Reduction Of Mitral Regurgitation Research Articles

Left ventricule remodeling with improvement of mitral regurgitation after resynchronization therapy

Abstract Introduction Moderate or severe mitral regurgitation is common in patients with dilated cardiomyopathy who are candidates for resynchronization therapy (CRT). In many patients there is no improvement in mitral regurgitation (MR), and this factor may be associated with a lower response to CRT and worse prognosis. Purpose This study seeks to evaluate the association between MR reduction with left ventricular remodeling (LVR), left ventricular ejection fraction (LVEF) and mortality after CRT implantation. Methods This is a 4-year retrospective observational study. Patients who had CRT implantation according to the indications in the guidelines with moderate or severe MR were selected. A pre-implantation transthoracic echocardiogram and another at 12-month follow-up were performed. The LVEF, the left ventricle end-systolic volume (LVESV) and the severity of MR were evaluated, which was categorized into without, mild, moderate or severe, according to vena contracta and quantitative method of proximal isovelocity surface area. Patients with a reduction greater or equal to 15% in LVESV or an increase greater or equal to 5% in LVEF were considered responders to CRT. Results 86 patients had moderate or severe MR pre-CRT, with a mean age of 71.9±9.8 years and 62.2% were female. In 51.2% of the patients there was a reduction in the severity of the MR to without or mild. LVEF recovery was significantly greater in patients with MR reduction (13.1% vs 6.3%, p=0.01). Although not statistically significant, reverse remodeling was more frequent among patients with MR reduction (DLVESV 13.1% vs 6.3%, p=0.119) and mortality was also lower in patients with MR reduction (56% vs 44%, p=0.395). Conclusion Improvement in RM severity after CRT implantation appears to be associated with better response to this therapy and better prognosis at 1-year follow-up.

PERCUTANEOUS EDGE–TO–EDGE REPAIR OF MITRAL REGURGITATION IN CARDIAC AMYLOIDOSIS: DO IT BUT NOT TOO MUCH

Abstract We report the case of a 68 year old man with history of wild type TTR cardiac amyloidosis, treated with tafamidis since 1 year, symptomatic for advanced cardiac failure, already in optimal medical treatment, CRT–D, oral anticoagulation for permanent atrial fibrillation. The patient was hospitalised in our intensive care unit for refractory NYHA IV cardiac failure, anuria, very low ejection fraction combined with severe mitral regurgitation. He was treated with inotropes and diuretics then levosimendan however he remained in very critical state and we discussed the opportunity to reduce the mitral regurgitation by percutaneous edge to edge repair. In this setting of restrictive physiology literature is not unanimous and preload reduction secondary to mitral regurgitation treatment may sometimes be deleterious. We decided to offer our patient edge to edge repair by targeting a moderate reduction of mitral regurgitation and also considering some challenges linked to this pathology as atrial septal involvement with ovalis fossa relevant thickness. The procedure was successful with a reduction of mitral regurgitation grade from severe to mild–to moderate and this allowed the patient to re equilibrate his hemodynamic balance and he was able to be dismissed with a short term follow up program.

A RARE COMPLICATION OF MITRAL TEER PROCEDURE: CLIP LATE DETACHMENT AND EMBOLIZATION

Abstract Intraprocedural and late complications of MitraClip implantation have already been described. This report highlights the importance of conventional surgical options in the event of percutaneous treatment failure. An 85–year–old woman with a history of chronic anemia, and thalassemia Minor was referred to our clinic for severe mitral regurgitation (MR) due to a P2 flail with significant calcification of the posterior mitral annulus. During the Heart Team discussion, age and comorbidities led to consider the patient eligible for TEER with the MitraClip system (EuroSCORE II 9,34%; STS score 7,47%). TEER procedure was uneventful: one XTW was deployed at the level of the flail (A2–P2), a second XTW was then placed more lateral to treat a separate residual jet, and one NTW was finally placed between them. MR reduction was considered acceptable (moderate MR, mean grad 6 mmHg). After two months, symptoms worsened, and TTE showed severe MR (no device detachment) with increased sPAP and associated moderate TR. A couple of weeks later, the patient was hospitalized. Chest X–ray revealed clip embolization confirmed by coronary angiography that showed an XTW Clip embolized to the Right coronary sinus with partial occlusion of the ostium. Percutaneous clip retrieval is described in the literature, but the embolized device position and the presence of recurrent severe MR led us to prefer an urgent surgical intervention. Under CPB, the embolized XTW was easily retrieved through a small aortotomy; the intervention was completed by mitral valve replacement and tricuspid valve repair. The postoperative course was uneventful. Predischarge TTE showed normal mitral bioprosthesis function, mild AR, mild TR, and preserved LV function. DISCUSSION Clip embolization is a rare but potentially critical complication of TEER and can happen periprocedurally or on early follow–up. Single leaflet detachment is more common, but complete detachment and embolization can occur. Therapeutic options are represented by surgical or transcatheter approaches according to embolization sites and patient comorbidities. In our case, the risk of potential coronary obstruction or thrombosis and the concomitant need for MR treatment have led us to consider surgery as the first option. CONCLUSION TEER can be graved by acute or late complications. The best approach has to be tailored to each patient, and surgery can be an effective and safe option even for initially discarded high–risk patients.

