ORIGINAL ARTICLE

European Journal of Cardio-Thoracic Surgery 46 (2014) e21–e27 doi:10.1093/ejcts/ezu224 Advance Access publication 10 June 2014

Treatment for severe functional tricuspid regurgitation: annuloplasty versus valve replacement Ho Young Hwang, Kyung-Hwan Kim, Ki-Bong Kim and Hyuk Ahn* Department of Thoracic and Cardiovascular Surgery, Seoul National University Hospital, Seoul, Republic of Korea * Corresponding author. Department of Thoracic and Cardiovascular Surgery, Seoul National University Hospital, 101 Daehak-ro, Chongno-gu, Seoul 110-744, Korea. Tel: +82-2-20723349; fax: +82-2-7623566; e-mail: [email protected] (H. Ahn). Received 7 January 2014; received in revised form 24 February 2014; accepted 4 March 2014

OBJECTIVES: Previous studies have compared the outcomes of mitral annuloplasty with those of mitral valve replacement in patients with functional mitral regurgitation. However, data comparing the results of tricuspid annuloplasty (TAP) with those of tricuspid valve replacement (TVR) in patients with functional tricuspid regurgitation (FTR) have been scarce. We evaluated whether TAP was an optimal option for severe FTR. METHODS: From 1996 to 2012, 175 patients (57 ± 11 years old) underwent surgical correction for severe FTR. A total of 108 patients underwent TAP (the TAP group), and 67 underwent TVR (the TVR group). Inverse probability of treatment weighting (IPTW) analysis and propensity score matching with 37 patients in each group were performed to adjust for the baseline differences between the two groups. RESULTS: Early mortality occurred in 13 patients without any inter-group differences. There were 35 late mortalities, including 24 cardiac deaths. The 5- and 10-year freedom rates from cardiac death were 93.0 and 88.5%, respectively, in the TAP group, and 84.7 and 69.8%, respectively, in the TVR group. The IPTW-adjusted multivariable analysis revealed that the freedom rates from cardiac death were higher in the TAP group than in the TVR group (P = 0.01). In the propensity score-matched patients, the freedom rates from cardiac death and tricuspid valve-related event were higher in the TAP group than in the TVR group, although the difference was not statistically significant. CONCLUSIONS: TAP should be considered as a treatment of choice for patients with severe FTR because TVR has been associated with long-term cardiac death and valve-related events. Keywords: Tricuspid annuloplasty • Tricuspid valve replacement • Tricuspid regurgitation • Propensity score matching

INTRODUCTION Functional tricuspid regurgitation (FTR) deferred to tricuspid regurgitation (TR) occurrs without organic leaflet pathology. It results from (i) tricuspid annular dilatation, primarily in the anteroposterior direction, and (ii) increase in the leaflet-tethering height, and reduction in the coaptation surface area between leaflets, due to right ventricular dilatation and changes in right ventricular geometry [1]. Most patients with FTR undergo tricuspid annuloplasty (TAP), using annular plication sutures or prosthetic rings [2–5]. However, there has been concern that the long-term results of TAP, even after using prosthetic rings, might be suboptimal in terms of freedom from recurrent TR [1, 2]. Failure of the TAP and resultant tricuspid reoperation can be a high-risk procedure [6, 7]. Although recent studies have compared the outcomes of mitral annuloplasty with those of mitral valve replacement in patients with functional mitral regurgitation [8–10], data comparing the results of TAP with those of tricuspid valve replacement (TVR) in FTR have been scarce. At our institution, TVR has been frequently performed in patients with severe FTR with and without combined cardiac disease to avoid future reoperations.

We evaluated whether the long-term clinical outcomes of TVR were beneficial compared with those of TAP in patients with severe FTR.

MATERIALS AND METHODS Patient characteristics The study protocol was reviewed by the Institutional Review Board and was approved as a minimal risk retrospective study (Approval Number: H-1306-089-498), which did not require individual consent based on the institutional guidelines for waiving consent. From January 1996 to December 2012, 175 patients (57 ± 11 years old, male : female = 51 : 124) underwent surgical correction for severe FTR. Patients with histories of previous TAP and those with organic tricuspid leaflet pathology were excluded. One hundred and eight patients underwent TAP (the TAP group) and 67 patients underwent TVR (the TVR group). In the TAP group, 77 patients underwent suture annuloplasty, and 31 underwent annuloplasty using prosthetic rings. In the TVR group, 30 patients

© The Author 2014. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

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underwent mechanical TVR, and 37 underwent bioprosthetic TVR. There were differences in the preoperative characteristics between the two groups, such as smoking history, previous cardiac surgery and New York Heart Association functional class (Table 1).

