ADULT CARDIAC
Repair of Functional Tricuspid Regurgitation: Comparison Between Suture Annuloplasty and Rings Annuloplasty Xinsheng Huang, PhD, Chengxiong Gu, MD, Xu Men, MD, Jianqun Zhang, MD, Bin You, MD, Hongjia Zhang, PhD, Hua Wei, MD, and Jingxing Li, PhD Cardiac Surgery Department, Beijing Anzhen Hospital, Capital Medical University, Beijing, China
Background. The purpose of this study was to review our experience with modified De Vega tricuspid annuloplasty versus ring annuloplasty for treating functional tricuspid regurgitation (TR). Methods. In all, 448 consecutive patients undergoing tricuspid annuloplasty with concomitant procedures between 2000 and 2012 were included. Modified De Vega annuloplasty was performed in 216 patients (group 1) and ring annuloplasty in 232 patients (group 2). Clinical and echocardiographic follow-up results were used to assess TR grade. Recurrent TR was defined as grade 2 or greater at echocardiography. Results. Preoperative clinical and echocardiographic characteristics were comparable in the two groups. Early mortality was similar (group 1, 0.9%, versus group 2, 1.3%; p < 0.67). Follow-up was available for 97%; New York Heart Association class and symptoms of right-side heart failure were significantly improved. Survival rates at 1 and
5 years were comparable (97% and 84% for group 1, and 96% and 82% for group 2, respectively). Postoperative echocardiography showed significant improvement in tricuspid valve function, with reduction in TR grade from 3.4 to 0.6, and no differences between groups. However, recurrence-free survival was better for group 2 than for group 1 (78.8% versus 74.5%; p < 0.62). Risk factors for recurrent TR included severity of preoperative TR, atrial fibrillation, and pulmonary hypertension. Conclusions. The modified De Vega tricuspid annuloplasty is acceptable for repair of functional TR and improvements in clinical and echocardiographic status on a long-term basis, although the long-term recurrence-free survival appeared to be lower than that for ring annuloplasty.
lthough both rigid and flexible system provide acceptable results for tricuspid valve (TV) repair, the use of a rigid ring significantly increases the risk of early annular dehiscence [1, 2]. A possible explanation is that increased shearing forces are being experienced at the septal portion of the annulus, and that these shearing forces would be even higher when a rigid ring is used [1, 2]. This line of argument finds support in the studies addressing the dynamics of the native tricuspid annulus [3, 4]. There are significant changes in the tricuspid annular dimensions from systole to diastole, with a 19% change of annular circumference and a 30% change in the annular area [4]. In addition, Ton-Nu and coworkers [5] demonstrated that tricuspid dilation occurs mainly in the free wall of the tricuspid annulus at the middle part of the anterior leaflet and extending to the septal part of the septal leaflet. On the basis of this concept, beginning in 2000, we developed a new method of TV repair with a modified De Vega’s suture annuloplasty. This method, however, has since been considered to remodel annular structures by
maintaining a trileaflet valve that is more physiologic, to maintain flexibility of right ventricular (RV) pumping action, and to prevent redilation. In this study, we review and compare the long-term clinic and echocardiographic results of the modified De Vega and ring annuloplasty for repair of functional tricuspid regurgitation (TR) to determine the efficacy and durability of tricuspid annuloplasty. In addition, we also analyzed the risk factors for recurrence of TR.
A
Accepted for publication Oct 11, 2013. Address correspondence to Dr Gu, Beijing Anzhen Hospital, Anding Rd 2, Beijing 100029, China; e-mail: [email protected].
