For Functional Mitral Regurgitation Research Articles

The effect of a smaller spacer in the PASCAL Ace on residual mitral valve orifice area.

Mitral transcatheter edge-to-edge repair (M-TEER) is an established treatment for functional mitral regurgitation (FMR) associated with a risk of creating iatrogenic stenosis. To investigate the impact of the P10 and its larger spacer compared to the narrower Ace and its smaller spacer on reduction of mitral valve orifice area (MVOA) during M-TEER. Consecutive patients undergoing M-TEER for treatment of severe FMR were screened retrospectively. Patients with a single PASCAL device implantation within the central segments of the MV leaflets, non-complex anatomy, and baseline MVOA ≥ 3.5cm2 were selected. Intraprocedural transesophageal echocardiography was used to compare MVOA reduction with 3D multiplanar reconstruction and direct planimetry. Device selection did not follow a prespecified MVOA threshold. Seventy-two patients (81.0 years, IQR {74.3-85.0}) were included. In 32 patients, the P10 was implanted (44.4%). MR severity (p = 0.66), MR reduction (p = 0.73), and body surface area (p = 0.56) were comparable. Baseline MVOA tended to be smaller in P10 patients with the larger spacer (5.0 ± 1.1 vs. 5.4 ± 1.3cm2, p = 0.18), however, residual MVOA was larger in these patients (2.7 ± 0.7 vs. 2.3 ± 0.6cm2, p = 0.03). Accordingly, relative MVOA reduction was significantly less in P10 patients (- 45.9 ± 7.6 vs. - 56.3 ± 7.0%, p < 0.01). Indirect annuloplasty was more pronounced in Ace patients whereas mean transmitral gradients were similar. In FMR patients with non-complex anatomy, the larger spacer of the P10 maintains greater MVOA with similar MR reduction. Hence, the use of the PASCAL Ace device in patients with small MVOAs might correlate with a risk of both clinically relevant orifice reduction and even iatrogenic stenosis.

Impact of Gender on Mortality After Transcatheter Edge-to-Edge Repair for Functional Mitral Regurgitation

Recent studies suggested short-term mortality after transcatheter edge-to-edge repair (TEER) was comparable between men and women. However, the gender-specific prognostic difference in the long-term follow-up after TEER is still unknown. To evaluate the impact of gender on long-term mortality after TEER for functional mitral regurgitation (FMR) using multicenter registry data. We retrospectively analyzed 1,233 patients (male 60.3%) who underwent TEER for FMR at 24 centers. The impact of gender on all-cause death and hospitalization for heart failure (HF) after TEER was evaluated using multivariate regression analysis and propensity score (PS) matching methods. During the 2-year follow-up, 207 all-cause death and 263 hospitalizations for HF were observed after TEER for FMR. Men had a significantly higher incidence of all-cause death than women (18.6% vs 14.1%, log-rank p=0.03). After adjustment by multivariate Cox regression and PS matching, the male gender was significantly associated with a higher incidence of all-cause mortality after TEER than the female gender (hazard ratio 2.11, 95% confidence interval 1.42 to 3.14 in multivariate Cox regression; hazard ratio 1.89, 95% confidence interval 1.03 to 3.48 in PS matching). The gender-specific prognostic difference was even more pronounced after 1-year of TEER. On the contrary, there was no gender-related difference in hospitalization for HF after TEER. In conclusion, women with FMR had a better prognosis after TEER than men, whereas this was not observed in hospitalization for HF. This result might indicate that women with FMR are more likely to benefit from TEER.

