, New York
^b Brigham and Women’s Hospital and Harvard Medical School, Boston, Massachusetts

Accepted for publication December 20, 2004.

^_* Address reprint requests to Dr Filsoufi, Department of Cardiothoracic Surgery, Mount Sinai Medical Center, 1190 Fifth Avenue, Box 1028, New York, NY10028 (Email: farzan.filsoufi{at}mountsinai.org).

	Abstract

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BACKGROUND: Regardless of the indication, tricuspid valve replacement (TVR) has historically been associated with high mortality and morbidity. We report the results of our experience in a high-risk patient population with an emphasis on operative mortality, long-term survival, and valve related events according to the type of prosthesis.

METHODS: Between 1985 and 1999 TVR was performed in 81 patients (isolated n = 25, combined with valve surgery n = 44, combined with CABG or other n = 12). The mean age was 61 years old (range 19–83 years old). Risk factors included New York Heart Association functional class III/IV (n = 73, 90%), reoperation (n = 58, 72%), urgent/emergent indication (n = 62, 76%), and hepatic dysfunction (n = 13, 16%). Mean pulmonary artery pressure was 34 mmHg. Etiology of tricuspid regurgitation was classified as functional (n = 18, 22%) or organic (n = 52, 64%), or failed previous tricuspid valve surgery (n = 11, 14%).

RESULTS: Tricuspid valve replacement was performed with either a bioprosthetic (n = 34, 42%) or mechanical valve (n = 47, 58%). The overall operative mortality was 22% (n = 18). Risk factors for mortality included urgent/emergent status, age greater than 50 years old, functional etiology, and elevated pulmonary artery pressure. Of the 60 survivors, 26 (43%) died during follow up. After univariate analysis, organic etiology was the only predictor of late death (p = 0.01). Kaplan-Meier survival at 2.5, 5, and 10 years was 80%, 60%, and 45% for bioprosthetic, and 84%, 69%, and 59% for mechanical valves, respectively.

CONCLUSIONS: Patients requiring TVR are typically high-risk with a high-percentage of reoperations, concomitant cardiac procedures, and end-stage functional class. Operative and overall mortality remains high. Heart failure was the predominant cause of early and late deaths, emphasizing importance of timely referral before the development of end-stage cardiac impairment.

	Introduction

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The prevalence of clinically significant tricuspid valve disease is far less than that of aortic and mitral valve disease and although the tricuspid valve disease is of surgical significance, it is usually amenable to repair. Replacement of the tricuspid valve is therefore a comparatively rare operation and is reserved for those few occasions where repair of the tricuspid valve is not feasible or attempts at repair have failed. Because of the rarity of the procedure, published series are few and are limited by small sample size, often spanning from the 1960s through 1990s and including patients whose results might not be generalizable to current practice. Historically, the mortality and morbidity of tricuspid valve replacement (TVR) have been very high, with most series reporting operative mortality in excess of 20% [1–5]. Although both mechanical and bioprosthetic replacement of the tricuspid valve have been performed for over 30 years, the choice of prosthesis, biological versus mechanical, still remains controversial [6, 7]. With this background in mind, we have examined the current practice and outcome in a consecutive series of patients undergoing TVR in a single institution with a view to determining the outcome of TVR in the recent era.

	Material and Methods

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We retrospectively reviewed data on 81 consecutive patients who underwent TVR at the Brigham and Women’s Hospital over a 15-year period from January 1985 to December 1999. Data were extracted from the hospital’s computerized database with additional information obtained through retrospective chart review. We included all patients who underwent TVR either as an isolated procedure or in combination with other procedures. We included patients based on the completed surgical technique rather than on intention to treat (in some patients tricuspid replacement may have been prompted by intraoperative proceedings or may have followed attempted repair). The decision to replace the tricuspid valve, and also the type of prosthesis used, was based on surgeon’s discretion and preference. It was our practice during the study period to preferentially repair all tricuspid valves, with replacement undertaken if the surgeon deemed the valve irreparable. This was a retrospective study and we could not ascertain the proportion of cases in which replacement followed a failed repair.

Patient Characteristics
All 81 patients who underwent TVR in the study period were included in this study. Patient demographics are presented in Table 1. The majority of patients (70%) were female and the mean age at surgery was 61 years old (range 19–83 years old). Seventy-three patients (90%) were in New York Heart Association functional class III or IV and 46 (57%) had prior atrial fibrillation. Hepatic dysfunction (defined as total bilirubin > 2 mg/dL or hepatic transaminase > 5-fold normal) was present in 13 patients. Sixty-two operations (76%) were performed on an emergent/urgent basis. The average mean preoperative pulmonary artery pressure was 34 mm Hg (range: 7–67 mm Hg). Previous cardiac surgery had been performed in 58 patients (72%). Of these, 50 patients (86%) had 1 previous surgery, the most common being mitral or aortic valve replacement. Multiple previous operations (range 2–5) had been performed in 8 patients. Etiology of tricuspid regurgitation was defined as functional in 17 (21%) and organic in 52 patients (64%; Table 2). Twelve patients (15%) were undergoing TVR for a failed previous tricuspid procedure.