Ó 2014 by The Society of Thoracic Surgeons Published by Elsevier Inc
(Ann Thorac Surg 2014;97:1286–93) Ó 2014 by The Society of Thoracic Surgeons
Material and Methods Patient Characteristics Between January 2000 and April 2012, 448 consecutive patients with functional TR underwent tricuspid annuloplasty with mitral valve replacement and mitral-aortic valve replacement at our institution. Patients with concomitant procedures such as mitral valve repair or with endocarditis or significant organic disease of the tricuspid valve leaflets or patients with congenital anomalies were excluded. The TR was always secondary to right ventricular dilation or dysfunction caused by mitral valve rheumatic disease in 358 patients (79.9%), mitral and aortic valves rheumatic disease in 87 (19.4%), and mitral prosthesis dysfunction in 3 (0.7%). Indications 0003-4975/$36.00 http://dx.doi.org/10.1016/j.athoracsur.2013.10.037
for TV surgery were symptomatic severe TR in 409 (91.3%) patients or else asymptomatic moderate TR or marked tricuspid annular dilation (>4.0 cm) in the presence of other indications for cardiac surgery in 39 (8.7%). Of these, the main TV disease was annulus dilation in all patients, combined with restriction of the leaflets in 12 (2.7%) patients, and rolled up and thickened leaflets in 3 (0.7%) patients. All patients were prospectively entered into our patient data management system and then retrospectively analyzed. Our Institutional Review Board approved this study and waived the need for individual consent.
Surgical Procedure All annuloplasties were performed during concomitant mitral or aortic valve surgery with cardioplegic arrest. Three surgeons performed operations during the study periods (G.C.X., M.X., Z.J.Q.). The choice of tricuspid annuloplasty methods was selected by the surgeons’ preference: in group 1, modified De Vega’s suture annuloplasty was performed in 216 patients; in group 2, a flexible ring (Cosgrove-Edwards annuloplasty system; Edwards Lifesciences, Irvine, CA) was implanted in 147 patients and a rigid ring (Edwards Lifesciences) in 85 patients. Ring annuloplasty was performed by standard operative techniques [6]. Modified De Vega’s suture annuloplasty was performed by placing a doubled pledget-supported suture of 3-0 polypropylene from the level of the septal annulus in front of the coronary sinus to the midportion of the annulus of the anterior leaflet (Fig 1). The pledget was placed on the RV surface of the septal annulus; the other pledget was placed at the atrial surface of the anterior annulus. This double multifilament suture is then tied down snugly over a Hegar dilator calibrated to 2 mm to 3 mm larger than the predicted appropriate pulmonary annulus size derived from published nomograms [7], satisfactorily reducing the orifice size without placing undue strain on the annuloplasty repair. In all patients, intraoperative transesophageal echocardiography was performed to confirm elimination of TR.
HUANG ET AL SUTURE AND RINGS ANNULOPLASTY FOR FUNCTIONAL TR
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Echocardiography Assessment of Tricuspid Annuloplasty Serial transthoracic echocardiographic reports were used to assess TR grade. Recurrent TR was defined by grade 2 or greater at echocardiography. The severity of TR was characterized as trivial (grade 1, jet area/right atrial area, less than 10%); mild (grade 2, jet area/right atrial area, 10% to 20%); moderate (grade 3, jet area/right atrial area, 20% to 33%); and severe (grade 4, jet area/right atrial area, 33% or more) [8]. All echocardiographic examinations were performed by the same two cardiologists. We did not assess intraobserver or interobserver variability in estimating severity of TR, but accepted the readings used for clinical decision making.
Follow-Up Follow-up data were obtained from hospital chart reviews and telephone interviews with patients or family members, When follow-up was not possible, information on vital status (alive or dead) was obtained through the social security database. Follow-up was closed on April 30, 2013. We described postoperative events and results according to the guidelines for reporting mortality and morbidity after cardiac valve interventions, approved by The Society of Thoracic Surgeons [9]. Every patient underwent clinical assessment by a physician who was blinded to the treatment assigned. Deaths and redo valve-related surgery were recorded. Patients’ records included age, sex, findings of physical examination (cyanosis, jaundice, neck vein engorgement, ascites, hepatomegaly, and pitting edema), and presence of atrial fibrillation on electrocardiogram. Follow-up was 96.7% complete, with a median follow-up of 7.4 years (range, 6 months to 12 years).
