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Ann Thorac Surg 2009;88:1492-1498. doi:10.1016/j.athoracsur.2009.07.017
© 2009 The Society of Thoracic Surgeons
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Original Articles: Adult Cardiac

Early Clinical Experience and Echocardiographic Results With a New Semirigid Mitral Annuloplasty Ring: The Sorin Memo 3D

Pier Giorgio Bruno, MD, PhDa,*, Cristian Leva, MD, PhDa, Luisa Santambrogio, MD, PhDb, Ilaria Lazzarini, MDa, Giorgio Musazzi, MDb, Gianfranco Del Rosso, MDc, Germano Di Credico, MDa

a Department of Cardiac Surgery, Echocardiography Unit, Ospedale Civile di Legnano, Milan, Italy
b Department of Anesthesia and Critical Care, Echocardiography Unit, Ospedale Civile di Legnano, Milan, Italy
c Department of Cardiology, Echocardiography Unit, Ospedale Civile di Legnano, Milan, Italy

Accepted for publication July 10, 2009.

* Address correspondence to Dr Bruno, Department of Cardiac Surgery, Ospedale Civile di Legnano, Via Candiani 2, Legnano, Milan, 20025, Italy (Email: piergiorgiob{at}yahoo.it).


   Abstract
Top
 Abstract
Introduction
 Material and Methods
 Results
 Comment
 References
 
Background: The Sorin Memo 3D (Sorin Biomedica Cardio S.r.L., Saluggia, Italy) is a new, complete semirigid annuloplasty ring. Clinical use, outcomes, and echocardiographic results are reported as an evaluation of its safety and efficacy in the treatment of mitral valve regurgitation (MVR).

Methods: This device was assessed in 63 patients (63.5% men; mean age, 70.2 ± 10.3 years) who underwent MVR operations between January 2007 and June 2008. Functional classification was normal leaflet motion (type I; 1.6%), leaflet prolapse (type II; 66.7%), and restricted leaflet motion (type III; 31.7%). Valve disease was degenerative (68.25%), ischemic (25.4%), and nonischemic dilated cardiomyopathy (6.35%).

Results: Early mortality (≤30 days) was 3.3% (2 patients). Late mortality (11.2 ± 5.1 months) was 4.9% (3 patients). No deaths were device-related. Thromboembolic stroke occurred in 3.3% and endocarditis in 1.6%. Freedom from reoperation was 98.4%. At 6 months, MVR was grade 0/1 in 93.7% and grade 2+ in 6.4%. Left end-diastolic ventricular diameters decreased significantly from 59.3 ± 6.9 mm preoperatively to 50.6 ± 12.2 mm at 6 months, pulmonary arterial pressure decreased from 44.8 ± 7.1 mm Hg to 38.4 ± 5.5 mm Hg, and left ventricular ejection fraction increased significantly from 0.469 ± 0.129 to 0.582 ± 0.106. New York Heart Association functional class was I in 81% and II in 13.8%.

Conclusions: Early results indicate the Sorin Memo 3D ring safely and effectively minimizes secondary MVR resulting from all causes and preserves mitral annular flexibility and function at follow-up.


   Introduction
Top
 Abstract
 Introduction
Material and Methods
 Results
 Comment
 References
 
In the last decade, techniques for mitral valve repair have demonstrated better results than prosthetic mitral valve replacement. This is mainly due to the better left ventricular (LV) function resulting from the preservation of the subvalvular apparatus. These improved results include lower operative mortality rates, excellent long-term survival, a lower failure rate, and fewer long-term complications [1–9].

Although mitral valve repair is considered to be the procedure of choice, the necessity of annular stabilization with a device is a topic of ongoing discussion. This said, a wide range of annuloplasty rings have been proposed that differ in form and mechanical flexibility. In addition to the general discussion about the necessity for ring use, the optimal mechanical characteristics of an annuloplasty ring are also currently being debated. When considering the choice between a rigid and a flexible ring, one must consider a trade-off between improved stabilization and remodelling [10–13].

Recently published articles suggest that a complete flexible ring has the advantage of preserving annular motion throughout the cardiac cycle [14–17]. It can conform to the natural saddle-shape of the valve annulus within the cycle and remodel the mitral annulus without disturbing physiologic movements. It has also been demonstrated, especially in cases of ischemia or dilated cardiomyopathy, that dilatation of the mitral annulus is a progressive phenomenon that affects both the anterior and the posterior annulus [12].

