Reduction Of Mitral Regurgitation Research Articles

Clinical Outcomes Following Urgent vs. Elective Percutaneous Mitral Valve Repair

AimTo examine procedural and clinical outcomes among patients undergoing percutaneous mitral valve repair (PMVR) within an admission for acute-decompensated heart failure (ADHF). Methods and resultsProspective registry of all consecutive patients with symptomatic mitral regurgitation (MR) grade 3+ or 4+ who underwent PMVR our centre and classified in 2 groups: elective group and urgent PMVR group (within the index admission for ADHF). Echocardiographic, procedural and clinical outcomes were compared between groups. 85 patients (median age 77.0 [67.8–83.4] years, 64.7% male) were treated within the recruitment period. Among them, 17 (20%) underwent urgent MitraClip®. Urgent PMVR were at a higher risk for conventional surgery (p = 0.002) and had worse estimated prognosis according to HF risk scores (p < 0.001). Overall technical success was 100%, without differences between groups. At 30 days, no differences were found in mortality, MR reduction and in NYHA functional improvement between groups. Cumulative estimated survival free from all-cause death was 92.9% (82.4% vs. 95.6%), 89.4% (82.4% vs. 91.1%), 76.3% (82.4 vs. 74.9%) at 6 months, 1-year and 2-years, respectively, with no significant differences between urgent or elective PMVR (p = 0.769). ConclusionMitraClip® implantation can be considered as an urgent therapy during admission for ADHF.

Predictors for procedural success and all-cause mortality in patients undergoing transcatheter mitral valve edge-to-edge repair for mitral regurgitation

A growing body of evidence shows that transcatheter mitral valve edge-to-edge repair (TMVr) for mitral regurgitation (MR) improves symptoms and prognosis of patients with heart failure. Still, as recently shown by two large randomized controlled trials (COAPT and MITRA-FR), there is differing information on which patients have the largest benefit. We aimed to summarize the current knowledge of clinical and anatomic predictors for acute procedural failure and long-term all-cause mortality after TMVr. TMVr is an effective treatment option for patients with symptomatic MR fulfilling certain echocardiographic and clinical criteria or being ineligible for surgery despite optimal medical therapy. Acute procedural failure is influenced by anatomic features of the mitral valve, among those are increased tenting and mitral valve leaflet configuration, leaflet-to-annulus index, as well as the mitral valve opening area. In contrast, anatomy of the mitral valve plays a minor role in predicting all-cause mortality after TMVr. This endpoint is associated with patient comorbidities (e.g., renal failure and chronic lung disease), severe heart failure as expressed by New York Hear Association functional class (NYHA) IV, left and right heart dysfunction, laboratory parameters (NT-proBNP), clinical scoring systems (STS and EuroScore), and procedural MR reduction. In patients undergoing TMVr for severe MR, careful preprocedural evaluation of relevant comorbidities, mitral valve anatomy, as well as left and right heart function can provide detailed prognostic value regarding acute procedural success and long-term survival.

Effects of the MitraClip on right heart function and tricuspid valve regurgitation

Abstract The MitraClip has been established as a therapeutic option for patients with symptomatic mitral regurgitation (MR) and increased risk of Surgery. MR is often combined with a decrease in right heart function due to the volume and pressure overload it leads to. The effects of MR reduction by MitraClip on right heart function is currently not adequately determined. The study further addresses the question of whether and when it makes sense to correct combined tricuspid regurgitation (TR). Methods All Patients that took part in this study underwent 2D and 3D Echocardiography before MitraClip implantation as well as six months afterwards. RV Function was evaluated through 4 Parameters: Tricuspid annular plane systolic excursion (TAPSE) in mm, tricuspid annular systolic velocity (TASV) in cm/s, right ventricular fractional area change (RVFAC) in % and myocardial performance index (MPI). Estimated right ventricular systolic pressure (RVSP) in mmHg was used as evidence for the presence of pulmonic Hypertension. Further Parameters determined the severity of TR and the dimensions of the right ventricle (RV) and atrium (RA) in cm respectively the volume in ml. Results 60 Patients were recruited (63% male, Age 81.4±7.1). Six Months (±3) after MitraClip implantation a significant improvement in right heart parameters was noticed. Most of the parameters used in this study showed a significant change. (TASV 9.3±2.4 vs. 10.5±2.6, p=0.01), (RVFAC 33.1±10.9 vs. 39.0±9.6, p&amp;lt;0.05). TAPSE showed an improvement by trend (16.1±4.6 vs. 17.4±4.8, p=0.06). RVSP showed a significant decrease (51.9±12.3 vs. 44.6±13.4, P&amp;lt;0.05). However, Dimensions and Volume of the right atrium and ventricle showed no significant change. On the other hand, the average TR severity has noticeably declined after 6 months (2.1±0.7 vs. 1.6±0.6, p&amp;lt;0.05). Flow Convergence and Vena contracta of Tricuspid regurgitation also demonstrated a significant reduction (Flow Convergence 7.6±4.5 vs. 5.9±2.5, P=0.01), (Vena contracta 6.8±2.5 vs. 5.4±1.9, p&amp;lt;0.05). Conclusion MitralClip leads to a reduction in Mitral regurgitation which leads to a significant improvement in the right heart parameters, especially the RV Function. A noticeable decrease in the TR severity was often seen as an accompanying effect. An initially wait-and-see approach to a residual TR appears justified. Funding Acknowledgement Type of funding source: Public hospital(s). Main funding source(s): Heart Center University Clinic Dresden, Germany

