The methods, devices, and systems are provided for performing endovascular repair of atrioventricular and other cardiac valves in the heart. Regurgitation of an atrioventricular valve, particularly a mitral valve, can be repaired by modifying a tissue structure selected from the valve leaflets, the valve annulus, the valve chordae, and the papillary muscles. These structures may be modified by suturing, stapling, snaring, or shortening, using interventional tools which are introduced to a heart chamber. Preferably, the tissue structures will be temporarily modified prior to permanent modification. For example, opposed valve leaflets may be temporarily grasped and held into position prior to permanent attachment.

Methods and apparatus for cardiac valve repair

BackgroundIn a trial comparing coronary-artery bypass grafting (CABG) alone with CABG plus mitral-valve repair in patients with moderate ischemic mitral regurgitation, we found no significant difference in the left ventricular end-systolic volume index (LVESVI) or survival after 1 year. Concomitant mitral-valve repair was associated with a reduced prevalence of moderate or severe mitral regurgitation, but patients had more adverse events. We now report 2-year outcomes. MethodsWe randomly assigned 301 patients to undergo either CABG alone or the combined procedure. Patients were followed for 2 years for clinical and echocardiographic outcomes. ResultsAt 2 years, the mean (±SD) LVESVI was 41.2±20.0 ml per square meter of body-surface area in the CABG-alone group and 43.2±20.6 ml per square meter in the combined-procedure group (mean improvement over baseline, −14.1 ml per square meter and −14.6 ml per square meter, respectively). The rate of death was 10.6% in the CABG-alone group and 10.0% in the combined-...

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Two-year outcomes of surgical treatment of severe ischemic mitral regurgitation

Background Ischemic mitral regurgitation is associated with a substantial risk of death. Practice guidelines recommend surgery for patients with a severe form of this condition but acknowledge that the supporting evidence for repair or replacement is limited. Methods We randomly assigned 251 patients with severe ischemic mitral regurgitation to undergo either mitral-valve repair or chordal-sparing replacement in order to evaluate efficacy and safety. The primary end point was the left ventricular end-systolic volume index (LVESVI) at 12 months, as assessed with the use of a Wilcoxon rank-sum test in which deaths were categorized below the lowest LVESVI rank. Results At 12 months, the mean LVESVI among surviving patients was 54.6±25.0 ml per square meter of body-surface area in the repair group and 60.7±31.5 ml per square meter in the replacement group (mean change from baseline, −6.6 and −6.8 ml per square meter, respectively). The rate of death was 14.3% in the repair group and 17.6% in the replacement g...

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Mitral-Valve Repair versus Replacement for Severe Ischemic Mitral Regurgitation

Recurrent mitral regurgitation after annuloplasty for functional ischemic mitral regurgitation

The present invention provides methods and devices for grasping, and optional repositioning and fixation of the valve leaflets to treat cardiac valve regurgitation, particularly mitral valve regurgitation. Such grasping will typically be atraumatic providing a number of benefits. For example, atraumatic grasping may allow repositioning of the devices relative to the leaflets and repositioning of the leaflets themselves without damage to the leaflets. However, in some cases it may be necessary or desired to include grasping which pierces or otherwise permanently affects the leaflets. In some of these cases, the grasping step includes fixation.

Methods and devices for capturing and fixing leaflets in valve repair

Background— Patients who undergo ring annuloplasty for ischemic mitral regurgitation (MR) often have persistent or recurrent MR. This may relate to persistent leaflet tethering from left ventricle (LV) dilatation that is not relieved by ring annuloplasty. Therefore, the purpose of this study was to test the hypothesis that recurrent MR in patients after ring annuloplasty relates to continued LV remodeling. Methods and Results— Serial echoes were reviewed in 30 patients (aged 72±11 years) who showed recurrent MR late (47±27 months) versus early (3.8±5.8 months) after ring annuloplasty for ischemic MR during coronary artery bypass grafting without interval infarction. Patients with intrinsic mitral valve disease were excluded. Echocardiographic measures of MR (vena contracta and jet area/left atrial area) and LV remodeling (LV dimensions, volumes, and sphericity) were assessed at each stage. The degree of MR increased from mild to moderate, on average, from early to late postoperative stages, without significant change in LV ejection fraction. Changes in MR paralleled increases in LV volumes and sphericity index at end-systole and end-diastole. The only independent predictor of late postoperative MR was LV sphericity index at end-systole. Conclusions— Recurrent MR late after ring annuloplasty is associated with continued LV remodeling, emphasizing its dynamic relation to the LV.

Mechanism of Recurrent Ischemic Mitral Regurgitation After Annuloplasty: Continued LV Remodeling as a Moving Target

Background and aim of the study Functional ischemic mitral regurgitation (MR) can occur secondary to coronary artery disease. Controversy exists regarding management of these patients. Mitral valve annuloplasty in conjunction with coronary artery bypass grafting (CABG), accepted as the best treatment for severe MR, has been disputed for lesser degrees of regurgitation due to higher mortality. The results of a combined procedure approach were reviewed. Methods Between February 1992 and June 1999, 100 consecutive patients (mean age 67+/-11 years) with functional ischemic MR underwent mitral valve repair + CABG. The repair was limited to a Duran flexible annuloplasty ring. Among patients, 72% had a preoperative myocardial infarction and 51% required perioperative intra-aortic balloon pump. NYHA functional class was III-IV in 72%; preoperative MR by transesophageal echocardiography (TEE) was grade 3-4+ in 80% and grade 2+ in 20%. Results Intraoperative completion TEE indicated 0-1+ MR in 98%. Early mortality was 12% and late mortality 14%, for an overall survival of 74%. The mean follow up was 35.8 months. Follow up TEE on 82% of patients showed zero to trivial MR in 42% of patients, grade 1+ MR in 29%, 2+ MR in 24%, and 3-4+ MR in 5%. Follow up NYHA class was I-II in 81% of patients and III-IV in 19%. A significant correlation was found between recurrent MR and declining left ventricular function on follow up only, as well as the occurrence of preoperative myocardial infarction. Conclusion Functional ischemic MR remains a difficult problem to treat, and has a poor long-term outcome. Ring annuloplasty for functional ischemic MR with coronary artery disease achieves immediate valve competence. However, a significant number of patients develop recurrent MR at intermediate follow up.