The new Sorin Memo 3D (Sorin Biomedica Cardio S.r.L., Saluggia, Italy) is a complete semirigid annuloplasty ring intended to adapt to the physiologic dynamism of the annulus and to restore the geometric relation between the leaflets and the annulus [16].

This retrospective study collected data on the clinical outcomes obtained when the Sorin Memo 3D was used for the treatment of different pathophysiologic features of mitral regurgitation with mitral valve repair. The study was performed in a single Italian center with a cohort of more than 60 patients. Data collected included patient survival, morbidities, and modifications of left heart chamber diameters measured with echocardiography.


   Material and Methods
Top
 Abstract
 Introduction
 Material and Methods
Results
 Comment
 References
 
Approval for the study was obtained by the Ethics Committee before the study began. Before entering the study, each patient signed an informed consent form.

Patient Population
Between January 2007 and June 2008, 63 consecutive patients underwent mitral repair for mitral regurgitation with implantation of a Sorin Memo 3D annuloplasty device at the Cardiac Surgery Department of the Ospedale Civile di Legnano in Milan, Italy. Patients agreed to return for an echocardiographic follow-up at 6 months and a clinical interview at the end of the study. Preoperative characteristics are listed in Table 1.


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  		Table 1 Preoperative Patient Characteristics
 
Sorin Memo 3D Ring
The device is a complete ring (Fig 1) with a core in a shape memory and superelastic metal alloy (nitinol). This core is enclosed in a sewing ring of silicone and knitted polyester fabric, which is in turn coated with a film of turbostratic carbon (Carbofilm, Sorin Biomedica, Cardio S.r.L., Saluggia, Italy). The ring is flexible, accommodating to the 3-dimensional (3D) motion of the annulus. Its shape memory and the nitinol alloy core are designed to restore the natural systolic diameter ratio.


Figure 1
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  		Fig 1. The Sorin Memo 3D ring has a core with an innovative, shape memory cell structure achieved by laser cutting a tube of a nitinol metal alloy. This core is enclosed in a sewing ring of silicone and knitted polyester fabric, which is in turn coated with a film of turbostratic carbon (Carbofilm) to enhance hemocompatibility and biocompatibility. (Permission obtained by Sorin Biomedica Cardio S.r.L., Saluggia, Italy).

 
To support remodelling, the flexibility is maximal in the posterior curved portion and gradually decreases toward the anterior linear segment. The transversal flexibility allows for contractility of the corresponding part of the annulus, and the longitudinal rigidity avoids plication and a pursestring effect when tying the sutures. The selective rigidity in the anterior section is expected to significantly reduce stress on the sutures while simultaneously maintaining the annulus remodelling effect. Above all, in ischemic or idiopathic dilated cardiomyopathy, dilation of the mitral ring is proportional and does not exclusively affect the posterior portion. Anterior rigidity has the advantage of fixing the trigone-to-trigone distance, which permits the physiologic annular movements to be respected.

The device is premounted on a holder, positioning suture guidelines are present, and two commissural markers and a midline posterior marker are provided for alignment with the annulus. The ring is available in sizes of 24 to 38 mm.

Causes of Valvular Diseases and Functional Classifications
The functional classification for the entire patient population is given in Table 2. According to preoperative clinical and echocardiographic data, the cause of mitral regurgitation was fibroelastic deficiency in 39 patients (61.9%). For the functional analysis of the valve, patients were classified in three groups following the Carpentier classification. Leaflet prolapse was the major cause of valve regurgitation and was present in 42 patients (66.7%).


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  		Table 2 Causes of Valvular Diseases and Functional Classifications
 
Surgical Procedure
The operation was performed according to standard hospital routine. Central cannulation was achieved for both sternal and thoracotomy access in all but 2 patients. These patients underwent a redo procedure with thoracotomy access in which femoral vessels were cannulated and vacuum-assisted drainage was used.

