WO2008081450A2

WO2008081450A2 - Device and method for remodeling a heart valve

Info

Publication number: WO2008081450A2
Application number: PCT/IL2008/000018
Authority: WO
Inventors: Gad Keren
Original assignee: Medical Research Fund At The Tel Aviv Sourasky Medical Center
Priority date: 2007-01-03
Filing date: 2008-01-03
Publication date: 2008-07-10
Also published as: WO2008081450A3

Abstract

A device and method for remodeling a heart valve, such as a mitral or tricuspid valve. The device is adapted for insertion into the annulus of the valve and, and when inserted into the annulus alters the shape of an annulus in order to decrease the orifice between the valve leaflets when the valve is closed. The device may be used in the treatment of valve regurgitation. The invention also provides a catheter for deploying the device of the invention.

Description

DEVICE AND METHOD FOR REMODELING A HEART VALVE

FIELD OF THE INVENTION

This invention relates to medical devices and methods, and more particular to such devices and methods for treating a heart valve.

BACKGROUND OF THE INVENTION Normal mitral valve function and closure is dependent on faultless interaction of six components which include: The mitral leaflets, the mitral annulus, the chordae, papillary muscles, left ventricle, and left atrium. Coordinated function of these components is needed for effective valve closure and prevention of mitral regurgitation. Malfunction of any of these components may lead to regurgitation. Motion of the mitral leaflets is affected by the pressure gradient across the valve between the left atrium and the ventricle, although annular dynamic motion, with effective contraction during systole in conjunction with papillary muscle traction in the appropriate direction may also be important in maintaining closure.

The mitral valve has two leaflets that are not equal in shape and size. The anterior leaflet has, on average, a length of 3 cm and a width of about 1.8 cm , with an area of about 4.3 cm². The width of the posterior leaflet is 1.2 cm on average with an annular length of 5.2 cm and an average area of 1.7 cm². The combined area of both leaflets is 2.5 times the annulus area and when the leaflets coapt the zone of leaflet apposition results in leaflet overlap. Changes in leaflet tissue, restricted motion, and annular dilatation results in malapposition and mitral regurgitation. The two leaflets are located at the base of the atrium adjacent to the mitral annulus which is a saddle shaped elliptical region made of fibrous tissue. Anteriorly, there is fibrous continuity between the mitral valve leaflet and the posterior aspect of the aortic root without histological evidence of a distinct annular structure. Posteriorly, there is usually a discrete C-shaped fibrous annulus which causes changes in the annular size in various disease states. The chordae tendineae are elongated fibrous structures that extend from the papillary muscle to the mitral valve leaflets and mainly to the free edge of the leaflets. Basal chordae attach to the ventricular surface of the leaflets and commissural chordae to the area of the commissures. Chordae from both papillary muscles are attached to both leaflets. Chordae from the posteromedial are attached to the medial aspect and chordae from the anterolateral papillary muscle to the lateral aspect of the leaflets.

The papillary muscles anchored to the left ventricular wall oppose the tendency of the leaflets to prolapse into the left atrium under the systolic pressure generated in the left ventricle. The left ventricle affects the closure of the mitral valve by a few mechanisms.

Dilatation or regional wall motion abnormalities may cause tenting of the leaflets or tethering with inadequate closure. Dynamics of the annulus in systole and diastole are affected by ventricular function. Since the posterior aspect of the annulus is less fibrotic it may dilate more significantly than other parts of the annulus thereby increasing the anteroposterior diameter more than the mediolateral diameter.

Left atrium enlargement may distort mitral annular shape and dimension and thereby affect the severity of mitral regurgitation. Moreover, rhythm disorder and mainly loss of proper sinus function is associated with atrial shape change that may affect changes in the size of the annulus. A wide variety of disease processes lead to mitral regurgitation. These diseases affect one or more components of the mitral valve apparatus. The list of causes is quite long and includes primary diseases of the valve such as myoxomatous degeneration with prolpase, rheumatic fever, endocarditis or diseases secondary to another cardiac disease such as ischemic heart disease and acute MI (myocardial infarction) or global ventricular dysfunction. Primary myocardial diseases may affect valve function (hypertrophic cardiomyopathy, dilated cardiomyopathy, endomyocardial finbrosis).