MitraClip therapy in patients with acute severe mitral regurgitation

Abstract Background There is a lack of data to support the optimal management of high-risk patients with acute severe mitral regurgitation (MR). The role of the MitraClip implantation in treatment of acute severe mitral regurgitation (MR) is undetermined. Methods We screened all patients who underwent MitraClip implantation at the Hadassah Medical Center between October 2015 and December 2019. We evaluated immediate, 30-day and 1-year outcomes after the procedure. We evaluated patients with severe MR due to ruptured cord because of degenerative disease and acute-on-chronic functional MR due to ischemic (after a recent myocardial infarction (MI)) or non-ischemic etiology (secondary to decompensated HF). Results From a cohort of 151 patients, who underwent MitraClip implantation in our center, we identified 35 patients (23.2%) with acute severe mitral regurgitation (4+) and decompensated refractory heart failure. Patients' mean age was 74.15 years, 66.9% - were males. One, 2, or 3 clips were implanted. Reduction of MR from 4+ to 1+ was achieved in 34 patients (66.7%). Twenty-eight patients (80%) had acute-on-chronic severe MR and refractory heart failure including 6 cases after recent MI, other 7 patients presented with heart failure and acute severe MR secondary to ruptured cord due to degenerative disease. After MitraClip implantation, reduction of MR severity was achieved in all patients. Seven patients were withdrawn from intravenous therapy and intra-aortic balloon pump 2–3 days after the procedure. Four patients died during hospitalization, three of them due to sepsis. 30-day follow-up showed improvement of NYHA functional class and a tendency toward improvement in left ventricle systolic function with signs of reverse remodeling. Nevertheless, we observed high 30-day and 1-year mortality rate (11.4 and 23.8% respectively). Conclusions MitraClip therapy could be an alternative option for treatment of patients with acute and acute-on-chronic severe MR of ischemic and non-ischemic etiology. Funding Acknowledgement Type of funding source: None

The incidence, clinical significance of depression and its clinical course after a cardac device implantation in patients with severe heart failure

Abstract Aim To assess the incidence, clinical significance of depression and the impact of a cardioverter-defibrillator (ICD) or cardiac resynchronization therapy-defibrillator (CRT-D) implantation on psychiatric status in patients with heart failure (HF). Methods The prospective, single-center study encompassed 575 consecutive HF patients implanted with a CRT-D or ICD. Finally, the study population consisted of 494 subjects (186 ICD and 308 CRT-D patients), as 81 patients taking antidepressants were excluded from the analysis. All patients underwent psychiatric examination at the time of implantation, and the assessment of psychiatric status was repeated after 3, 6, 12 and 24 months. The study population was divided into 4 groups: Group 1 encompassed 101 (20.4%) patients with persistent depression, Group 2 constituted of 95 (19.2%) patients with depression that developed after ICD/CRT-D implantation, whereas 43 (8.7%) patients with remission of depression comprised Group 3, and Group 4 encompassed 255 (51.6%) patients with never diagnosed depression. Data on long-term follow-up (median 34.1 months) were screened to identify patients who developed a composite endpoint defined as death or hospitalization for decompensated HF. Results The cumulative incidence of depression at the baseline assessment was 39.1%. Depression developed in 95 (27.1%) patients, whereas remission of depression was observed in 43 (29.9%) subjects after ICD/CRT-D implantation. ICD intervention (HR 3.3) and increase in NYHA class by at least one class (HR 2.6) were the independent risk factors for depression development, whereas mitral regurgitation reduction (HR 1.9), as well as improvement in NYHA class by at least one class (HR 2.4) were the independent predictors for depression remission. Patients with persistent depression (Group 1) and those with newly developed depression (Group 2) were at significantly higher risk of a composite endpoint compared to patients in Group 3 and Group 4 (Table 1). Conclusions Depression is a common comorbidity associated with HF, as it affects 4 of 10 HF patients. ICD intervention and HF worsening are the strongest predictors for depression development after ICD/CRT-D implantation. Depression is a strong, independent risk factor of poor outcomes in HF population. Funding Acknowledgement Type of funding source: None