Isolated TVR was performed in 25 patients (30%). We performed TVR concomitantly with other valve procedures in 44 patients (55%) and with CABG or other procedures in 12 patients (15%) (Table 3). Bioprosthetic valves were implanted in 34 patients (42%) and mechanical valves in 47 patients (58%). Mean bypass time was 163 minutes (range 54–451 minutes) and cross-clamp time was 97 minutes (range 35–277 minutes).

Follow-Up Data
Follow-up was by telephone interviews and was 95% complete (60 of 63 survivors). Mean time to last follow-up was 57 months (68 months for mechanical and 39 months for bioprosthetic valves). Additional follow-up data were obtained from hospital charts for patients followed locally. Valve-related complications were reported according to the American Association for Thoracic Surgery Guidelines for reporting morbidity and mortality after cardiac valvular operations [8].

Statistical Analysis
Statistical data were analyzed using SPSS software (SPSS Inc., Chicago, IL). Continuous variables were given as means ± standard deviation. Univariate analysis, using the Chi-square or t tests for categorical and continuous data respectively, was performed to determine if any of the collected variables (in Table 1 and 2) were predictors of in-hospital mortality. The p values less than or equal to 0.05 were considered significant. Survival and valve-related complication data were displayed using the Kaplan-Meier method.

	Results

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Operative and In-Hospital Mortality and Morbidity
The overall in-hospital mortality was 22% (n = 18). There was a tendency toward higher early mortality with bioprosthetic valves (n = 11, 32%) compared with mechanical valves (n = 7, 15%) (p = 0.06), but this difference did not persist beyond the first year. Twenty-four patients (29%) suffered from postoperative low cardiac output syndrome and 15 (18%) returned to the operating room for excessive postoperative bleeding. There were 2 patients (2%) who developed deep sternal wound infections and 4 patients (4%) experienced postoperative stroke. There were no substantial differences in morbidity between the mechanical and bioprosthetic groups (Table 4).

Late Results
Of the 60 survivors with complete follow-up, 26 (43%) died after discharge. None of the deaths were deemed valve related; 12 deaths were of cardiac cause and 7 of noncardiac cause. However, the exact cause of death could not be ascribed in the remaining 7 patients. There was 1 documented case of structural valve failure in a patient with bioprosthetic valve, but reoperation was not required. For patients receiving mechanical valves, there were 3 (8%) reported valve thrombosis of which 2 required reoperation. There were 11 (29%) documented cases of anticoagulant-related hemorrhage described as gastrointestinal in 6, hematoma in 3, and intracranial hemorrhage in 3 (Table 5). Kaplan-Meier survival at 2.5, 5, and 10 years was 80%, 60%, and 45% for bioprosthetic valves, and 84%, 69%, and 59% for mechanical valves, respectively. On univariate analysis, the only identified predictor of late death was organic etiology (vs functional; p = 0.01).

View larger version (15K): [in this window] [in a new window]   Fig 1. Kaplan-Meier curves for freedom from thromboembolism in patients with bioprosthetic versus mechanical valves who survived the first postoperative year. (Bio = bioprosthetic; Mech = mechanical.)

View larger version (14K): [in this window] [in a new window]   Fig 2. Kaplan-Meier curves for freedom from structural failure in patients with bioprosthetic versus mechanical valves for patients surviving the first postoperative year. (Bio = bioprosthetic; Mech = mechanical.)

	Comment

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Immediate Survival
Our early mortality rate of 22% compares well with most series published in the literature. Ratnatunga and colleagues [9] reported the largest series in the literature, a multicenter registry study from the United Kingdom that included 425 patients with an operative mortality of 17.3%. However only 4.5% of their cases were reoperations, suggesting that their experience is not typical of that in most other centers and may represent, in part, a lower threshold to replace rather than repair tricuspid valves. A metaanalysis of studies published between 1994 and 2003 found a mortality of 19.2% in 1258 patients from 11 series [7]. Therefore, a high mortality rate is universal and has remained relatively stagnant over the last 30 years despite advances in perioperative care. This is unique among valve operations (aortic and mitral replacements have experienced substantial declines in mortality over the last 30 years), suggesting that tricuspid regurgitation requiring replacement may be a marker of end-stage valvular heart disease. There may be a subset of patients who will not survive correction of tricuspid regurgitation regardless of improvements in intraoperative and postoperative management.