Outcome after mitral valve repair for functional ischemic mitral regurgitation.

BACKGROUND AND AIM OF THE STUDY The standard treatment for functional ischemic mitral regurgitation (FIMR) is revascularization and reduction annuloplasty. Although the immediate results are excellent, some patients develop recurrent mitral regurgitation (MR) at mid-term follow up. The study aim was to identify possible preoperative echocardiographic parameters that might predict the risk of recurrent FIMR. METHODS From 124 consecutive patients who underwent revascularization and ring annuloplasty, 48 were selected if they: (i) had a complete preoperative and follow up transthoracic echocardiogram; and (ii) left the operating room with grade 1+ MR. Those patients with moderate or greater late MR were classified as having significant recurrent FIMR (MR group), and those with mild or no MR were classified as no significant FIMR (No-MR group). Left ventricular ejection fraction (LVEF), left ventricular (LV) sphericity, percentage MR jet area, mitral valve tenting area, mitral valve coaptation height, papillary muscle (PM) tethering distance, PM depth, and PM angle were measured by echocardiography preoperatively and at mid-term follow up. RESULTS No preoperative differences were found between groups except in posterior PM depth and PM angle. The posterior PM depth and angle in the MR group were significantly smaller than in the No-MR group. In the No-MR group, the posterior PM tethering distance decreased and the PM angle increased significantly with decreasing LV sphericity. In contrast, in the MR group, posterior PM tethering distance, PM depth, and PM angle were unchanged, and the anterior PM depth and PM angle decreased significantly with decreasing LVEF. CONCLUSION FIMR is primarily due to PM displacement, and posterior PM relocation is especially important. Ring annuloplasty does not protect against recurrent FIMR in patients with severe outward displacement of the posterior PM. The severity of posterior PM displacement might be a predictor of ring annuloplasty failure.

Failure of reduction annuloplasty for functional ischemic mitral regurgitation.

BACKGROUND AND AIM OF THE STUDY: The presence of conformational changes in the aortic root during the cardiac cycle is well known, but precise information on time-related changes at each level of the root is lacking. METHODS: High-resolution, 3D sonomicrometry (200 Hz) was applied in an acute sheep model. Twelve crystals were implanted in eight sheep at each base (n = 3), commissure (n = 3), sinotubular junction (n = 3) and ascending aorta (n = 3). Under stable hemodynamic conditions, geometric changes of the perimeter of each sinus of Valsalva, sinus height, and twist and root tilt angles were time-related to left ventricluar (LV) and aortic pressures. RESULTS: Expansion of the perimeter of the three sinuses of Valsalva was homogeneous, but in significantly different proportions (p < 0.001): the right sinus expanded (+32.4 +/- 2.4%) more than the left (+29.3 +/- 3.2%), and more than the non-coronary (NC) sinus (+25.8 +/- 1.7%). A similar pattern was found for aortic root height: right greater than left, and left greater than NC sinus (p < 0.001). This asymmetry resulted in changes of the root's twist and tilt angles. Although the twist deformation was consistent for each sheep, no general pattern was found. The aortic root tilt angle (between the basal plane and the commissural plane) was 16.3 +/- 1.5 degrees at end-diastole (angle oriented posteriorly and to the left). During systole, it was reduced by 6.6 +/- 0.5 degrees, aligning the LV outflow tract with the ascending aorta. This tilt angle returned to its original value after valve closure. CONCLUSION: Aortic root expansion is asymmetric, generating precise changes in its tilt angle. During systole, tilt angle reduction resulted in a straight cylinder that probably facilitates ejection; during diastole, the tilt angle increased, probably reducing leaflet stress. These findings should impact upon surgical procedures and the design of new prostheses.

Aortic root dynamics are asymmetric.

A pair of templates form a mold for substantially flat biological membranes to shape the membrane into a configuration that, after trimming of excess tissue, is adapted for forming a replacement aortic, pulmonary, tricuspid or mitral heart valve. Each template has three members joined to another laterally, with each member configured to form, together with its mating member, the mold for one leaflet or cusp of the replacement heart valve. The negative template has concave surfaces for each member and the positive template has convex surfaces which mate with the concave surfaces of the first template. Each of the templates is made of thin, shell like material and has beveled edges. The biological membrane is placed between the mating convex and concave surfaces of the two templates assembled to one another to form the membrane into the configuration of the three leaflets of the replacement heart valve.

Carlos M. G. Duran

Papers

Mechanism of Recurrent Ischemic Mitral Regurgitation After Annuloplasty: Continued LV Remodeling as a Moving Target

Outcome after mitral valve repair for functional ischemic mitral regurgitation.

Failure of reduction annuloplasty for functional ischemic mitral regurgitation.

Aortic root dynamics are asymmetric.

Mold to form stent-less replacement heart valves from biological membranes