Acute changes in mitral valve geometry after MitraClip procedure assessed by 3D transoesophageal echocardiography

Abstract Background MitraClip procedure is a treatment option in patients with symptomatic mitral regurgitation (MR) and prohibitive surgical risk. Echocardiographic evaluation of mitral valve (MV) is of paramount importance for the correct identification of patient eligibility and procedural success. Our aim is to assess the acute effect of device implantation on mitral annular geometric parameters still little explored with the use of three-dimensional (3D) transoesophageal echocardiography (TEE) and to investigate its relationship with residual MR at discharge. Methods 67 consecutive patients (mean age78.7±7.2 yrs, 41 males) undergoing percutaneous MV repair with MitraClip in our Centre were enrolled. Patients eligibility was evaluated according to the EVEREST criteria and current guidelines. Four groups were identified on the base of MR aetiology: 22 were degenerative (DMR), 19 ischemic functional (IFMR), 19 non-ischemic functional (NIFMR) and 7 atrial functional (AFMR). 3D TEE was performed before and immediately after clip deployment with MV anatomical quantification by PHILIPS® QLAB MVQ and GE® 4D-AUTO-MVQ software. Results Severe MR (4+) was found in 17 pts, and moderate-severe MR (3+) in 50 pts. Thirteen cases were unsuccessful because of unchanged or residual MR&amp;gt;2+. Immediately after device positioning, almost all the evaluated parameters showed a significant modification within each group with a reduction of anterior-posterior (AP-D) and bi-commissural (CC-D) MV diameters, MV annulus area and perimeter and an increase in tenting volume, tenting height and posterior mitral leaflet angle (PML α). Anterior mitral leaflet angle (AML α), sphericity index and aorto-mitral angle remained unchanged. We observed no significant difference in the sub-analysis between degenerative and all functional MR groups, although a different trend of parameters variation could be evidenced. Post-procedural tenting height with cut off of 5.5 mm was a predictor of procedural success (see fig.), while at univariate analysis basal AP-D in DMR group and sphericity index, PMLα and annulus height at baseline in the FMR group were all significantly correlated to the entity of MR reduction at discharge. Conclusions Percutaneous edge-to-edge repair with MitraClip acutely changes the MV annular geometry in degenerative and both ventricular and atrial functional MR, with a different trend within each group. Post-procedural tenting height correlates with significant MR reduction at discharge, a promising marker that could be used in clinical practice for identification of MitraClip procedure success. Funding Acknowledgement Type of funding source: None

Time, magnitude and patterns of left ventricular remodeling after MitraClip implantation: clinical implications

Abstract Background The reverse left ventricular remodeling (LV-R) is well known phenomenon that may occurs in a wide spectrum of heart disease, generally associated with an improvement of prognosis. Recently, conflicting data are reported from two randomized trials assessing prognosis after MitraClip implantation. Purpose To assess time, magnitude and pattern of LV-R and its relationship with outcome, and to assess the role of ejection fraction (EF) in selection of patients for MitraClip procedure. Methods and results Among 47 patients treated with MitraClip for severe mitral regurgitation (MR), 2 switched to surgical intervention. All patients underwent echo before, at discharge, 1 and 6-month after procedure (age 78.2±8.3 years, NYHA 3.74±0.44, LV EF 36.5±12.8%, logistic EuroSCORE I 22.41±8.4, STS-PROM 4.6±1.9, functional MR 82%). From baseline to 6-month reverse LV-R was defined as a ≥15% decrease in LV end-systolic volume (LVESV) and an adverse LV-R as a increase of ≥10% in LVESV, respectively. At 6-month, sustained reduction of MR ≤2 was observed in all patients, but 2; reverse LV-R occurred in 51% (23), adverse LV-R in 18% (8) and no LV-R in 31% (14) patients. In a multivariate regression model, baseline LVEDV were a strong independent predictor of reverse LV remodeling [β −0.564, 95% CI: −0.363 to −0.074; P=0.004], whereas baseline LVEF was not (P=0.126). Furthermore, an LVEDV ≤130 mL was strongly associated with reverse remodeling with an OR: 0.796 (CI: 0.052–0.792, P=0.022). During follow-up (17.5±9.3 months), in adverse/no LV-R patients mortality for any cause and hospitalization for heart failure (HF) occurred in 50% vs. 95.7% (log-rank, P value= 0.006). By Cox analysis, adverse LV-R was strongly associated with mortality for any cause and hospitalization for HF with adjusted OR of 5.6 (95% CI: 1.65–19.00, P=0.006). Finally, combining adverse/no LV-R together the risk of mortality for any cause and hospitalization for HF increased with adjusted OR of 10.08 (95% CI: 1.29–78.6, P=0.027). Conclusion The half of real-world patients undergoing percutaneous mitral valve repair for severe MR showed reverse remodeling. However, there was a half of patients in whom afterload mismatch resulted in early and sustained adverse and no remodeling associated with subsequently high mortality and recurrence of HF. Baseline larger LV volumes rather than EF may help us to refine selection patients for MitraClip procedure, avoiding futility. Funding Acknowledgement Type of funding source: None

