Long-term results of annuloplasty in trivial-to-mild functional tricuspid regurgitation during mitral valve replacement: should we perform annuloplasty on the tricuspid valve or leave it alone?

Long-term results of annuloplasty in trivial-to-mild functional tricuspid regurgitation during... Abstract OBJECTIVES The benefits of concomitant tricuspid annuloplasty (TAP) for non-significant functional tricuspid regurgitation (TR) during mitral valve replacement (MVR) are controversial. We evaluated the long-term outcomes—particularly the long-term tricuspid valve (TV) functional outcomes—of MVR with or without tricuspid ring annuloplasty. METHODS From 2004 to 2014, 256 patients (56.4 ± 12.1 years) with trivial or mild functional TR who underwent MVR were enrolled. Eighty-two patients underwent concomitant tricuspid ring annuloplasty (TAP group), and 174 patients did not undergo the TV procedure (nTAP group). Propensity score-matched analysis was performed (n = 72 in each group). The follow-up duration was 77.4 ± 42.4 months. RESULTS The early clinical outcomes were similar between the 2 groups before and after propensity score matching with an early mortality rate of 3.5% (9 of 256). No patients experienced ring-related complications during follow-up. Eleven (6.3%) patients developed significant TR (≥moderate) in the nTAP group, while no patients developed significant TR in the TAP group. There were no significant differences in overall survival between the 2 groups before or after matching. However, propensity score-matched analysis revealed that the freedom from significant TR aggravation and freedom from TV-related event rates were significantly higher in the TAP group than in the nTAP group (P = 0.047 and P = 0.043, respectively). CONCLUSIONS Patients with untreated trivial or mild functional TR accompanied by mitral valve disease can develop significant TR during follow-up. TV ring annuloplasty can be performed without complications and can be beneficial for patients with trivial or mild functional TR who are undergoing MVR. Functional tricuspid regurgitation, Tricuspid annuloplasty, Ring annuloplasty INTRODUCTION Functional tricuspid regurgitation (TR) is a common finding in patients undergoing left-sided valve surgery with a reported incidence ranging from 25% to 30% [1]. Improvements in functional TR are expected after left-sided valve surgery; however, recent studies have reported that late TR can develop in patients undergoing isolated left-sided valve surgery. Therefore, the current guidelines recommend the performance of concomitant tricuspid valve (TV) surgery for patients with severe TR who are undergoing left-sided valve surgery (Class I) and patients with mild, moderate or greater TR with either tricuspid annular dilation or prior evidence of right heart failure (Class IIa). Although the current guidelines recommend concomitant TV surgery for patients with mild TR, only a few studies have reported the long-term results of concomitant TV surgery for patients with non-significant functional TR who are undergoing left-sided valve surgery. Some recent studies reported that prophylactic tricuspid annuloplasty (TAP) is beneficial for patients with less-than-moderate functional TR [2, 3]; however, concerns remain regarding the risks of combined valve surgery [4–7]. Therefore, the benefits of performing concomitant TV surgery during mitral valve replacement (MVR) are controversial. The aim of this study was to evaluate the long-term outcomes—particularly the long-term TV functional outcomes—of MVR with or without tricuspid ring annuloplasty for trivial or mild functional TR. MATERIALS AND METHODS Patient characteristics The appropriate institutional review board reviewed the protocol for this study, which was approved as a minimal risk retrospective study (approval number: H-1608-036-783) that did not require the informed consent of the individual patients who participated herein. From January 2004 to December 2014, 356 patients with a trivial or mild functional TR underwent MVR at our institution. Fifty-three patients with infective endocarditis, 35 patients undergoing other TV procedures (De Vega annuloplasty = 32, Kay-type annuloplasty = 2 and TV replacement = 1) and 12 patients with other disease (ischaemic mitral regurgitation = 5, cardiac tumour = 3, congenital anomaly = 3 and Takayasu arteritis = 1) were excluded from the study, and 256 patients were ultimately enrolled herein (Fig. 1). Eighty-two patients underwent concomitant tricuspid ring annuloplasty (TAP group) with the Edwards MC3 tricuspid annuloplasty ring (n = 81) or the Carpentier-Edwards classic ring (n = 1), and 174 patients did not undergo a tricuspid valve procedure (nTAP group). Trivial TR was observed in 154 (60%) patients and mild TR was observed in 102 (40%) patients. Rheumatic disease was the main cause of mitral valve dysfunction in the patients enrolled in this study (82.8%). A propensity score model was constructed, and 72 patients in each group were extracted in a 1:1 ratio using the nearest neighbour matching method. Statistically significant differences in the aetiologies and pathologies of the mitral valve disease, primarily diseased valve, hypertension and atrial fibrillation existed between the 2 groups prior to matching (Table 1). However, no differences in preoperative characteristics were noted between the 2 groups after matching (Table 1). Table 1: Preoperative characteristics and risk factors of the study patients Variables  All study patients   Propensity-matched patients   nTAP (n = 174)  TAP (n = 82)  P-value  nTAP (n = 72)  TAP (n = 72)  P-value  Age (years)  56.8 ± 12.4  55.3 ± 11.2  0.337  55.6 ± 10.6  54.5 ± 11.4  0.574  Female  97 (55.7)  53 (64.6)  0.178a  43 (59.7)  46 (63.9)  0.701  NYHA functional class ≥3  61 (35.1)  32 (39.0)  0.538a  32 (44.4)  27 (37.5)  0.424  Combined AV disease  112 (64.4)  44 (53.7)  0.101a  45 (62.5)  41 (56.9)  0.597  Aetiology (rheumatic)  136 (78.2)  76 (92.7)  0.004a  66 (91.7)  66 (91.7)  >0.999  Pathology (stenosis)  100 (57.5)  64 (78.0)  0.001a  15 (20.8)  16 (22.2)  >0.999  Primarily diseased valve (MV)  120 (69.0)  69 (84.1)  0.010a  60 (83.3)  59 (81.9)  >0.999  PASP (mmHg)  43.6 ± 15.9  44.3 ± 12.0  0.698  42.9 ± 11.7  42.1 ± 10.3  0.686  Risk factors      Smoking  31 (18.0)  12 (14.6)  0.501a  11 (15.3)  12 (16.7)  >0.999  BMI >25 kg/m2  34 (19.5)  16 (19.5)  0.996a  12 (16.7)  14 (19.4)  0.815  Diabetes mellitus  26 (14.9)  6 (7.3)  0.085a  6 (8.3)  5 (6.9)  >0.999  Hypertension  42 (24.1)  6 (7.3)  0.001a  5 (6.9)  5 (6.9)  >0.999  History of stroke  27 (15.5)  12 (14.6)  0.854a  11 (15.3)  12 (16.7)  >0.999  Coronary artery disease  13 (7.5)  3 (3.7)  0.240a  3 (4.2)  3 (4.2)  >0.999  CRF (GFR<60 ml/min)  47 (27.0)  17 (20.7)  0.279a  15 (20.8)  15 (20.8)  >0.999  Atrial fibrillation  100 (57.5)  67 (81.7)  <0.001a  61 (84.7)  57 (79.2)  0.481  LV dysfunction (EF < 45%)  17 (9.8)  12 (14.6)  0.252a  4 (5.6)  8 (11.1)  0.344  Variables  All study patients   Propensity-matched patients   nTAP (n = 174)  TAP (n = 82)  P-value  nTAP (n = 72)  TAP (n = 72)  P-value  Age (years)  56.8 ± 12.4  55.3 ± 11.2  0.337  55.6 ± 10.6  54.5 ± 11.4  0.574  Female  97 (55.7)  53 (64.6)  0.178a  43 (59.7)  46 (63.9)  0.701  NYHA functional class ≥3  61 (35.1)  32 (39.0)  0.538a  32 (44.4)  27 (37.5)  0.424  Combined AV disease  112 (64.4)  44 (53.7)  0.101a  45 (62.5)  41 (56.9)  0.597  Aetiology (rheumatic)  136 (78.2)  76 (92.7)  0.004a  66 (91.7)  66 (91.7)  >0.999  Pathology (stenosis)  100 (57.5)  64 (78.0)  0.001a  15 (20.8)  16 (22.2)  >0.999  Primarily diseased valve (MV)  120 (69.0)  69 (84.1)  0.010a  60 (83.3)  59 (81.9)  >0.999  PASP (mmHg)  43.6 ± 15.9  44.3 ± 12.0  0.698  42.9 ± 11.7  42.1 ± 10.3  0.686  Risk factors      Smoking  31 (18.0)  12 (14.6)  0.501a  11 (15.3)  12 (16.7)  >0.999  BMI >25 kg/m2  34 (19.5)  16 (19.5)  0.996a  12 (16.7)  14 (19.4)  0.815  Diabetes mellitus  26 (14.9)  6 (7.3)  0.085a  6 (8.3)  5 (6.9)  >0.999  Hypertension  42 (24.1)  6 (7.3)  0.001a  5 (6.9)  5 (6.9)  >0.999  History of stroke  27 (15.5)  12 (14.6)  0.854a  11 (15.3)  12 (16.7)  >0.999  Coronary artery disease  13 (7.5)  3 (3.7)  0.240a  3 (4.2)  3 (4.2)  >0.999  CRF (GFR<60 ml/min)  47 (27.0)  17 (20.7)  0.279a  15 (20.8)  15 (20.8)  >0.999  Atrial fibrillation  100 (57.5)  67 (81.7)  <0.001a  61 (84.7)  57 (79.2)  0.481  LV dysfunction (EF < 45%)  17 (9.8)  12 (14.6)  0.252a  4 (5.6)  8 (11.1)  0.344  Values are mean ± standard deviation or n (%). a P-value was calculated by the χ2 test. AV: aortic valve; BMI: body mass index; CRF: chronic renal failure; EF: ejection fraction; GFR: glomerular filtration rate; LV: left ventricle; MV: mitral valve; NYHA: New York heart association; PASP: pulmonary artery systolic pressure; TAP: tricuspid annuloplasty. Figure 1: View largeDownload slide A flow diagram of patient enrolment. MR: mitral regurgitation; MVR: mitral valve replacement; PS: propensity score; TAP: tricuspid annuloplasty; TR: tricuspid regurgitation; TV: tricuspid valve; TVR: tricuspid valve replacement. Figure 1: View largeDownload slide A flow diagram of