Percutaneous mitral annuloplasty with the Carillon device: Outcomes in proportionate and disproportionate functional mitral regurgitation

It has been suggested that the disparity of outcomes between the studies of transcutaneous edge-to-edge repair (TEER) for functional mitral regurgitation (FMR) in heart failure with reduced ejection fraction (HFrEF) could be due to systematic differences in the populations studied. One proposal is that there are two broad groups: those with proportional FMR who respond less favourably, and those in whom the FMR is greater than expected (disproportionate) FMR where edge-to-edge TEER seems to be more effective. Whether this grouping is relevant for other percutaneous interventions for FMR is unknown. We sought to compare clinical and echocardiographic outcomes of patients with HFrEF and proportionate and disproportionate FMR treated with indirect annuloplasty using the Carillon device. This is a pooled analysis from three trials of patients with FMR. Key patient eligibility in these trials specified persistent grade 2+ to 4+ FMR with >5.5 cm left ventricular (LV) end-diastolic diameter (LVEDD) and reduced ejection fraction. Patients with an effective regurgitant orifice area/LV end-diastolic volume (EROA/LVEDV) ratio under 0.15 were assigned to the proportionate FMR group (n=74;65%) and those with a ratio above 0.15 were classed as having disproportionate FMR (n=39;35%). At 12 months following treatment, both groups showed improvements in all MR variables including regurgitation volume, EROA and vena contracta. Moreover, in patients with proportionate MR there were clinically relevant and statistically significant improvements in LV volumes and diameters. There was no independent relationship between the degree of proportionality as a continuous variable and the remodeling response to Carillon therapy (change in LVEDV r=0.17; change in LVESV r=0.14). Percutaneous mitral annuloplasty with the Carillon device reduces MR in patients with both proportionate and disproportionate FMR, and also results in LV reverse remodeling in those with proportionate FMR. The effect on remodeling remains to be verified in a large scale trial.

Long-term outcomes of papillary muscle relocation anteriorly for functional mitral regurgitation.

This study aimed to evaluate the outcomes of the patients who underwent restrictive annuloplasty (RA) plus papillary muscle relocation anteriorly (PMR-A) with the risk factors in mitral valve repair for functional mitral regurgitation (FMR). Eighty-six patients underwent mitral valve repair with RA for FMR. Thirty-five of them received additional bilateral papillary muscle relocation for severe leaflet tethering. The papillary muscles were relocated posteriorly (PMR-P) early in the study. Then, in the later period, the technique was modified to PMR-A, in which the papillary muscles were relocated anteriorly for 24 cases. The survival of the patients undergoing RA + PMR-A was examined retrospectively, adjusting for differences in patient background. Twenty-three deaths were observed during the follow-up period out of the 86 cases. Independent preoperative risk factors for survival were left ventricular ejection fraction, patient age and B-type natriuretic peptide (BNP) level. Among the patients with BNP <1000 pg/ml, 5-year survival after RA plus PMR-A was 84.7%, while RA alone was 78.6% and RA + PMR-P 57.1%. Cox proportional hazards regression adjusted for the preoperative risk factors showed a significantly higher hazard ratio of RA + PMR-P to RA + PMR-A (12.77, P = 0.011), while the hazard ratio of RA alone to RA + PMR-A was not significantly different. Furthermore, reverse remodelling of the left ventricle was observed for 3 years only in RA + PMR-A. Long-term survival for patients who underwent RA plus bilateral PMR-A was promising. Patients with significantly higher BNP had lower survival after valve repair for FMR.

The impact of transcatheter edge-to-edge repair on right ventricle-pulmonary artery coupling in patients with functional mitral regurgitation.

The impact of transcatheter edge-to-edge repair on right ventricle-pulmonary artery coupling in patients with functional mitral regurgitation.

Translocation of the Mitral Valve in an Acute Large Animal Model.

Current repair options for functional mitral regurgitation (FMR) are not durable and do not adequately address underlying pathophysiology including leaflet tethering and insufficient coaptation. The feasibility of mitral valve translocation as a repair strategy for FMR was examined in normal swine. Seven pigs (median 62kg, IQR 55-65kg) with normal cardiac function were implanted with a 1-cm frustum-shaped pericardial patch inserted between the native mitral annulus and intact mitral leaflets. Operative survival was 100% with no post-procedure mitral stenosis, systolic anterior motion, or central mitral regurgitation observed on echocardiography. Post-translocation mean gradient was 3.5mmHg (IQR 1.5-4mmHg); trace or mild suture line leaks on the atrial suture line were noted in 5/7 pigs. Median leaflet coaptation increased from 2.4 (IQR 2.1-4.3mm) to 12.4mm (IQR 10.8-13.4mm) after translocation (P = 0.016). Translocation dramatically increases leaflet coaptation without impairing diastolic function in animals with normal left ventricular function and is a promising technique for repair of FMR. Implantation of a 1.0-cm circumferential pericardial patch (mitral valve translocation) increases leaflet coaptation in a normal animal model.