SEVERE SYMPTOMATIC MITRAL REGURGITATION AFTER ANNULOPLASTY FAILURE: SUCCESSFUL TRANSCATHETER EDGE TO EDGE REPAIR

Abstract Surgical mitral valve repair is the most common, feasible and preferred procedure to treat primary and secondary mitral regurgitation (MR). However, 30% of patients suffer from residue severe regurgitation 10 years after surgical intervention, resulting in a considerable number of Redo procedures. In elderly and high–risk patients with major comorbidities medical treatment is the only and often insufficient option for symptoms’ relief. Percutaneous Transcatheter Edge to Edge repair technique (TEER) with MitraClip system is emerging as an off–label valid alternative to successfully treat severe mitral regurgitation after surgical valvuloplasty failure. Transesophageal echocardiography (TEE) is essential in diagnosis, planning, intraprocedural device placement, and follow up. In the peculiar setting of failed annuloplasty, with small residual valve area, the main risk is the creation of a gradient across the mitral valve. We present two cases of severe mitral regurgitation after surgical annuloplasty with ring placement, carefully evaluated for TEER and successfully treated with this procedure: 1) a 79–year–old man presented with exertional dyspnea and orthopnea in the setting of previous surgical mitral Annuloplasty (2003) with a 32–mm Carpentier Ring. Transesophageal echocardiography demonstrated severe mitral regurgitation due to P2 prolapse and central V–shaped cut of the valve, mean diastolic gradient 1.8 mmHg. 2) a 83 year–old woman presented with dyspnea (NYHA functional class III) and severe mitral regurgitation after previous Annuloplasty with a 34–mm Edwards Ring and placement of Goretex artificial Chordae (2016). TEE showed prolapse of P2 and P3 leaflets, mean diastolic gradient 2.17 mmHg, valvular area 3.5 cmq. Both patients underwent transfemoral and transseptal implantation of one MitraClip device (XTw and XT, respectively) under Transesophageal echocardiography guidance with successful reduction of mitral regurgitation to mild level and symptoms relief. In the first case post procedural mean diastolic gradient was 3.7 mmHg, in the second case it was 3.16 mmHg.

Impact of heart failure hospitalizations on clinical outcomes after mitral transcatheter edge-to-edge repair: Results from the EXPAND study.

This analysis aimed to compare the clinical outcomes associated with heart failure (HF) readmissions and to identify associations with HF hospitalizations (HFH) in patients treated with the MitraClip™ NTR/XTR System in the EXPAND study. The global, real-world EXPAND study enrolled 1041 patients with primary or secondary mitral regurgitation (MR) treated with the MitraClip NTR/XTR System. Echocardiograms were analysed by an independent echocardiographic core laboratory. The study population was stratified into HFH and No-HFH groups based on the occurrence of HFH 1 year post-index procedure. Clinical outcomes including MR severity, New York Heart Association (NYHA) functional class, Kansas City Cardiomyopathy Questionnaire (KCCQ) score, and all-cause mortality were compared (HFH: n = 181; No-HFH: n = 860). Both groups achieved consistent 1-year MR reduction to ≤1+ (HFH vs. No-HFH: 87.3% vs. 89.5%, p = 0.6) and significant 1-year improvement in KCCQ scores (+16.5 vs. +22.3, p = 0.09) and NYHA functional class. However, more patients in the No-HFH group had 1-year NYHA class ≤II (HFH vs. No-HFH: 67.9% vs. 81.9%, p < 0.01). All-cause mortality at 1 year was 36.8% in the HFH group versus 10.4% in the No-HFH group (p < 0.001). The HFH rate decreased by 63% at 1 year post-M-TEER versus 1 year pre-treatment (relative risk 0.4, p < 0.001). Independent HFH associations were MR ≥2+ at discharge, HFH 1 year prior to treatment, baseline NYHA class ≥III, baseline tricuspid regurgitation ≥2+, and baseline left ventricular ejection fraction ≤40%. This study reports the impact of HFH on clinical outcomes post-treatment in the EXPAND study. Results demonstrate that the occurrence of HFH was associated with worse 1-year survival, and treatment with the MitraClip system substantially reduced HFH and improved patient symptoms and quality of life.

Ertugliflozin for Functional Mitral Regurgitation Associated With Heart Failure: EFFORT Trial.