patient enrolment. MR: mitral regurgitation; MVR: mitral valve replacement; PS: propensity score; TAP: tricuspid annuloplasty; TR: tricuspid regurgitation; TV: tricuspid valve; TVR: tricuspid valve replacement. Surgical procedures and operative data The surgical techniques for MVR and TAP were described previously [8, 9]. All surgeries were performed via median sternotomy. The mitral valve was replaced via left atriotomy (n = 230) or a trans-septal approach (n = 26), and the TV was examined via right atriotomy in 214 (83.6%) patients. TAP was considered when patients exhibited (i) a preoperative pulmonary artery systolic pressure >50 mmHg or (ii) annular dilatation, the latter of which was evaluated by measuring the intercommissural distance of the septal leaflet with the aid of tricuspid ring annuloplasty sizer (Fig. 2). Annular dilatation was diagnosed when the annulus was larger than the ring sizer used to measure the intercommissural distance. The final decision regarding whether a particular patient with annular dilatation underwent surgery was made by the patient’s surgeon. According to the surgeon’s preference, not all of the patients with annular dilatation, as determined using a tricuspid ring annuloplasty sizer, underwent TAP. The 28-mm and 30-mm rings were used in more than 80% of the 82 patients. The size of the ring was chosen based on the intercommissural distance of the septal leaflet and the area of the leaflet attached to the chordae originating from the anterior papillary muscle [10]. Figure 2: View largeDownload slide Measurement of the tricuspid annular size with the aid of tricuspid ring annuloplasty sizer in normal annulus (A) and dilated annulus (B). Figure 2: View largeDownload slide Measurement of the tricuspid annular size with the aid of tricuspid ring annuloplasty sizer in normal annulus (A) and dilated annulus (B). A total of 208 (81.2%) patients underwent concomitant procedures, including aortic valve surgery (n = 114), arrhythmia surgery (n = 143), aorta surgery (n = 18) and coronary artery bypass surgery (n = 14). The cardiopulmonary bypass and aortic cross-clamp (ACC) times were 214.9 ± 70.6 and 148.3 ± 51.0 min, respectively. Patients in the TAP group underwent concomitant arrhythmia surgery and received mechanical prostheses more frequently than patients in the nTAP group prior to matching. Mechanical valves were used more frequently in the TAP group than in the non-TAP group, because the patients in the former group were younger than the patients in the latter group. Patients with long-standing persistent atrial fibrillation or chronic renal failure requiring dialysis were also considered for mechanical valve surgery. There were no statistically significant differences in operative parameters between the 2 groups in the matched patients; however, relatively longer cardiopulmonary bypass and ACC times were noted in the TAP group than in the nTAP group (Table 2). Table 2: Operative characteristics Variables  All study patients   Propensity-matched patients   nTAP (n = 174)  TAP (n = 82)  P-value  nTAP (n = 72)  TAP (n = 72)  P-value  Concomitant surgery  137 (79.2)  71 (86.6)  0.155a  59 (83.1)  61 (85.9)  0.804   Aortic valve surgery  82 (47.1)  32 (39.0)  0.224a  26 (36.1)  29 (40.3)  0.711   Aorta surgery  15 (8.6)  3 (3.7)  0.154a  2 (2.8)  3 (4.2)  >0.999   Arrhythmia surgery  78 (44.8)  65 (79.3)  <0.001a  52 (72.2)  56 (77.8)  0.541   CABG  11 (6.3)  3 (3.7)  0.558a  2 (2.8)  3 (4.2)  >0.999  Prosthesis type (mechanical)  119 (68.8)  69 (85.2)  0.005a  58 (81.6)  62 (86.1)  0.523  CPB time (min)  205 ± 75  237 ± 55  <0.001  197 ± 61  238 ± 57  <0.001  ACC time (min)  142 ± 54  162 ± 42  0.004  136 ± 45  163 ± 43  <0.001  Variables  All study patients   Propensity-matched patients   nTAP (n = 174)  TAP (n = 82)  P-value  nTAP (n = 72)  TAP (n = 72)  P-value  Concomitant surgery  137 (79.2)  71 (86.6)  0.155a  59 (83.1)  61 (85.9)  0.804   Aortic valve surgery  82 (47.1)  32 (39.0)  0.224a  26 (36.1)  29 (40.3)  0.711   Aorta surgery  15 (8.6)  3 (3.7)  0.154a  2 (2.8)  3 (4.2)  >0.999   Arrhythmia surgery  78 (44.8)  65 (79.3)  <0.001a  52 (72.2)  56 (77.8)  0.541   CABG  11 (6.3)  3 (3.7)  0.558a  2 (2.8)  3 (4.2)  >0.999  Prosthesis type (mechanical)  119 (68.8)  69 (85.2)  0.005a  58 (81.6)  62 (86.1)  0.523  CPB time (min)  205 ± 75  237 ± 55  <0.001  197 ± 61  238 ± 57  <0.001  ACC time (min)  142 ± 54  162 ± 42  0.004  136 ± 45  163 ± 43  <0.001  Values are mean ± standard deviation or n (%). a P-value was calculated by the χ2 test. ACC: aortic cross-clamp; CABG: coronary artery bypass grafting; CPB: cardiopulmonary bypass; TAP: tricuspid annuloplasty. Evaluation of clinical outcomes Operative mortality was defined as any death within 30 days after surgery or during the same hospital admission. All survivors underwent echocardiography at 7 days (range 2–144 days) after surgery and regular postoperative follow-up visits in the outpatient clinic at 3- to 4-month intervals. The clinical follow-up period ended on 31 May 2016. Patients who did not visit the clinic at the scheduled time were contacted via telephone to confirm their conditions. Follow-up was completed in 248 (96.9%) patients within 77.4 ± 42.4 months (range 0.1–150.9 months). Routine echocardiographic evaluations were performed at the discretion of the patients’ surgeons, and 224 (90.7%) of the 247 early survivors underwent at least 1 echocardiographic examination after discharge. The TR grade was graded as none, trivial, mild, moderate or severe [11]. Significant TR was defined as equal or more-than-moderate degree. We did not consider TR significance in cases where it improved naturally, i.e. without the aid of additional procedure, as determined by echocardiography. The last follow-up echocardiographic evaluation was performed at 52.0 ± 39.4 months after surgery. According to the established guidelines, the following events were considered TV-related events (TVREs) [12]: (i) cardiac death, (ii) TV-related surgery, (iii) significant TR, (iv) composite of thromboembolism and bleeding and (v) permanent pacemaker insertion due to complete atrioventricular block. Statistical analysis The statistical analyses were performed using IBM SPSS statistical software version 21.0 (IBM Inc., Armonk, NY, USA) and SAS V.9.2 (SAS Institute, Cary, NC, USA). The data were expressed as the means ± standard deviation, medians with ranges or proportions. Propensity score-matched analysis was performed to adjust for differences in preoperative characteristics, and a logistic regression model was constructed using non-parsimonious methods to generate the propensity scores. Sixteen preoperative characteristics were included in the propensity score model (P-value of the Hosmer–Lemeshow test = 0.402 and C-statistic = 0.756, see Supplementary Material, Table S1). After calculating of the propensity score, 72 pairs were extracted in a 1:1 manner using the nearest neighbour matching method without replacement. Comparisons between the 2 groups were performed using the χ2 test or the Fisher’s exact test for categorical variables and the Student’s t-test for continuous variables. The Fisher’s exact tests were used when the expected frequency was lower than 5 in more than 20% of cells. In matched groups, the McNemar’s test was used for categorical variables, and a paired t-test was used for continuous variables. Survival was estimated using the Kaplan–Meier method, and the survival rates in the 2 groups were compared using a log-rank test in all patients and a robust sandwich covariance matrix estimate in marginal Cox model approach to account for the intracluster correlation in matched patients [13]. The average time for developing significant TR was calculated using the arithmetic mean among patients who had it. A P-value <0.05 was considered statistically significant. RESULTS Early clinical outcomes Operative mortality rate was 3.5% (9 of 256 patients). The causes of death were low cardiac output syndrome (n = 4), acute respiratory distress syndrome (n = 3), left ventricular rupture (n = 1) and hypoxic brain damage (n = 1). The following postoperative morbidities were noted among the patients enrolled in the study: new-onset atrial fibrillation (n = 23), low cardiac output syndrome (n = 12), respiratory complications (n = 11), bleeding requiring reoperation (n = 11) and acute kidney injury (n = 8). No ring-related complications, such as atrioventricular block, permanent pacemaker insertion, ring dehiscence, infective endocarditis or thromboembolism were noted during the immediate postoperative period. Early aggravation of moderate or more severe TR occurred in 9 patients in the nTAP group. No statistically significant differences in operative mortality or postoperative morbidity were noted between the 2 matched groups (Table 3). Table 3: Early clinical results Variables  All study patients   Propensity-matched patients   nTAP (n = 174)  TAP (n = 82)  P-value  nTAP (n = 72)  TAP (n = 72)  P-value  Operative mortality  7 (4.0)  2 (2.4)  0.723a  3 (4.2)  1 (1.4)  0.625  Hospital stay (days)  21.7 ± 65.4  18.5 ± 34.7  0.681  