Surgical procedures and operative data The surgical techniques for TVR and TAP have been previously described [11–13]. All operations were performed under routine aorto-bicaval cannulation, moderate hypothermia and cold cardioplegic arrest via a median sternotomy. Until 2002, TAP was preferred for the majority of patients (TAP, n = 38; TVR, n = 5). Subsequently, TVR has been performed more frequently at the discretion of the attending surgeons. The concomitant cardiac procedures included mitral valve operations (n = 98), arrhythmia surgeries (n = 62) and aortic valve procedures (n = 40). More patients in the TAP group underwent concomitant surgeries, such as mitral valve operations (P < 0.01) and arrhythmia surgeries (P < 0.01), than in the TVR group. The mean cardiopulmonary bypass and aortic cross-clamp times were 199 ± 76 and 122 ± 55 min, respectively (Table 1).

clinic visit was not conducted at the scheduled time. The anticoagulant dose was adjusted to obtain a target international normalized ratio (INR) of 2.5 for the patients with left-sided heart valve and/or atrial fibrillation and an INR of 3.0 for the patients with mechanical tricuspid valves. A specialized anticoagulation service team comprised of experienced pharmacists regularly followed up all patients. The clinical follow-up was closed in June 2013. The follow-up was completed in 96% of patients (168 of 175), with a follow-up duration of 83 months (range 3–212 months). The operative mortality was defined as death occurring within 30 days or during the same hospitalization as the surgery. Cardiac death was defined as any death related to cardiac events, including sudden death during follow-up. The valve-related complications were recorded according to the previous guidelines [14]. The tricuspid valve-related events (TVREs) included the following events: (i) cardiac death; (ii) structural valve deterioration of the replaced valve or recurrent TR after TAP; (iii) tricuspid valve reoperations; (iv) congestive heart failure requiring readmission; (v) a composite of thromboembolism and bleeding that caused death, hospitalization or permanent injury, or that necessitated a transfusion; (vi) tricuspid valve endocarditis and (vii) permanent pacemaker implantation within 1 month post surgery.

Echocardiographic evaluation Evaluation of early and long-term clinical outcomes Patients underwent regular postoperative follow-ups through the outpatient clinic at 3- or 4-month intervals, and they were contacted by telephone for confirmation of their conditions if the last

An initial postoperative echocardiographic evaluation was performed before patient discharge. Follow-up echocardiograms were performed at the discretion of the operating surgeon or the referring physician during the follow-up. At least one echocardiogram was performed in 94% (152 of 162) of the survivors. The last follow-up echocardiogram was performed 63 ± 47 months after

Table 1: Preoperative characteristics, risk factors and operative data of the study patients Variables

Total (n = 175)

TAP group (n = 108)

TVR group (n = 67)

Age (years) Male : female Risk factors, n (%) Smoking Diabetes mellitus Hypertension History of stroke Overweight (BMI >25 kg/m2) Chronic obstructive pulmonary disease Chronic renal failure Atrial fibrillation NYHA class ≥3 Previous cardiac surgery Left ventricle dysfunction (LVEF 0.99 >0.99 0.58 >0.99 0.23 0.17 0.07

30 (81%) 12 (32%) 13 (35%) 1 (3%)

11 (30%) 5 (14%) 9 (24%) 1 (3%)

0.99

BMI: body mass index; NYHA: New York Heart Association; LVEF: left ventricular ejection fraction; TAP: tricuspid annuloplasty; TVR: tricuspid valve replacement.