The morbidity and mortality rates of patients with heart failure (HF) and functional mitral regurgitation (MR) remain substantial despite guideline-directed medical therapy for HF. We evaluated the efficacy of ertugliflozin for reduction of functional MR associated with HF with mild to moderately reduced ejection fraction. The EFFORT trial (Ertugliflozin for Functional Mitral Regurgitation) was a multicenter, double-blind, randomized trial to examine the hypothesis that the sodium-glucose cotransporter 2 inhibitor ertugliflozin is effective for improving MR in patients with HF with New York Heart Association functional class II or III, 35%≤ejection fraction<50%, and effective regurgitant orifice area of chronic functional MR >0.1 cm2 on baseline echocardiography. We randomly assigned 128 patients to receive either ertugliflozin or placebo in addition to guideline-directed medical therapy for HF. The primary end point was change in effective regurgitant orifice area of functional MR from baseline to the 12-month follow-up. Secondary end points included changes in regurgitant volume, left ventricular (LV) volume indices, left atrial volume index, LV global longitudinal strain, and NT-proBNP (N-terminal pro-B-type natriuretic peptide). The treatment groups were generally well-balanced with regard to baseline characteristics: mean age, 66±11 years; 61% men; 13% diabetes; 51% atrial fibrillation; 43% use of angiotensin receptor-neprilysin inhibitor; ejection fraction, 42±8%; and effective regurgitant orifice area, 0.20±0.12 cm2. The decrease in effective regurgitant orifice area was significantly greater in the ertugliflozin group than in the placebo group (-0.05±0.06 versus 0.03±0.12 cm2; P<0.001). Compared with placebo, ertugliflozin significantly reduced regurgitant volume by 11.2 mL (95% CI, -16.1 to -6.3; P=0.009), left atrial volume index by 6.0 mL/m2 (95% CI, -12.16 to 0.15; P=0.005), and LV global longitudinal strain by 1.44% (95% CI, -2.42% to -0.46%; P=0.004). There were no significant between-group differences regarding changes in LV volume indices, ejection fraction, or NT-proBNP levels. Serious adverse events occurred in one patient (1.6%) in the ertugliflozin group and 6 (9.2%) in the placebo group (P=0.12). Among patients with functional MR associated with HF, ertugliflozin significantly improved LV global longitudinal strain and left atrial remodeling, and reduced functional MR. Sodium-glucose cotransporter 2 inhibitors may be considered for patients with functional MR. URL: https://www.clinicaltrials.gov; Unique identifier: NCT04231331.

Impact of pulmonary hypertension on outcomes after TEER in patients suffering from mitral regurgitation.

Data on associations of invasively determined hemodynamic parameters with procedural success and outcomes in patients suffering from mitral regurgitation (MR) undergoing transcatheter edge-to-edge repair of the mitral valve (M-TEER) is limited. We enrolled 239 patients with symptomatic MR of grade 2 + , who received M-TEER. All patients underwent extensive pre-interventional invasive hemodynamic measurements via right heart catheterization (mean pulmonary arterial pressure (mPAP), systolic- (PAPsys) and diastolic pulmonary arterial pressure (PAPdia), pulmonary arterial wedge pressure (PAWP), a-wave, v-wave, pulmonary vascular resistance (PVR), transpulmonary pressure gradient (TPG), cardiac index (CI), stroke volume index (SVI)). mPAP and PAWP at baseline were neither associated with procedural success, immediate reduction of MR, nor residual MR after 6months of follow-up. The composite outcome (All-cause mortality (ACM) and/or heart failure induced rehospitalization (HFH)) and HFH differed significantly after M-TEER when stratified according to mPAP, PAWP, PAPdia, a-wave and v-wave. ACM was not associated with the afore mentioned parameters. Neither PVR, TPG, CI nor SVI were associated with the composite outcome and HFH, respectively. In multivariable analyses, PAWP was independently associated with the composite outcome and HFH. PVR and SVI were not associated with outcomes. PAWP at baseline was significantly and independently associated with HFH and might serve as a valuable parameter for identifying patients at high risk for HFH after M-TEER. ACM and procedural success were not affected by pulmonary arterial pressure before M-TEER. We suggest that the post-capillary component of PH serves as the driving force behind the risk of HFH.

Transcatheter Edge-to-Edge Mitral Valve Repair versus Minimally Invasive Mitral Valve Surgery: An Observational Study.

Background: Minimally invasive mitral valve surgery (MIC-MVS) has been established as preferred treatment of mitral regurgitation (MR), but mitral transcatheter edge-to-edge valve repair (M-TEER) is routinely performed in patients at high surgical risk and is increasingly performed in intermediate risk patients. Methods: From 2010 to 2021, we performed 723 M-TEER and 123 isolated MIC-MVS procedures. We applied a sensitivity analysis by matching age, left ventricular ejection fraction (LVEF), EuroSCORE II and etiology of MR. Results: Baseline characteristics showed significant differences in the overall cohort (p < 0.01): age 78.3 years vs. 61.5 years, EuroSCORE II 5.5% vs. 1.3% and LVEF 48.4% vs. 60.4% in M-TEER vs. MIC-MVS patients. Grade of MR at discharge was moderate/severe in 24.5% (171/697) in M-TEER vs. 6.5% (8/123) in MIC-MVS (p < 0.01). One-year survival was 91.5% (552/723) in M-TEER vs. 97.6% (95/123) in MIC-MVS (p = 0.04). A matching with 49 pairs (n = 98) showed comparable survival during follow-up, but a numerically higher mean mitral valve gradient of 4.1 mmHg (95% CI: 3.6-4.6) vs. 3.4 mmHg (95% CI: 3.0-3.8) in M-TEER (p = 0.04). Conclusions: Patients undergoing M-TEER had lower one-year survival than MIC-MVS, but differences disappeared after matching. Reduction in MR was less effective in M-TEER patients and postprocedural mitral valve gradients were higher.