17.9 ± 33.7  17.9 ± 35.4  0.994  Postoperative PASP (mmHg)  35.6 ± 8.3  35.3 ± 6.4  0.772  34.3 ± 7.0  35.3 ± 6.5  0.425  Postoperative complication               Low cardiac output syndrome  11 (6.3)  1 (1.2)  0.110a  3 (4.2)  1 (1.4)  0.625   Atrial fibrillation (new onset)  21 (12.1)  2 (2.4)  0.012a  5 (6.9)  2 (2.8)  0.375   Acute kidney injury  7 (4.0)  1 (1.2)  0.442a  2 (2.8)  1 (1.4)  >0.999   Bleeding reoperation  10 (5.7)  1 (1.2)  0.182a  5 (6.9)  1 (1.4)  0.219   Stroke  1 (0.6)  2 (2.4)  0.241a  1 (1.4)  1 (1.4)  >0.999   Respiratory complication  9 (5.2)  2 (2.4)  0.511a  2 (2.8)  1 (1.4)  >0.999   Early aggravation of TR  9 (5.1)  0 (0)  0.061a  4 (5.5)  0 (0)  0.125   Others  1 (0.6)  1 (1.2)  0.320a  1 (1.4)  1 (1.4)  >0.999  Variables  All study patients   Propensity-matched patients   nTAP (n = 174)  TAP (n = 82)  P-value  nTAP (n = 72)  TAP (n = 72)  P-value  Operative mortality  7 (4.0)  2 (2.4)  0.723a  3 (4.2)  1 (1.4)  0.625  Hospital stay (days)  21.7 ± 65.4  18.5 ± 34.7  0.681  17.9 ± 33.7  17.9 ± 35.4  0.994  Postoperative PASP (mmHg)  35.6 ± 8.3  35.3 ± 6.4  0.772  34.3 ± 7.0  35.3 ± 6.5  0.425  Postoperative complication               Low cardiac output syndrome  11 (6.3)  1 (1.2)  0.110a  3 (4.2)  1 (1.4)  0.625   Atrial fibrillation (new onset)  21 (12.1)  2 (2.4)  0.012a  5 (6.9)  2 (2.8)  0.375   Acute kidney injury  7 (4.0)  1 (1.2)  0.442a  2 (2.8)  1 (1.4)  >0.999   Bleeding reoperation  10 (5.7)  1 (1.2)  0.182a  5 (6.9)  1 (1.4)  0.219   Stroke  1 (0.6)  2 (2.4)  0.241a  1 (1.4)  1 (1.4)  >0.999   Respiratory complication  9 (5.2)  2 (2.4)  0.511a  2 (2.8)  1 (1.4)  >0.999   Early aggravation of TR  9 (5.1)  0 (0)  0.061a  4 (5.5)  0 (0)  0.125   Others  1 (0.6)  1 (1.2)  0.320a  1 (1.4)  1 (1.4)  >0.999  Values are mean ± standard deviation or n (%). a P-value was calculated by the Fisher’s exact test. PASP: pulmonary artery systolic pressure; TAP: tricuspid annuloplasty; TR: tricuspid regurgitation. Long-term clinical outcomes Among the 247 survivors, 18 patients suffered late deaths, and 7 of those patients due to cardiac deaths. The overall survival at 5 and 10 years were 90.8% and 86.7%, respectively. There was no significant difference in the overall survival between the 2 groups (P = 0.139, Fig. 3A). Moreover, the overall survival of the 2 groups were very similar after matching (P = 0.550, Fig. 3A). Freedoms from cardiac death rates were 94.3% and 93.6% at 5 and 10 years post-surgery, respectively, and no cardiac deaths were observed in the TAP group during the follow-up period. However, there were no significant differences in freedom from cardiac death between the 2 groups before or after matching (P = 0.115, P = 0.313). Prosthetic mitral valve failure occurred in 8 patients during follow-up, including 3 patients who presented with structural valve deterioration and 5 patients who presented with non-structural valve dysfunction (paravalvular leakage = 3 and pannus formation = 2). The incidences of prosthetic mitral valve failure in the TAP and nTAP groups were 1.3% (1 of 81) and 4.2% (7 of 167), respectively. Of the indicated patients, 2 developed significant TR and subsequently underwent DeVega TAP or TV replacement, respectively. Only 1 patient in the TAP group experienced prosthetic valve failure. The patient in question did not develop TR for 4 years, despite exhibiting moderate mitral paravalvular leakage on echocardiography. Figure 3: View largeDownload slide Comparison of overall survival (A), freedom from significant tricuspid regurgitation (≥ moderate) (B) and freedom from TVREs (C) in the tricuspid annuloplasty (TAP) and untreated tricuspid valve (nTAP) groups before and after propensity score matching. TAP: tricuspid annuloplasty; TR: tricuspid regurgitation; TV: tricuspid valve; TVRE: tricuspid valve-related events. Figure 3: View largeDownload slide Comparison of overall survival (A), freedom from significant tricuspid regurgitation (≥ moderate) (B) and freedom from TVREs (C) in the tricuspid annuloplasty (TAP) and untreated tricuspid valve (nTAP) groups before and after propensity score matching. TAP: tricuspid annuloplasty; TR: tricuspid regurgitation; TV: tricuspid valve; TVRE: tricuspid valve-related events. Development of significant tricuspid regurgitation No patients in the TAP group developed moderate or more severe TR after surgery. However, 18 of 174 (10.3%) patients in the nTAP group developed moderate or more severe TR. Nine of these 18 patients developed moderate or more severe TR before discharge (range 5–24 days) and 9 patients developed moderate or more severe TR on an average of 29.7 months (range 2.4–115.4 months) after discharge. Among the 9 patients who developed moderate or more severe TR during the early postoperative period, 7 improved spontaneously, i.e. without undergoing additional procedures. Finally, 11 of 174 patients (6.3%, moderate: 6, moderate to severe: 2, severe: 3) in the nTAP group developed significant TR (Fig. 4). Figure 4: View largeDownload slide Incidence of significant TR in the untreated TV (nTAP) group. TR: tricuspid regurgitation; TV: tricuspid valve. Figure 4: View largeDownload slide Incidence of significant TR in the untreated TV (nTAP) group. TR: tricuspid regurgitation; TV: tricuspid valve. Among them, 5 patients had a preoperative trivial TR. No patients who developed significant TR displayed signs of rheumatic disease progression on echocardiography. Two patients died within 6 months after surgery, 1 patient underwent TV replacement after 93 months, 1 patient underwent TAP after 26 months and 7 patients were under medical follow-up without undergoing TV procedures. The freedom from significant TR rates at 5 and 10 years were 94.7% and 89.7%, respectively, and were significantly higher in the TAP group than in the nTAP group before and after propensity score matching (P = 0.013, P = 0.047, respectively, Fig. 3B). Tricuspid valve-related events TVREs occurred in 46 patients, including a composite of thromboembolism and bleeding (n = 23), cardiac death (n = 16), significant TR (n = 11) and TV-related surgery (n = 3). No patients experienced the implantation of permanent pacemaker because of the complete atrioventricular block during follow-up. Freedom from TVRE rates at 5 and 10 years were 87.5% and 76.7%, respectively, and these rates were significantly higher in the TAP group than in the nTAP group before (P = 0.008, Fig. 3C) and after matching (P = 0.043, Fig. 3C). DISCUSSION The main findings of this study were as follows: (i) although the mitral lesions were treated appropriately, patients with untreated trivial or mild functional TR accompanied by mitral valve disease can develop significant TR during follow-up; (ii) TV ring annuloplasty for trivial or mild functional TR would be performed without complications during primary MVR and (iii) TV ring annuloplasty can be beneficial for patients with trivial or mild functional TR, as the patients who underwent TV ring annuloplasty are associated with higher freedom from TR aggravation and freedom from TVRE rates compared to the patients with uncorrected trivial or mild functional TR. Functional TR was previously thought to diminish or disappear after left-sided valve surgery [14, 15]. However, this concept was changed by several studies describing TR recurrence in patients who have undergone left-sided valve surgery [16]. These studies demonstrated that untreated preoperative moderate or more severe functional TR was associated with TR recurrence [17, 18] and lower survival [19]. Therefore, it was determined that the performance of concomitant TV surgery was reasonable for patients with moderate-to-severe TR. However, data are lacking regarding the performance of concomitant TV surgery for patients with less-than-moderate functional TR. In our previous study, the findings of which inspired this study, we determined the incidence of significant late TR after left-sided valve surgery in patients with insignificant TR [16]. The study showed that significant TR long after the left-sided valve surgery was common—the estimated incidence of the disease was 27%—and was associated with a poor prognosis. After that, aggressive surgery is performed more frequently in patients with insignificant TR to prevent late TR exacerbations. Kusajima et al. [20] also reported that more than half of the untreated mild functional TR progressed to moderate or more severe TR in a long-term follow-up study. Some recent studies demonstrated that prophylactic TAP is beneficial for patients with less-than-moderate TR [2, 3, 21]. Lee et al. [3] reported that the rate of freedom from moderate-to-severe TR recurrence was higher in a concomitant TAP group than in an nTAP group via propensity score matching analysis, and Benedetto et al. [2] demonstrated that prophylactic TAP was associated with a reduced rate of TR progression and improved right ventricular remodelling and functional outcomes in a randomized controlled study. Moreover, Kara et al. [22] demonstrated that performing TV annuloplasty in patients with moderate or less-than-moderate TR reduced the probability