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Ann Thorac Surg 1995;60:1177-1185
© 1995 The Society of Thoracic Surgeons


Original Articles: Cardiovascular

The ``Physio-Ring'': An Advanced Concept in Mitral Valve Annuloplasty

Alain F. Carpentier, MD, PhD, Arrigo Lessana, MD, John Y. M. Relland, MD, Emre Belli, MD, Serban Mihaileanu, MD, Alain J. Berrebi, MD, Evelyn Palsky, MD, Didier F. Loulmet, MD

Department of Cardiovascular Surgery and Organ Transplantation, Hôpital Broussais, Paris, and Hôpital Européen de Paris-La Roseraie, Aubervilliers, France


    Abstract
 Top
 Footnotes
 Abstract
 Introduction
 Material and Methods
 Results
 Comment
 References
 
Background. A new annuloplasty ring has been developed with the aim of adding flexibility to the remodeling annuloplasty concept. Here we report its clinical use with special emphasis on segmental valve analysis and valve sizing.

Methods. From October 1992 through June 1994, 137 patients aged 4 to 76 years (mean age, 49.1 years) were operated on. The main causes of mitral valve insufficiency were degenerative, 90; bacterial endocarditis, 15; and rheumatic, 13. The indication for operation was based on the severity of the mitral valve insufficiency (90 patients were in grade III or IV) rather than on functional class (60 patients were in class III or IV). At echocardiography 6 patients had normal leaflet motion (type I), 119 leaflet prolapse (type II), and 12 restricted leaflet motion (type III). Surgical repair was carried out using Carpentier techniques of valve reconstruction. In 3 patients, inadequate ring sizing was responsible for systolic anterior motion of the anterior leaflet diagnosed by intraoperative echo. The valve was replaced in 2 patients. There were three hospital deaths, no late deaths, one reoperation for recurrent mitral valve insufficiency due to chordal rupture 1 month after repair, one reoperation for atrial thrombus formation 5 months after repair, one anticoagulant-related hemorrhage, and one thromboembolic episode.

Results. Mid-term follow-up between 6 and 18 months was available in 94 patients. Echocardiography showed trivial or no regurgitation in 93.2% of the patients and minimal regurgitation in 6.8%. The average transmitral diastolic gradient was 3.55 ± 1.93 mm Hg. Left ventricular end-systolic diameter and volume decreased postoperatively, demonstrating an improved left ventricular function.

Conclusions. This preliminary experience has provided promising results and allowed us to define the indications of the Physio-Ring versus the classic ring. It has also shown that valve sizing and proper ring selection are of primary importance.


    Introduction
 Top
 Footnotes
 Abstract
 Introduction
 Material and Methods
 Results
 Comment
 References
 
See also page 1185.

Since 1968, the date of the first prosthetic ring annuloplasty [1], more than 7,000 mitral valve repairs have been performed in our institution. The results have been associated with a high degree of predictability and long-term stability [2]. Although the prosthetic ring annuloplasty was only one among the multiple reconstructive procedures developed to correct all the lesions [3], it was indeed a key factor in the efficacy of these operations. Remodeling the annulus to its proper size and shape implies some rigidity of the prosthetic ring. This rigidity has been criticized for being a potential source of left outflow tract obstruction [4] or impaired left ventricular (LV) function [5]. Although it has been subsequently demonstrated that the ring itself was not responsible for these drawbacks [6, 7] and that the LV performance actually improved after remodeling annuloplasty [8], we wanted to study the feasibility and potential advantages of adding flexibility to the remodeling annuloplasty concept. This led to the development of a new prosthetic ring, the technique of implantation and early results of which are analyzed in this article.