After cardiac arrest and dissection of the Sondergaard plane, the left atrium was opened and the mitral valve was exposed with the help of a self-retaining retractor. The functional and segmental analysis was then made. Once restoration of the leaflet coaptation was achieved, the repair procedure was completed with the implantation of a Sorin Memo 3D ring. To select the correct device size, the unfurled anterior leaflet height was measured with the ring sizer and the intercommissural distance was measured by placing the notches of the sizer at the commissures. All the patients underwent intraoperative transesophageal echocardiographic assessment before and after weaning from cardiopulmonary bypass.

Before the sternum was closed, transmitral gradients, mitral valve area, and presence of residual regurgitation were analyzed. If patients exhibited more than what could be considered trivial mitral regurgitation, cardiopulmonary bypass was reintroduced and the mitral valve was checked upon cross-clamp. If significant valve regurgitation persisted after the second repair, the annuloplastic ring and the native valve were replaced with a prosthetic valve. The repair procedures, the ring sizes implanted, and the operative data are listed in Tables 3, 4, and 5, Go Go respectively.


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  		Table 3 Valve Repair Procedures Used in This Series
 

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  		Table 4 Ring Sizes
 

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  		Table 5 Operative Data
 
All patients were treated with anticoagulation therapy for 12 weeks after the operation. If the patients had no other medical conditions requiring anticoagulation, the therapy was terminated at this point.

Patient Follow-Up
Follow-up was 100% completed. Patients returned to the hospital for a physical examination and echocardiographic evaluation 6 months after the operation. All hospital survivors were contacted by telephone in December 2008. The mean clinical follow-up time was 11.2 ± 5.1 months (range, 6 to 23 months).

Of the 63 patients in the cohort, 61 survived hospitalization. One patient required an operation for mitral endocarditis, and the Sorin Memo 3D was removed and a bioprosthetic valve was implanted. This patient was excluded from the echocardiographic postoperative analysis.

Definitions
The data provided in this article were obtained following the Guidelines for Reporting Mortality and Morbidity after Cardiac Valvular Operations [18].

Postoperative bleeding was defined as resternotomy for hemorrhage, postoperative renal complications as need for ultrafiltration, and neurologic complications as any postoperative transient or permanent neurologic deficits.

Echocardiography Measurements and Calculations
All patients underwent transthoracic echocardiography before the mitral valve repair and at hospital discharge. Each surviving patient had transthoracic echocardiography performed at 6 months. Two-dimensional/M-mode echocardiography was used to assess mitral valve structure and function as well as LV diastolic and systolic dimensions. Severity of mitral and tricuspid insufficiency was graded with a 5-point scale by integrating pulsatile wave and continuous wave Doppler blood flow data with morphologic information. The following scale was used for color echocardiography: 0, none or trivial; 1+, mild; 2+, moderate; 3+, moderate to severe; 4+, severe. In the cases of ischemic mitral regurgitation, the accepted thresholds for Doppler blood flow data were 20 mm2 for effective regurgitant orifice and 30 mL for regurgitant volume [19]. Tricuspid insufficiency was considered significant if the grade was 3 or higher.

Statistical Analysis
Continuous variables are expressed as mean ± standard deviation, and categoric variables are given as a percentage of the patient cohort. Continuous variables were compared using the paired t test. The differences between preoperative and postoperative echocardiography variables were considered to be significant at a value of p ≤ 0.05. All clinical data were analyzed using SPSS 11 software (SPSS Inc, Chicago, IL).


   Results
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 Material and Methods
 Results
Comment
 References
 
Early Mortality and Morbidity
Early postoperative (≤30 days) clinical characteristics are provided in Table 6. There were 2 deaths at 30 days. One patient with concomitant aortic valve replacement and coronary artery bypass grafting died at 16 days as a result of respiratory failure. The other patient had concomitant tricuspid repair and died at 20 days of right ventricular failure. No patients showed mitral stenosis.


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  		Table 6 Early Postoperative (≤30 Days) Characteristics
 
Late Mortality, Valve-Related Complications, and Functional Outcome
Valve related morbidity during the clinical follow-up is summarized in Table 7. No late deaths were device-related. One patient died at 8 months after an operation for arrhythmia due to myocardial infarction while he was waiting for cardioverter-defibrillator implantation. He received an annuloplasty procedure associated with ventriculoplasty for postischemic dilated cardiomyopathy. The second patient died at 5 months after an operation for gastrointestinal hemorrhages. The last patient had a pulmonary infection after an operation for lung cancer.


