Ann Thorac Surg 2006;81:2273-2277
© 2006 The Society of Thoracic Surgeons
New technology
A Three-Dimensional Ring Annuloplasty for the Treatment of Tricuspid Regurgitation
Farzan Filsoufi, MD
*
,
Sacha P. Salzberg, MD,
Marianne Coutu, MD,
David H. Adams, MD
Department of Cardiothoracic Surgery, Mount Sinai Hospital, New York, New York
Accepted for publication December 12, 2005.
* Address correspondence to Dr Filsoufi, Cardiac Valve Center, Department of Cardiothoracic Surgery, Mount Sinai Medical Center, 1190 Fifth Ave, Box 1028, New York, NY 10029; (Email: farzan.filsoufi{at}mountsinai.org).
| Dr Adams discloses that he has a financial relationship with Edwards LifeSciences.
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Abstract
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PURPOSE: Significant functional tricuspid regurgitation should be corrected in patients undergoing surgery for left-sided valvular diseases. Several clinical studies have shown the superiority of the remodeling annuloplasty over other repair techniques. Herein we report our early experience with a new three-dimensional remodeling prosthetic ring (Edwards MC3 annuloplasty system [Edwards LifeSciences, Irvine, CA]).
DESCRIPTION: From June 2002 to November 2004, 75 patients with functional tricuspid regurgitation (mean, 3.1 ± 0.9) underwent tricuspid valve repair with this new prosthesis. Concomitant procedures were mitral valve repair (70%), replacement (26%), aortic valve replacement (10%), coronary artery bypass grafting (13%), and left atrial maze (34%). Median predicted EuroScore mortality was 21% (r = 3 to 62).
EVALUATION: Operative mortality was 5.3% (n = 4). Pre-discharge echocardiography showed significant decrease in tricuspid regurgitation to 0.3 ± 0.4 (p < 0.001). Forty-five patients had follow-up transthoracic echocardiography after a median of 16 months (range, 4 to 34) demonstrating a stable result (mean tricuspid regurgitation, 0.3 ± 0.5). There were no cases of ring dehiscence, prosthetic ring endocarditis, or thromboembolic events.
CONCLUSIONS: This new three-dimensional ring is easy to implant, corrects tricuspid regurgitation effectively, and provides good short-term clinical and echocardiographic results. Long-term evaluation, however, is necessary to determine the stability of tricuspid valve repair using the MC3 annuloplasty system.
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Technology
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Tricuspid regurgitation (TR) is a common finding in patients with concomitant left-sided (aortic or mitral) valvular disease, and pulmonary hypertension [1]. The most common mechanism of TR is type I Carpentier's functional classification characterized by annular dilatation [2]. This so-called functional TR is most of the time amenable to surgical reconstructive techniques. Several types of tricuspid repair have been described in the literature including suture annuloplasty [3–5] and prosthetic annuloplasty (ie, flexible band and remodeling ring) [6–8]. Several clinical series have shown the superiority of prosthetic remodeling annuloplasty over other surgical techniques [2, 9–11]. However, recent clinical data suggests that moderate to severe TR remains present in 10% of patients after current repair techniques [9]. The Edwards MC3 annuloplasty system (Edwards LifeSciences, Irvine, CA) was recently introduced in the hope to further improve these results. It is a remodeling ring with a three-dimensional design, accommodating the three-dimensional aspect of the tricuspid annulus. In the present study, we report the early clinical results of patients with significant functional TR who underwent tricuspid valve (TV) repair with this prosthesis in combination with left-sided valvular surgery.
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Technique
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Patients
From June 2002 to November 2004, 75 patients with functional TR underwent TV repair with the Edwards MC3 annuloplasty system at Mount Sinai Medical Center in New York, NY. We used a computer-based operative registry to identify all patients. Clinical data were assessed retrospectively by thorough medical chart review. Follow-up information (eg, survival, clinical status, and most recent echocardiography) was obtained by contacting patients or referring physicians, or both, and by chart review. Additional survival information was obtained by cross matching the patient's social security number with the web-based social security death index. This research was approved by our local institutional review board, and a waiver for informed consent was obtained.
Preoperative characteristics of these 75 patients are summarized in Table 1. Patient population included 41 women (55%) and 34 men (45%) aged from 31 to 92 years old (mean, 64 ± 14 years). Eighty-five percent (n = 64) of the patients were in New York Heart Association functional classes III and IV preoperatively. Mean left ventricular ejection fraction was 49 ± 14%. Seventeen patients (23%) had previous cardiac surgery. Fifty-six patients (75%) were in sinus rhythm and 19 (25%) were in atrial fibrillation. Four patients (5%) had a permanent pacemaker prior to surgery. Pulmonary hypertension defined as a systolic pulmonary artery pressure greater than 45 mm Hg was present in 42 patients (56%). According to The New York State Cardiac Surgery Reporting System, 69 patients (92%) were operated on electively, 5 (7%) urgently, and 1 emergently. The median Euroscore predicted death rate was 21% (range, 3% to 62%).