Abstract 11458: Temporal Changes in Mitral Regurgitation After Percutaneous Mitral Valve Repair with MitraClip for Functional Mitral Regurgitation in Patients with Atrial Fibrillation

Background: Recently, percutaneous mitral valve (MV) repair has been increasingly performed for functional mitral regurgitation (FMR). However, few studies have examined the effectiveness of percutaneous MV repair for atrial FMR (AFMR). The aim of this study is to compare the effectiveness of MitraClip implantation between patients with AFMR and ventricular FMR (VFMR). Methods: We retrospectively reviewed 113 grade 3 to 4+ FMR patients with persistent atrial fibrillation or atrial flutter who underwent MitraClip implantation. We classified the patients into 2 groups; 43 patients with preserved left ventricular (LV) ejection fraction (LVEF) ≥ 50% and normal LV wall motion were defined as AFMR. 70 patients with LV dysfunction (LVEF &lt; 50 %) or LV wall motion abnormality were defined as VFMR. Transthoracic echocardiography (TTE) follow-up was performed at approximately 1-day, 1-month and 1-year after the procedure. Results: The percentage of grade 4+ mitral regurgitation (MR) was 53% in AFMR and 49% in VFMR at baseline (P=0.61). Acute procedural success rate was similar between AFMR and VFMR (95.3% vs. 97.1%, P=0.49). The median period of 1-month and 1-year follow-up TTE were 33 [interquartile range (IQR): 28-36] days and 356 (IQR: 248-399) days in AFMR, and 34 (IQR: 30-38) days and 366 (IQR: 336-415) days in VFMR, respectively. The percentage of grade 3 or 4+ MR at 1-day, 1-month, and 1-year after the procedure were 4.7% (2/43), 10% (3/30), and 5.6% (1/18) in AFMR, and 2.9% (2/70), 7.3% (4/55), and 2.9% (1/35) in VFMR (P=0.49, 0.48, and 0.57, respectively, AFMR vs. VFMR at the same follow-up point). The rates of redo MitraClip or MV surgery for recurrent MR within 1-month and between 1-month/1-year were 0% and 9.3% in AFMR, and 1.4% and 1.4% in VFMR. The percentage of New York Heart Association functional class III or IV at baseline, 1-month, and 1-year after the procedure were 90.7% (39/43), 23.3% (7/30), and 33.3% (6/18) in AFMR and 97.1% (68/70), 27.3% (15/55), and 22.9% (8/35) in VFMR (P=0.15, 0.69, and 0.41, respectively, AFMR vs. VFMR at the same follow-up point). Conclusions: In our series, MitraClip implantation had comparable therapeutic effect on both MR severity and heart failure symptoms between patients with AFMR and VFMR.

Mitral Valve Translocation: Optimization of Patch Geometry in an Ex Vivo Model of Secondary Mitral Regurgitation.

Optimal translocation patch width for functional mitral regurgitation (FMR) treatment was evaluated in an air-filled ex vivo system. FMR was created in 19 isolated swine hearts by annular dilation and papillary muscle displacement. Frustum-shaped pericardial patches of varying widths (Group 1 = 0.5cm; Group 2 = 1.0cm; Group 3 = 1.5cm) were implanted and imaged via a 3D-structured light scanner. Median leaflet coaptation decreased (P < 0.001) from 5.5 ± 2.0mm at baseline to 2.4 ± 1.3mm following FMR creation. Translocation repair increased coaptation length over FMR levels by 2.2mm in Group 1 (P < 0.001), 4.6mm in Group 2 (P < 0.001), and 4.7mm in Group 3 (P < 0.001). After repair, no significant differences were found between groups for annular height, circularity index, tenting height, tenting area, and non-coapting surface area. The supranormal coaptation and minimal valve geometric changes support using a 1.0- or 1.5-cm translocation patch for FMR treatment. Implantation of a 1.0-cm or 1.5-cm circumferential pericardial patch (mitral valve translocation) increases leaflet coaptation length without significantly altering valve geometry.