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  		Table 7 Follow-Up Clinical Results
 
Only 3 patients were in New York Heart Association (NYHA) class III postoperatively. In all cases the preoperative pathophysiologic mechanism of mitral regurgitation was annular dilation in dilated cardiomyopathy, with a LV ejection fraction (LVEF) of less than 0.30.

Echocardiographic Findings
The echocardiographic assessments performed preoperatively, at discharge, and at follow-up are presented in Table 8. The results of the Doppler echocardiography did not reveal mitral valve stenosis in any of the patients. Ventricular contractility was normal in 42 patients. Among the 26 patients with pulmonary hypertension preoperatively, 1 died at follow-up. Pulmonary arterial pressure decreased significantly at 6 months, and 13 patients reached normality.


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  		Table 8 Comparative Echocardiographic Findings
 

   Comment
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 Abstract
 Introduction
 Material and Methods
 Results
 Comment
References
 
Mitral valve repair is considered the gold standard for the treatment of mitral insufficiency, showing excellent long-term results [1–9, 20–22]. Ring annuloplasty is a fundamental part of the operation, either when used alone or combined with repair techniques for the leaflets and the structures below the level of the mitral annulus. Nonetheless, the choice of an annuloplasty device is still controversial because of the anatomy and physiology of the valve in normal and pathologic states.

The mitral annulus is saddle-shaped, being higher at the anterior and posterior segments and lower at the commissures. This shape helps the anterior mitral annulus to surround and conform to the shape of the LV outflow tract (LVOT). The mitral annulus periodically changes in size and shape throughout the cardiac cycle, contracting during systole. This sphincter mechanism increases the depth of coaptation of the leaflets during systole and increases the annular orifice area during diastole [15, 23, 24]. Systolic reduction of mitral annular orifice area is due to the contraction of the entire posterior annulus. The anterior annulus is also a highly dynamic component of the mitral apparatus [25–27].

These dynamic aspects of mitral valve physiology must be considered. In fact, mitral annular inflexibility due to rigid devices has been indicated as contributing to the mechanism of dynamic LVOT obstruction after mitral valve repair [28]. At our institution, we routinely use semirigid complete annuloplasty rings because we believe that partial rigidity restores the physiologic annular ratio, while the flexibility allows for better adaptation to the complex dynamism of the mitral valve during the cardiac cycle.

Although no conclusive evidence shows that the type of annuloplasty ring affects LV function, the data do suggest that use of a semirigid or flexible ring results in better preservation of mitral annular function [29, 30]. We can also presume that a narrowing fixed annuloplasty will be hemodynamically inferior to a remodelling annuloplasty because the anatomic and dynamic relationships of the mitral-ventricular entity are maintained. The physiologic 3D motion of the native mitral annulus is mimicked and there is accommodation to the anatomic saddle shape. The harmonic mitral valvular-ventricular movements, the septal-lateral dimension, and the saddle shape of the annulus are preserved.

Furthermore, remodelling annuloplasty allows for the physiologic distribution of forces and stresses on valve components and the LV. In addition, as has been noted by several different groups, the assumption that the anterior segment of the anterior annulus does not dilate in mitral regurgitation is no longer thought to be valid. For this reason, we prefer to use a closed ring.

Finally, the anterior—or fibrotic portion—and the posterior—or muscular segment—of the mitral valve annulus have both been shown to dilate symmetrically [31]. This dilation can be even more evident in ischemic and idiopathic dilated cardiomyopathy [12, 17, 32–34]. These observations suggest that a complete ring annuloplasty that fixes the intertrigone segment may offer improved results, including the prevention of recurrent insufficiency.

The design of the Sorin Memo 3D ring could bring together the necessary flexibility for the preservation of the saddle shape of the annulus with the adequate consolidated support for the entire mitral annulus [17]. The Sorin Memo 3D permits periodic changes in size and shape throughout the cardiac cycle. It allows for contraction during systole, an increased depth of coaptation of the leaflets, and an improvement in annular orifice area during diastole. This sphincter mechanism due to contraction/relaxation of the mitral annulus along the attachment of the posterior leaflet is given by the selective flexibility of the posterior segment of the devices that supports the physiologic movements of the mitral annulus. The proposed superior engineering of the ring is supported by our preliminary 3D echocardiographic results, which demonstrate significant systolic-diastolic changes of both septal-lateral and anterior-posterior dimensions.