Transapical Mitral Valve Replacement: 1-Year Results of the Real-World Tendyne European Experience Registry

BackgroundEarly studies of the Tendyne transcatheter mitral valve replacement (TMVR) showed promising results in a small selective cohort. ObjectivesThe authors present 1-year data from the currently largest commercial, real-world cohort originating from the investigator-initiated TENDER (Tendyne European Experience) registry. MethodsAll patients from the TENDER registry eligible for 1-year follow-up were included. The primary safety endpoint was 1-year cardiovascular mortality. Primary performance endpoint was reduction of mitral regurgitation (MR) up to 1 year. ResultsAmong 195 eligible patients undergoing TMVR (median age 77 years [Q1-Q3: 71-81 years], 60% men, median Society of Thoracic Surgeons Predicted Risk of Mortality 5.6% [Q1-Q3: 3.6%-8.9%], 81% in NYHA functional class III or IV, 94% with MR 3+/4+), 31% had “real-world” indications for TMVR (severe mitral annular calcification, prior mitral valve treatment, or others) outside of the instructions for use. The technical success rate was 95%. The cardiovascular mortality rate was 7% at 30 day and 17% at 1 year (all-cause mortality rates were 9% and 29%, respectively). Reintervention or surgery following discharge was 4%, while rates of heart failure hospitalization reduced from 68% in the preceding year to 25% during 1-year follow-up. Durable MR reduction to ≤1+ was achieved in 98% of patients, and at 1 year, 83% were in NYHA functional class I or II. There was no difference in survival and major adverse events between on-label use and “real-world” indications up to 1 year. ConclusionsThis large, real-world, observational registry reports high technical success, durable and complete MR elimination, significant clinical benefits, and a 1-year cardiovascular mortality rate of 17% after Tendyne TMVR. Outcomes were comparable between on-label use and “real-world” indications, offering a safe and efficacious treatment option for patients without alternative treatments. (Tendyne European Experience Registry [TENDER]; NCT04898335)

Transcatheter edge-to-edge repair in papillary muscle injury complicating acute myocardial infarction.

Acute mitral regurgitation (MR) in the setting of myocardial infarction (MI) may be the result of papillary muscle rupture (PMR). This condition is associated with high morbidity and mortality. We aim to evaluate the feasibility of transcatheter edge-to-edge mitral valve repair (TEER) in this acute setting. We analysed data from the International Registry of MitraClip in Acute Mitral Regurgitation following acute Myocardial Infarction (IREMMI) of 30 centres in Europe, North America, and the middle east. We included patients with post-MI PMR treated with TEER as a salvage procedure, and we evaluated immediate and 30-day outcomes. Twenty-three patients were included in this analysis (9 patients suffered complete papillary muscle rupture, 9 partial and 5 chordal rupture). The patients' mean age was 68±14years. Patients were at high surgical risk with median EuroSCORE II 27% (IQR 16, 28) and 20 out of 23 (87% were in cardiogenic shock). All patients were treated with vasopressors, and 17 out of 23 patients required mechanical support. TEER procedure was performed on the median 6days after the index MI date IQR (3, 11). Procedural success was achieved in 87% of patients. The grade of MR was significantly decreased after the procedure. MR reduction to 0 or 1+was achieved in 13 patients (57%), to 2+in 7 patients (30%), P<0.01. V-Wave was reduced from 49±8mmHg to 26±10mmHg post-procedure, P<0.01. Sixteen out of 23 patients (70%) were discharged from hospital and 5 of them required reintervention with surgical mitral valve replacement. No additional death at 1year was documented. TEER is a feasible therapy in critically ill patients with PMR due to a recent MI. TEER may have a role as salvage treatment or bridge to surgery in this population.

Posterior Annulus Elevation Technique in Reducing Residual Regurgitation During Mitral Valve Repair in Children: A Randomized Controlled Trial.