Influence of preoperative right ventricular function on left ventricular remodeling and survival after subvalvular repair for functional mitral regurgitation.

The objective of this study was to analyze our surgical experiences with mitral valve plasty (MVP) combined with subvalvular procedures (SVPs) for functional mitral regurgitation (FMR) and to determine which preoperative factors affected clinical outcomes. This study retrospectively analyzed 33 patients who underwent MVP combined with SVPs for FMR with a left ventricular ejection fraction lower than 40% and advanced remodeled left ventricles. The mean follow-up period was 49 ± 33months. The preoperative mean right ventricular fractional area change (RVFAC) used to quantify right ventricular (RV) systolic function was 26 ± 11%. Sixteen patients (48%) had an RVFAC < 26%. One patient died during hospital stay, and nine more patients died of cardiac causes during follow-up. The 3- and 5-year rates of freedom from cardiac-related mortality were 78% and 68%, respectively. RVFAC was the significant predictor of cardiac-related mortality in a univariate analysis (risk ratio [RR] = 0.92, 95% confidence interval [CI] 0.85-0.99, p = 0.03) and demonstrated a non-significant tendency to predict cardiac-related mortality in the Cox multivariate analysis (RR = 0.94, 95% CI 0.86-1.003, p = 0.08). Continued reverse left ventricular remodeling was associated with an RVFAC ≥ 26%. At 3years, there was also a significant difference in survival rates of cardiac-related mortality between patients with an RVFAC ≥ 26% and < 26% (94% vs. 61%; p = 0.03). Preoperative RV function affected left ventricular remodeling and cardiac-related mortality after MV surgery. MVP combined with SVPs for FMR provided promising results for patients without severe RV dysfunction.

Relationship Between Mitral Leaflet Size and Coaptation and Their Associated Factors in Patients with Normal Left Ventricular Size and Systolic Function.

Enlargement of the mitral valve (MV) has gained attention as a compensatory mechanism for functional mitral regurgitation (FMR). We aimed to determine if MV leaflet area is associated with MV coaptation-zone area and identify the clinical factors associated with MV leaflet size and coaptation-zone area in patients with normal left ventricle (LV) systolic function and size using real-time 3D echocardiography (RT3DE).We performed RT3DE in 135 patients with normal LV size and ejection fraction. MV leaflet and coaptation-zone areas were measured using custom 3D software. The clinical factors associated with MV leaflet and coaptation-zone areas were evaluated using univariate and multivariate linear regression analyses.There was a significant relationship between MV leaflet and coaptation-zone areas (r = 0.499, P < 0.001). MV leaflet area was strongly associated with body surface area (BSA) (r = 0.905, P < 0.001) rather than LV size and age. MV leaflet area/BSA was independently associated with male gender (P = 0.002), lower diastolic blood pressure (P = 0.042), and LV end-diastolic volume (LVEDV) index (P = 0.048); MV coaptation-zone area/BSA was independently associated with lower LVEDV index (P = 0.01).In patients with normal LV systolic function and size, MV leaflet size has a significant impact on competent MV coaptation. MV leaflet area might be intrinsically determined by body size rather than age and LV size, and the MV leaflet area/BSA is relatively constant. On the other hand, some clinical factors might also influence MV leaflet and coaptation-zone area.

Long-term prognosis of patients treated by coronary sinus-based percutaneous annuloplasty: single centre experience.