The Effect of a Novel Transcatheter Edge-to-Edge Mitral Valve Repair Device in a Porcine Model of Mitral Regurgitation.

A new technique has been developed for treating mitral regurgitation (MR) via a transapical approach, which encompasses an easy-to-use leaflet clamp and a smaller-sized delivery system (14F-16F). We aimed to evaluate the effectiveness of this device in a porcine model of acute MR. Acute MR was induced in 36 anesthetized porcine subjects by severing the chordae supporting the corresponding segment of the leaflet. The ValveClamp system was then transapically implanted on the prolapsing segment under epicardial echocardiographic guidance. Echocardiographic assessments were performed before and after the transapical interventions. All of the animals were killed 30 days after the procedure to verify the proper location of the implanted devices. Epicardial echocardiography revealed severe MR (n = 26) or moderate to severe MR (n = 10) in the pig model of acute MR. Overt MR reduction was observed following the procedure through echocardiography; residual MR was absent in 10 cases, mild in 17 cases, and moderate in 9 cases. There was no evidence of mitral stenosis at the end of the procedure in terms of mitral valve area and mitral valve pressure gradient. Autopsy demonstrated that all ValveClamp devices were precisely placed to clamp the prolapsing segment of the mitral valve. Transapical implantation of the ValveClamp device under epicardial echocardiographic guidance was effective and safe in reducing acutely induced MR in this pig model. It is potentially applicable as a novel user-friendly transcatheter edge-to-edge mitral valve repair device for the treatment of MR in humans.

Doppler echocardiographic predictors of low mitral valve area after implantation of one MitraClip: time for a paradigm shift?

Abstract Introduction During edge-to-edge therapy using MitraClip (MC) for severe mitral regurgitation (MR) the interventional cardiologists usually rely on the mean transmitral gradient to decide if they “go for” a second clip in case of suboptimal MR reduction or to stabilise the first MC in the context of prolapse or flail leaflet. The value of this parameter to detect low mitral valve area (MVA) is unknown. Method During each intervention of the last two years, high quality volumes focused on the MV were acquired. Using a dedicated 3-D analysis software and a new planimetry method, we measured the MVA before and after the implantation of one MC (each orifice was evaluate independently on the most optimal plane). The usual transmitral CW-Doppler parameters (mean gradient (MG), VTI, PHT) were evaluated. Results We included 120 patients, 69 primary (PMR) and 51 secondary (SMR) mitral regurgitation. For all the parameters, the best model for the curve fitting was y = a + b / x and the two parameters who best correlated with the MVA after MC were PHT (R2 0.67, p=0.0001) and MG (R2 0.28, p. 0001). Looking at SMR, the correlation with PHT was even better but there was no correlation with MG. In PMR, the correlation with MG was good but still lower than with PHT (Figure 1). The ROC analysis for PHT showed an AUC of 0.948 and defined an optimal cut-off of 127ms with sensibility and specificity 91% to detect a MVA &amp;lt;2 cm2 after one MC. Conclusion The transmitral MG appears as a poor parameter to predict low MVA after the implantation of one MC, especially in SMR probably because in this population the MG depends more on the flow than on the MVA. In the contrary PHT appears as a robust parameter. Figure 1 Funding Acknowledgement Type of funding source: None

Six-month and one-year outcomes with the PASCAL transcatheter valve repair system for patients with mitral regurgitation from the multicentre, prospective CLASP study