Background: The current technique used in severe mitral regurgitation in children can occasionally lead to residual regurgitation. To address this issue, the posterior annulus elevation technique was developed to enhance coaptation and reduce residual lesions. This study aims to evaluate the effectiveness of this technique in reducing residual regurgitation during mitral valve repair in children. Methods: A total of 64 patients aged <18 years old undergoing mitral valve repair were randomized into two groups: the intervention (with posterior annulus elevation) group and the control group, which underwent conventional repair techniques. Various parameters, including coaptation area, residual mitral regurgitation, clinical outcomes, metabolic, and hemolytic markers, were measured on days 0, 5, 2 weeks, and 3 months after surgery. Results: The intervention group (n = 32) showed a significant reduction in residual mitral regurgitation compared with the control group (n = 32) on each evaluation. At three months after surgery, we found that the posterior annulus elevation technique could be a protective factor that reduces the chance of residual regurgitation compared with the control group (RR = 0.31; confidence interval: 0.18-0.54; P ≤ .001). Coaptation length and index were also found to be significantly higher in the intervention group (P ≤ .001). Clinical outcomes, metabolic markers, and hemolysis marker did not show any significant differences between the two groups. Conclusions: The posterior annulus elevation technique demonstrated effectiveness in reducing residual mitral regurgitation and improving coaptation area in pediatric mitral valve repair. This technique showed better short-term surgical outcomes in children with mitral regurgitation compared with the conventional technique.

In Situ Transesophageal Echocardiography During Electrical Cardioversion in Patients With Atrial Fibrillation—Safety and Echocardiographic Findings

Transesophageal echocardiography (TEE) can reliably detect left atrial (LA) and LA appendage (LAA) thrombus in patients with atrial fibrillation (AF) before electrical cardioversion (ECV). However, evaluating cardiac and valve function pre-ECV can be challenging due to the increased and irregular heart rate. Additionally, post-ECV atrial stunning increases the risk of LAA thrombosis. Therefore, post-ECV TEE may allow for useful appendage, ventricular, and valve function assessment. However, the safety and usefulness of leaving the TEE probe in situ during ECV for post-ECV cardiac evaluation in clinical practice have not been previously evaluated. We analyzed 37 out of 86 consecutive patients who had the TEE probe left in situ, for clinical reasons, during ECV by a single operator between February 20, 2019, and January 3, 2023. We examined changes in left ventricular (LV) function, dynamic changes in valvular regurgitation, electromechanical coupling of the left atrium, and qualitative spontaneous echo contrast. We also assessed the presence of any complications related to the periprocedural TEE exam. The mean age of the patients was 74±9.65years, and 29 (78%) were male. The periprocedural TEE time ranged from 7 to 55minutes, with an average of 20.78minutes. Immediately after ECV and restoration of normal sinus rhythm, there was an improvement in LV ejection fraction (47%±11.9% vs 40%±15.8%; P=.035). There was also a reduction in baseline mitral regurgitation of greater than moderate degree. However, spontaneous echo contrast worsened in the LAA in 11 (31.4%) patients. Additionally, 1 patient developed a new LAA thrombus, and 24 patients (72%) had evidence of electromechanical coupling with Doppler evidence of LA contraction. Clinically significant degenerative aortic and mitral stenosis were identified in 8% and mild or greater aortic regurgitation in 8% of patients post-ECV. No procedural complications were observed. In situ TEE before, during, and after ECV is safe and provides useful clinical information regarding immediate cardiac changes after ECV, with diagnostic and therapeutic implications.

Mitral valve leaflet stiffness predicts residual mitral regurgitation after transcatheter edge-to-edge mitral valve repair.

Residual regurgitation after transcatheter edge-to-edge mitral valve repair (TMVR) is a predictor of poor prognosis in patients with functional mitral regurgitation (FMR). This study sought to identify the mitral valve (MV) parameters measured by three-dimensional transesophageal echocardiography (3D-TEE) and MV leaflet features that predict residual mitral regurgitation (MR) after TMVR in patients with FMR. Consecutive patients with FMR who underwent TMVR were classified into two groups based on the degree of residual MR just after TMVR:<2+ in the optimal MR reduction group and ≥ 2+ in the suboptimal MR reduction group. The two groups were compared with respect to 3D-TEE parameters and the MV leaflet features, including the following parameters: stiffness, defined as a leaflet that remains at a fixed angle even during diastole, and thickness, measured in both clear and rough zones. Thirty-four of 46 patients (74%) were classified as the optimal MR reduction group. Multivariable analysis showed that anterior mitral leaflet + posterior mitral leaflet length/anteroposterior annulus diameter (p=.044) and MV leaflet stiffness (p=.007) were independent predictors of residual MR. MV leaflet stiffness and the ratio of MV leaflet lengths to the annulus diameter may be good predictors of residual MR after TMVR in patients with FMR.