AimsThis study aims to report long‐term mortality, echocardiographic, and clinical outcomes of patients receiving treatment for functional mitral regurgitation (FMR) with the Carillon device.Methods and resultsThis was a single centre analysis of prospectively collected data from patients treated with the Carillon Mitral Contour System for symptomatic congestive heart failure despite guideline‐directed medical therapy, who were included from a single centre from the TITAN II study. All patients presented with New York Heart Association (NYHA) class 2 or greater symptoms, grade 2+ to 4+ FMR, left ventricular enlargement, and reduced ejection fraction. Surviving patients were evaluated for long‐term follow‐up post‐procedure, averaging 6.9 years. Fifteen (15) patients (mean age 72 years, 60% male, 100% NYHA class III or IV, 50% MR grade 3+ or 4+) were treated with the Carillon device. The Kaplan–Meier mortality rate was 40% at 6 years of follow‐up. Long‐term survival through 6 years was associated with echocardiographic improvement in mitral regurgitation (change in effective regurgitant orifice area in survivors versus non‐survivors from baseline to 1 year follow‐up, −9.0 ± 5.6 vs. −1.7 ± 1.5, P = 0.02) and clinical status at 12 months (difference in NYHA at 1 year follow‐up between survivors versus non‐survivors, P = 0. 05) which was sustained throughout follow‐up. All patients at 6 year follow‐up had ≤2+ MR, with 6 of 7 having 0–1+ MR. Left ventricular end‐diastolic volume was reduced from 154.0 ± 65.7 mL at baseline to 104.5 ± 59.2 mL at 6 year follow‐up, P = 0.03 in survivors with both measurements.ConclusionsAmong patients with congestive heart failure treated with the Carillon device, long‐term survival is associated with favourable 1 year and sustained improvements in mitral regurgitation, left ventricular volume, ejection fraction, and clinical status.

Ex Vivo Model of Functional Mitral Regurgitation Using Deer Hearts

Transcatheter therapies are emerging for functional mitral regurgitation (FMR) treatment, however there is lack of pathological models for their preclinical assessment. We investigated the applicability of deer hearts for this purpose.8 whole deer hearts were housed in a pulsatile flow bench. At baseline, all mitral valves featured normal coaptation. The pathological state was induced by 60-minutes intraventricular constant pressurization. It caused mitral annulus dilation (antero-posterior diameter increase from 31.8 ± 5.6 mm to 39.5 ± 4.9 mm, p = 0.001), leaflets tethering (maximal tenting height increase from 7.3 ± 2.5 mm to 12.7 ± 3.4 mm, p < 0.001) and left ventricular diameter increase (from 67.8 ± 7.5 mm to 79.4 ± 6.5 mm, p = 0.004). These geometrical reconfigurations led to restricted mitral valve leaflets motion and leaflet coaptation loss. Preliminary feasibility assessment of two FMR treatments was performed in the developed model.Deer hearts showed ability to dilate under constant pressurization and have potential to be used for realistic preclinical research of novel FMR therapies.Graphical abstract figure legend: Deer heart mitral valve fiberscopic and echocardiographic images in peak systole at baseline and after inducing the pathological conditions representing functional mitral regurgitation. In the pathological conditions lack of coaptation between the leaflets, enlargement of the antero-posterior distance (red dashed line) and the left ventricular diameter (orange dashed line) were observed.

A Novel Quantitative Ex Vivo Model of Functional Mitral Regurgitation.

Durability of mitral valve (MV) repair for functional mitral regurgitation (FMR) remains suboptimal. We sought to create a highly reproducible, quantitative ex vivo model of FMR that functions as a platform to test novel repair techniques. Fresh swine hearts (n = 10) were pressurized with air to a left ventricular pressure of 120 mmHg. The left atrium was excised and the altered geometry of FMR was created by radially dilating the annulus and displacing the papillary muscle tips apically and radially in a calibrated fashion. This was continued in a graduated fashion until coaptation was exhausted. Imaging of the MV was performed with a 3-dimensional (3D) structured-light scanner, which records 3D structure, texture, and color. The model was validated using transesophageal echocardiography in patients with normal MVs and severe FMR. Compared to controls, the anteroposterior diameter in the FMR state increased 32% and the annular area increased 35% (P < 0.001). While the anterior annular circumference remained fixed, the posterior circumference increased by 20% (P = 0.026). The annulus became more planar and the tenting height increased 56% (9 to 14 mm, P < 0.001). The median coaptation depth significantly decreased (anterior leaflet: 5 vs 2 mm; posterior leaflet: 7 vs 3 mm, P < 0.001). The ex vivo normal and FMR models had similar characteristics as clinical controls and patients with severe FMR. This novel quantitative ex vivo model provides a simple, reproducible, and inexpensive benchtop representation of FMR that mimics the systolic valvular changes of patients with FMR.