The amount of mitral regurgitation across an incompetent mitral valve is related to the systolic pressure gradient between the left ventricle and left atrium, the size of the regurgitant orifice and the duration of regurgitation. It was shown in animal experimentation as well as in human trials that during pharmacological interventions, the volume of regurgitation is determined mainly by the size of the regurgitant orfice and less by the pressure gradient across the valve. A dynamic change in the size of the orifice is responsible for the reduction in the regurgitant volume during hemodynamic interventions.

Treatment of mitral regurgitation may be pharmaceutical or surgical depending on the severity of the condition, the anatomy of the valve and comorbidities. Surgical therapy includes mitral valve replacement or valve repair. A wide variety of repair techniques have been developed that may include annulus size reduction with or without an annuloplasty ring. Prosthetic ring annuloplasty is of utmost importance in most cases of surgical valve repair since annular dilatation occurs in most cases of severe mitral regurgitation or in patients with dilated left ventricles and associated mitral regurgitation. An alternate approach to mitral valve repair is the Alfieri technique which involves suturing the anterior and posterior leaflets together in the central section of the leaflets. Other methods include mitral valve repair with LV (left ventricle) remodeling and reshaping techniques to re-orient the papillary muscles and the chordae and leaflets such that the approximation of the edges improves and closure of the valve is obtained.

There are two major different minimally invasive catheter approaches that have been applied to treat mitral regurgitation. Both of these approaches try to replace current surgical techniques with percutaneous techniques. These approaches are a) trying to partially plicate, or attach, the mitral leaflets to each other in order to minimize leakiness, or b) trying to partially "cinch" the valve with a "belt." ''" At this time it is unclear which of them will prove to be the better approach and whether these approaches are actually complementary "'.

The first method of using a catheter to partially attach the mitral leaflets is known as the "edge-to-edge " technique. This approach mimics a surgical technique that has been performed in several hundred cases.^lv Feasibility animal studies using catheters that can clip or suture the mitral leaflets have been performed. These studies suggest that the technique can be performed quite reliably. The studies show that the clip which holds the leaflets is endothlialized. Intracardiac or 3D echo may help in guiding the clip during deployment. Initial human procedures suggest that there are no procedural complications but a significant amount of residual MR (mitral regurgitation) occurred in many of the patients/

A catheter based suturing device has been disclosed and used for suturing themitral leaflets together. ^V1 The tip of the suturing catheter has two side holes that are positioned so that each hole faces a different mitral leaflet. A suction device is applied on the side holes, which maintains the leaflets in a closed position and the fixation device is fired. Two needles with monofilament sutures transfixing the leaflets are deployed and exteriorized through the apical port. The sutures are tied using a knot pusher. Another percutaneous suturing device, known as the "Cardiostitch", and produced by US Surgical Corporation, has also been used to suture mitral leaflets together.^vii

The second catheter approach for treating mitral regurgitation aims to mimic the surgical procedure of annuloplasty. These catheter devices take advantage of the anatomic location of the coronary sinus relative to the mitral valve. In these procedures, these catheter devices crimp the valve by leaving stiff devices in the coronary sinus. The goal of this transcoronary sinus annuloplasty is to help narrow and limit the expansion of the mitral valve annulus. Animal feasibility studies have been completed and human experimentations are on going.^{vul> Ix} The ring inserted into the coronary sinus is localized to the posterior aspect of the annulus and is thus incomplete leaving the posteromedial commissure and the anterior half of the annulus unsupported. Moreover, the coronary sinus is sometimes localized distant from the annulus thus not allowing effective down-sizing of the annulus. Several devices are currently being studied. Most of the available data regarding trans-coronary prosthetic ring annuloplasy is preliminary .^x

SUMMARY OF THE INVENTION

The present invention is based on the finding that regurgitation through a heart valve can be reduced or eliminated by altering the shape of the muscular annulus surrounding the valve. The heart valve may be a mitral valve or a tricuspid valve. In the case of the mitral valve, for example, mitral regurgitation can be reduced or eliminated by decreasing the anterior-posterior axis of the mitral valve. By decreasing the length of the anterior posterior axis, the anterior and posterior leaflets of the valve are drawn closer together thus reducing the spacing between the two leaflets. This in turn reduces or eliminates the amount of valve regurgitation. Thus, the present invention provides a device and method for remodeling a heart valve by altering the shape of the annulus surrounding the valve in order to approximate the valve leaflets. In the case of the mitral valve, for example, the anterior-posterior axis of the animlusof the valve is decreased. The device of the invention is deployed in the annulus of the valve and remodels the annulus to achieve a decrease in the length of the posterior-anterior axis. In one embodiment, the device of the invention is a rod that is deployed parallel to the medio-lateral axis of the valve and increases the length of the medio-lateral axis. The increase in the length of the medio-lateral axis induces a corresponding decrease in the anterior-posterior axis. In another embodiment of the device of the invention, the device comprises a frame surrounding a grid-like structure.