All patients underwent a transthoracic echocardiography, as well as right and left heart catheterizations. All patients had functional TR and were classified as type I according to Carpentier's functional classification (ie, annular dilatation) [2]. The severity of TR assessed by Doppler echocardiography was graded on a scale from 1+ to 4+ (1+ mild, 2+ moderate, 3+ moderate to severe, 4+ severe) [12]. The severity of TR was as follows: fifty-seven patients (76 %) had greater than or equal to 3+ TR, 14 (18%) had 2+ TR, and 4 (5%) had only 1+ TR. Mean TR grade was 3.1 ± 0.8. Patients with 1+ and 2+ TRs had a severe dilatation of the tricuspid annulus on the transthoracic echocardiogram (ie, annular diameter greater than 40 mm).
All patients had primary left-sided valvular disease. Sixty-seven patients (89%) had combined mitral and tricuspid valve disease and 5 (7%) had triple valve disease. Sixty-two patients (83%) had pure mitral regurgitation (mean grade, 3.2 ± 1), and 10 (13%) had mixed mitral regurgitation and stenosis. The causes of mitral valve disease were rheumatic (n = 26; 36%), degenerative (n = 18; 25%), ischemic (n = 14; 19%), infectious (n = 5; 8%), dilated cardiomyopathy (n = 4; 5%), and others (n = 5; 7%). The causes of aortic valve disease were predominantly infectious and rheumatic.
Surgical Technique
A small skin incision and a full sternotomy were performed in all patients. Epiaortic scanning of the ascending aorta was done to rule out ascending aortic atherosclerotic disease prior to cannulation. After systemic heparinization, cardiopulmonary bypass was instituted between the ascending aorta and both venae cavae. Cardioplegia using high potassium cold blood was administered in an antegrade and retrograde fashion for myocardial protection. Further myocardial protection was obtained with mild-to-moderate systemic cooling (28°C to 30°C) and local hypothermia with topical ice. Left-sided valvular heart diseases were corrected first. In patients with a history of atrial fibrillation, a modified left atrial Maze procedure was performed by cryothermia (CryoCath Technology, Pointe-Claire, Canada) prior to the mitral valve procedure (n = 26; 36%). Mitral valve repair was performed in 53 patients (71%), whereas replacement was done in 19 (25%). Other concomitant procedures included aortic valve replacement (n = 8; 11%) and coronary artery bypass graft procedures (n = 10; 13%) (Table 2).
A right atriotomy parallel to the atrioventricular groove was performed, and the tricuspid valve was analyzed confirming type I dysfunction (ie, annular dilatation) in all patients. Tricuspid valve repair was performed using the Edwards MC3 annuloplasty system. The ring is a rigid structure and has a three-dimensional saddle shape, and is constructed of titanium alloy with a sewing ring that consists of a layer of silicone rubber, covered with polyester velour cloth, which is sewn with a single seam. Using the Carpentier's technique of measurement, the appropriate size of the ring was selected based on the length of the attachments of the tricuspid septal leaflet and on the surface area of the anterior leaflet. For functional TR, based on the measured distance, the size of the ring was downsized by at least one size. Ring implantation was performed by placing a series (ie, 8 to 10) mattress sutures through the tricuspid annulus around the orifice, while avoiding the area of atrioventricular conduction tissue. The sutures were then placed through the sewing ring of the Edwards MC3 prosthesis. Next, the ring was lowered into position and secured to the annulus. Figures 1A and 1B show the surgical and intraoperative echocardiographic aspects, respectively, of the Edwards MC3 ring. The size of the prosthesis implanted for the TV repair varied from 26 mm to 34 mm with 29 patients (39%) with a 26-mm ring, 21 (28%) with a 28-mm ring, 13 (17%) with a 30-mm ring, 10 (13%) with a 32-mm ring, and 2 (3%) with a 34-mm ring (Table 2). In the majority of patients, tricuspid valve repair was performed under cardioplegic arrest. The procedure was performed on all patients in less than 20 minutes.
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Fig 1. (A) Intraoperative and (B) two-chamber transesophageal echocardiography views of the Edwards MC3 annuloplasty system (Edwards LifeSciences, Irvine, CA).
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Statistical Analysis
Values are expressed as the mean ± standard deviation, median (range), or as a percentage. Statistical significance was considered when a p value was less than 0.05. Comparisons between groups were performed by using analysis of variance, the Student's t test, or the 
2 as appropriate. The Kaplan-Meier method was used to determine the actuarial survival curve.