Abstract Background Transcatheter mitral valve repair has emerged as a viable option for treating mitral regurgitation (MR). We report results from the multicentre, prospective, single arm CLASP study with the PASCAL transcatheter valve repair system. Methods 109 patients with clinically significant MR deemed candidates for transcatheter repair by the local heart team were treated in the CLASP study. The study evaluated safety, performance, clinical and echocardiographic outcomes and included an independent clinical events committee and echocardiographic core lab. The primary safety endpoint was a composite MAE rate at 30 days of cardiovascular mortality, stroke, MI, new need for renal replacement therapy, severe bleeding, and re-intervention for study device-related complications. Results Mean age was 76 years, 54% male, 57% NYHA Class III/IV, 100% MR grade ≥3+ with 62% functional, 31% degenerative, 7% mixed etiology. Successful implantation was achieved in 95% of patients. At 30 days, the MAE rate was 8.3% including one cardiovascular mortality due to cardiogenic shock as a result of severe bleeding at the contralateral arterial access site for hemodynamic monitoring further complicated by disseminated intravascular coagulation, one stroke, and one conversion to mitral valve replacement surgery. In paired analysis, 88% of patients were in NYHA Class I/II (p&amp;lt;0.001), MR grade was ≤1+ in 79% of patients and ≤2+ in 96% of patients. Significant improvements in 6MWD (+27 m, p&amp;lt;0.001) and KCCQ (+16 points, p&amp;lt;0.001) were observed. The six-month data will be available for presentation. In addition, we report one-year follow up of the first 62 patients (ITT): 93% one-year survival rate (Kaplan-Meier estimate), no stroke, no late reintervention, one late MI. In paired analysis, MR grade was ≤1+ in 82% of patients and ≤2+ in 100% of patients. 88% of patients were in NYHA Class I/II (p&amp;lt;0.001), 6MWD improved by 21 m (p=0.124) and KCCQ improved by 13 points (p&amp;lt;0.001). Conclusions This study demonstrates the PASCAL transcatheter valve repair system is safe and resulted in robust MR reduction with 100% of patients achieving MR ≤2+, and ∼ 80% MR ≤1+, sustained at one year. Results show high survival and low complication rates, and sustained improvements in functional status, exercise capacity, and quality of life at one year in patients with clinically significant, symptomatic MR. The CLASP IID/IIF pivotal trial is underway. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Edwards Lifesciences (Irvine, CA)

Safety and performance of a novel transventricular beating heart mitral valve repair system: 1-year outcomes.

The objective of this study was to evaluate the safety and performance of a novel, beating heart procedure that enables echocardiographic-guided beating heart implantation of expanded polytetrafluoroethylene (ePTFE) artificial cords on the posterior mitral leaflet of patients with degenerative mitral regurgitation. Two prospective multicentre studies enrolled 13 (first-in-human) and 52 subjects, respectively. Patients were treated with the HARPOON beating heart mitral valve repair system. The primary (30-day) end point was successful implantation of cord(s) with mitral regurgitation reduction to ≤moderate. An independent core laboratory analysed echocardiograms. Of 65 patients enrolled, 62 (95%) achieved technical success, 2 patients required conversion to open surgery and 1 procedure was terminated. The primary end point was met in 59/65 (91%) patients. Among the 62 treated patients, the mean procedural time was 2.1 ± 0.5 h. Through discharge, there were no deaths, strokes or renal failure events. At 1 year, 2 of the 62 patients died (3%) and 8 (13%) others required reoperations. At 1 year, 98% of the patients with HARPOON cords were in New York Heart Association class I or II, and mitral regurgitation was none/trace in 52% (n = 27), mild in 23% (n = 12), moderate in 23% (n = 12) and severe in 2% (n = 1). Favourable cardiac remodelling outcomes at 1 year included decreased end-diastolic left ventricular volume (153 ± 41 to 119 ± 28 ml) and diameter (53 ± 5 to 47 ± 6 mm), and the mean transmitral gradient was 1.4 ± 0.7 mmHg. This initial clinical experience with the HARPOON beating heart mitral valve repair system demonstrates encouraging early safety and performance. NCT02432196 and NCT02768870.

Impact of cleft-like indentations on procedural outcome of percutaneous edge-to-edge mitral valve repair.

Percutaneous edge-to-edge mitral valve (MV) repair (PMVR) is broadly applied in high-risk patients with relevant mitral regurgitation (MR). We investigated the incidence of cleft-like indentations (CLI) and their impact on PMVR. In a retrospective single center analysis including 263 patients undergoing PMVR with the MitraClip®-system between 11/2012 and 7/2016, MV anatomy was assessed by 3-dimensional transesophageal echocardiography. CLI were present in 37/263 patients (14.1%). Of these, 62.2% had 1 CLI, 27% had 2 CLI, and 10.8% had 3 CLI, mostly concerning segment P2 or P2/3 of the MV. Baseline characteristics were similarly distributed. Interestingly, most patients with CLI suffered from secondary MR (n=29, 78%). The number of deployed MitraClips was higher in patients with CLI (2 [1.25-2] vs. 2 [1, 2], p=.035), whereas procedural as well as clinical success was similar: MR grade (1.2 vs. 1.5, p=.061), vena contracta width (4.2 vs. 4.5 mm, p=.293), dPmean (4.2 vs. 4.0 mmHg, p=.618) at discharge and NYHA class at 30 days did not differ between groups. Periprocedural complications were rare and equally distributed between groups. At 30 days, MR reduction persisted in patients with CLI (95.8% of these selected patients had a MR grade ≤ 2). CLI of the MV are common in patients undergoing PMVR, also when presenting mainly with secondary MR. While the number of clips needed to address MR is slightly higher in patients with CLI, procedural success rates appear not to be affected. PMVR seems to be a safe treatment option for patients with CLI.