The invention also provides a catheter for deploying the device of the invention. The catheter of the invention is adapted to have a device of the invention mounted on its distal end. The catheter may also include a suturing assembly at its distal end for suturing the device to the annulus at one or more sites.

The method of the invention comprises decreasing the length of the anterior- posterior axis of an annulus of a heart valve that may be a mitral valve or a tricuspid valve. The method of the invention may be carried out, for example, by deploying a device of the invention in the annulus. The method of the invention may also be carried out by suturing one or more cords across the annulus to achieve the decrease in the anterior-posterior axis. The method of the invention may be carried out percutaneously using a catheter-based suturing device.

Thus, in one of its aspects, the invention provides a device for remodeling a heart valve adapted for insertion into an annulus of the valve and altering a shape of an annulus surrounding the valve.

In another of its aspects, the invention provides use of the device of the invention for the treatment of valve regurgitation.

The invention also provides a catheter having a proximal end and a distal end configured for deploying a device of the invention.

The invention further provides a method for remodeling a heart valve comprising deploying in an annulus of the heart valve a device of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS In order to understand the invention and to see how it may be carried out in practice, embodiments will now be described, by way of non-limiting example only, with reference to the accompanying drawings, in which: Fig. 1 shows a normal mitral valve;

Fig. 2 shows an abnormal mitral valve;

Fig. 3 shows a device for remodeling a mitral valve having a rod shape, in accordance with one embodiment of the invention; Fig. 4 shows deployment of the device of Fig. 3 in an annulus of a mitral valve;

Fig. 5 shows a device for remodeling a mitral valve having frame and a grid, in accordance with a second embodiment of the invention;

Fig. 6 shows deployment of the device of Fig. 5 in an annulus of a mitral valve;

Fig. 7 shows a catheter for delivering a device of the invention to a mitral valve and deploying the device;

Fig. 8 shows the catheter of Fig. 7 with a device of the invention mounted on a distal end of the catheter; and

Fig. 9 shows remodeling of a mitral valve using cords sutured to the annulus.

DETAILED DESCRIPTION OF EMBODIMENTS

In the following embodiments, the invention will be described in relation to a mitral valve. This is by way of example only, and the invention may be implemented in any heart valve such as a mitral valve or a tricuspid valve.

Fig. 1 shows the structure of a normal mitral valve 2. The valve 2 has a mitral annulus 4 surrounding the valve that is generally elliptical in shape having a major axis CD extending from medial to lateral aspects of the valve, and an anterior-posterior minor axis AB. The anterior leaflet 6 and the posterior leaflet 8 are oriented in a medial to lateral direction, and the orifice 10 between the leaflets 6 and 8 is substantially parallel to the major axis CD of the annulus. The anterior leaflet is larger than the posterior leaflet. During functioning of the valve, dilatation of the mitral annulus occurs mainly in the anterior posterior direction AB.

Mitral regurgitation can occur due to a pathology at a specific site or along the entire length of the orifice 10. Fig. 2 shows the structure of a diseased mitral valve 16 in which pronounced expansion of the annulus 18 has occurred. The expansion is mainly in the posterior portion of the annulus 18, which is more prone to expansion than the anterior portion. Expansion of the posterior region of the annulus 18 results in lengthening of the anterior-posterior axis A¹B' of the annulus, in comparison to the normal length AB shown in Fig. 1. A concomitant reduction in the medial lateral axis CD', in comparison to the normal length CD shown in Fig. 1, may also be observed though this axis may dilate as well. These changes in the lengths of the annular axes and mainly the increase in the antero-posterior aspects (AB) increase the separation between the anterior leaflet 22 and the posterior leaflet 24. Under these conditions, the valve 16 may fail to completely close during systole, resulting in mitral regurgitation.