    Material and Methods
 Top
 Footnotes
 Abstract
 Introduction
 Material and Methods
 Results
 Comment
 References
 
The Physio-Ring
Based on a 25-year experience, the Physio-Ring (Carpentier-Edwards Physio Annuloplasty Ring; Baxter-Edwards Laboratories, Irvine, CA) incorporates all of the features mandatory for a physiologic and durable repair of the mitral valve annulus (Fig 1Go). It conforms to the configuration of the normal mitral valve annulus during systole, with the characteristic 3:4 ratio between the anteroposterior diameter and the transverse diameter. Compared with the classic ring, the anteroposterior diameter has been slightly increased to better fit the degenerative and ischemic valvular diseases that are prevalent today. The anterior section is saddle-shaped to conform to the bulging of the aortic root. It acts as a foundation for optimal and durable posterior movement. The commissural and posterior sections exhibit a differential flexibility to make possible changes in size and shape of the annulus fibrosus during ventricular contraction. This flexible section, however, is longitudinally undeformable to avoid plication and the pursestring effect seen with the currently available flexible rings when tying the mattress sutures used to secure the ring. The Physio-Ring is constructed of Elgiloy bands separated by polyester film strips, which provide high-strength fatigue resistance and excellent spring efficiency. This combination of selective rigidity at the anterior section and selective flexibility at the posterior section is expected to give a significant reduction of stress on sutures while maintaining the annulus remodeling effect.






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Fig 1. . The Physio-Ring restores the normal shape and size of the mitral valve orifice. Its saddle-shape configuration allows a better fit of the mitral valve annulus. The posterior section is transversally flexible, allowing contractility of the corresponding part of the annulus, but longitudinally rigid to avoid plication and pursestring effect when tying the sutures.

 
Patient Population
Between October 1992 and January 1995, the Physio-Ring was used in 137 patients (82 men and 55 women) undergoing mitral valve repair at Broussais Hospital and La Roseraie European Hospital in Paris. The mean age of these patients was 49.1 years (range, 4 to 76 years). Other patient characteristics are listed in Table 1Go. Excluded from this study were patients living in a foreign country because of the inherent difficulty of accurate follow-up, and patients who did not accept participation in this investigational study. All the other patients signed an informed consent form. They understood that the new ring effectively remodeled the annulus, as did the classic prosthetic ring, and had in addition some potential advantages resulting from its selective flexibility and saddle-shaped configuration. They were also informed that the Physio-Ring would be used only if at operation the configuration of the valve proved to be suitable.


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The causes of valvular diseases are as follows:

They show a majority of degenerative valvular diseases. Because there was no Marfan's disease in this series, valve degeneration comprised only two groups: (1) fibroelastic deficiency, a pathologic and clinical entity that has been described previously [9], and (2) Barlow's disease, characterized by excess valvular tissue and global myxoid degeneration. Extensive calcification of the mitral valve annulus was present in 12 cases (8.5%). The indications for operation were based on the severity of the mitral valve insufficiency (90 patients had grade III or IV) rather than on New York Heart Association functional class (60 patients were in class III or IV).

Valve Analysis
Accurate valve analysis was achieved by TM echocardiography before the operation, and by transesophageal echocardiography and visual inspection during the operation. Two conceptual approaches were used: (1) the functional classification already described in previous publications [3, 9] and (2) segmental valve analysis. In segmental valve analysis, the valvular apparatus is separated into eight segments (Fig 2Go). The three scallops of the posterior leaflet are identified as P1 (anterior scallop), P2 (middle scallop), and P3 (posterior scallop). The three corresponding segments of the anterior leaflet are termed A1 (anterior part), A2 (middle part), and A3 (posterior part). The remaining two segments are the anterior commissure and the posterior commissure. These 8 segments are analyzed comparatively using P1 as the reference point [10] because leaflet prolapse is rare at this level. The free edges of the other seven segments are compared with P1 to recognize and measure occasional prolapse. Leaflet pliability is also explored at each segment. This segmental valve analysis provides precise information, which serves as a guideline to valve reconstruction. For example, a type II, A3 P3 indicates a prolapse (type II) of both the posterior scallop (P3) and the corresponding posterior part of the anterior leaflet (A3), two prolapses that must be corrected. A combined type II A2, type IIIa P3 indicates a localized prolapse (II) of the middle part of the anterior leaflet (A2) associated with a restricted opening (IIIa) of the posterior scallop (P3) of the posterior leaflet; the anterior leaflet prolapse needs to be corrected and the restricted posterior leaflet motion requires leaflet mobilization. This method of valve analysis makes it possible, before operation, to classify the mitral valve dysfunctions (Table 2Go), to assess the feasibility of the repair, and to predict the techniques to be used (Table 3Go).