1-Year Outcomes for Transcatheter Repair in Patients With Mitral Regurgitation From the CLASP Study.

The authors report the CLASP (Edwards PASCAL Transcatheter Mitral Valve Repair System Study) expanded experience, 1-year outcomes, and analysis by functional mitral regurgitation (FMR) and degenerative mitral regurgitation (DMR). The 30-day results from the CLASP study of the PASCAL transcatheter valve repair system for clinically significant mitral regurgitation (MR) have been previously reported. Eligible patients had symptomatic MR≥3+, were receiving optimal medical therapy, and were deemed candidates for transcatheter mitral repair by the local heart team. Primary endpoints included procedural success, clinical success, and major adverse event rate at 30days. Follow-up was continued to 1 year. One hundred nine patients were treated (67% FMR, 33% DMR); the mean age was 75.5 years, and 57% were in New York Heart Association functional class III or IV. At 30days, there was 1 cardiovascular death (0.9%), MR≤1+ was achieved in 80% of patients (77% FMR, 86% DMR) and MR≤2+ in 96% (96% FMR, 97% DMR), 88% of patients were in New York Heart Association functional class I or II, 6-min walk distance had improved by 28 m, and Kansas City Cardiomyopathy Questionnaire score had improved by 16 points (p<0.001 for all). At 1 year, Kaplan-Meier survival was 92% (89% FMR 96% DMR) with 88% freedom from heart failure hospitalization (80% FMR, 100% DMR), MR was≤1+ in 82% of patients (79% FMR, 86% DMR) and≤2+ in 100% of patients, 88% of patients were in New York Heart Association functional class I or II, and Kansas City Cardiomyopathy Questionnaire score had improved by 14 points (p<0.001 for all). The PASCAL transcatheter valve repair system demonstrated a low complication rate and high survival, with robust sustained MR reduction accompanied by significant improvements in functional status and quality of life at 1year. (The CLASP Study Edwards PASCAL Transcatheter Mitral Valve Repair System Study [CLASP]; NCT03170349).

Transcatheter Edge-to-Edge Mitral Valve Repair With the MitraClip G4 System

The primary objective of this study was to evaluate the effectiveness of the MitraClip G4 in the reduction of mitral regurgitation (MR). The next-generation MitraClip G4 system was recently introduced for the treatment of MR in the United States. The study included consecutive patients undergoing transcatheter mitral edge-to-edge repair for MR with the MitraClip G4. The key outcome was the proportion of patients with MR reduction to≤2+ at 30days. Fifty-nine patients (median age 77 years, 62.7% men) were treated with the MitraClip G4. Reduction of MR to≤2+ was achieved in 57 patients (96.6%) during the procedure, 58 patients (98.3%) at discharge, and 57 patients (96.6%) by 30days. The median number of MitraClips used per patient was 2 (interquartile range: 1 to 3). Wide clips (NTW/XTW) were used in 82.7% of patients. The XTW clip was used most frequently as the first clip in patients with degenerative MR (65.4%) and the NTW clip in those with secondary MR (72.7%). The independent grasping mechanism was used in 49.2% of patients. Use of the MitraClip G4 system was associated with excellent reduction in MR to≤2+ in 96.6% of patients at 30days. The availability of multiple MitraClip G4 sizes, especially the wide clips, and the ability to independently grasp leaflets are the likely contributors to MR reduction.

Mid-term hemodynamic and functional results after transcatheter mitral valve leaflet repair with the new PASCAL device.