Fig. 3 shows a device 28 for treating mitral regurgitation in accordance with one embodiment of the invention. The device 28 is shown in perspective projection in Fig. 3a, and in a longitudinal section in Fig. 3b. The device 28 is rod shaped having a first end 30 and a second end 32. The device 28 is used to increase the medial lateral axis of a diseased mitral valve to a desired length, and to maintain the medial lateral axis at the desired length. The length of the device 28 is selected to correspond to the desired length of the medial lateral axis. The ends 30 and 32 of the device 28 are configured for attachment to the annulus. The device 28 is delivered to the left side of the heart, and the ends 30 and 32 of the device 28 are attached, for example, by suturing the ends to the annulus. The device 28 preferably has an adjustable length that may be selected after delivery of the device 28 to the site of its deployment. For example, as shown in Fig. 3, the device 28 may comprise a first member 34 and a second member 36. The first member 34 is a hollow cylinder dimensioned to receive in its interior a portion of the second member 36. The second member 36 is thus slidable relative to the first member 34, so that the overall length of the device 28 can be selected. Once the length of the device 28 has been set, the length may be fixed by suturing the first and second portions together. The first member 34 has along its length one or more pairs of diametrically opposed holes 40a and 40b. Similarly, the second member 36 has along its length one or more pairs of diametrically opposed holes 42a and 42b. At least one of the pairs of holes 40a 40b on the first member is aligned with a pair of holes 42a 42b on the second member. A suture is then inserted through the four aligned holes 40a, 40b, 42a, and 42b, and the suture is tied to prevent further sliding of the second member relative to the first member.

Fig. 4 shows the device 28 after deployment in a left ventricle adjacent to the mitral valve 42. The first end 30 of the device 28 has been sutured to a point C" on the mitral annulus 47 by a suture 44, and the second end 32 has been sutured to a point D" on the mitral annulus 47 by a suture 46. Proper positioning of the device 28 is facilitated by angiographically or ultrasonograhically visible markers 40 on the surface of the first and second members of the device that are separated by a fixed distance, for example, in the range of 5-10 mm. The overall length of the device 28 was selected to achieve a desired separation between me points C" and D". The length of the device 28 was fixed by a suture 48 through the device, as explained above. The increased length of the lateral medial axis has decreased the anterior posterior axis, so that the separation between the anterior leaflet 22 and the posterior leaflet 34 has decreased in comparison to the separation prior to deployment of the device 28, as shown in Fig. 3. Decreasing the separation of the leaflets reduces or eliminates mitral regurgitation.

Additional stabilization of the device 28 in the heart may be obtained by introducing sutures 50 from the device 28 to various locations on one or both leaflets 22 and 24 in order to obtain changes in the motion and shape of a dysfunctional leaflet and improve leaflet alignment. Sutures can be extended to the various parts of the left ventricle including papillary muscles in order to induce shape changes in the left ventricle.

The device 28 can be somewhat flexible. After implantation, the rod can also serve as an anchor for any further future interventions involving devices for reducing mitral regurgitation or improving valve function. An artificial leaflet may be sutured to the device 28 and to one or two dysfunctional leaflets in order to improve leaflet coaptation. The device 28 can also function as a hinge around which the artificial leaflets move between open and closed positions during the phases of the cardiac cycle (systole and diastole) in order to improve the effective closure and opening of the mitral valve.

Fig. 5 shows a device 52 for treating mitral regurgitation in accordance with another embodiment of the invention. The device 52 comprises a frame 54 enclosing a grid 56 The device 52 is deployed in the left atrial aspect of the mitral valve with the frame 54 adjacent to the mitral annulus. The device 52 is preferably flexible, so that it can be folded or otherwise collapsed during delivery and then brought back to its unfolded or uncollapsed configuration in the heart for deployment. Fig. 6 shows the device 54 after deployment adjacent to a mitral valve. The shape of the frame 54 is selected to have a shape that is to be imposed on the annulus 58. The frame 54 is sutured by sutures 60 at several locations around the annulus 58, in order to immobilize the device 52 in the left atrium. Suturing of the device 52 to the annulus 58 fixes the annulus in a desired shape and size, fixes the lengths of the lateral medial axis C^MtD'" and the anterior posterior axis A'^MB'" at desired lengths so as to reduce the separation of the anterior leaflet 62 and the posterior leaflet 64, and thus reduce or eliminate mitral regurgitation. Alternatively, the frame 54 may be flexibly resilient and shaped to be lodged in the appropriate position in the atrium without the need for suturing. The frame 54 can have a generally circular or elliptic shape. The device 52 may be provided with angiographically visible markers 66 for assistance in positioning the device during deployment. The device 52 is preferably not flow limiting and enables new chordae and attachments to be tied to the mitral valve, thus enhancing re-orientation of the papillary muscle and walls and remodeling of the shape of the mitral valve. During deployment of the device of the invention, mitral regurgitation can be monitored by echocardiography, transesophageal echo-cardiography or Doppler cardiography.