The preoperative factors associated with early mortality in our study were age, left-sided valvular disease (functional tricuspid regurgitation), atrial arrhythmia, and pulmonary hypertension. The associations were not sufficient to allow meaningful deductions regarding patient selection, but we suspect that it is cardiac rather than comorbid factors that principally determine outcome of tricuspid valve replacement. As our predominant cause of death was low cardiac output syndrome, often secondary to right ventricular failure, it seems likely that the major factor limiting survival is the condition of the right ventricle. Because of the retrospective nature of the study we could not formally evaluate the right ventricular structure and function in a way that would allow meaningful risk modeling. Prospective series correlating echocardiographic, magnetic resonance imaging, hemodynamic, and clinical and biochemical factors with outcome may identify those hearts that will not tolerate surgical correction of regurgitation. We believe that it is only by identification and exclusion of such patients that the mortality of TVR can be significantly reduced. In some patients who had previously undergone cardiac surgery, the tricuspid valve, although regurgitant, had not been addressed during the previous operation. The importance of addressing the tricuspid valve during primary mitral repair or replacement has been recognized [10]. We believe that a more aggressive approach to addressing tricuspid regurgitation in patients undergoing other cardiac procedures will reduce the number of patients progressing to the advanced stages of tricuspid disease requiring replacement. Although the additional risk of performing a tricuspid operation is low at the first operation, this risk increases dramatically at reoperation because of the advanced right ventricular dysfunction that has often ensued in the years after the first operation. Even where previous surgery has been performed, we recommend close follow-up and early surgical referral of patients with increasing tricuspid regurgitation before they develop end-stage valvular heart disease.

Long-Term Survival
The long-term survival after TVR is modest. Our study indicated that about 50% of patients were alive 10 years after surgery. Other series have reported 10-year survival between 33% and 52% [1, 2, 4, 9], with a notable exception of those from Nakano and colleagues [11, 12] that revealed a 68% survival at 18 years. They do not suggest reasons for their superior results, although it may in part be due to aggressive reoperation strategy for bioprosthetic failure (25% reoperated within 10 years). Their results have not been replicated by others. In our experience, late deaths have not been due to valve-related complications but have resulted mainly from continuing heart failure and its attendant morbidity. It is possible that improved medical management may be a strategy to increase the long-term survival. Surgical technique, including type of prosthesis, did not have any bearing on long-term survival in our experience. The persistence and worsening of heart failure in some patients may support our assertion that, in some patients, the heart dysfunction is so advanced that TVR will not sustain long-term improvement in cardiac function. However, for those patients who do survive into the long-term, quality of life is good with most in New York Heart Association functional class I or II [4, 13].

Mechanical or Bioprosthetic Valve
The choice of prosthesis for TVR remains controversial with some groups favoring mechanical [3, 6], others biological [1, 2, 5, 14, 15], and some are indifferent [9, 13]. In our series the long-term survival was similar regardless of prosthesis type. Although we found a high incidence of anticoagulation-related bleeding in the mechanical group, we cannot be certain that this would have been avoided if biological valves had been used, as several would have been anticoagulated regardless of tricuspid valve choice because of mechanical mitral prostheses. We did not observe bleeding complications in the bioprosthetic group, which reflected our practice of using these valves primarily when there was no other indication for anticoagulation. The incidence of both valve thrombosis and structural deterioration were low in our series, with only 2 reoperations. Based on our data, there is no clear superiority of one valve type over another. Our results are supported by a recent metaanalysis by Rizzoli and colleagues [7] comparing 646 biological and 514 mechanical valves from 11 studies that also did not find a difference in early survival, late survival, or reoperations. Concerns that tricuspid valves are more prone to thrombosis or structural valve deterioration, compared with mitral or aortic valves, are not supported by outcomes. In the metaanalysis, the pooled incidence of valve thrombosis in mechanical valves was similar to that of structural valve deterioration in biological valves (about 1% patients per year) [7]. However, the metaanalysis included series starting in the 1960s and 1970s, with first-generation valve prostheses, and therefore conclusions cannot be reliably extrapolated to the current era.

Because there is no clear superiority of one prosthesis over another, the decision should be individualized to the patient. With the potential for anticoagulant-related bleeding with mechanical valves, we would now favor the use of bioprosthetic valves in most patients, a notable exception would be the patient who requires a mechanical valve in the mitral position. In those patients with end-stage valvular heart disease, age is of limited importance in choice of prosthesis; the use of a bioprosthetic valve seems reasonable because the durability of the bioprosthesis often exceeds the life expectancy.

Limitations
Like other published series, our study is necessarily limited by its retrospective nature, relatively small sample size, and heterogeneity of patients and surgical techniques. These limitations are imposed by the relative rarity of TVR. Our data are consistent with published reports.