Influence of device generations on alternations of mitral annulus after transcatheter edge-to-edge repair: a real-time three-dimensional transesophageal echocardiography study

Abstract Background Alternation of the mitral annulus (MA) after transcatheter edge-to-edge mitral valve repair (TEER) is reported to be associated with a reduction of mitral regurgitation (MR). However, the influence of the new device system with 4 device size options (MitraClip G4) on MA geometry compared to the conventional device (G2) remains unknown. Methods and results A total of 129 patients (mean age 79±10 years, male 66%) including 38 primary MR and 91 secondary MR who underwent TEER guided with three-dimensional (3D) transesophageal echocardiography (TEE) were included. MA area, anterior-posterior (AP) diameter, inter-commissure (CC) diameter, and MA ellipticity before and after MitraClip implantation were measured using 3D TEE images assessed by dedicated software. MitraClip G4 was used in 54 cases (42%). In patients with secondary MR, greater changes in MA area, AP diameter, and MA ellipticity were observed in patients treated with G4 compared to G2 (P=0.001, 0.003, and 0.39, respectively). In contrast, patients with primary MR had no differences in the change of MA parameters between G2 and G4. Patients with significant residual MR had less increase of MA ellipticity after device implantation in secondary MR (P=0.014), but not in primary MR (P=0.062). Conclusion In patients with secondary MR, MitraClip G4 made greater changes in MAA, AP diameter, and MA ellipticity compared to MitraClip G2, but not in CC diameter. The change of ellipticity was associated with a reduction of MR after device implantation in secondary MR. These findings indicated that MitraClip G4 may lead favorable MA alternation than G2, especially in secondary MR.

Impact of transcatheter edge-to-edge repair (TEER) of mitral valve on the clinical outcomes in the management of atrial functional mitral regurgitation

Abstract Background Atrial functional mitral regurgitation (aFMR) has become a novel topic of interest. Data on the safety and efficacy of transcatheter edge-to-edge repair (TEER) of mitral valve among patients with aFMR and ventricular functional mitral regurgitation (vFMR) is scarce and limited to single center studies. Purpose We conducted a systematic review and meta-analysis to assess the safety and efficacy of TEER in the management of aFMR vs vFMR and its impact on clinical outcomes. Methods PubMed/MEDLINE, Cochrane Library and EMBASE databases were queried to identify studies comparing the efficacy of TEER between aFMR and vFMR. The primary outcome of interest was mortality at 1 year and composite of all-cause mortality and heart failure (HF) hospitalizations. Secondary outcomes included mitral regurgitation (MR) reduction, presence of residual MR, improvement in NYHA functional class, postoperatively and at 1-year. Risk ratios (RR’s) and their corresponding 95% confidence intervals (CIs) were calculated using random-effects model. Results We included a total of 3,314 patients from 6 observational studies which met the inclusion criteria (mean age 63.8 ± 3.8 years, 43% male). There were 443 aFMR patients and 2871 vFMR patients with an average follow-up of 12 months. Mortality at 1-year and the composite outcome of all-cause mortality and heart failure hospitalizations were comparable between aFMR and vFMR groups (RR 1.06; 95% CI 0.64 - 1.75; p = 0.81 and RR 0.92; 95% CI 0.75 - 1.14; p = 0.47, respectively). There were no significant differences between aFMR and vFMR groups in terms of MR reduction postoperatively (RR 0.99; 95% CI 0.96 - 1.02; p = 0.53) or at 1-year (RR 1.15; 95% CI 0.96 - 1.38; p = 0.14). Moreover, the presence of residual MR grade ≥ 3+ postoperatively (RR 1.31; 95% CI 0.83 - 2.08; p = 0.25) and at 1-year (RR 0.96; 95% CI 0.44 - 2.11; p = 0.92) was similar between aFMR and vFMR cohorts. Overall, although there was a clinical improvement in symptoms in terms of NYHA functional class at 1 year (grade ≤ 2), there was no statistical significance between the two groups (RR 1.02; 95% CI 0.93 - 1.11; p = 0.74). Conclusion This meta-analysis suggests that transcatheter edge-to-edge repair is likely to be an efficacious and safe option in patients with aFMR and vFMR. Future randomized control trials are needed to fully assess the clinical impact of this procedure in the two MR etiologies.Figure 1Figure 2

Mitral leaflet retraction and left ventricular reverse remodeling in patients with treated dilated cardiomyopathy