that such patients will progress to moderate-to-severe TR in meta-analysis. This study also demonstrated that performing TAP for trivial or mild TR prevented TR exacerbations and reduced TVRE rates. The current guidelines suggest that several criteria can be used to evaluate TV annular dilatation, which is usually diagnosed in patients with a TV annulus >40 mm or 21 mm/m2 on preoperative transthoracic echocardiography or patients with an anteroseptal (between anterosuperior and septal leaflets) commissure–anteroposterior (between anterosuperior and inferior leaflets) commissure distance >70 mm on intraoperative finding [23]. However, measurements of the distance from the anteroseptal commissure to the anteroposterior commissure in arrested hearts are not reliable or reproducible, and the cut-off value of >70 mm may be too high in patients with trivial or mild functional TR. Therefore, this study evaluated the TV annulus by measuring the length of the septal leaflet (i.e. the intercommissural distance), which indicates the smallest changes in functional TR [10] and diagnosed annular dilatation in cases in which the annulus was larger than the area of the equivalent ring sizer. Additional studies are required to determine whether our method of diagnosing annular dilatation is reasonable to evaluate the TV annular dilataion. In addition, although the current guidelines do not recommend the performance of TAP for patients with trivial TV regurgitation, 5 patients with preoperative trivial TR developed significant TR in this study. These results showed that criteria on the treatment of trivial TR are also required. Currently, mitral valve repair is recommended for patients with primary MR in whom a successful and durable repair can be performed. However, some clinicians have raised concerns regarding recurrent MR after mitral valve repair, as this particular phenomenon is not uncommon [24] and may lead to the development of recurrent functional TR. Ito et al. [25] demonstrated that recurrent MR was a risk factor for late TR progression in patients who have undergone mitral valve repair, and Gatti et al. [26] reported that freedom from recurrent TR rates were marginally significantly higher in patients who underwent MVR than in patients who underwent mitral valve repair. In this study, 8 patients suffered prosthetic mitral valve failure. Only 1 patient in the TAP group experienced mitral paravalvular leakage; however, the patient did not develop significant functional TR for 4 years after developing moderate paravalvular leakage. It is possible that the prosthetic ring prevented TV annular dilation even though the left-sided valvular lesion recurred. Therefore, we surmised that performing TAP for non-significant functional TR would be more beneficial for patients undergoing mitral valve repair than in patients who underwent MVR. However, additional studies are required to clarify the role of TAP in mitral valve repair. Concerns remain regarding the immediate postoperative outcomes of TV ring annuloplasty, because the additional ring annuloplasty requires relatively longer cardiopulmonary bypass and ACC times. Some studies have reported the occurrence of ring-related complications, such as fractures [7] and dehiscence [6], as well as the development of conduction disorders [4, 5] after TV ring annuloplasty. However, the authors of those reports used a Carpentier-Edwards classic ring or Cosgrove-Edwards ring rather than a 3D annuloplasty ring. The ACC time was approximately 30 min longer in the TAP group than in the nTAP group in this study; however, the data pertaining to other immediate postoperative parameters, such as mortality rates, length of hospital stay and postoperative complications rates, were similar between the 2 groups in matched patients. We did not observe any ring-related complications during the postoperative period, perhaps because we placed an annuloplasty suture in the lateral portion of the septal annulus to prevent conduction disturbances and used a 3D prosthetic ring. Previous studies also reported that TV ring annuloplasty was not associated with an increased risk of adverse events during the immediate postoperative period [3, 17, 27]. Limitations This study had several limitations that must be noted. First, this study was a retrospective observational study conducted at a single institution. Second, we did not obtain specific data regarding TV annulus diameters or RV function-related parameters on preoperative echocardiography. Therefore, TV annular size and RV function-related parameters were not considered during propensity score matching. Third, the indications for TAP were not strictly adapted for all patients due to the retrospective nature of the study and surgeon’s preference. Fourth, rheumatic disease was the main cause of mitral valve dysfunction in most of the patients enrolled herein. Therefore, the results of this study may not be applicable to patients with other types of valvular heart disease. However, this study has provided us with useful information pertaining to patients with rheumatic valvular disease. CONCLUSIONS Patient with untreated trivial or mild functional TR accompanied by mitral valve disease can develop significant TR during follow-up. TV ring annuloplasty would be performed without complications and can be beneficial for patients with trivial or mild functional TR who are undergoing MVR, as uncorrected trivial or mild functional TR are associated with TR aggravation and TVRE. SUPPLEMENTARY MATERIAL Supplementary material is available at EJCTS online. Conflict of interest: none declared. REFERENCES 1 Raja SG, Dreyfus GD. Basis for intervention on functional tricuspid regurgitation. Semin Thorac Cardiovasc Surg  2010; 22: 79– 83. Google Scholar CrossRef Search ADS PubMed  2 Benedetto U, Melina G, Angeloni E, Refice S, Roscitano A, Comito C. Prophylactic tricuspid annuloplasty in patients with dilated tricuspid annulus undergoing mitral valve surgery. J Thorac Cardiovasc Surg  2012; 143: 632– 8. Google Scholar CrossRef Search ADS PubMed  3 Lee H, Sung K, Kim WS, Lee YT, Park SJ, Carriere KC et al.   Clinical and hemodynamic influences of prophylactic tricuspid annuloplasty in mechanical mitral valve replacement. J Thorac Cardiovasc Surg  2016; 151: 788– 95. Google Scholar CrossRef Search ADS PubMed  4 Jokinen JJ, Turpeinen AK, Pitkanen O, Hippelainen MJ, Hartikainen JE. Pacemaker therapy after tricuspid valve operations: implications on mortality, morbidity, and quality of life. Ann Thorac Surg  2009; 87: 1806– 14. Google Scholar CrossRef Search ADS PubMed  5 Jouan J, Mele A, Florens E, Chatellier G, Carpentier A, Achouh P et al.   Conduction disorders after tricuspid annuloplasty with mitral valve surgery: implications for earlier tricuspid intervention. J Thorac Cardiovasc Surg  2016; 151: 99– 103. Google Scholar CrossRef Search ADS PubMed  6 Pfannmuller B, Doenst T, Eberhardt K, Seeburger J, Borger MA, Mohr FW. Increased risk of dehiscence after tricuspid valve repair with rigid annuloplasty rings. J Thorac Cardiovasc Surg  2012; 143: 1050– 5. Google Scholar CrossRef Search ADS PubMed  7 Galinanes M, Duarte J, de Caleya DF, Garcia-Dorado D, Fdez-Aviles F, Elbal LM et al.   Fracture of the Carpentier-Edwards ring in tricuspid position: a report of three cases. Ann Thorac Surg  1986; 42: 94– 6. Google Scholar CrossRef Search ADS   8 Hwang HY, Choi JW, Kim HK, Kim KH, Kim KB, Ahn H. Paravalvular leak after mitral valve replacement: 20-year follow-up. Ann Thorac Surg  2015; 100: 1347– 52. Google Scholar CrossRef Search ADS PubMed  9 Jeong DS, Kim KH. Tricuspid annuloplasty using the MC3 ring for functional tricuspid regurgitation. Circ J  2010; 74: 278– 83. Google Scholar CrossRef Search ADS PubMed  10 Carpentier A, Adams DH, Filsoufi F. Tricuspid valve reconstruction. In: Carpentier A (ed). Carpentier’s Reconstructive Valve Surgery , 1st edn. Maryland Heights: Saunders-Elsevier, 2010, 196– 7. 11 Zoghbi WA, Enriquez-Sarano M, Foster E, Grayburn PA, Kraft CD, Levine RA et al.   Recommendations for evaluation of the severity of native valvular regurgitation with two-dimensional and Doppler echocardiography. J Am Soc Echocardiogr  2003; 16: 777– 802. Google Scholar CrossRef Search ADS PubMed  12 Akins CW, Miller DC, Turina MI, Kouchoukos NT, Blackstone EH, Grunkemeier GL et al.   Guidelines for reporting mortality and morbidity after cardiac valve interventions. J Thorac Cardiovasc Surg  2008; 135: 732– 8. Google Scholar CrossRef Search ADS PubMed  13 Lee EW, Wei LJ, Amato DA. Cox-type regression analysis for large numbers of small groups of correlated failure time observations. In: Klein JP, God PK (eds). Survival Analysis: State of the Art . Dordrecht: Springer, 1992, 237– 47. Google Scholar CrossRef Search ADS   14 Braunwald N, Ross JJr, Ross JJr, Mrrow AG. Conservative management of tricuspid regurgitation in patients undergoing mitral valve replacement. Circulation  1967; 35: I63– 9. Google Scholar CrossRef Search ADS PubMed  15 Duran CM, Pomar JL, Colman T, Figueroa A, Revuelta JM, Ubago JL. Is tricuspid valve repair necessary? J Thorac Cardiovasc Surg  1980; 80: 849– 60. Google Scholar PubMed  16 Kwak J-J, Kim Y-J, Kim M-K, Kim H-K, Park J-S, Kim K-H et al.   