Table 5: Operative mortality and postoperative complications among the propensity score-matched patients Variables

Operative mortality Complications, n (%) Low cardiac output syndrome Respiratory complication Acute renal failure Bleeding reoperation Stroke Mediastinitis

TAP group (n = 37)

TVR group (n = 37)

P-value

3 (8%)

5 (14%)

0.73

10 (27%)

7 (19%)

0.55

9 (24%)

3 (8%)

0.11

2 (5%) 1 (3%) 2 (5%) 0 (0%)

3 (8%) 3 (8%) 1 (3%) 1 (3%)

>0.99 0.63 >0.99 –

TAP: tricuspid annuloplasty; TVR: tricuspid valve replacement.

in patients who underwent TAP using prosthetic rings [3]. The subsequent tricuspid reoperation because of TAP failure could result in high operative mortality [6, 7]. Traditionally, mitral annuloplasty has been preferred for patients with functional mitral regurgitation [15]. However, there has been concern that mitral annuloplasty is unsatisfactory for patients with functional mitral regurgitation [8, 9]. A recent study demonstrated that, in a propensity score-adjusted multivariable analysis of 132 patients, mitral valve replacement was associated with higher in-hospital and late mortalities compared with mitral valve repair in patients with dilated and ischaemic cardiomyopathies [10]. In another study, however, the authors suggested performing mitral valve replacement because the mitral valve repair was associated with an increased risk of reoperation without any benefits compared with mitral valve replacement [9]. The present study was inspired by a similar question. Is TAP sufficient to treat FTR, particularly FTR of a severe degree? Contrary to numerous studies of functional mitral regurgitation, however, only a few studies have compared the results of TAP with those of

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Table 4: Preoperative characteristics, risk factors and operative data of the propensity score-matched patients

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using two methods: IPTW-adjusted multivariable analysis [17] and propensity score matching. After these adjustments, TVR was associated with a high rate of long-term cardiac death. This finding aligned with the results of previous studies reporting higher longterm mortality after TVR compared with mortality after TAP [19, 20]. A theoretical disadvantage of TVR that has been suggested is progressive right ventricular dysfunction, which might occur after TVR because of a large, rigid prosthetic object being inserted into a deformable, low-pressure cavity [19, 20]. In the TAP group, 8 patients experienced recurrent FTR of a severe degree, and 7 underwent tricuspid valve reoperations. However, there were no differences in the TVRE-free rates between the two groups for the entire patient group, and there was a trend towards higher TVRE-free rates in the TAP group than in the TVR group in the propensity score-matched patient population. The majority of patients in the TAP group in the present study underwent TAP without a prosthetic ring, which has been suggested to be a risk factor for recurrent TR after TAP [21]. Our current practice includes a modification of suture annuloplasty and 3D ring annuloplasty [12, 13]. It is expected that improved results with TAP might further decrease the risks of cardiac death and TVREs in the TAP group. The present study had limitations that must be noted. Firstly, the present study was a retrospective, observational study that was conducted at a single institution. Although we enrolled only patients with severe FTR, and we performed IPTW-adjusted analysis and propensity score matching, selection bias and confounding variables might have affected the study results. Secondly, the indications for TAP and TVR were not precisely defined because of the retrospective nature of the present study. Thirdly, the followup duration was different between the two groups because we preferred performing TAP during the early period of the study. Fourthly, the technique of TAP changed over time with later use of annuloplasty rings. Finally, the number of patients enrolled in the present study might be too small to draw definite conclusions. A randomized, controlled trial with a large cohort might be necessary to reach more definitive conclusions.

Conflict of interest: none declared. Figure 3: Survival curves for freedom from cardiac death (A) and tricuspid valve-related events (TVREs) (B) between the propensity score-matched tricuspid annuloplasty (TAP) and tricuspid valve replacement (TVR) groups.

TVR [16, 17]. One of the most important limitations when comparing the results of TAP with those of TVR is that there might be baseline differences between the patients who underwent TVP and those who underwent TVR. To overcome this limitation, a previous study compared the results of TAP with those of TVR using propensity score-matching analysis [18]. The authors matched 68 patients in each group, and they demonstrated that there were no advantages favouring TAP over TVR in terms of the long-term clinical outcomes. In their study, however, they demonstrated only overall survival as a long-term clinical outcome. In the present study, to minimize selection bias, we only enrolled patients with FTR of a severe degree. However, there were still baseline differences between the two groups. To overcome these differences, we constructed a propensity score model that included 14 variables, and the baseline differences were adjusted

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Treatment for severe functional tricuspid regurgitation: annuloplasty versus valve replacement.

Previous studies have compared the outcomes of mitral annuloplasty with those of mitral valve replacement in patients with functional mitral regurgita...
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