Abstract Background Enlargement of the mitral leaflets (MLs) adaptive to mechanical stress caused by dilated left ventricle (LV) was recognized, but their changes after the stimuli withdrawn remained unexplored. Aims To observe morphological changes in the MLs along with LV reverse remodeling (LVRR) occurred after standard care. Methods Patients with recent-onset dilated cardiomyopathy (RODCM) were prospectively enrolled (n=82), as well as a group of age, sex and body surface area matched normal controls (NC) (n=50). Two-dimensional transthoracic echocardiography was performed at baseline and 6-month follow-up with special interests in the length of anterior and posterior mitral leaflet (AML and PML), mitral annular dimension (MAD) and tenting height (TH). LVRR was measured as a reduction in the LV end-diastolic volume (LVEDV) of ≥15%. Results At the 6-month follow-up, LVRR was achieved in 69.5% patients and there were 26.9% patients who reported ≥1 grade reduction in secondary mitral regurgitation that related to LVRR. The AML (28±3 vs. 26±3mm, p=0.004) and PML (19±4 vs. 17±3mm, p&amp;lt;0.001) were decreased, as well as the MAD (31±5 vs. 28±5mm, p=0.001) and TH (10±3 vs. 8±2mm, p&amp;lt;0.001), but all remained larger than that of the NC group (all p&amp;lt;0.05). When compared with the control group, the AML and PML of the RODCM group was 16.7% and 35.7% longer at baseline, which remained 8.3% and 21.2% longer at the follow-up, respectively. The change in the AML (△AML) or PML (△PML) correlated moderately to the change in the LVEDV (△LVEDV) (r=0.487, p&amp;lt;0.001; r=0.516, p &amp;lt;0.001, respectively) (Figure 1). When compared between the subgroups stratified by LVRR, both the AML and PML decreased in the patients who had LVRR (+) (AML, 28±3 vs. 26±3, p=0.001; PML, 20±4 vs. 16±3, p&amp;lt;0.001), but remained the same length in those with LVRR (-) (AML, 27±4 vs. 28±4, p=0.318; PML, 17±3 vs. 17±3, p=0.790). The comparison in the △AML and △PML between the two subgroups is shown in Figure 2. Conclusion The enlarged MLs could retract with different behavior in the AML and PML, accompanied by LV reverse remodeling. This study conducted in patients with RODCM who received standard therapy provided the other facet of mitral leaflet plasticity adaptive to mechanical stretch.correlation between △MLs and △LVEDVCompare △MLs between LVRR subgroups

Efficacy and evolution of edge-to-edge transcatheter valve repair procedures

Abstract Background Edge-to-edge transcatheter mitral valve repair (M-TEER) has shown safety and efficacy in reducing secondary mitral regurgitation (MR) (1,2) and led to the development of similar devices for transcatheter valve repair (T-TEER) for tricuspid regurgitation (TR) (Fig. 1A). However, T-TEER implementation is challenging due to complex valve anatomy and periprocedural imaging. We sought to understand to which extent procedural success of M-TEER changed over time and possibly impacted T-TEER results. Methods We retrospectively analyzed intraprocedural reduction of secondary MR and TR after release of a valve specific device, between 2018, when M-TEER was implemented in our center, through 2020, when T-TEER procedures started, and up to the end of 2022. We compared results between the 55 T-TEER procedures performed (age 81.8±4.7, 55% females) and 3 M-TEER cohorts: the very first 55 M-TEER, the last 55 M-TEER before T-TEER, and the very last 55 M-TEER (overall mean-age 78.4±8.2, 49% females) (Fig. 1B). Severe MR III/IV was defined by an effective regurgitation orifice area (EROA) of 20-39mm², and IV/IV by EROA ≥40mm², while TR was evaluated using the I/V to V/V classification. Considering that a 5-grade reduction of TR is either not possible or not desirable, the extension of regurgitation reduction for both valves was set on a scale from 1- to 4-grade. Also, optimal results were defined as residual MR 0+ (none or trace) or TR I+ (mild or mild to moderate), while acceptable results were considered MR I+ and TR II+ (moderate or moderate to severe). Results In all groups, regurgitation was successfully and significantly reduced within-group (Fig. 1C). MR reduction to optimal or acceptable levels increased over time from 60% at the start of the M-TEER program to 78% after 12-18 months (p=0.039), and 84% (p=0.005) after approximately 3 years. Accordingly, the extent of regurgitation reduction significantly improved between the first 2 M-TEER cohorts (p=0.016), as well as the first and the last 55 M-TEER (p=0.045), with no significant change from the second to the third population (p=0.267) (Fig. 2). Two years after the first M-TEER, T-TEER with valve specific devices was implemented and achieved 84% optimal or acceptable residual TR, better than initial M-TEER (p=0.005) and similar to the second (p=0.466) and third M-TEER cohorts (p=1.000). In terms of extent of regurgitation reduction, T-TEER also performed similar to the very first (p=0.645) and the very last M-TEER procedures (p=0.076), despite higher mean-EROA (78.5±32.2mm² vs 44.8±16.1mm² in all MR patients, p&amp;lt;0.001), more complex anatomy, more challenging imaging, and sicker patients (mean-EuroSCORE II 8.8±6.6% vs 6.4±5.3% in all MR patients, p&amp;lt;0.001). Conclusions In our center, gain in knowledge and experience, coupled with technological advances, have significantly impacted procedural M-TEER success over time and allowed similar successful implementation of a T-TEER program.Figure 1Figure 2

A novel hemodynamic index characterizing mitral regurgitation undergoing transcatheter edge to edge repair: the mitral pulse pressure fraction