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Clinical Experience
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Mortality and Morbidity
Thirty-day and in-hospital mortality was 5.3 % (n = 4). Table 3
shows causes of death, which were multiorgan system failure (n = 2), renal failure (n = 1), and endocarditis (n = 1). Postoperative complications included low cardiac output requiring inotropic support (n = 2), respiratory failure (requiring ventilation > 72 hours postoperatively) (n = 1), renal failure requiring dialysis (n = 1), and deep sternal infection (n = 2). Seven patients (9.3%) required permanent pacemaker insertion (n = 3 for third degree atrioventricular block and n = 4 for sick sinus syndrome). In 1 patient with a 10% preoperative ejection fraction, electrophysiological studies after surgery led to the implantation of an automatic intracardiac defibrillator.
Follow-Up
Follow-up was obtained by telephone interview of patients or referring physicians, or both. Median follow-up was 16 months (range, 4 to 34) and was 91% complete. Late mortality was 14% (n = 10). The causes of death were gastrointestinal hemorrhage (n = 1), renal failure (n = 1), and systemic neoplasia (n = 2), and in 6 patients the cause of death could not be identified. Among the surviving patients, no cases of documented ring dehiscence, prosthetic ring endocarditis, and thromboembolic events occurred. Kaplan Meier survival rate at 6, 12, and 24 months was 94, 89, and 89%, respectively (Fig 2). All surviving patients showed an improvement of the New York Heart Association functional class. Ninety percent of survivors (47 of 52) were in New York Heart Association functional class I or II at last follow-up.
Echocardiographic Results
Mitral regurgitation and TR were significantly reduced at discharge and at the most recent echocardiographic follow-up. At discharge, transthoracic echocardiography (n = 72; 96%) showed a significant decrease of the mean TR from 3.1 ± 0.8 to 0.3 ± 0.4 (p < 0.001) and the mean mitral regurgitation from 3.2 ± 1.0 to 0.1 ± 0.1 (p < 0.001). No significant change in mean ejection fraction was demonstrated (from 49 ± 14 to 48 ± 14%, p = not significant). No patient had more than mild (> 1+) TR after surgery. At discharge, 49 patients (72%) had none to trace TR, whereas 19 patients (28%) presented with mild TR (Fig 3).
At follow-up, 45 of 61 patients (74%) underwent transthoracic echocardiography. Mean TR and MR were 0.5 ± 0.5 and 0.8 ± 0.6, respectively (p = not significant). As shown in Figure 3, all patients but 1 had mild (1+) or less TR at follow-up (ie, 28 patients [62%] had none to trace TR; 17 patients [38%] had mild [1+ TR]; and 1 patient had 2+ TR).
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Comment
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This observational study reports the first series of TV repair with the Edwards MC3 annuloplasty system. The implantation of the device was easy and reproducible. This prosthetic ring effectively corrects functional TR with minimal residual TR and excellent early clinical outcomes. After a median follow-up of 16 months, echocardiographic findings suggest that the TV competence is sustained with a low rate of recurrent TR. In addition, no prosthesis-related complication (ie, prosthetic endocarditis, ring dehiscence, and thromboembolic event) occurred during this time period.
It is well accepted that significant TR (3+ to 4+) should be treated at the time of surgical correction of left-sided valvular disease [13, 14]. However, surgical indication for the correction of mild to moderate TR remains controversial. Recently, Dreyfus and colleagues [15] suggested that tricuspid annular dilatation is an ongoing process that will lead to severe TR with time, and they warrant early surgical correction regardless of the severity of TR. In their series, patients with severe annular dilatation and minimal TR (ie, 0.7 ± 0.5) who did not undergo a prosthetic annuloplasty presented with a significant worsening of TR (ie, 2.1 ± 1) after a mean follow-up of 5 years [15]. These findings led us to adopt a more aggressive approach to tricuspid valve repair by including patients with mild to moderate (ie, 1+ and 2+) TR (n = 18; 24%) and severe annular dilatation (diameter > 40 mm).
In patients with functional TR and annular dilatation, several techniques of annuloplasty have been described. Recently, McCarthy and colleagues [9] reported the Cleveland Clinic experience including 790 patients who underwent a TV annuloplasty using four different techniques (ie, the De Vega repair, the pericardial patch, the Cosgrove flexible band [Edwards LifeSciences], and the Carpentier-Edwards ring [Edwards LifeSciences]). Similar to the previous studies [6, 10, 11], this clinical series also confirmed the superiority of prosthetic annuloplasty over other repair techniques [9]. An important finding of McCarthy and colleagues' [9] study was the fact that a tricuspid annuloplasty did not consistently eliminate functional TR. The authors reported the presence of significant residual TR (ie, 3+ to 4+) at 1 month in about 15% of patients who underwent a prosthetic annuloplasty. They also reported that the size of the ring was not identified as a risk factor for recurrent TR. However, in their series, 16% of patients who underwent a remodeling annuloplasty had a 26-mm or 28-mm ring implanted, whereas 84% had a ring that was greater than or equal to 30 mm [9]. In contrast, in our series, a size 26-mm or 28-mm ring was used in 67% of patients, and rings that were greater than or equal to 30 mm were implanted in only 33% of patients, and pre-discharge and follow-up echocardiography (n = 45; 74%) in our series did not show any residual or recurrent TR (ie, > 1+), except for 1 patient. Despite the fact that it is difficult to compare these two studies, it seems that the systematic downsizing of the prosthetic ring in our series rather than the type of the ring has probably played an important role in decreasing the incidence of significant residual or recurrent TR, or both, after repair.