Impact of preinterventional tricuspid regurgitation on outcome of MitraClip therapy in patients with severely reduced ejection fraction

AimTo evaluate the impact of preinterventional moderate-to-severe functional tricuspid regurgitation (FTR) on early outcome after percutaneous edge-to-edge mitral valve repair (pMVR) with MitraClip procedures for functional mitral regurgitation (FMR) in...

Long-Term Survival Following Transcatheter Mitral Valve Repair: Pooled Analysis of Prospective Trials with the Carillon Device

PurposeTo report long-term survival and to identify potential determinants of survival among patients receiving treatment for functional mitral regurgitation (FMR) with the Carillon device. MethodsThis was a post hoc analysis in which we pooled prospectively collected data from three studies of the Carillon device with available long-term vital status data. Patient eligibility in these trials specified symptomatic congestive heart failure despite guideline-directed medical therapy, grade 2 to 4 FMR, left ventricular enlargement, and reduced ejection fraction. Echocardiographic parameters were available through the 12-month visit and vital status was available through 5 years. The association of patient characteristics and changes in echocardiographic parameters at 6 and 12 months with long-term survival was analyzed using Cox proportional hazards regression. ResultsA total of 74 patients (mean age 67 years, 72% male, 59% MR grade 3 or 4) were treated with the Carillon device. Over 1 year of follow-up, the New York Heart Association (NYHA) class decreased in 64% of patients, distance on the 6-minute walk test increased, and echocardiographic measures indicated significant decreases in MR grade and favorable left ventricular remodeling. The Kaplan-Meier survival rate was 83.6% at 1 year, 73.1% at 2 years, 67.9% at 3 years, and 56.2% at 4 and 5 years of follow-up. Primary determinants of long-term survival were a decrease in NYHA class, an increase in 6-minute walk test distance, and a decrease in regurgitant volume during the first year of follow-up. ConclusionsAmong patients with congestive heart failure and grade 2 to 4 FMR who were symptomatic despite guideline-directed medical therapy, transcatheter mitral valve repair with the Carillon device resulted in a favorable 5-year survival rate. The survival benefit was greatest among patients with improvement in clinical and hemodynamic parameters during the first year of follow-up.

P760 Stress echocardiography testing of a novel trans annular mitral bridge implantation for mitral regurgitation

Abstract Objectives Indirect reduction of septal- lateral diameter (SLD) by circumferential cinching of the annulus with ring annuloplasty (RA) is the standard part of mitral valve repair surgery. Direct SLD reduction without circumferential annular cinching by a novel trans-annular Mitral Bridge with an infra-annular curvature has been used for functional mitral regurgitation (FMR) as a sole procedure and for mitral valve prolapse (MVP)as a part of valve repair. The aim of this study was to assess the functional and hemodynamic outcomes at rest and exercise at 2 yr. follow up in the patients with this novel type of annuloplasty. Methods 30 of 34 patients with FMR who had trans annular Mitral Bridge as the sole treatment of their MR and 5 of 8 patients with MVP in a prospective trial underwent at 2yr F/U bicycle ergometer exercise echocardiography on a special semi-recumbent bicycle. Mitral regurgitation, mitral peak and mean gradient, mitral valve area, systolic pulmonary arterial pressure, systolic function of the left ventricle were assessed at rest and peak exercise. Results Mitral regurgitation was 0.3 ± 0.5 at rest and 0.4 ± 0.5 at peak exercise (p = 0.264). The resting mean mitral gradient was 2.3 ± 0.9 mmHg and peak 4.6 ± 1.9 mmHg (p &amp;lt;.0001) and valve area was at rest 3.5 ± 0.7cm2 and at peak 3.9 ± 0.9 cm2 (p = 0.026). Pulmonary systolic arterial pressure was 25.8 ± 17 at rest and 36.9 ± 21.8 at peak exercise (P = 0.012). LVEF was 60,4± 10.5 at rest and at peak 66,4± 12.5 (p &amp;lt;.0001). Conclusion Trans annular Mitral Bridge as a alternative to standard annuloplasty ring is effective. At 2 yr follow up there was only trace mitral regurgitation and no mitral stenosis. The stress test verified the durability of the mitral repair both in FMR and MVP. There was no mitral stenosis and no mitral regurgitation at exercise. The raise of the mean mitral gradient was statistically important, but the values remained within the normal range. The raise of gradients is in correlation with the presence of cardiac reserve and increased LVEF. There were no signs of pulmonary hypertension caused by the stress. Abstract P760 Figure. Mitral Bridge

Functional and Degenerative Mitral Regurgitation: One Ring Fits All?