To examine the functional and hemodynamic mid-term outcome at 5months of mitral regurgitation (MR) reduction using the PASCAL repair system. Between July 2019 and February 2020 31 consecutive patients with MR 3 +/4 + (mean age 77.5years, all in New York Heart Association (NYHA) class III-IV, STS score 9.1 ± 7.4) underwent MR reduction in our institute using the PASCAL device. 61.3% had a functional, 29.0% a degenerative, and 9.7% a mixed etiology. Successful implantation was achieved in 30/31 (96.8%) patients. 27/31 patients (87.1%) completed 5-month follow-up with clinical, echocardiographic, laboratory and hemodynamic assessment. At 5months, 70.4% of the patients had MR grade ≤ 1 (p < 0.001). 85.2% were in NYHA class I or II (p < 0.001). Six-minute walk distance improved by 145m (p = 0.010), Kansas City cardiomyopathy questionnaire and European quality of life 5 dimensions questionnaire (EQ5D) improved by 31 (p < 0.001) and 9 points (p = 0.001), respectively. Mean pulmonary capillary wedge pressure decreased significantly from 22.1 ± 9mmHg to 17.3 ± 8mmHg (p = 0.041) and right atrial pressure from 10.3 ± 6mmHg to 8.0 ± 6mmHg (p = 0.013) from baseline to 5months. In addition, propensity score matching showed that PASCAL and MitraClip procedures resulted in equally hemodynamic and functional improvement. MR reduction of severe MR with the PASCAL device is feasible and safe regardless of etiologies. Mid-term follow-up at 5months showed a sustained MR reduction, improvement of exercise capacity, quality of life, proBNP levels and hemodynamics regarding pulmonary capillary wedge pressure and right atrial pressure.

Predictors of Clinical Response to Transcatheter Reduction of Secondary Mitral Regurgitation: The COAPT Trial

BackgroundTranscatheter mitral valve repair with the MitraClip results in marked clinical improvement in some but not all patients with secondary mitral regurgitation (MR) and heart failure (HF). ObjectivesThis study sought to evaluate the clinical predictors of a major response to treatment in the COAPT trial. MethodsPatients with HF and severe MR who were symptomatic on maximally tolerated guideline-directed medical therapy (GDMT) were randomly assigned to MitraClip plus GDMT or GDMT alone. Super-responders were defined as those alive without HF hospitalization and with ≥20-point improvement in the Kansas City Cardiomyopathy Questionnaire overall summary (KCCQ-OS) score at 12 months. Responders were defined as those alive without HF hospitalization and with a 5 to <20-point KCCQ-OS improvement at 12 months. Nonresponders were those who either died, were hospitalized for HF, or had <5-point improvement in KCCQ-OS at 12 months. ResultsAmong 614 enrolled patients, 41 (6.7%) had missing KCCQ-OS data and could not be classified. At 12 months, there were 79 super-responders (27.2%), 55 responders (19.0%), and 156 nonresponders (53.8%) in the MitraClip arm compared with 29 super-responders (10.2%), 46 responders (16.3%), and 208 nonresponders (73.5%) in the GDMT-alone arm (overall p < 0.0001). Independent baseline predictors of clinical responder status were lower serum creatinine and KCCQ-OS scores and treatment assignment to MitraClip. MR grade and estimated right ventricular systolic pressure at 30 days were improved to a greater degree in super-responders and responders but not in nonresponders. ConclusionsBaseline predictors of clinical super-responders in patients with HF and severe secondary MR in the COAPT trial were lower serum creatinine, KCCQ-OS score and MitraClip treatment. Improved MR severity and reduced right ventricular systolic pressure at 30 days are associated with a long-term favorable clinical response after transcatheter mitral valve repair. (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation [COAPT]; NCT01626079)

Percutaneous mitral valve repair in acute mitral regurgitation: case report and review of the literature

Acute mitral regurgitation is a heterogeneous and life-threatening pathology, with severe hemodynamic consequences and extremely adverse outcomes. Traditionally, the definitive treatment is prompt surgical intervention after hemodynamic stabilization. Nowadays, however, percutaneous repair of mitral valve with MitraClip device has emerged as a safe and effective therapeutic option. Evidences in this field are still scarce. Hereby, we report the case of an 82-year-old woman with lateral ST-elevation myocardial infarction determining severe acute mitral regurgitation (MR) with an asymmetric leaflet tethering mechanism. Due to prohibitive operative risk and unstable hemodynamic status, the patient underwent a successful urgent MitraClip procedure with optimal reduction of MR and immediate hemodynamic improvement. Moreover, we provide a review of the available literature regarding the echocardiographic assessment of acute MR, results of published cases and possible management of this complex pathology.

Impact of disproportionate secondary mitral regurgitation in patients undergoing edge-to-edge percutaneous mitral valve repair.