In this preliminary experience with the Sorin Memo 3D ring, there were no in-hospital valve-related deaths. Among the 3 patients who died during follow-up, two were noncardiac deaths, and non-valve-related cardiac death occurred in a patient with severe complications and impaired LV function.

The 3-months of anticoagulation therapy promoted gradual and successful healing of the exposed cloth and sutures. In fact, only 2 patients experienced a thromboembolic event. These were non-valve-related and occurred in patients at high-risk for cerebrovascular events related to atherosclerosis of epiaortic trunks and the brain circulation who had a preoperative history of stroke. No patients experienced hemolytic anemia. Carpentier and colleagues [35] suggested that the low incidence of thromboembolism in their series was due to the low transvalvular gradients and large valve orifice area (mean, 3.55 cm2) achieved with the Carpentier-Edwards Physio Annuloplasty Ring (Baxter-Edwards Laboratories, Irvine, CA). Similar mitral valve areas (mean, 4.1 cm2) were obtained in the present study.

Only one patient needed mitral valve reoperation for severe mitral regurgitant jet caused by disruptions of the posterior leaflet by Escherichia coli endocarditis; this patient was obese, a heavy smoker, had diabetes mellitus type 1 with difficult glucose management postoperatively, and had impaired LV function preoperatively. The ring was explanted to perform a radical surgical toilette of mitral valve apparatus, and a bioprosthesis was implanted.

Although dehiscence of the annuloplasty ring is sometimes reported as a cause of reoperation after mitral repair [36, 37], ring dehiscence was not observed in this present study, even if our clinical experience was relatively short.

Mitral insufficiency was well controlled within grade 2 in all survivors, with most patients having either no or mild regurgitation. The effectiveness of the Sorin Memo 3D ring was also demonstrated by the high percentage of patients in NYHA classes I and II (94.8%). Mitral insufficiency was well controlled even in dilated cardiomyopathy, but eventual changes in anterior-posterior diameter of the mitral annulus were not calculated.

After mitral valve repair, most patients demonstrated a significant decrease of the LV dimensions, with a return to close to normal diameters. Pulmonary arterial pressure also decreased significantly at follow-up, even if it did not reach normal values. This can probably be explained by the relatively short follow-up period in the study. There were no LVOT obstructions due to systolic anterior motion with any different pathophysiologic features.

The "respect rather than resect" (RRR) surgical technique described by Perrier was used in 6 patients with isolated posterior leaflet prolapse. Experimental work has shown that preserving the posterior leaflet tissue, coupled with the use of artificial chordae, can maintain the anatomic and dynamic relationships and interactions. This allows for the physiologic distribution of forces and stresses on valve components and the LV [38]. Anomalous accumulation of myxomatous material at the base of the posterior leaflet is considered a contraindication for RRR repair. In this case it should be removed during leaflet resection because it deforms and prevents the leaflet from hanging vertically. The deformation causes it to protrude anteriorly and increases the risk of systolic anterior motion. All patients treated with RRR repair were in NYHA class I, with mitral regurgitation 1+ at follow-up.

In conclusion, the present study details the preliminary clinical and echocardiographic follow-up of patients undergoing mitral valve repair with the Sorin Memo 3D. This device limits LVOT obstruction due to systolic anterior motion, minimizes residual and recurrent mitral insufficiency, and preserves LV function. There was no valve-related death and only one reoperation in the cohort. Moreover, no hemolysis occurred and the incidence of thromboembolism was very low. These early results demonstrate that the Sorin Memo 3D ring is safe and effective when used alone or with other techniques for repair of the mitral valve. We trust in the superiority of the mitral valve repair technique over mitral valve replacement when it is possible and in the superior design of the Sorin Memo 3D ring. Further clinical and echocardiographic evaluations with a larger patient cohort and a longer follow-up period will be necessary to confirm the findings of this preliminary experience.


   References
Top
 Abstract
 Introduction
 Material and Methods
 Results
 Comment
 References
 

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