Statistics Analysis Preoperative variables were compared between groups by the Fisher exact test (categorical variables) and the Student t test (continuous variables). Kaplan-Meier analysis was used to evaluate mortality and development of 2þ (moderate) recurrent TR. Univariate analysis was performed using the Breslow test and log rank test to
Fig 1. Schematic drawing of modification of De Vega’s technique. (A) Operative technique. Modified De Vaga annuloplasty is performed by placement of a 3–0 pledgetsupported polypropylene suture from the posteroseptal commissures to the midportion of anterior leaflet along the posterior annulus. (B) Operative technique (continued). The suture was tied down snugly over a Hegar dilator calibrated to 2 to 3 mm larger than the predicted appropriate pulmonary annulus size. (A ¼ anterior leaflet; CS ¼ coronary sinus; P ¼ posterior leaflet; S ¼ septal leaflet.)
ADULT CARDIAC
Ann Thorac Surg 2014;97:1286–93
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HUANG ET AL SUTURE AND RINGS ANNULOPLASTY FOR FUNCTIONAL TR
Table 1. Patient Preoperative Characteristics Variable ADULT CARDIAC
Age, years Hypertension Atrial fibrillation NYHA class IV III II Physical examination Cyanosis Jaundice Neck vein engorgement Ascites Hepatomegaly Pitting edema
Group 1 (n ¼ 216)
Group 2 (n ¼ 232)
p Value
62.7 12.4 76 (35.2) 198 (91.7)
64.2 13.2 83 (35.8) 208 (89.7)
0.56 0.09 0.54 0.11
78 (36.1) 96 (44.4) 42 (19.4)
96 (41.3) 112 (48.3) 24 (10.3) 0.12
198 89 203 86 186 146
(91.7) (41.2) (94.0) (40.0) (86.1) (67.6)
215 114 221 102 206 176
(92.7) (49.1) (95.2) (44.0) (88.8) (75.9)
Data are mean SD or number (%). A p value less than 0.05 was considered significant. NYHA ¼ New York Heart Association.
determine whether any of the collected variables were predictors of late mortality. Multivariate analysis was performed using Cox regression as well. Survival was expressed using Kaplan-Meier curves. Midterm survival and freedom from morbid events (event-free survival status) were compared using the Kaplan-Meier method; independent predictors were determined by means of Cox regression analysis. Statistical data were analyzed
Ann Thorac Surg 2014;97:1286–93
using SPSS software version 12.0 (SPSS, Chicago, IL). Probability values of 0.05 or less were considered statistically significant.
Results Perioperative Characteristics Table 1 shows the demographic data of all patients. More than half of the patients had atrial fibrillation and 80% of patients were in New York Heart Association (NYHA) functional class III or IV. There was no significant difference between the two groups of patients in age, sex, NYHA class, preoperative pulmonary artery systolic pressure (PASP), preoperative RV dysfunction, and concomitant surgical procedures. There were higher incidences of symptoms of right-side heart failure, such as neck vein distention, hepatomegaly, and pretibial pitting edema, and lower left ventricular ejection fraction (LVEF) in group 2. Table 2 also shows that there was a higher percentage of patients with 3þ to 4þ TR in the ring annuloplasty group than in the De Vega annuloplasty group (93.0% versus 88.2%; p < 0.23), and the mean TR was worse in the ring group (3.6 versus 3.4; p < 0 .14). Table 3 shows perioperative characteristics. The rate of mitral valve replacement (80% in group 1, 81% in group 2; p ¼ 0 .75), and Maze procedure (60% versus 61%, p ¼ 0.37) were similarly performed in both treatment groups. Operative time averaged 4 hours in all cases. With regard to mean cardiopulmonary bypass time and aortic cross-clamp time, the times in group 2 (200 82 and
Table 2. Perioperative and Follow-Up Echocardiographic Characteristics Group 1 (n ¼ 216)
Group 2 (n ¼ 232)
Variable
Baseline
At Discharge
Follow-Up
Baseline
At Discharge
Follow-Up
NYHA class Left atrial diameter, mm LV end-diastolic diameter, mm LV end-systolic diameter, mm LV ejection fraction, %