Three-dimensional saddle-shaped annuloplasty rings have been shown to create a larger surface of leaflet coaptation in mitral valve repair (MVR) for functional mitral regurgitation (FMR) and degenerative mitral regurgitation (DMR) which may increase repair durability. For the first time, this study reports mid-term results after MVR for DMR and FMR using a rigid three-dimensional ring (Profile 3D, Medtronic). Between June 2009 and June 2012, 369 patients with DMR (n = 326) or FMR (n = 43) underwent MVR (mean age 62.3 ± 12.6 years). A total of 205 patients (55.6%) underwent isolated MVR and 164 patients (44.4%) a combined procedure. Follow-up examinations were performed in 94.9% (mean 4.9 ± 0.9 years). Echocardiographic assessment was complete in 93.2% (mean 4.3 ± 1.2 years). The 30-day mortality was 1.5% (5/326) for DMR (1.5% for isolated and 1.6% for combined procedures) and 9.3% (4/43) for FMR (0% for isolated and 10.5% for combined procedures). Survival at 6 years was 92.1 ± 1.9% for DMR (92.9 ± 2.6% for isolated and 90.7 ± 2.7% for combined procedures) and 66.4 ± 7.9% for FMR (80.0 ± 17.9% for isolated and 63.7 ± 8.9% for combined procedures). Cumulative risk for mitral valve-related reoperation at 6 years was 0% for FMR and 7.1 ± 1.5% for DMR. At echocardiographic follow-up, one patient presented with mitral regurgitation (MR) more than moderate. The only predictor of recurrent MR after MVR for DMR was residual mild MR at discharge. Repair of FMR with the three-dimensional Profile 3D annuloplasty ring shows excellent mid-term results with regard to recurrence of MR. In cases of DMR, the results are conforming to the current literature.

Left Ventricular Dilatation and Posterior Papillary Muscle Displacement in an Ex Vivo Pulsatile Model of Functional Mitral Regurgitation.

Surgical method of choice for functional mitral regurgitation (FMR) is debatable, since recurrence of FMR post-annuloplasty has been reported in a significant number of cases. Developing a pulsatile FMR heart model by left ventricular dilatation can be a favorable option for usage in the primary stages of developing new surgical techniques that adjunctively targets the posterior papillary muscle (PPM) geometry. PPM of ex vivo ovine hearts (N = 22) was displaced by three different sizes of patches to induce left ventricular dilatation and FMR. Mitral regurgitation (MR) flow, left ventricular and annular geometry were measured from the dynamic pulsatile flow system before and after patch placement. Outward displacement of PPM was significantly increased in all patch sizes compared to baseline (P = .016, P = .031, and P = .008 from small to large patch, respectively). Left ventricular volume (LVV) significantly increased from 18.53 (15.01-26.03) mL at baseline to 27.5 (19.45-42.46) mL after large patch placement (P = .031). However, the small and medium patch groups did not show significant changes in the LVV after patch placement. MR significantly increased 554 (185-1,919.3) mL/min after applying the large patch compared to baseline (P = .016). There were no significant changes from baseline in MR flow after applying the small and medium patch. Application of the large patch produced the highest proportion of FMR heart models (87.5%, P = .031). The large patch ex vivo pulsatile heart model demonstrated outward displacement of the PPM and significantly produced MR flow. This ex vivo pulsatile heart model can be used to facilitate surgical techniques that targets the PPM displacement in FMR patients.

Does implantation of a single clip provide reliable durability after transcatheter mitral repair?