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Fig 2. . The mitral valve is separated into eight segments, which are analyzed sequentially with P1 (anterior scallop of the posterior leaflet) serving as a reference point. Then, the motion of each leaflet segment is defined according to the functional classification: type I = normal leaflet motion; type II = leaflet prolapse; type III = restricted leaflet motion during diastole (IIIa) or systole (IIIb).

 

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Table 1. . Preoperative Patient Characteristics
 
Surgical Technique
The technique of implantation of the Physio-Ring does not differ from that used for the classic ring. The same care must be taken to accurately size the anterior leaflet of the mitral valve, to place the sutures within the annulus, and to pass these sutures through the corresponding areas of the prosthetic ring.

APPROACH.
In the past 6 years, we have been using the following interatrial approach, which was first demonstrated during the 1988 Le Club Mitrale sessions (Fig 3Go). Two cannulas are used to drain the blood from the venae cavae. Those vessels are surrounded by tapes. The interatrial groove is incised and the two atria are dissected and divided up to the fossa ovalis. With the roof of the left atrium widely exposed, the left atrial incision is carried out very close to the mitral valve, approximately 3 to 4 cm from the classic left atrial incision. Two blades of a self-retaining retractor are then used to expose the mitral valve. This approach has provided excellent exposure even when a small atrium was present.



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Fig 3. . The interatrial approach. After the interatrial groove has been incised, the dissection of the interatrial septum permits separation of the right atrium from the left atrium. The approach to the mitral valve is then possible by incising the roof of the left atrium about 3 to 4 cm away from the commonly used left atrial incision at the pulmonary vein junction.

 
VALVE SIZING.
Valve sizing is particularly important, because too small a ring may lead to systolic anterior motion of the mitral valve (SAM) [6, 7]. Once the mattress sutures have been placed through the annulus, opposite traction is applied to the commissural stitches to slightly distend the intercommissural distance (Fig 4Go). Various sizers are tried, and the one whose intercommissural distance (between the two notches) corresponds to that of the annulus is selected. Using the same sizer, the height of the anterior leaflet is then measured. The anterior leaflet is unfurled by gentle downward traction on the marginal chords using nerve hooks, and the sizer is placed so as to cover the unfurled leaflet. The free edge of the leaflet must not extend more than 1 mm beyond the inferior edge of the sizer. In most cases, a good correlation between the width and the height of the anterior leaflet is found. If this is not the case, a classic ring is preferred, the vertical diameter of which can be enlarged by bending upward the free ends of the ring until its vertical diameter corresponds to the height of the anterior leaflet (Fig 5Go). During this study, a classic ring was the preferred choice in 9 patients (9/137; 6.5%) because of an abnormally high anterior leaflet.



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Fig 4. . Valve sizing: After traction is established on the two commissural sutures, sizers are used to measure the intercommissural distance between the two notches. Then, verification that the vertical diameter of the selected sizer covers the height of the anterior leaflet after unfurling it by traction of marginal chordae is carried out.

 


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Fig 5. . In most cases, the width and the height of the anterior leaflet correspond to those of the sizer: a Physio-Ring is then selected, the size of which corresponds to the sizer (left). Whenever the height of the anterior leaflet is larger than the vertical dimension of the sizer that has been selected on the base of the intercommissural dimension, a classic ring must be selected, the anteroposterior diameter of which is increased by bending upward its two extremities until the vertical diameter matches the height of the anterior leaflet (right).

 
VALVULOPLASTY PROCEDURES.
Before placement of the Physio-Ring, various techniques of valve repair involving commissures, leaflets, chordae, or papillary muscles were performed (see Table 3Go). They have been described in previous publications [3, 6, 10]. Of particular importance is to make sure that no excess tissue of the mural leaflet has been left in place, another potential cause of SAM. Whenever the height of the valvular remnants of the posterior leaflet is greater than 1 cm, the excess leaflet tissue must be resected or plicated using the sliding leaflet technique [2, 6]. The associated cardiac procedures carried out in this series were as follows:


    Results
 Top
 Footnotes
 Abstract
 Introduction
 Material and Methods
 Results
 Comment
 References
 
Mortality
There were three early deaths (1 month), for an early mortality rate of 2%. The causes of death were hemorrhage in 1 case of calcified mitral valve annulus, myocardial infarction, and lung sepsis at 1, 7, and 20 days respectively. There were no late deaths in this series.