Repair of Functional Tricuspid Regurgitation: Comparison Between Suture Annuloplasty and Rings Annuloplasty Xinsheng Huang, PhD, Chengxiong Gu, MD, Xu Men, MD, Jianqun Zhang, MD, Bin You, MD, Hongjia Zhang, PhD, Hua Wei, MD, and Jingxing Li, PhD Cardiac Surgery Department, Beijing Anzhen Hospital, Capital Medical University, Beijing, China
Background. The purpose of this study was to review our experience with modified De Vega tricuspid annuloplasty versus ring annuloplasty for treating functional tricuspid regurgitation (TR). Methods. In all, 448 consecutive patients undergoing tricuspid annuloplasty with concomitant procedures between 2000 and 2012 were included. Modified De Vega annuloplasty was performed in 216 patients (group 1) and ring annuloplasty in 232 patients (group 2). Clinical and echocardiographic follow-up results were used to assess TR grade. Recurrent TR was defined as grade 2 or greater at echocardiography. Results. Preoperative clinical and echocardiographic characteristics were comparable in the two groups. Early mortality was similar (group 1, 0.9%, versus group 2, 1.3%; p < 0.67). Follow-up was available for 97%; New York Heart Association class and symptoms of right-side heart failure were significantly improved. Survival rates at 1 and
5 years were comparable (97% and 84% for group 1, and 96% and 82% for group 2, respectively). Postoperative echocardiography showed significant improvement in tricuspid valve function, with reduction in TR grade from 3.4 to 0.6, and no differences between groups. However, recurrence-free survival was better for group 2 than for group 1 (78.8% versus 74.5%; p < 0.62). Risk factors for recurrent TR included severity of preoperative TR, atrial fibrillation, and pulmonary hypertension. Conclusions. The modified De Vega tricuspid annuloplasty is acceptable for repair of functional TR and improvements in clinical and echocardiographic status on a long-term basis, although the long-term recurrence-free survival appeared to be lower than that for ring annuloplasty.
lthough both rigid and flexible system provide acceptable results for tricuspid valve (TV) repair, the use of a rigid ring significantly increases the risk of early annular dehiscence [1, 2]. A possible explanation is that increased shearing forces are being experienced at the septal portion of the annulus, and that these shearing forces would be even higher when a rigid ring is used [1, 2]. This line of argument finds support in the studies addressing the dynamics of the native tricuspid annulus [3, 4]. There are significant changes in the tricuspid annular dimensions from systole to diastole, with a 19% change of annular circumference and a 30% change in the annular area [4]. In addition, Ton-Nu and coworkers [5] demonstrated that tricuspid dilation occurs mainly in the free wall of the tricuspid annulus at the middle part of the anterior leaflet and extending to the septal part of the septal leaflet. On the basis of this concept, beginning in 2000, we developed a new method of TV repair with a modified De Vega’s suture annuloplasty. This method, however, has since been considered to remodel annular structures by
maintaining a trileaflet valve that is more physiologic, to maintain flexibility of right ventricular (RV) pumping action, and to prevent redilation. In this study, we review and compare the long-term clinic and echocardiographic results of the modified De Vega and ring annuloplasty for repair of functional tricuspid regurgitation (TR) to determine the efficacy and durability of tricuspid annuloplasty. In addition, we also analyzed the risk factors for recurrence of TR.
A
Accepted for publication Oct 11, 2013. Address correspondence to Dr Gu, Beijing Anzhen Hospital, Anding Rd 2, Beijing 100029, China; e-mail: [email protected].