Our series is unique because we have a balanced experience in both mechanical and biological valves and our series is fairly recent, dating back only to 1985, compared with most previously published series that date back to the late 1960s and 1970s. We believe our results reflect TVR in the current era. Further studies should be directed at developing approaches to patient stratification in order to exclude those patients who are unlikely to survive, or unlikely to benefit, from TVR.

	Requirements for Recertification/Maintenance of Certification in 2006

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Diplomates of the American Board of Thoracic Surgery who plan to participate in the Recertification/Maintenance of Certification process in 2006 must hold an active medical license and must hold clinical privileges in thoracic surgery. In addition, a valid certificate is an absolute requirement for entrance into the recertification/maintenance of certification process. if your certificate has expired, the only pathway for renewal of a certificate is to take and pass the Part I (written) and the Part II (oral) certifying examinations.

The American Board of Thoracic Surgery will no longer publish the names of individuals who have not recertified in the American Board of Medical Specialties directories. The Diplomate’s name will be published upon successful completion of the recertification/maintenance of certification process.

The CME requirements are 70 Category I credits in either cardiothoracic surgery or general surgery earned during the 2 years prior to application. SESATS and SESAPS are the only self-instructional materials allowed for credit. Category II credits are not allowed. The Physicians Recognition Award for recertifying in general surgery is not allowed in fulfillment of the CME requirements. Interested individuals should refer to the Booklet of Information for a complete description of acceptable CME credits.

Diplomates should maintain a documented list of their major cases performed during the year prior to application for recertification. This practice review should consist of 1 year’s consecutive major operative experiences. If more than 100 cases occur in 1 year, only 100 should be listed.

Candidates for recertification/maintenance of certification will be required to complete all sections of the SESATS self-assessment examination. It is not necessary for candidates to purchase SESATS individually because it will be sent to candidates after their application has been approved.

Diplomates may recertify the year their certificate expires, or if they wish to do so, they may recertify up to two years before it expires. However, the new certificate will be dated 10 years from the date of expiration of their original certificate or most recent recertification certificate. In other words, recertifying early does not alter the 10-year validation.

Recertification/maintenance of certification is also open to Diplomates with an unlimited certificate and will in no way affect the validity of their original certificate. The deadline for submission of applications for the recertification/maintenance of certification process is May 10 each year. A brochure outlining the rules and requirements for recertification/maintenance of certification in thoracic surgery is available upon request from the American Board of Thoracic Surgery, 633 N St. Clair St, Suite 2320, Chicago, IL 60611; telephone: (312) 202-5900; fax: (312) 202-5960; e-mail: mailto:info{at}abts.org. This booklet is also published on the website: www.abts.org.

	References

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1. Carrier M, Hebert Y, Pellerin M, et al. Tricuspid valve replacementan analysis of 25 years of experience at a single center. Ann Thorac Surg 2003;75:47-50.[Abstract/Free Full Text]
2. Dalrymple-Hay MJ, Leung Y, Ohri SK, et al. Tricuspid valve replacementbioprostheses are preferable. J Heart Valve Dis 1999;8:644-648.[Medline]
3. Rizzoli G, De Perini L, Bottio T, Minutolo G, Thiene G, Casarotto D. Prosthetic replacement of the tricuspid valvebiological or mechanical?. Ann Thorac Surg 1998;66(6 Suppl):S62-S67.
4. Van Nooten GJ, Caes F, Taeymans Y, et al. Tricuspid valve replacementpostoperative and long-term results. J Thorac Cardiovasc Surg 1995;110:672-679.[Abstract/Free Full Text]
5. Munro AI, Jamieson WR, Tyers GF, Germann E. Tricuspid valve replacementporcine bioprostheses and mechanical prostheses. Ann Thorac Surg 1995;60(2 Suppl):S470-S473.
6. Kaplan M, Kut MS, Demirtas MM, Cimen S, Ozler A. Prosthetic replacement of tricuspid valvebioprosthetic or mechanical. Ann Thorac Surg 2002;73:467-473.[Abstract/Free Full Text]
7. Rizzoli G, Vendramin I, Nesseris G, Bottio T, Guglielmi C, Schiavon L. Biological or mechanical prostheses in tricuspid position? A meta-analysis of intra-institutional results Ann Thorac Surg 2004;77:1607-1614.[Abstract/Free Full Text]
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This Article Abstract Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Add to Personal Folders Download to citation manager Author home page(s): Farzan Filsoufi Sacha P. Salzberg Lawrence H. Cohn David H. Adams Permission Requests Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Filsoufi, F. Articles by Adams, D. H. Search for Related Content PubMed PubMed Citation Articles by Filsoufi, F. Articles by Adams, D. H. Related Collections Valve disease