Development of tricuspid regurgitation late after left-sided valve surgery: a single-center experience with long-term echocardiographic examinations. Am Heart J  2008; 155: 732– 7. Google Scholar CrossRef Search ADS PubMed  17 Navia JL, Brozzi NA, Klein AL, Ling LF, Kittayarak C, Nowicki ER et al.   Moderate tricuspid regurgitation with left-sided degenerative heart valve disease: to repair or not to repair? Ann Thorac Surg  2012; 93: 59– 67. Google Scholar CrossRef Search ADS PubMed  18 Matsuyama K, Matsumoto M, Sugita T, Nishizawa J, Tokuda Y, Matsuo T. Predictors of residual tricuspid regurgitation after mitral valve surgery. Ann Thorac Surg  2003; 75: 1826– 8. Google Scholar CrossRef Search ADS PubMed  19 Calafiore AM, Gallina S, Iaco AL, Contini M, Bivona A, Gagliard M et al.   Mitral valve surgery for functional mitral regurgitation: should moderate-or-more tricuspid regurgitation be treated? a propensity score analysis. Ann Thorac Surg  2009; 87: 69– 703. 20 Kusajima K, Fujita T, Hata H, Shimahara Y, Miura S, Kobayashi J. Long-term echocardiographic follow-up of untreated 2+ functional tricuspid regurgitation in patients undergoing mitral valve surgery. Interact CardioVasc Thorac Surg  2016; 23: 96– 103. Google Scholar CrossRef Search ADS PubMed  21 Ren WJ, Zhang BG, Liu JS, Qian YJ, Guo YQ. Outcomes of tricuspid annuloplasty with and without prosthetic rings: a retrospective follow-up study. J Cardiothorac Surg  2015; 10: 81-8. Google Scholar CrossRef Search ADS   22 Kara I, Koksal C, Erkin A, Sacli H, Demirtas M, Percin B et al.   Outcomes of mild to moderate functional tricuspid regurgitation in patients undergoing mitral valve operations: a meta-analysis of 2488 patients. Ann Thorac Surg  2015; 100: 2398– 407. Google Scholar CrossRef Search ADS PubMed  23 Nishimura RA, Otto CM, Bonow RO, Carabello BA, Erwin JP3rd, Guyton RA et al.   2014 AHA/ACC guideline for the management of patients with valvular heart disease: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Col Cardiol  2014; 63: 2438– 88. Google Scholar CrossRef Search ADS   24 Shimokawa T, Kasegawa H, Katayama Y, Matsuyama S, Manabe S, Tabata M et al.   Mechanisms of recurrent regurgitation after valve repair for prolapsed mitral valve disease. Ann Thorac Surg  2011; 91: 1433– 99. 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Long-term results of annuloplasty in trivial-to-mild functional tricuspid regurgitation during mitral valve replacement: should we perform annuloplasty on the tricuspid valve or leave it alone?

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Oxford University Press
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1010-7940
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1873-734X
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10.1093/ejcts/ezx395
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Abstract

Abstract OBJECTIVES The benefits of concomitant tricuspid annuloplasty (TAP) for non-significant functional tricuspid regurgitation (TR) during mitral valve replacement (MVR) are controversial. We evaluated the long-term outcomes—particularly the long-term tricuspid valve (TV) functional outcomes—of MVR with or without tricuspid ring annuloplasty. METHODS From 2004 to 2014, 256 patients (56.4 ± 12.1 years) with trivial or mild functional TR who underwent MVR were enrolled. Eighty-two patients underwent concomitant tricuspid ring annuloplasty (TAP group), and 174 patients did not undergo the TV procedure (nTAP group). Propensity score-matched analysis was performed (n = 72 in each group). The follow-up duration was 77.4 ± 42.4 months. RESULTS The early clinical outcomes were similar between the 2 groups before and after propensity score matching with an early mortality rate of 3.5% (9 of 256). No patients experienced ring-related complications during follow-up. Eleven (6.3%) patients developed significant TR (≥moderate) in the nTAP group, while no patients developed significant TR in the TAP group. There were no significant differences in overall survival between the 2 groups before or after matching. However, propensity score-matched analysis revealed that the freedom from significant TR aggravation and freedom from TV-related event rates were significantly higher in the TAP group than in the nTAP group (P = 0.047 and P = 0.043, respectively). CONCLUSIONS Patients with untreated trivial or mild functional TR accompanied by mitral valve disease can develop significant TR during follow-up. TV ring annuloplasty can be performed without complications and can be beneficial for patients with trivial or mild functional TR who are undergoing MVR. Functional tricuspid regurgitation, Tricuspid annuloplasty, Ring annuloplasty INTRODUCTION Functional tricuspid regurgitation (TR) is a common finding in patients undergoing left-sided valve surgery with a reported incidence ranging from 25% to 30% [1]. Improvements in functional TR are expected after left-sided valve surgery; however, recent studies have reported that late TR can develop in patients undergoing isolated left-sided valve surgery. Therefore, the current guidelines recommend the performance of concomitant tricuspid valve (TV) surgery for patients with severe TR who are undergoing left-sided valve surgery (Class I) and patients with mild, moderate or greater TR with either tricuspid annular dilation or prior evidence of right heart failure (Class IIa). Although the current guidelines recommend concomitant TV surgery for patients with mild TR, only a few studies have reported the long-term results of concomitant TV surgery for patients with non-significant functional TR who are undergoing left-sided valve surgery. Some recent studies reported that prophylactic tricuspid annuloplasty (TAP) is beneficial for patients with less-than-moderate functional TR [2, 3]; however, concerns remain regarding the risks of combined valve surgery [4–7]. Therefore, the benefits of performing concomitant TV surgery during mitral valve replacement (MVR) are controversial. The aim of this study was to evaluate the long-term outcomes—particularly the long-term TV functional outcomes—of MVR with or without tricuspid ring annuloplasty for trivial or mild functional TR. MATERIALS AND METHODS Patient characteristics The appropriate institutional review board reviewed the protocol for this study, which was approved as a minimal risk retrospective study (approval number: H-1608-036-783) that did not require the informed consent of the individual patients who participated herein. From January 2004 to December 2014, 356 patients with a trivial or mild functional TR underwent MVR at our institution. Fifty-three patients with infective endocarditis, 35 patients undergoing other TV procedures (De Vega annuloplasty = 32, Kay-type annuloplasty = 2 and TV replacement = 1) and 12 patients with other disease (ischaemic mitral regurgitation = 5, cardiac tumour = 3, congenital anomaly = 3 and Takayasu arteritis = 1) were excluded from the study, and 256 patients were ultimately enrolled herein (Fig. 1). Eighty-two patients underwent concomitant tricuspid ring annuloplasty (TAP group) with the Edwards MC3 tricuspid annuloplasty ring (n = 81) or the Carpentier-Edwards classic ring (n = 1), and 174 patients did not undergo a tricuspid valve procedure (nTAP group). Trivial TR was observed in 154 (60%) patients and mild TR was observed in 102 (40%) patients. Rheumatic disease was the main cause of mitral valve dysfunction in the patients enrolled in this study (82.8%). A propensity score model was constructed, and 72 patients in each group were extracted in a 1:1 ratio using the nearest neighbour matching method. Statistically significant differences in the aetiologies and pathologies of the mitral valve disease, primarily diseased valve, hypertension and atrial fibrillation existed between the 2 groups prior to matching (Table 1). However, no differences in preoperative characteristics were noted between the 2 groups after matching (Table 1). Table 1: Preoperative characteristics and risk factors of the study patients Variables  All study patients   Propensity-matched patients   nTAP (n = 174)  TAP (n = 82)  P-value  nTAP (n = 72)  TAP (n = 72)  P-value  Age (years)  56.8 ± 12.4  55.3 ± 11.2  0.337  55.6 ± 10.6  54.5 ± 11.4  0.574  Female  97 (55.7)  53 (64.6)  0.178a  43 (59.7)  46 (63.9)  0.701  NYHA functional class ≥3  61 (35.1)  32 (39.0)  0.538a  32 (44.4)  27 (37.5)  0.424  Combined AV disease  112 (64.4)  44 (53.7)  0.101a  45 (62.5)  41 (56.9)  0.597  Aetiology (rheumatic)  136 (78.2)  76 (92.7)  0.004a  66 (91.7)  66 (91.7)  >0.999  Pathology (stenosis)  100 (57.5)  64 (78.0)  0.001a  15 (20.8)  16 (22.2)  >0.999  Primarily diseased valve (MV)  120 (69.0)  69 (84.1)  0.010a  60 (83.3)  59 (81.9)  >0.999  PASP (mmHg)  43.6 ± 15.9  44.3 ± 12.0  0.698  42.9 ± 11.7  42.1 ± 10.3  0.686  Risk factors      Smoking  31 (18.0)  12 (14.6)  0.501a  11 (15.3)  12 (16.7)  >0.999  BMI >25 kg/m2  34 (19.5)  16 (19.5)  0.996a  12 (16.7)  14 (19.4)  0.815  Diabetes