Figs. 7 and 8 show a catheter 70 for delivering and deploying a device of the invention in an atrium adjacent to a mitral valve to be treated by the device. The catheter 70 has a slender flexible shaft 72 having a proximal end 74 and a distal end 76. The distal end 76 is configured to have mounted upon it a device 79 of the invention for treating a mitral valve. Fig. 8 shows the device 52 mounted on the distal end 76 of the catheter 70. This is by way of example only, and the distal end 76 can be adapted to mount any device 79 of the invention for treating a mitral valve. A control wire 80 extends along me interior of the shaft from the proximal end to the distal end that allows an operator to release the device 79 from the distal end 76 when the device 79 is deployed adjacent to a mitral valve. The distal end is also provided with a suture assembly 78 for suturing the device 79 at the site of deployment of the device. The suture assembly may be used with spring sutures or cords. The distal end 76 of the catheter 70 may be delivered to the mitral valve via a transseptal approach.

Fig. 9 shows a method for treating a mitral valve 82 in accordance with one embodiment of this aspect of the invention. In the method of the invention for treating a mitral valve, the mitral annulus 83 is remodeled into a desired shape by introducing one or more cords, such as the cords 84, 86 and 88, into the interior of the annulus that are sutured at each end to the annulus. The length of each cord is determined so as to draw opposite points on the annulus towards each other so as to impose upon the annulus a desired shape and size. After suturing, the cord should be taut in order to maintain the desired shape of the annulus. The length of the cord extending from one suture to the other can be determined by multiple angiographically visible markers 90 on the cord separated by predetermined known distances of 5-10 mm. The origin of the mitral regurgitation can be monitored during the procedure, for example, by echocardiography, transesophageal echco- cardiography, or Doppler cardiography in order to determine where additional multiple sutures should be introduced to further reduce the annulus to reduce the amount of mitral regurgitation.

A suturing catheter is used to carry out the method of the invention. The distal end of the catheter is inserted via the aortic root towards the papillary muscle. A suture is then made at the medio-anterior aspect of the annulus and then the string attached and sutured to the head of the posteromedial papillary muscle. Extra tension is then applied during suture positioning in order to approximate the papillary muscle and the adjacent left ventricle wall towards the annulus thus reducing the amount of mitral regurgitation.

In one embodiment of the method of the invention shown in Fig. 9, a first cord 86 sutured at one end to a point J on the annulus 83,and at another end to a point K on the annulus. A second cord 88 is then sutured at one end to a point Jl on the annulus 83 and at another end to a point Kl. The cords 86 and 88 extend substantially parallel to the minor axis AB of the annulus from the anterior to the posterior aspects of the annulus. Additional cords can then be inserted as required to achieve effective remodeling of the anterior-posterior aspects of the annulus. This results in approximation of the mitral valve leaflets at their longitudinal orifice.

The method of the invention may be used to correct papillary muscle malorientation in dilated cardiomyopathy and ischemic cardiomyopathy using sutures extending from the head of the papillary muscle to the anterior aspect of the annulus and mainly to the fibrous ring. References:

¹ Block PC. Percutaneous mitral valve repair for mitral regurgitation. J Interv

Cardiol. 2003 Feb;16(l):93-6.

^II Condado JA, Velez-Gimon M. Catheter-based approach to mitral regurgitation.

J Interv Cardiol. 2003 Dec;16(6):523-34.

^III Vahanian A, Pallacios IF: Percutaneous approaches to valvular disease. Circulation 2004;109:1572-1579.

^1V Maisano F₅ Caldarola A, Blasio A, De Bonis M, La Canna G, Alfieri O. Midterm results of edge-to-edge mitral valve repair without annuloplasty. J Thorac Cardiovasc Surg. 2003 Dec;126(6):1987-97.

^v Feldman T, Wasserman HS, Herman HC₅ Gray W₅ Block PC, Whiltlow P₅ St.

Goar F₅ Rodriguez L, Silverty F, Schwartz A₅ Sanborn TA₅ Condado JA₅ Foster E:

Percutaneous mitral valve repair using the edge technique. 6 month results of the

EVEREST phase I clinical trial. JACC 2005,46:2130-40.