A single MitraClip implant is often considered enough to achieve adequate mitral regurgitation (MR) reduction. The aim of this study was to compare MR recurrence in patients with an initial optimal result treated with a single clip versus those treated with two clips. From October 2008 to May 2016, 322 patients were treated with the MitraClip procedure at our institution. We retrospectively selected all patients treated for functional MR (FMR) and degenerative MR (DMR) aetiologies with residual MR ≤1+, excluding patients who required >2 clips. FMR and DMR were analysed separately. In FMR, a single clip was used in 45 patients and 2 clips in 99 patients. The single clip group had smaller coaptation depth (1.1 ± 0.3 vs 1.3 ± 0.3 mm, P = 0.022) and jet extension (10.5 ± 2.1 vs 13.0 ± 3.6 mm, P = 0.026) as well as left ventricular end-diastolic diameter (64.4 ± 7.3 vs 69.0 ± 7.9 mm, P = 0.001). Freedom from MR ≥ 3+ after 4 years was 71.9 ± 8.9% in patients receiving a single clip vs 88.0 ± 5.2% in those receiving 2 clips, single clip use being an independent predictor of MR recurrence (HR 3.48, CI 1.24-9.81, P = 0.018). In DMR, a single clip was deployed in 24 patients and 2 clips in 30 patients. The single clip group had a smaller flail gap (3.6 ± 0.7 vs 6.8 ± 2.5, P = 0.002). Freedom from MR ≥ 3+ after 2 years was 82.5 ± 8% in patients with a single clip vs 100% in those with 2 clips, P = 0.014. The residual mitral area was reduced in patients with 2 clips compared with those with single clip, both in FMR ( P = 0.015) and DMR ( P = 0.039), but it was not associated with increased death rate during the follow-up period (all P > 0.05). Despite favourable anatomical characteristics and an optimal initial result, implantation of a single clip was associated with an increased recurrence of MR compared with that of 2 clips, both in FMR and in DMR. Caution should be exercised with the implantation of a single clip.

Treatment of Chronic Functional Mitral Valve Regurgitation With a Percutaneous Annuloplasty System

BackgroundCurrent surgical and medical treatment options for functional mitral regurgitation (FMR) are limited and additional interventional approaches are required. ObjectivesThis study sought to report the safety and performance data from the feasibility study with a novel direct annuloplasty system. MethodsSeventy-one patients with moderate to severe FMR (mean 67.7 ± 11.3 years of age, left ventricular [LV] ejection fraction 34.0 ± 8.3%), on stable medical heart failure medication were prospectively enrolled. ResultsDevice success rate was 70.4% (n = 50 of 71). No intraprocedural death occurred. In patients receiving implants, 4 patients (8.9%) experienced cardiac tamponade. Thirty-day (n = 45) and 6-month (n = 41) rates for all-cause mortality, stroke, and myocardial infarction were 4.4%, 4.4%, and 0.0% and 12.2%, 4.9%, and 0%, respectively. At 6 months, nonurgent mitral surgery was performed in 1 patient (2.4%) and nonurgent percutaneous repair in 7 patients (17.1%). Echocardiographic core analysis after 6 months showed mitral regurgitation reduction in 50% of treated patients by a mean of 1.3 grades. Concerning mitral valve (MV) annular geometry, we found significant reduction of anterior-posterior (–0.31 ± 0.4 cm) and septal-lateral dimensions (–0.21 ± 0.3 cm), a decreased MV-tenting area (–0.57 ± 1.1 cm2) and increase in MV coaptation length (0.13 ± 0.2 cm). Transthoracic echocardiography indicated reverse LV remodeling with reduction of LV end-diastolic diameter (–0.20 ± 0.4 mm) and volume (–22 ± 39 ml). Treatment was associated with significant improvement in 6-min walking distances (56.5 ± 92.0 m) and improvements in New York Heart Association functional class III/IV at 6 months from 53.3% to 23.3%. ConclusionsPercutaneous direct annuloplasty is feasible and safe in high-risk FMR patients. This treatment initiates LV reverse remodeling, and provides clinical improvement during 6 months after treatment. (Mitralign Percutaneous Annuloplasty First in Man Study; NCT01852149).