Ó 2014 by The Society of Thoracic Surgeons Published by Elsevier Inc
(Ann Thorac Surg 2014;97:1286–93) Ó 2014 by The Society of Thoracic Surgeons
Material and Methods Patient Characteristics Between January 2000 and April 2012, 448 consecutive patients with functional TR underwent tricuspid annuloplasty with mitral valve replacement and mitral-aortic valve replacement at our institution. Patients with concomitant procedures such as mitral valve repair or with endocarditis or significant organic disease of the tricuspid valve leaflets or patients with congenital anomalies were excluded. The TR was always secondary to right ventricular dilation or dysfunction caused by mitral valve rheumatic disease in 358 patients (79.9%), mitral and aortic valves rheumatic disease in 87 (19.4%), and mitral prosthesis dysfunction in 3 (0.7%). Indications 0003-4975/$36.00 http://dx.doi.org/10.1016/j.athoracsur.2013.10.037
for TV surgery were symptomatic severe TR in 409 (91.3%) patients or else asymptomatic moderate TR or marked tricuspid annular dilation (>4.0 cm) in the presence of other indications for cardiac surgery in 39 (8.7%). Of these, the main TV disease was annulus dilation in all patients, combined with restriction of the leaflets in 12 (2.7%) patients, and rolled up and thickened leaflets in 3 (0.7%) patients. All patients were prospectively entered into our patient data management system and then retrospectively analyzed. Our Institutional Review Board approved this study and waived the need for individual consent.
Surgical Procedure All annuloplasties were performed during concomitant mitral or aortic valve surgery with cardioplegic arrest. Three surgeons performed operations during the study periods (G.C.X., M.X., Z.J.Q.). The choice of tricuspid annuloplasty methods was selected by the surgeons’ preference: in group 1, modified De Vega’s suture annuloplasty was performed in 216 patients; in group 2, a flexible ring (Cosgrove-Edwards annuloplasty system; Edwards Lifesciences, Irvine, CA) was implanted in 147 patients and a rigid ring (Edwards Lifesciences) in 85 patients. Ring annuloplasty was performed by standard operative techniques [6]. Modified De Vega’s suture annuloplasty was performed by placing a doubled pledget-supported suture of 3-0 polypropylene from the level of the septal annulus in front of the coronary sinus to the midportion of the annulus of the anterior leaflet (Fig 1). The pledget was placed on the RV surface of the septal annulus; the other pledget was placed at the atrial surface of the anterior annulus. This double multifilament suture is then tied down snugly over a Hegar dilator calibrated to 2 mm to 3 mm larger than the predicted appropriate pulmonary annulus size derived from published nomograms [7], satisfactorily reducing the orifice size without placing undue strain on the annuloplasty repair. In all patients, intraoperative transesophageal echocardiography was performed to confirm elimination of TR.
HUANG ET AL SUTURE AND RINGS ANNULOPLASTY FOR FUNCTIONAL TR
1287
Echocardiography Assessment of Tricuspid Annuloplasty Serial transthoracic echocardiographic reports were used to assess TR grade. Recurrent TR was defined by grade 2 or greater at echocardiography. The severity of TR was characterized as trivial (grade 1, jet area/right atrial area, less than 10%); mild (grade 2, jet area/right atrial area, 10% to 20%); moderate (grade 3, jet area/right atrial area, 20% to 33%); and severe (grade 4, jet area/right atrial area, 33% or more) [8]. All echocardiographic examinations were performed by the same two cardiologists. We did not assess intraobserver or interobserver variability in estimating severity of TR, but accepted the readings used for clinical decision making.
Follow-Up Follow-up data were obtained from hospital chart reviews and telephone interviews with patients or family members, When follow-up was not possible, information on vital status (alive or dead) was obtained through the social security database. Follow-up was closed on April 30, 2013. We described postoperative events and results according to the guidelines for reporting mortality and morbidity after cardiac valve interventions, approved by The Society of Thoracic Surgeons [9]. Every patient underwent clinical assessment by a physician who was blinded to the treatment assigned. Deaths and redo valve-related surgery were recorded. Patients’ records included age, sex, findings of physical examination (cyanosis, jaundice, neck vein engorgement, ascites, hepatomegaly, and pitting edema), and presence of atrial fibrillation on electrocardiogram. Follow-up was 96.7% complete, with a median follow-up of 7.4 years (range, 6 months to 12 years).