mellitus  26 (14.9)  6 (7.3)  0.085a  6 (8.3)  5 (6.9)  >0.999  Hypertension  42 (24.1)  6 (7.3)  0.001a  5 (6.9)  5 (6.9)  >0.999  History of stroke  27 (15.5)  12 (14.6)  0.854a  11 (15.3)  12 (16.7)  >0.999  Coronary artery disease  13 (7.5)  3 (3.7)  0.240a  3 (4.2)  3 (4.2)  >0.999  CRF (GFR<60 ml/min)  47 (27.0)  17 (20.7)  0.279a  15 (20.8)  15 (20.8)  >0.999  Atrial fibrillation  100 (57.5)  67 (81.7)  <0.001a  61 (84.7)  57 (79.2)  0.481  LV dysfunction (EF < 45%)  17 (9.8)  12 (14.6)  0.252a  4 (5.6)  8 (11.1)  0.344  Variables  All study patients   Propensity-matched patients   nTAP (n = 174)  TAP (n = 82)  P-value  nTAP (n = 72)  TAP (n = 72)  P-value  Age (years)  56.8 ± 12.4  55.3 ± 11.2  0.337  55.6 ± 10.6  54.5 ± 11.4  0.574  Female  97 (55.7)  53 (64.6)  0.178a  43 (59.7)  46 (63.9)  0.701  NYHA functional class ≥3  61 (35.1)  32 (39.0)  0.538a  32 (44.4)  27 (37.5)  0.424  Combined AV disease  112 (64.4)  44 (53.7)  0.101a  45 (62.5)  41 (56.9)  0.597  Aetiology (rheumatic)  136 (78.2)  76 (92.7)  0.004a  66 (91.7)  66 (91.7)  >0.999  Pathology (stenosis)  100 (57.5)  64 (78.0)  0.001a  15 (20.8)  16 (22.2)  >0.999  Primarily diseased valve (MV)  120 (69.0)  69 (84.1)  0.010a  60 (83.3)  59 (81.9)  >0.999  PASP (mmHg)  43.6 ± 15.9  44.3 ± 12.0  0.698  42.9 ± 11.7  42.1 ± 10.3  0.686  Risk factors      Smoking  31 (18.0)  12 (14.6)  0.501a  11 (15.3)  12 (16.7)  >0.999  BMI >25 kg/m2  34 (19.5)  16 (19.5)  0.996a  12 (16.7)  14 (19.4)  0.815  Diabetes mellitus  26 (14.9)  6 (7.3)  0.085a  6 (8.3)  5 (6.9)  >0.999  Hypertension  42 (24.1)  6 (7.3)  0.001a  5 (6.9)  5 (6.9)  >0.999  History of stroke  27 (15.5)  12 (14.6)  0.854a  11 (15.3)  12 (16.7)  >0.999  Coronary artery disease  13 (7.5)  3 (3.7)  0.240a  3 (4.2)  3 (4.2)  >0.999  CRF (GFR<60 ml/min)  47 (27.0)  17 (20.7)  0.279a  15 (20.8)  15 (20.8)  >0.999  Atrial fibrillation  100 (57.5)  67 (81.7)  <0.001a  61 (84.7)  57 (79.2)  0.481  LV dysfunction (EF < 45%)  17 (9.8)  12 (14.6)  0.252a  4 (5.6)  8 (11.1)  0.344  Values are mean ± standard deviation or n (%). a P-value was calculated by the χ2 test. AV: aortic valve; BMI: body mass index; CRF: chronic renal failure; EF: ejection fraction; GFR: glomerular filtration rate; LV: left ventricle; MV: mitral valve; NYHA: New York heart association; PASP: pulmonary artery systolic pressure; TAP: tricuspid annuloplasty. Figure 1: View largeDownload slide A flow diagram of patient enrolment. MR: mitral regurgitation; MVR: mitral valve replacement; PS: propensity score; TAP: tricuspid annuloplasty; TR: tricuspid regurgitation; TV: tricuspid valve; TVR: tricuspid valve replacement. Figure 1: View largeDownload slide A flow diagram of patient enrolment. MR: mitral regurgitation; MVR: mitral valve replacement; PS: propensity score; TAP: tricuspid annuloplasty; TR: tricuspid regurgitation; TV: tricuspid valve; TVR: tricuspid valve replacement. Surgical procedures and operative data The surgical techniques for MVR and TAP were described previously [8, 9]. All surgeries were performed via median sternotomy. The mitral valve was replaced via left atriotomy (n = 230) or a trans-septal approach (n = 26), and the TV was examined via right atriotomy in 214 (83.6%) patients. TAP was considered when patients exhibited (i) a preoperative pulmonary artery systolic pressure >50 mmHg or (ii) annular dilatation, the latter of which was evaluated by measuring the intercommissural distance of the septal leaflet with the aid of tricuspid ring annuloplasty sizer (Fig. 2). Annular dilatation was diagnosed when the annulus was larger than the ring sizer used to measure the intercommissural distance. The final decision regarding whether a particular patient with annular dilatation underwent surgery was made by the patient’s surgeon. According to the surgeon’s preference, not all of the patients with annular dilatation, as determined using a tricuspid ring annuloplasty sizer, underwent TAP. The 28-mm and 30-mm rings were used in more than 80% of the 82 patients. The size of the ring was chosen based on the intercommissural distance of the septal leaflet and the area of the leaflet attached to the chordae originating from the anterior papillary muscle [10]. Figure 2: View largeDownload slide Measurement of the tricuspid annular size with the aid of tricuspid ring annuloplasty sizer in normal annulus (A) and dilated annulus (B). Figure 2: View largeDownload slide Measurement of the tricuspid annular size with the aid of tricuspid ring annuloplasty sizer in normal annulus (A) and dilated annulus (B). A total of 208 (81.2%) patients underwent concomitant procedures, including aortic valve surgery (n = 114), arrhythmia surgery (n = 143), aorta surgery (n = 18) and coronary artery bypass surgery (n = 14). The cardiopulmonary bypass and aortic cross-clamp (ACC) times were 214.9 ± 70.6 and 148.3 ± 51.0 min, respectively. Patients in the TAP group underwent concomitant arrhythmia surgery and received mechanical prostheses more frequently than patients in the nTAP group prior to matching. Mechanical valves were used more frequently in the TAP group than in the non-TAP group, because the patients in the former group were younger than the patients in the latter group. Patients with long-standing persistent atrial fibrillation or chronic renal failure requiring dialysis were also considered for mechanical valve surgery. There were no statistically significant differences in operative parameters between the 2 groups in the matched patients; however, relatively longer cardiopulmonary bypass and ACC times were noted in the TAP group than in the nTAP group (Table 2). Table 2: Operative characteristics Variables  All study patients   Propensity-matched patients   nTAP (n = 174)  TAP (n = 82)  P-value  nTAP (n = 72)  TAP (n = 72)  P-value  Concomitant surgery  137 (79.2)  71 (86.6)  0.155a  59 (83.1)  61 (85.9)  0.804   Aortic valve surgery  82 (47.1)  32 (39.0)  0.224a  26 (36.1)  29 (40.3)  0.711   Aorta surgery  15 (8.6)  3 (3.7)  0.154a  2 (2.8)  3 (4.2)  >0.999   Arrhythmia surgery  78 (44.8)  65 (79.3)  <0.001a  52 (72.2)  56 (77.8)  0.541   CABG  11 (6.3)  3 (3.7)  0.558a  2 (2.8)  3 (4.2)  >0.999  Prosthesis type (mechanical)  119 (68.8)  69 (85.2)  0.005a  58 (81.6)  62 (86.1)  0.523  CPB time (min)  205 ± 75  237 ± 55  <0.001  197 ± 61  238 ± 57  <0.001  ACC time (min)  142 ± 54  162 ± 42  0.004  136 ± 45  163 ± 43  <0.001  Variables  All study patients   Propensity-matched patients   nTAP (n = 174)  TAP (n = 82)  P-value  nTAP (n = 72)  TAP (n = 72)  P-value  Concomitant surgery  137 (79.2)  71 (86.6)  0.155a  59 (83.1)  61 (85.9)  0.804   Aortic valve surgery  82 (47.1)  32 (39.0)  0.224a  26 (36.1)  29 (40.3)  0.711   Aorta surgery  15 (8.6)  3 (3.7)  0.154a  2 (2.8)  3 (4.2)  >0.999   Arrhythmia surgery  78 (44.8)  65 (79.3)  <0.001a  52 (72.2)  56 (77.8)  0.541   CABG  11 (6.3)  3 (3.7)  0.558a  2 (2.8)  3 (4.2)  >0.999  Prosthesis type (mechanical)  119 (68.8)  69 (85.2)  0.005a  58 (81.6)  62 (86.1)  0.523  CPB time (min)  205 ± 75  237 ± 55  <0.001  197 ± 61  238 ± 57  <0.001  ACC time (min)  142 ± 54  162 ± 42  0.004  136 ± 45  163 ± 43  <0.001  Values are mean ± standard deviation or n (%). a P-value was calculated by the χ2 test. ACC: aortic cross-clamp; CABG: coronary artery bypass grafting; CPB: cardiopulmonary bypass; TAP: tricuspid annuloplasty. Evaluation of clinical outcomes Operative mortality was defined as any death within 30 days after surgery or during the same hospital admission. All survivors underwent echocardiography at 7 days (range 2–144 days) after surgery and regular postoperative follow-up visits in the outpatient clinic at 3- to 4-month intervals. The clinical follow-up period ended on 31 May 2016. Patients who did not visit the clinic at the scheduled time were contacted via telephone to confirm their conditions. Follow-up was completed in 248 (96.9%) patients within 77.4 ± 42.4 months (range 0.1–150.9 months). Routine echocardiographic evaluations were performed at the discretion of the patients’ surgeons, and 224 (90.7%) of the 247 early survivors underwent at least 1 echocardiographic examination after discharge. The TR grade was graded as none, trivial, mild, moderate or severe [11]. Significant TR was defined as equal or more-than-moderate degree. We did not consider TR significance in cases where it improved naturally, i.e. without the aid of additional procedure, as determined by echocardiography. The last follow-up echocardiographic evaluation was performed at 52.0 ± 39.4 months after surgery. According to the established guidelines, the following events were considered TV-related events (TVREs) [12]: (i) cardiac death, (ii) TV-related surgery, (iii) significant TR, (iv) composite of thromboembolism and bleeding and (v) permanent pacemaker insertion due to complete atrioventricular block. Statistical analysis The statistical analyses were performed using IBM SPSS statistical software version 21.0 (IBM Inc., Armonk, NY, USA) and SAS V.9.2 (SAS Institute, Cary, NC, USA). The data were expressed as the means ± standard deviation, medians with ranges or proportions. Propensity