Complications
Table 4Go summarizes the complications encountered in this experience. A SAM was diagnosed by intraoperative transesophageal echocardiography in 3 patients. Because of the unknown significance and fate of the resulting ventriculoaortic gradient, the valve was replaced in 2 patients who had a gradient of more than 30 mm Hg. In 1 patient with a ventriculoaortic gradient of less than 30 mm Hg, the ring was left in place and both the gradient and SAM disappeared within 4 months. A recurrent mitral valve insufficiency was observed in 1 patient 30 days after valve repair. The cause was rupture of the chords of the anterior leaflet arising from the posterior papillary muscle. Chordal abrasion, due to improper placement of the sutures that were used to close the trench of the papillary muscle after chordal shortening, was most probably the cause of this complication. Finally, 1 patient had a thrombus in the left atrial appendage. The patient was reoperated on and the thrombus was removed.


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Table 2. . Functional Classificationa
 
Follow-up
Follow-up from 6 to 18 months was complete in all 94 patients. The functional results at 6, 12, and 18 months showed a significant improvement in the New York Heart Association functional class with continuing improvement beyond 6 and 12 months (Table 5Go). Echocardiography over 6 months was obtained in 73 patients at 6 months and 56 patients at 12 months. Although the ring orifice area varied from 325 to 722 mm2 (Table 6Go), a minimal diastolic gradient averaging 3.5 ± 1.93 mm Hg was noted, which surprisingly tended to diminish over a period of 1 year (Table 7Go). At 6 months, 93.2% of the patients had no residual mitral valve regurgitation, and at 12 months, it was 94.7%. Mild regurgitation was observed in 6.8% and 5.3% of the patients after 6 and 12 months, respectively (Table 8Go). With the exception of the patient who required a reoperation 30 days after valve repair (0.7%), none of the patients had severe or moderate residual or recurrent mitral regurgitation. End-diastolic diameters and volumes and end-systolic diameters and volumes of the LV returned to normal after the operation (Fig 6Go).


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Table 3. . Valve Repair Procedures Used in This Seriesa
 

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Table 4. . Complications
 

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Table 5. . Postoperative Functional Status at Six Months or More
 

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Table 6. . Ring Sizes and Orifice Areas
 


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Fig 6. . Variations in left ventricular end-diastolic volume (mL, line) and ejection fraction (bars) after operation.

 

    Comment
 Top
 Footnotes
 Abstract
 Introduction
 Material and Methods
 Results
 Comment
 References
 
In 1957, Lillehei and associates [11] reported the first successful repair of a regurgitant mitral valve by annulus plication under direct vision. Subsequent attempts were made by several authors using either valve plication [12], annulus plication [13, 14], or posterior annulus support using a semicircular strip of Teflon or Dacron sutured to the annulus of the posterior leaflet [15, 16]. Although these techniques were associated with good initial results, in many instances they failed to achieve a sufficient degree of predictability (incidence of residual leak) or long-term stability (incidence of recurrent leak). As a consequence, valve replacement became the preferred surgical technique in the years 1965 to 1975. In 1969, the introduction of the ring annuloplasty concept [1] was seen as a breakthrough in valve reconstruction because of superior predictability and long-term stability of the results [16, 17]. It allowed the development of a variety of techniques of valve reconstruction [13], which made it possible to repair an increasing number of mitral valve insufficiencies (Fig 7Go). Thus, in our institution, although fewer than 5% of the mitral valve insufficiency cases could be repaired in the early 1970s, the percentage was 25% in the 1980s, and more than 70% in the 1990s. In 1976, seven years after the introduction of the ring annuloplasty concept and most of the reconstructive procedures, Duran and colleagues [18] proposed the use of a totally flexible ring with the aim of retaining a more normal systolic motion of the mitral annulus. The same year, Cooley and associates [19] introduced a horseshoe ring, very similar to Belcher's posterior reinforcement, to avoid sutures at the anterior leaflet, but this technique was abandoned after few years because of the increased fragility associated with noncircumferential supports.



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Fig 7. . The development of Carpentier techniques of valvuloplasty between 1970 and 1994. New techniques (upper part of the figure) developed throughout the years allowed the surgeon to operate on more cases (curve) and for more complex valvular diseases (lower part of the figure). (P.M. = papillary muscle.)