The concept of a remodeling tricuspid ring was developed by Carpentier more than 3 decades ago [6]. This ring has a two-dimensional shape but is semi-rigid, which allows the surgeon to adapt its shape to the saddle configuration of TV annulus during implantation. This ring has been shown to be effective in large series and provides a benchmark to examine our current results [11]. The Edwards MC3 annuloplasty system (Edwards LifeSciences) has adopted this concept. It has a three-dimensional design, is rigid and pre-configured to accommodate the saddle shape of the annulus.
Our study shows that the Edwards MC3 remodeling ring is easy to implant and significantly reduces functional TR. Further follow-up and larger clinical series are required to establish the long-term stability of this repair technique.
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Disclosures and Freedom of Investigation
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This study was funded completely through the department of cardiothoracic surgery. No commercial sponsor exists. The technology was purchased, and regular reimbursement was sought for these patients.
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Footnotes
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Disclaimer The Society of Thoracic Surgeons, the Southern Thoracic Surgical Association, and The Annals of Thoracic Surgery neither endorse nor discourage use of the new technology described in this article.
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References
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- Cohn LH. Tricuspid regurgitation secondary to mitral valve diseasewhen and how to repair. J Card Surg 1994;9(Suppl 2):237-241.[Medline]
- Carpentier A. Cardiac valve surgery–the "French correction." J Thorac Cardiovasc Surg 1983;86(3):323-337.[Medline]
- Kay GL, Morita S, Mendez M, et al. Tricuspid regurgitation associated with mitral valve diseaserepair and replacement. Ann Thorac Surg 1989;48(Suppl 3):S93-S95.[Medline]
- De Vega NG, De Rabago G, Castillon L, et al. A new tricuspid repairshort-term clinical results in 23 cases. J Cardiovasc Surg (Torino) 1973Spec No.:384-6.
- Bernal JM, Morales D, Revuelta C, et al. Reoperations after tricuspid valve repair J Thorac Cardiovasc Surg 2005;130(2):498-503.[Abstract/Free Full Text]
- Carpentier A, Deloche A, Dauptain J, et al. A new reconstructive operation for correction of mitral and tricuspid insufficiency J Thorac Cardiovasc Surg 1971;61(1):1-13.[Medline]
- McCarthy JF, Cosgrove 3rd DM. Tricuspid valve repair with the Cosgrove-Edwards annuloplasty system Ann Thorac Surg 1997;64(1):267-268.[Abstract/Free Full Text]
- Carrier M, Pellerin M, Guertin MC, et al. Twenty-five years' clinical experience with repair of tricuspid insufficiency J Heart Valve Dis 2004;13(6):952-956.[Medline]
- McCarthy PM, Bhudia SK, Rajeswaran J, et al. Tricuspid valve repairdurability and risk factors for failure. J Thorac Cardiovasc Surg 2004;127(3):674-685.[Abstract/Free Full Text]
- Rivera R, Duran E, Ajuria M. Carpentier's flexible ring versus De Vega's annuloplastya prospective randomized study. J Thorac Cardiovasc Surg 1985;89(2):196-203.[Abstract]
- Matsuyama K, Matsumoto M, Sugita T, et al. De Vega annuloplasty and Carpentier-Edwards ring annuloplasty for secondary tricuspid regurgitation J Heart Valve Dis 2001;10(4):520-524.[Medline]
- Zoghbi WA, Enriquez-Sarano M, Foster E, et al. Recommendations for evaluation of the severity of native valvular regurgitation with two-dimensional and Doppler echocardiography J Am Soc Echocardiogr 2003;16(7):777-802.[Medline]
- Singh JP, Evans JC, Levy D, et al. Prevalence and clinical determinants of mitral, tricuspid, and aortic regurgitation (the Framingham Heart Study) Am J Cardiol 1999;83(6):897-902.[Medline]
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- Dreyfus GD, Corbi PJ, Chan KM, et al. Secondary tricuspid regurgitation or dilatationwhich should be the criteria for surgical repair?. Ann Thorac Surg 2005;79(1):127-132.[Abstract/Free Full Text]
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Abstract
Introduction