Abstract Objectives Our study sought to investigate the role of invasive hemodynamic monitoring during Transcatheter Edge to Edge Repair (TEER) procedure on top of transesophageal echocardiographic (TEE) guidance. Background Direct hemodynamic impact of residual MR after TEER is not always univocally measured by TEE assessment alone. When analyzing TEER procedure result operators often encounter discrepancy between TEE guidance and invasive hemodynamic monitoring. Methods We analyzed 78 patients with moderate-to-severe or severe mitral regurgitation (MR) who underwent TEER. Mitral pulse Pressure Fraction (MPF) was extracted from intraprocedural continuous left atrial pressure monitoring. 23 patients with the same grade of MR not undergoing TEER were included as a control group. Results TEER had a significant impact reducing MR burden on both TEE guidance and invasive hemodynamic monitoring. Post-TEER MPF was significantly reduced compared to both pre-TEER setting (p &amp;lt; 0.001) and control group (p = 0.004). MR reduction assessed by TEE guidance was not found to be correlated with improved clinical and functional status at follow-up as assessed by New York Heart Association (NYHA) classification (p = 0.424) and 12-items Kansas City Cardiomyopathy Questionnaire (KCCQ) (p = 0.1). On the contrary, a greater reduction in MPF was associated with a significant amelioration of both NYHA classification (p = 0.003) and 12-items KCCQ (p&amp;lt;0.001) during the follow-up period. Conclusions MPF provides an immediate estimate of the real hemodynamic impact of MR and can offer a prompt prediction of the functional improvement after TEER.

1-Year Outcomes With Fourth-Generation Mitral Valve Transcatheter Edge-to-Edge Repair From the EXPAND G4 Study

BackgroundThe fourth-generation mitral transcatheter edge-to-edge repair (M-TEER) device introduced an improved clip deployment sequence, independent leaflet grasping, and 2 wider clip sizes to tailor the treatment of patients with mitral regurgitation (MR) for a broad range of anatomies. The 30-day safety and effectiveness of the fourth-generation M-TEER device were previously demonstrated. ObjectivesThe aim of this study was to evaluate 1-year outcomes in a contemporary, real-world cohort of subjects treated with the MitraClip G4 system. MethodsEXPAND G4 is an ongoing prospective, multicenter, international, single-arm study that enrolled subjects with primary and secondary MR. One-year outcomes included MR severity (echocardiographic core laboratory assessed), heart failure hospitalization, all-cause mortality, functional capacity (NYHA functional class), and quality of life (Kansas City Cardiomyopathy Questionnaire). ResultsA total of 1,164 subjects underwent M-TEER from 2020 to 2022. At 1 year, there was a durable reduction in MR to mild or less in 92.6% and to none or trace in 44.2% (P < 0.0001 vs baseline). Few subjects had major adverse events through 1 year (<2% for myocardial infarction, surgical reintervention, or single-leaflet device attachment). The 1-year Kaplan-Meier estimates for all-cause mortality and heart failure hospitalization were 12.3% and 16.9%. Significant improvements in functional capacity (NYHA functional class I or II in 82%; P < 0.0001 vs baseline) and quality of life (18.5-point Kansas City Cardiomyopathy Questionnaire overall summary score improvement; P < 0.0001) were observed. ConclusionsM-TEER with the fourth-generation M-TEER device was safe and effective at 1 year, with durable reductions in MR severity to ≤1+ in more than 90% of patients and concomitant improvements in functional status and quality of life.

1-Year Outcomes of Transcatheter Edge-to-Edge Repair in Anatomically Complex Degenerative Mitral Regurgitation Patients

BackgroundFavorable 6-month outcomes from the CLASP IID Registry (Edwards PASCAL transcatheter valve repair system pivotal clinical trial) demonstrated that mitral valve transcatheter edge-to-edge repair with the PASCAL transcatheter valve repair system is safe and beneficial for treating prohibitive surgical risk degenerative mitral regurgitation (DMR) patients with complex mitral valve anatomy. ObjectivesThe authors sought to assess 1-year safety, echocardiographic and clinical outcomes from the CLASP IID Registry. MethodsPatients with 3+ or 4+ DMR who were at prohibitive surgical risk, had complex mitral valve anatomy based on the MitraClip Instructions for Use, and deemed suitable for treatment with the PASCAL system were enrolled prospectively. Safety, clinical, echocardiographic, functional, and quality-of-life outcomes were assessed at 1 year. Study oversight included a central screening committee, echocardiographic core laboratory, and clinical events committee. ResultsNinety-eight patients were enrolled. One-year Kaplan-Meier (KM) estimates of freedom from composite major adverse events, all-cause mortality, and heart failure hospitalization were 83.5%, 89.3%, and 91.5%, respectively. Significant mitral regurgitation (MR) reduction was achieved at 1 year (P < 0.001 vs baseline) including 93.2% at MR ≤2+ and 57.6% at MR ≤1+ with improvements in related echocardiographic measures. NYHA functional class and Kansas City Cardiomyopathy Questionnaire score also improved significantly (P < 0.001 vs baseline). ConclusionsAt 1 year, treatment with the PASCAL system demonstrated safety and significant MR reduction, with continued improvement in clinical, echocardiographic, functional, and quality-of-life outcomes, illustrating the value of the PASCAL system in the treatment of prohibitive surgical risk patients with 3+ or 4+ DMR and complex mitral valve anatomy.