Search Results (39)

Mitral regurgitation (MR) is a common valvular heart disease associated with significant morbidity and mortality. For patients at high or prohibitive surgical risk, mitral transcatheter edge-to-edge repair (M-TEER) offers a less invasive alternative to surgery. This review outlines key aspects of patient selection and procedural planning for M-TEER, with a focus on clinical and echocardiographic criteria essential for success. Comprehensive imaging—especially 2D and 3D transesophageal echocardiography—is critical to assess leaflet anatomy, coaptation geometry, and mitral valve area. Selection criteria differ between primary and secondary MR and are guided by trials such as COAPT and MITRA-FR. Optimal outcomes rely on careful screening, anatomical suitability, and multidisciplinary evaluation. With growing experience and advancing technology, M-TEER has become a transformative option for treating severe MR in non-surgical candidates. Full article

Secondary mitral regurgitation (sMR) is commonly understood to be secondary to heart failure (HF), left ventricular (LV) dilation, and altered coaptation of the mitral annulus. Three forms of sMR exist: non-ischemic sMR, ischemic sMR, and atrial functional sMR. In the past, there have been limited treatment options for this condition besides medication. Recently, the management of sMR has been revolutionized by the recent advances in percutaneous transcatheter edge-to-edge repair of the mitral valve (m-TEER). However, the major trials investigating this technology have shown that appropriate patient selection is of critical importance to achieve benefit. As such, there is a renewed interest in the accurate diagnosis of sMR. Herein, we review the etiology, management, and diagnosis of sMR in the era m-TEER. Full article

Background: Chronic mitral regurgitation (MR) is categorized into primary and secondary MR (SMR). While primary MR arises from structural abnormalities of the mitral valve apparatus, SMR is a consequence of cardiac remodeling, typically due to heart failure or atrial fibrillation. Management strategies differ significantly, with primary MR requiring direct valvular intervention and SMR necessitating a comprehensive approach incorporating guideline-directed medical therapy (GDMT), revascularization, and resynchronization strategies. The MitraClip, a transcatheter edge-to-edge repair (TEER) device, has emerged as a recommended intervention for symptomatic severe SMR despite optimal GDMT. Objectives: This study aims to evaluate national trends in MitraClip placements in the U.S. from 2016 to 2021 and to assess 90-day readmission events following the procedure. Additionally, we analyze patient and socioeconomic factors associated with heart failure readmissions post-MitraClip placement to optimize patient selection criteria. Methods: The study utilized data from the National Inpatient Sample (NIS) for the years 2016–2021 and the National Readmissions Database (NRD) for 2021. Patients who underwent MitraClip placement were identified using ICD-10 code 02UG3JZ. We stratified the population based on demographics, hospital resource utilization, and comorbidities. Index admissions were classified based on the presence or absence of heart failure remissions within 90 days post-procedure. Statistical analyses, including ANOVA and logistic regression, were conducted to identify factors associated with readmissions. Results: MitraClip utilization demonstrated a rising trend from 2016 to 2021, with total annual procedures increasing from 869 to 2488. Mean patient age remained stable at 76–79 years, with a nearly equal sex distribution. In-hospital mortality remained low (1–3%) throughout the study period. A steady increase in hospital charges was observed, alongside a decline in the mean length of stay. Analysis of 4918 index admissions for MitraClip placement in 2021 identified 780 total readmissions within 90 days, with 206 (26.4%) attributed to heart failure. Factors significantly associated with increased risk of heart failure readmissions included atrial fibrillation (OR 3.77, CI 1.82–4.23), pulmonary hypertension (OR 3.96, CI 1.49–5.55), and chronic lung disease (OR 1.91, CI 1.32–2.77). Conclusions: The increasing adoption of MitraClip underscores its growing role in managing SMR. However, heart failure readmissions remain a significant concern. Identifying high-risk patient profiles can refine selection criteria and enhance post-procedural management strategies to improve clinical outcomes. Further research is needed to optimize patient selection and refine risk stratification for MitraClip interventions. Full article

Background and Objectives: MitraClip^® (MC) placement has been extensively used as an intervention for mitral transcatheter edge-to-edge repair (mTEER) for functional mitral regurgitation (FMR). The aim of our study is to analyze the association between the pre-procedural echocardiographic parameters of diastolic function (DF) and one-year outcomes after MC placement. Materials and Methods: The study was designed in a retrospective longitudinal cross-sectional format. In total, 224 patients who underwent MC placement between January of 2021 and March of 2024 were included in the study. The Primary Efficacy Endpoint (PEE) was determined by an absence of heart failure hospitalizations requiring Intravenous Diuretics or cardiac-related death in the one-year follow-up period. Multivariate regression analysis was carried out to identify the pre-procedural echocardiographic parameters of DF that had a significant association with a failure to reach the PEE. A two-tailed p-value < 0.05 was used to determine statistical significance. Results: Of the 224 patients included in the study, 85 patients (37.94%) failed to reach the PEE or had worsening symptoms. The mean mitral valve (MV) deceleration time was 176.88 ms (164.14–189.62) in the symptom-worsening group compared to 201.53 ms (186.01–217.07) in the symptom-improvement group. The mean of the E/A ratio (MV peak E velocity/A velocity) was noted to be 2.35 (1.97–2.74) in the symptom-worsening group compared to 1.90 (1.68–2.13) in the symptom-improvement group. After multivariate regression analysis, the E/A ratio was found to have a significant association with a failure to reach PEE: Odds Ratio (OR): 1.61 (1.13–2.29), p-value: 0.008. The area under the curve (AUC) analysis for the E/A ratio was calculated at 0.603 (0.50–0.69) for the symptom-worsening group. Conclusions: Patients that failed to reach the PEE had a lower pre-procedural MV deceleration time of 176.88 ms (164.14–189.62); however, no association was observed between MV deceleration time and a failure to reach the PEE in the multivariate regression analysis. The pre-procedural E/A ratio had a significant association with symptom worsening after multivariate regression analysis: OR: 1.61 (1.13–2.29). The AUC for the E/A ratio in the symptom-worsening group was 0.603, making it a more moderate predictor than random guessing for the failure to reach the PEE. Full article