 
More recently, attention has been drawn to possible impairment of left outflow tract obstruction [4] or LV function [5] after ring annuloplasty. Too hastily, the remodeling annuloplasty technique was judged to be the cause of these drawbacks. Controversy flourished between partisans of ring flexibility and supporters of the remodeling concept. The Physio-Ring was developed to combine flexibility and remodeling and to reconcile the opponents. Indeed, the configuration and composition of the ring provides ring flexibility where it is necessary, ie, at the posterior aspect of the mitral valve annulus, and the remodeling effect where it is necessary, ie, between the two commissures, thus restoring the 3:4 physiologic relationship between the vertical diameter and the transverse diameter of the annulus, the key factor of predictability and long-term stability in annuloplasty.

Left Outflow Tract Obstruction and Systolic Anterior Motion
Some years ago, our group carefully analyzed the mechanism producing postrepair SAM of the mitral valve and the risk factors involved [7]. The main two reasons were excess tissue of the posterior leaflet (Fig 8Go) and inadequate ring sizing, resulting in too small a ring for a too large anterior leaflet. The latter was the cause of the 3 cases of SAM observed in this series, because the mural leaflet had been reduced in size in all of these 3 cases using the sliding leaflet technique [6]. Of these 3 cases, 1 with a moderate gradient was not reoperated on, whereas the 2 others with a gradient greater than 30 mm Hg were reoperated upon. The valve could have been repaired a second time in these cases by using a larger ring. However, the policy in this investigational series was to replace the valve whenever such a problem occurred. As experience grew, the technique of valve sizing was refined as described in this article, and no case of SAM was seen in the last 56 patients. On the other hand, it is interesting to note that in the patient who was not reoperated on, SAM and ventriculoaortic gradient disappeared after 4 months, a common finding whenever SAM is seen with a limited gradient [6, 7].



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Fig 8. . Mechanism producing systolic anterior motion in Barlow's disease and the technique to prevent it. (A) Before operation: excess tissue of anterior and posterior leaflets associated with an enlarged mitral valve orifice. (B) After ring implantation, the extra amount of valvular tissue displaces the closure line and the anterior leaflet toward the left outflow tract. The anterior leaflet may obstruct the left outflow tract. The systolic anterior motion may also produce a mitral valve regurgitation in spite of the large surface of coaption. (C) Reducing the amount of tissue at the posterior leaflet (sliding leaflet techniques) and selecting a ring of the appropriate size (vertical diameter equal to the height of the anterior leaflet) places the closure line far from the outflow tract and prevents systolic anterior motion.

 
Left Ventricular Function
It is well established that the mitral valve annulus contracts during systole. However, controversy remains as to whether annular fixation by a rigid ring can cause LV dysfunction and deleterious hemodynamic changes. Tsakiris and associates [20] were first to address this question and found, 2 to 10 weeks after ring implantation in dogs, no significant impairment of LV pump function between dogs undergoing rigid ring annuloplasty and control animals. In contrast, Van Rijk-Zwiller and colleagues [21], who examined the effect of rigid ring annuloplasty in pigs with an ex vivo heart preparation and videoscopy, found a 14% drop in peak isovolumic pressures and a 25% lower unloaded maximal stroke volume, whereas a flexible ring seemed to preserve the counter-clockwise rotation of the posterior annulus and reduction of the mitral annular area during systole. Spence and co-workers [22], investigating rigid ring versus flexible ring in vivo in swine, also found that the rigid ring group had a significant decline in systolic pressure, developed LV pressure, and LV maximum rate of increase in LV pressure at higher filling volumes. However these findings have not been confirmed by the more recent and elegant study of Castro and associates [23]. Using tantalium markers they measured LV volume and geometry in vivo in dogs. After 1 to 6 weeks, biplane videofluoroscopic images were obtained and global and regional systolic function was assessed with load-insensitive indexes. Comparison between dogs with rigid rings, flexible rings, and no rings at all showed no significant differences in global or regional LV performance. Furthermore, neither type of annuloplasty ring significantly affected LV pump efficiency, ventricular arterial coupling ratio, or systolic circumferential contraction and rotation of the basal LV site. Finally, David and colleagues [5] reported results from 25 patients with chronic mitral regurgitation who received either a rigid or a flexible ring. They assessed LV performance by radionuclide angiography and echocardiography preoperatively and 2 to 3 months after operation. Compared with preoperative values, the LV end-diastolic volume fell significantly in both groups and LV end-systolic volume fell significantly only in the flexible ring group. However, this methodology gives a rough approximation of LV performance, and the number of patients studied in both groups was small. Moreover, the differences in LV performance between rigid and flexible rings were not found 1 year later, and the orifice mitral valve area on the contrary favored the rigid ring (average, 3.42 cm2) versus the flexible ring (2.92 cm2). In the series reported in this article, we also noticed a significant reduction in the LV end-diastolic volume, whereas the LV end-systolic volume was normal immediately after operation (see Fig 6Go).