Statistics Analysis Preoperative variables were compared between groups by the Fisher exact test (categorical variables) and the Student t test (continuous variables). Kaplan-Meier analysis was used to evaluate mortality and development of 2þ (moderate) recurrent TR. Univariate analysis was performed using the Breslow test and log rank test to
Fig 1. Schematic drawing of modification of De Vega’s technique. (A) Operative technique. Modified De Vaga annuloplasty is performed by placement of a 3–0 pledgetsupported polypropylene suture from the posteroseptal commissures to the midportion of anterior leaflet along the posterior annulus. (B) Operative technique (continued). The suture was tied down snugly over a Hegar dilator calibrated to 2 to 3 mm larger than the predicted appropriate pulmonary annulus size. (A ¼ anterior leaflet; CS ¼ coronary sinus; P ¼ posterior leaflet; S ¼ septal leaflet.)
ADULT CARDIAC
Ann Thorac Surg 2014;97:1286–93
1288
HUANG ET AL SUTURE AND RINGS ANNULOPLASTY FOR FUNCTIONAL TR
Table 1. Patient Preoperative Characteristics Variable ADULT CARDIAC
Age, years Hypertension Atrial fibrillation NYHA class IV III II Physical examination Cyanosis Jaundice Neck vein engorgement Ascites Hepatomegaly Pitting edema
Group 1 (n ¼ 216)
Group 2 (n ¼ 232)
p Value
62.7 12.4 76 (35.2) 198 (91.7)
64.2 13.2 83 (35.8) 208 (89.7)
0.56 0.09 0.54 0.11
78 (36.1) 96 (44.4) 42 (19.4)
96 (41.3) 112 (48.3) 24 (10.3) 0.12
198 89 203 86 186 146
(91.7) (41.2) (94.0) (40.0) (86.1) (67.6)
215 114 221 102 206 176
(92.7) (49.1) (95.2) (44.0) (88.8) (75.9)
Data are mean SD or number (%). A p value less than 0.05 was considered significant. NYHA ¼ New York Heart Association.
determine whether any of the collected variables were predictors of late mortality. Multivariate analysis was performed using Cox regression as well. Survival was expressed using Kaplan-Meier curves. Midterm survival and freedom from morbid events (event-free survival status) were compared using the Kaplan-Meier method; independent predictors were determined by means of Cox regression analysis. Statistical data were analyzed
Ann Thorac Surg 2014;97:1286–93
using SPSS software version 12.0 (SPSS, Chicago, IL). Probability values of 0.05 or less were considered statistically significant.
Results Perioperative Characteristics Table 1 shows the demographic data of all patients. More than half of the patients had atrial fibrillation and 80% of patients were in New York Heart Association (NYHA) functional class III or IV. There was no significant difference between the two groups of patients in age, sex, NYHA class, preoperative pulmonary artery systolic pressure (PASP), preoperative RV dysfunction, and concomitant surgical procedures. There were higher incidences of symptoms of right-side heart failure, such as neck vein distention, hepatomegaly, and pretibial pitting edema, and lower left ventricular ejection fraction (LVEF) in group 2. Table 2 also shows that there was a higher percentage of patients with 3þ to 4þ TR in the ring annuloplasty group than in the De Vega annuloplasty group (93.0% versus 88.2%; p < 0.23), and the mean TR was worse in the ring group (3.6 versus 3.4; p < 0 .14). Table 3 shows perioperative characteristics. The rate of mitral valve replacement (80% in group 1, 81% in group 2; p ¼ 0 .75), and Maze procedure (60% versus 61%, p ¼ 0.37) were similarly performed in both treatment groups. Operative time averaged 4 hours in all cases. With regard to mean cardiopulmonary bypass time and aortic cross-clamp time, the times in group 2 (200 82 and
Table 2. Perioperative and Follow-Up Echocardiographic Characteristics Group 1 (n ¼ 216)
Group 2 (n ¼ 232)
Variable
Baseline
At Discharge
Follow-Up
Baseline
At Discharge
Follow-Up
NYHA class Left atrial diameter, mm LV end-diastolic diameter, mm LV end-systolic diameter, mm LV ejection fraction, %