The aim of this study was to evaluate the prognostic role of echocardiographic parameters assessing secondary mitral regurgitation (SMR) severity and left ventricular dimension, including proportionate versus disproportionate SMR, in MitraClip recipients. We analysed 137 patients undergoing MitraClip implantation for SMR at three centres. SMR was classified as proportionate or disproportionate based on the median value of the ratio between effective regurgitant orifice area (EROA) and left ventricular end-diastolic volume (LVEDV). The primary endpoint was a composite of cardiovascular mortality and heart failure hospitalisation at two-year follow-up. Mean age was 70±10 years, 80% were male, and median EuroSCORE II was 5.7%. No differences were observed in the disproportionate compared to the proportionate group except for a more severe NYHA class and their expected higher EROA and lower LVEDV. Number of clips deployed, device success and procedural success were similar between the two groups. Residual mitral regurgitation (MR) >1+ at 30 days was more common among patients with an EROA >0.42 cm2 compared to those with an EROA ≤0.42 cm2 (81.3% vs 58%; p=0.004). The relative risk of the primary endpoint was independent from any echocardiographic parameter, including the presence of disproportionate SMR. The only independent predictors of clinical events were EuroSCORE II >8%, NYHA class and residual MR >1+ at 30 days. Echocardiographic parameters, including the EROA/LVEDV ratio, do not have independent prognostic value in patients undergoing MitraClip implantation. High surgical risk, advanced symptoms and non-optimal MR reduction increase the relative risk of two-year clinical events.

Initial experience of a MitraClip valve repair program in Spain.

BackgroundThe main objective of this study was to evaluate one-year clinical outcome of patients with symptomatic mitral regurgitation (MR) treated with transcatheter mitral valve repair (TMVR) according to the etiology of MR.MethodsData from a single high-volume center of all consecutive cases with symptomatic MR undergoing TMVR where prospectively included and followed.ResultsBetween October 2015 and October 2019, 81 consecutive patients underwent TMVR and were included in the investigation. The mean age was 75.73±7.81 years, 55 (67.9%) were male. The most frequent mechanism was functional MR (FMR) (59%). The mean EuroSCORE II was 5.7±4.94 [FMR 5.38±3.9, degenerative MR (DMR) 5.72±4.7 and mixed MR (MMR) 6.6±7.5; P=0.7776] and STS score mean was 5.21±3.31 (FMR 4.6±2.3, DMR 6.43±5.2 and MMR 5.7±3.2; P=0.126). Patients with FMR had higher rates of dilated (36 patients, 75.5%) and ischemic (15 patients, 31.3%) cardiomyopathy, as well as worse left ventricular ejection fraction (LVEF). Procedural success was achieved in 72 (88.9%) patients, with a similar distribution between groups. The median of follow-up was 16.3 months. The primary combined endpoint occurred in 19 (23.5%) cases. The number of the combined event regarding the different etiologies were 15 (31.2%) in FMR, 2 (11.8%) in DMR and 5 (31.3%) in MMR (P=0.276). Sixteen patients (20.0%) died during the first year of follow-up and 19 (23.5%) had unplanned heart failure (HF) hospitalization. Previous surgical revascularization (HR =4.94, P=0.004) and a redo TMVR (HR =11.3, P=0.006) predicted the main event.ConclusionsTMVR with the Mitraclip device is safe, with a low incidence of complications and a high rate of procedural success. One-year outcomes show reduction of all cause death and HF admissions. Moreover, most of the patients have sustained MR reduction and an improvement in the functional class at the end of follow-up.

Prognostic Impact of Redo Transcatheter Mitral Valve Repair for Recurrent Mitral Regurgitation

There is little known about the prognostic impact of a redo transcatheter mitral valve repair (TMVR) for residual or recurrent mitral regurgitation (MR). From January 2011 to March 2019, we identified 43 consecutive patients who underwent a redo TMVR procedure with the MitraClip system. A control cohort was treated medically for MR ≥2+ after the first TMVR and was propensity score 1:1 matched using age, gender, MR severity, trans-mitral pressure gradient, and etiology of MR. To investigate the association of redo TMVR with 1-year mortality, we fitted a Cox proportional hazard model. The technical success rate of redo TMVR was 95%. A reduction in MR to ≤2+ was achieved in 79% of patients, with a significant decline of tricuspid regurgitation pressure gradient and improvement of the New York Heart Association class. After matching was performed, 43 well-matched pairs of patients were analyzed. Redo TMVR patients showed lower 1-year mortality (10.5% vs 37.6%, p = 0.01) compared with the control patients. Redo TMVR was associated with better survival (hazard ratio [HR] 0.26, 95% confidence interval [CI] 0.08 to 0.79, p = 0.02) and lower risk of the composite end point (mortality and rehospitalization due to HF: HR 0.34, 95% CI 0.15 to 0.78; p = 0.01) at 1-year follow-up. The association with the primary end point remained significant after accounting for the New York Heart Association class III/IV, TR ≥severe, the type of MR (i.e., recurrent or residual MR), or the type of previous implanted TMVR device. In conclusion, redo TMVR in selected patients with residual or recurrent MR may be associated with lower 1-year mortality than medical therapy alone.