These contradictory findings between different well-documented experimental and clinical works point out the difficulty in analyzing and interpreting perturbed regional LV geometry and ventricular function whenever the changes are limited, the more so because the plasticity of the myocardium plays a significant role in smoothing out these changes. On the other hand, the clinical results do not always correlate with sophisticated measurements and theoretical considerations. For example, in David and colleagues' comparative clinical series of flexible versus rigid rings, no complications were seen in the rigid ring group, whereas 2 of 14 patients (15%) in the Duran ring group ``experienced serious postoperative complications: one patient was kept on ventilator for 15 days and the other required a reoperation in the third postoperative week because of paravalvular mitral regurgitation'' [5]. The reasons we introduced the Physio-Ring were not so much that we believe in the superiority of flexible rings over rigid rings in term of hemodynamics (we have not yet been able to find a statistically significant difference in LV function between this series and our previous series using the classic ring [2]), but rather the fact that a flexible structure may reduce the stress on the sutures and therefore may further reduce the incidence of residual or recurrent mitral valve insufficiency, particularly in complex cases [2428].

Mitral Valve Function
The low incidence of residual mitral valve insufficiency in this series was particularly striking. It seems lower than our previous figures using the rigid ring. Reviewing the long-term results in a consecutive series of 151 patients, Deloche and associates [2], from our group, found 74% of patients free from regurgitation at 13 years, whereas 10% had 1+ mitral regurgitation, 7.3% 2+, and 2.5% 3+. Indeed, it is not possible to compare two series of patients with such a difference in follow-up. However, Deloche and associates pointed out that two thirds of the residual mitral valve insufficiencies were present within the first year after the operation, for an incidence of 17% versus 12% in this series. The low transvalvar gradient may explain in part the low incidence of thromboembolism in this series, which contrasts sharply with the higher incidence reported in series in which narrowing annuloplasties with totally flexible and deformable rings or ``adjustable'' rings were used [29, 30]. In a series of 85 patients reviewed after 10 to 12 years, Duran and co-authors [29] found a 20.1% incidence of thromboembolic complications for a linearized rate of 2.52%/patient-year [29]. This correlates with a reduced mean valve orifice area of 1.93 ± 0.74 cm2, which contrasts with the 3.55 cm2 mean orifice area found in our series. Although it may be questionable to compare the results of different patient populations, recognizing in particular that Duran and co-authors' series comprised a large number of rheumatic valvular disease cases, differences of this magnitude must have some significance. We believe that not only the overnarrowing effect but also the pursestring effect with irregular contour of the totally flexible ring were the main causes of this higher rate of thromboembolism.

In conclusion, the results of this series have been promising so far. However, if the Physio-Ring represents a conceptual advance in mitral valve annuloplasty because it combines remodeling and flexibility, only longer follow-up will evaluate precisely its benefit over the classic annuloplasty ring.


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Table 7. . Diastolic Gradient at One, Six, and Twelve Months According to Causea
 

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Table 8. . Residual Regurgitation at 6 and 12 Months
 

    Footnotes
 Top
 Footnotes
 Abstract
 Introduction
 Material and Methods
 Results
 Comment
 References
 
Presented at the Thirty-first Annual Meeting of The Society of Thoracic Surgeons, Palm Springs, CA, Jan 30–Feb 2, 1995.

Address reprint requests to Dr Carpentier, Cardiovascular Surgery Department, Hôpital Broussais, 96, rue Didot, 75014 Paris, France.


    References
 Top
 Footnotes
 Abstract
 Introduction
 Material and Methods
 Results
 Comment
 References
 

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