^V1 Alfieri O₅ elefteriades JA, Chapolini RJ, et al. Novel suture device for beating- heart mitral leaflet approximation. Ann Thorac Surg 2002, 74:1488-1493.

^vii Downing SW, Herzog WA₅ Mclaughlin JS, Gilbert TP. Beating-heart mitral valve surgery: preliminary model and technology. J Thorac Cadiovasc Surg 2002; 123:1141- 1146.

^V1U Kaye DM, Byrne M, Alferness C, Power J. Feasibility and short-term efficacy of percutaneous mitral annular reduction for the therapy of heart failure-induced mitral regurgitation. Circulation. 2003 Oct 14; 108(15): 1795-7. Epub 2003 Oct 06.

* Liddicoat JR₅ Mac Neill BD, Gillinov AM, Cohn WE, Chin CH, Prado AD, Pandian NG, Oesterle SN. Percutaneous mitral valve repair: a feasibility study in an ovine model of acute ischemic mitral regurgitation. Catheter Cardiovasc Interv. 2003 Nov;60(3):410-6. ^x Vahanian A, Acar C: Percutaneous valve procedures : Percutaneous valve procedures : what is the future. Cur Opin. Cardiol 2005;20:100-6.

Claims

CLAIMS:

1. A device for remodeling a heart valve adapted for insertion into an annulus of the valve and altering a shape of an annulus surrounding the valve.

2. The device according to Claim 1 adapted for remodeling a mitral valve.

5 3. The device according to Claim 3 adapted for decreasing an anterior-posterior axis of the annulus when inserted in the annulus of the mitral valve.

4. The device according to Claim 1 adapted for remodeling a tricuspid valve.

5. The device according to any one of the previous claims adapted to be sutured in the annulus.

10 6. The device according to any one of Claims 1 to 5 adapted to be lodged in the annulus.

7. The device according to any one of the previous claims comprising one or more angiographic markers.

8. The device according to any one of the previous claims having a rod portion 15 with a first end adapted for attachment at a first site on the annulus and a second end adapted for attachment to a second site on the annulus.

9. The device according to Claim 8 wherein the rod has a selectable length.

10. The device according to Claim 9 comprising a first member and a second member, the first member having an interior configured to slidably receive a portion of

20 the second member.

11. The device according to Claim 9 or 10 wherein the length of the rod is fixed using one or more sutures.

12. The device according to any one of Claims 8 to 11, wherein the rod is flexible.

13. The device according to any one of Claims 8 to 11 wherein the rod is rigid.

25 14. The device according to any one of Claims 1 to 7 having a frame adapted for insertion in the annulus.

15. The device according to Claim 11 further comprising a grid held by the frame.

16. The device according to any one of the previous claims configured to increase a length of a medio-lateral axis of the annulus.

30 17. Use of the device according to any one of the previous claims for the treatment of valve regurgitation.

18. A catheter having a proximal end and a distal end configured for deploying a device according to any one of the previous claims.

19. The catheter according to Claim 18 adapted for mounting a device according to any one of Claims 1 to 17 at the distal end of the catheter.

20. The catheter according to Claim 18 or 19 further comprising a suturing assembly at the distal end of the catheter.

5 21. A method for remodeling a heart valve comprising deploying in an annulus of the heart valve a device according to any one of Claims 1 to 16.

22. The method according to Claim 21 comprising suturing the device in the annulus.

23. The method according to Claim 21 comprising lodging the device in the 10 annulus.

24. A method for remodeling a heart valve comprising, for each of one or more cords, suturing a first end of the cord at a first site of an annulus of the heart valve and suturing a second end of the cord at a second site of the annulus.

25. The method according to Claim 24 wherein at least one cord is taut after 15 suturing the first and second ends.

26. The method according to Claim 24 wherein a taut cord fixes a length of an anterior-posterior axis of the annulus at a length small than an initial length of the anterior-posterior axis.

27. A method for treating mitral regurgitation at a heart valve comprising decreasing 20 an anterior-posterior axis of an annulus of the heart valve.

28. A method for treating heart valve regurgitation comprising percutaneously stabilizing and fixing the medio lateral axis of an annulus of the heart valve.

29. The method according to any one of Claims 21 to 28 wherein the heart valve is a mitral valve.

25 30. The method according to any one of Claims 21 to 28 wherein the heart valve is a tricuspid valve.