score-matched analysis was performed to adjust for differences in preoperative characteristics, and a logistic regression model was constructed using non-parsimonious methods to generate the propensity scores. Sixteen preoperative characteristics were included in the propensity score model (P-value of the Hosmer–Lemeshow test = 0.402 and C-statistic = 0.756, see Supplementary Material, Table S1). After calculating of the propensity score, 72 pairs were extracted in a 1:1 manner using the nearest neighbour matching method without replacement. Comparisons between the 2 groups were performed using the χ2 test or the Fisher’s exact test for categorical variables and the Student’s t-test for continuous variables. The Fisher’s exact tests were used when the expected frequency was lower than 5 in more than 20% of cells. In matched groups, the McNemar’s test was used for categorical variables, and a paired t-test was used for continuous variables. Survival was estimated using the Kaplan–Meier method, and the survival rates in the 2 groups were compared using a log-rank test in all patients and a robust sandwich covariance matrix estimate in marginal Cox model approach to account for the intracluster correlation in matched patients [13]. The average time for developing significant TR was calculated using the arithmetic mean among patients who had it. A P-value <0.05 was considered statistically significant. RESULTS Early clinical outcomes Operative mortality rate was 3.5% (9 of 256 patients). The causes of death were low cardiac output syndrome (n = 4), acute respiratory distress syndrome (n = 3), left ventricular rupture (n = 1) and hypoxic brain damage (n = 1). The following postoperative morbidities were noted among the patients enrolled in the study: new-onset atrial fibrillation (n = 23), low cardiac output syndrome (n = 12), respiratory complications (n = 11), bleeding requiring reoperation (n = 11) and acute kidney injury (n = 8). No ring-related complications, such as atrioventricular block, permanent pacemaker insertion, ring dehiscence, infective endocarditis or thromboembolism were noted during the immediate postoperative period. Early aggravation of moderate or more severe TR occurred in 9 patients in the nTAP group. No statistically significant differences in operative mortality or postoperative morbidity were noted between the 2 matched groups (Table 3). Table 3: Early clinical results Variables  All study patients   Propensity-matched patients   nTAP (n = 174)  TAP (n = 82)  P-value  nTAP (n = 72)  TAP (n = 72)  P-value  Operative mortality  7 (4.0)  2 (2.4)  0.723a  3 (4.2)  1 (1.4)  0.625  Hospital stay (days)  21.7 ± 65.4  18.5 ± 34.7  0.681  17.9 ± 33.7  17.9 ± 35.4  0.994  Postoperative PASP (mmHg)  35.6 ± 8.3  35.3 ± 6.4  0.772  34.3 ± 7.0  35.3 ± 6.5  0.425  Postoperative complication               Low cardiac output syndrome  11 (6.3)  1 (1.2)  0.110a  3 (4.2)  1 (1.4)  0.625   Atrial fibrillation (new onset)  21 (12.1)  2 (2.4)  0.012a  5 (6.9)  2 (2.8)  0.375   Acute kidney injury  7 (4.0)  1 (1.2)  0.442a  2 (2.8)  1 (1.4)  >0.999   Bleeding reoperation  10 (5.7)  1 (1.2)  0.182a  5 (6.9)  1 (1.4)  0.219   Stroke  1 (0.6)  2 (2.4)  0.241a  1 (1.4)  1 (1.4)  >0.999   Respiratory complication  9 (5.2)  2 (2.4)  0.511a  2 (2.8)  1 (1.4)  >0.999   Early aggravation of TR  9 (5.1)  0 (0)  0.061a  4 (5.5)  0 (0)  0.125   Others  1 (0.6)  1 (1.2)  0.320a  1 (1.4)  1 (1.4)  >0.999  Variables  All study patients   Propensity-matched patients   nTAP (n = 174)  TAP (n = 82)  P-value  nTAP (n = 72)  TAP (n = 72)  P-value  Operative mortality  7 (4.0)  2 (2.4)  0.723a  3 (4.2)  1 (1.4)  0.625  Hospital stay (days)  21.7 ± 65.4  18.5 ± 34.7  0.681  17.9 ± 33.7  17.9 ± 35.4  0.994  Postoperative PASP (mmHg)  35.6 ± 8.3  35.3 ± 6.4  0.772  34.3 ± 7.0  35.3 ± 6.5  0.425  Postoperative complication               Low cardiac output syndrome  11 (6.3)  1 (1.2)  0.110a  3 (4.2)  1 (1.4)  0.625   Atrial fibrillation (new onset)  21 (12.1)  2 (2.4)  0.012a  5 (6.9)  2 (2.8)  0.375   Acute kidney injury  7 (4.0)  1 (1.2)  0.442a  2 (2.8)  1 (1.4)  >0.999   Bleeding reoperation  10 (5.7)  1 (1.2)  0.182a  5 (6.9)  1 (1.4)  0.219   Stroke  1 (0.6)  2 (2.4)  0.241a  1 (1.4)  1 (1.4)  >0.999   Respiratory complication  9 (5.2)  2 (2.4)  0.511a  2 (2.8)  1 (1.4)  >0.999   Early aggravation of TR  9 (5.1)  0 (0)  0.061a  4 (5.5)  0 (0)  0.125   Others  1 (0.6)  1 (1.2)  0.320a  1 (1.4)  1 (1.4)  >0.999  Values are mean ± standard deviation or n (%). a P-value was calculated by the Fisher’s exact test. PASP: pulmonary artery systolic pressure; TAP: tricuspid annuloplasty; TR: tricuspid regurgitation. Long-term clinical outcomes Among the 247 survivors, 18 patients suffered late deaths, and 7 of those patients due to cardiac deaths. The overall survival at 5 and 10 years were 90.8% and 86.7%, respectively. There was no significant difference in the overall survival between the 2 groups (P = 0.139, Fig. 3A). Moreover, the overall survival of the 2 groups were very similar after matching (P = 0.550, Fig. 3A). Freedoms from cardiac death rates were 94.3% and 93.6% at 5 and 10 years post-surgery, respectively, and no cardiac deaths were observed in the TAP group during the follow-up period. However, there were no significant differences in freedom from cardiac death between the 2 groups before or after matching (P = 0.115, P = 0.313). Prosthetic mitral valve failure occurred in 8 patients during follow-up, including 3 patients who presented with structural valve deterioration and 5 patients who presented with non-structural valve dysfunction (paravalvular leakage = 3 and pannus formation = 2). The incidences of prosthetic mitral valve failure in the TAP and nTAP groups were 1.3% (1 of 81) and 4.2% (7 of 167), respectively. Of the indicated patients, 2 developed significant TR and subsequently underwent DeVega TAP or TV replacement, respectively. Only 1 patient in the TAP group experienced prosthetic valve failure. The patient in question did not develop TR for 4 years, despite exhibiting moderate mitral paravalvular leakage on echocardiography. Figure 3: View largeDownload slide Comparison of overall survival (A), freedom from significant tricuspid regurgitation (≥ moderate) (B) and freedom from TVREs (C) in the tricuspid annuloplasty (TAP) and untreated tricuspid valve (nTAP) groups before and after propensity score matching. TAP: tricuspid annuloplasty; TR: tricuspid regurgitation; TV: tricuspid valve; TVRE: tricuspid valve-related events. Figure 3: View largeDownload slide Comparison of overall survival (A), freedom from significant tricuspid regurgitation (≥ moderate) (B) and freedom from TVREs (C) in the tricuspid annuloplasty (TAP) and untreated tricuspid valve (nTAP) groups before and after propensity score matching. TAP: tricuspid annuloplasty; TR: tricuspid regurgitation; TV: tricuspid valve; TVRE: tricuspid valve-related events. Development of significant tricuspid regurgitation No patients in the TAP group developed moderate or more severe TR after surgery. However, 18 of 174 (10.3%) patients in the nTAP group developed moderate or more severe TR. Nine of these 18 patients developed moderate or more severe TR before discharge (range 5–24 days) and 9 patients developed moderate or more severe TR on an average of 29.7 months (range 2.4–115.4 months) after discharge. Among the 9 patients who developed moderate or more severe TR during the early postoperative period, 7 improved spontaneously, i.e. without undergoing additional procedures. Finally, 11 of 174 patients (6.3%, moderate: 6, moderate to severe: 2, severe: 3) in the nTAP group developed significant TR (Fig. 4). Figure 4: View largeDownload slide Incidence of significant TR in the untreated TV (nTAP) group. TR: tricuspid regurgitation; TV: tricuspid valve. Figure 4: View largeDownload slide Incidence of significant TR in the untreated TV (nTAP) group. TR: tricuspid regurgitation; TV: tricuspid valve. Among them, 5 patients had a preoperative trivial TR. No patients who developed significant TR displayed signs of rheumatic disease progression on echocardiography. Two patients died within 6 months after surgery, 1 patient underwent TV replacement after 93 months, 1 patient underwent TAP after 26 months and 7 patients were under medical follow-up without undergoing TV procedures. The freedom from significant TR rates at 5 and 10 years were 94.7% and 89.7%, respectively, and were significantly higher in the TAP group than in the nTAP group before and after propensity score matching (P = 0.013, P = 0.047, respectively, Fig. 3B). Tricuspid valve-related events TVREs occurred in 46 patients, including a composite of thromboembolism and bleeding (n = 23), cardiac death (n = 16), significant TR (n = 11) and TV-related surgery (n = 3). No patients experienced the implantation of permanent pacemaker because of the complete atrioventricular block during follow-up. Freedom from TVRE rates at 5 and 10 years were 87.5% and 76.7%, respectively, and these rates were significantly higher in the TAP group than in the nTAP group before (P = 0.008, Fig. 3C) and after matching (P = 0.043, Fig. 3C). DISCUSSION The main findings of this study were as follows: (i) although the mitral lesions were treated appropriately, patients with untreated trivial or mild functional TR accompanied by mitral valve disease can develop significant TR during follow-up; (ii) TV ring annuloplasty for trivial or mild functional TR would be performed without complications during primary MVR and (iii) TV ring annuloplasty can be beneficial for patients with trivial or mild functional TR, as the patients who underwent TV ring annuloplasty are associated with higher freedom from TR aggravation and freedom from TVRE rates compared to the patients with uncorrected trivial or mild functional TR. Functional TR was previously thought to diminish or disappear after left-sided valve surgery [14, 15]. However, this concept was changed by several studies describing TR recurrence in patients who have undergone left-sided valve surgery [16]. These studies demonstrated that untreated preoperative moderate or more severe functional TR was associated with TR recurrence [17, 18] and lower survival [19]. Therefore, it was determined that the performance of concomitant TV surgery was reasonable for patients with moderate-to-severe TR. However, data are lacking regarding the performance of concomitant TV surgery for patients with less-than-moderate functional TR. In our previous study, the findings of which inspired this study, we determined the incidence of significant late TR after left-sided valve surgery in patients with insignificant TR [16]. The study showed that significant TR long after the left-sided valve surgery was common—the estimated incidence of the disease was 27%—and was associated with a poor prognosis. After that, aggressive surgery is performed more frequently in patients with insignificant TR to prevent late TR exacerbations. Kusajima et al. [20] also reported that more than half of the untreated mild functional TR progressed to moderate or more severe TR in a long-term follow-up study. Some recent studies demonstrated that prophylactic TAP is beneficial for patients with less-than-moderate TR [2, 3, 21]. Lee et al. [3] reported that the rate of freedom from moderate-to-severe TR recurrence was higher in a concomitant TAP group than in an nTAP group via propensity score matching analysis, and Benedetto et al. [2] demonstrated that prophylactic TAP was associated with a reduced rate of TR progression and improved right ventricular remodelling and functional outcomes in a randomized controlled study. Moreover, Kara et al. [22] demonstrated that performing TV annuloplasty in patients with moderate or less-than-moderate TR reduced the probability that such patients will progress to moderate-to-severe TR in meta-analysis. This study also demonstrated that performing TAP for trivial or mild TR prevented TR exacerbations and reduced TVRE rates. The current guidelines suggest that several criteria can be used to evaluate TV annular dilatation, which is usually diagnosed in patients with a TV annulus >40 mm or 21 mm/m2 on preoperative transthoracic echocardiography or patients with an anteroseptal (between anterosuperior and septal leaflets) commissure–anteroposterior (between anterosuperior and inferior leaflets) commissure distance >70 mm on intraoperative finding [23]. However, measurements of the distance from the anteroseptal commissure to the anteroposterior commissure in arrested hearts are not reliable or reproducible, and the cut-off value of >70 mm may be too high in patients with trivial or mild functional TR. Therefore, this study evaluated the TV annulus by measuring the length of the septal leaflet (i.e. the intercommissural distance), which indicates the smallest changes in functional TR [10] and diagnosed annular dilatation in cases in which the annulus was larger than the area of the equivalent ring sizer. Additional studies are required to determine whether our method of diagnosing annular dilatation is reasonable to evaluate the TV annular dilataion. In addition, although the current guidelines do not recommend the performance of TAP for patients with trivial TV regurgitation, 5 patients with preoperative trivial TR developed significant TR in this study. These results showed that criteria on the treatment of trivial TR are also required. Currently, mitral valve repair is recommended for patients with primary MR in whom a successful and durable repair can be performed. However, some clinicians have raised concerns regarding recurrent MR after mitral valve repair, as this particular phenomenon is not uncommon [24] and may lead to the development of recurrent functional TR. Ito et al. [25] demonstrated that recurrent MR was a risk factor for late TR progression in patients who have undergone mitral valve repair, and Gatti et al. [26] reported that freedom from recurrent TR rates were marginally significantly higher in patients who underwent MVR than in patients who underwent mitral valve repair. In this study, 8 patients suffered prosthetic mitral valve failure. Only 1 patient in the TAP group experienced mitral paravalvular leakage; however, the patient did not develop significant functional TR for 4 years after developing moderate paravalvular leakage. It is possible that the prosthetic ring prevented TV annular dilation even though the left-sided valvular lesion recurred. Therefore, we surmised that performing TAP for non-significant functional TR would be more beneficial for patients undergoing mitral valve repair than in patients who underwent MVR. However, additional studies are required to clarify the role of TAP in mitral valve repair. Concerns remain regarding the immediate postoperative outcomes of TV ring annuloplasty, because the additional ring annuloplasty requires relatively longer cardiopulmonary bypass and ACC times. Some studies have reported the occurrence of ring-related complications, such as fractures [7] and dehiscence [6], as well as the development of conduction disorders [4, 5] after TV ring annuloplasty. However, the authors of those reports used a Carpentier-Edwards classic ring or Cosgrove-Edwards ring rather than a 3D annuloplasty ring. The ACC time was approximately 30 min longer in the TAP group than in the nTAP group in this study; however, the data pertaining to other immediate postoperative parameters, such as mortality rates, length of hospital stay and postoperative complications rates, were similar between the 2 groups in matched patients. We did not observe any ring-related complications during the postoperative period, perhaps because we placed an annuloplasty suture in the lateral portion of the septal annulus to prevent conduction disturbances and used a 3D prosthetic ring. Previous studies also reported that TV ring annuloplasty was not associated with an increased risk of adverse events during the immediate postoperative period [3, 17, 27]. Limitations This study had several limitations that must be noted. First, this study was a retrospective observational study conducted at a single institution. Second, we did not obtain specific data regarding TV annulus diameters or RV function-related parameters on preoperative echocardiography. Therefore, TV annular size and RV function-related parameters were not considered during propensity score matching. Third, the indications for TAP were not strictly adapted for all patients due to the retrospective nature of the study and surgeon’s preference. Fourth, rheumatic disease was the main cause of mitral valve dysfunction in most of the patients enrolled herein. Therefore, the results of this study may not be applicable to patients with other types of valvular heart disease. However, this study has provided us with useful information pertaining to patients with rheumatic valvular disease. CONCLUSIONS Patient with untreated trivial or mild functional TR accompanied by mitral valve disease can develop significant TR during follow-up. TV ring annuloplasty would be performed without complications and can be beneficial for patients with trivial or mild functional TR who are undergoing MVR, as uncorrected trivial or mild functional TR are associated with TR aggravation and TVRE. SUPPLEMENTARY MATERIAL Supplementary material is available at EJCTS online. Conflict of interest: none declared. REFERENCES 1 Raja SG, Dreyfus GD. Basis for intervention on functional tricuspid regurgitation. Semin Thorac Cardiovasc Surg  2010; 22: 79– 83. Google Scholar CrossRef Search ADS PubMed  2 Benedetto U, Melina G, Angeloni E, Refice S, Roscitano A, Comito C. Prophylactic tricuspid annuloplasty in patients with dilated tricuspid annulus undergoing mitral valve surgery. J Thorac Cardiovasc Surg  2012; 143: 632– 8. Google Scholar CrossRef Search ADS PubMed  3 Lee H, Sung K, Kim WS, Lee YT, Park SJ, Carriere KC et al.   Clinical and hemodynamic influences of prophylactic tricuspid annuloplasty in mechanical mitral valve replacement. 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European Journal of Cardio-Thoracic SurgeryOxford University Press

Published: Apr 1, 2018

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