Background and Objectives: Mitral valve transcatheter edge-to-edge repair (TEER) is a widely adopted therapeutic approach for managing significant mitral regurgitation (MR) in high-risk surgical candidates. While procedural safety and efficacy have been demonstrated, the impact of institutional expertise on outcomes remains unclear. We aimed at evaluating whether the institutional monthly volume of TEER influences short- and long-term clinical results. Materials and Methods: This analysis from the multicenter, prospective GIOTTO trial study evaluated the impact of institutional monthly volume on outcomes of TEER to remedy significant mitral regurgitation. Centers were stratified into tertiles based on monthly volumes (≤2.0 cases/month, 2.1–3.5 cases/month, >3.5 cases/month), and key clinical, echocardiographic, and procedural outcomes were analyzed. Statistical analysis was based on standard bivariate tests as well as unadjusted and multivariable adjusted Cox models. Results: A total of 2213 patients were included, stratified into tertiles based on institutional procedural volume: 645 (29.1%) patients in the first tertile, 947 (42.8%) patients in the second tertile, and 621 (28.1%) patients in the third tertile. Several baseline differences were found, with some features disfavoring less busy centers (e.g., functional class and surgical risk, both p < 0.05), and others suggesting a worse risk profile in those treated in busier institutions (e.g., frailty and history of prior mitral valve intervention, both p < 0.05). Procedural success rates were higher in busier centers (p < 0.001), and hospital stay was also shorter there (p < 0.001). Long-term follow-up (median 14 months) suggested worse outcomes in patients treated in less busy centers at unadjusted analysis (e.g., p = 0.018 for death, p = 0.015 for cardiac death, p = 0.014 for death or hospitalization for heart failure, p < 0.001 for cardiac death or hospitalization for heart failure), even if these associations proved no longer significant after multivariable adjustment, except for cardiac death or hospitalization for heart failure, which appeared significantly less common in the busiest centers (p < 0.05). Similar trends were observed when focusing on tertiles of overall center volume and when comparing for each center the first 50 cases with the following ones. Conclusions: High institutional monthly volume of TEER mitral valve repair appears to correlate with an improved procedural success rate and shorter hospitalizations. Similarly favorable results were found for long-term rates of cardiac death or hospitalization for heart failure. These findings inform on the importance of operator experience and center expertise in achieving state-of-the-art results with TEER, while confirming the usefulness of the proctoring approach when naïve centers begin a TEER program. Full article

Background: Pulmonary hypertension (PH) is associated with the outcomes of mitral valve transcatheter edge-to-edge repair (M-TEER) in patients with severe mitral regurgitation (MR). However, the prognosis of baseline PH on MR patients after M-TEER has been controversial. This meta-analysis aimed to determine the prognostic value of PH with early and late outcomes after M-TEER with MitraClip. Methods: We systematically searched PubMed/MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials (CENTRAL) and Web of Science for studies. The results of the meta-analysis are summarized as the hazard ratio (HR), odds ratios (ORs) or mean difference (MD) and 95% confidence interval (CI). Results: A total of 20 publications were included in the systematic review, of which six were observational cohort studies including 5684 patients. The pooled incidence estimate of all-cause mortality was more common in severe PH than in patients who were non-PH. On pooled multivariate analysis, baseline PH was associated with late (≥1-year) all-cause mortality (HR = 1.61, 95% CI [1.23–2.11]) and the combined outcome of late HF rehospitalization and all-cause mortality (HR = 1.33, 95% CI [1.15–1.53]) after M-TEER. The level of SPAP significantly decreased after MitraClip in MR patients with PH (MD = −12.33 mmHg, 95% CI [−14.08–−10.58]). Conclusions: Baseline PH had a worse prognosis of early (≥30-day) cardiac mortality, late all-cause mortality as well as the composite outcome of HF rehospitalization and all-cause mortality after M-TEER compared to non-PH patients. Future studies are needed to prove these findings. Full article

Background/Objectives: Transcatheter edge-to-edge mitral valve repair (M-TEER) has emerged as an efficacious treatment modality among patients at high perioperative risk. Given the steady increase in procedures and the limited capacity for intensive care, there is a need to identify patients at high risk for postinterventional intensive care. Methods: All patients who underwent M-TEER between 2014 and 2023 were investigated. The intensive care unit (ICU) stay ended when patients met all the following criteria: no further need for catecholamine support, no oxygen requirement > 6 L O2/min, no indication for renal replacement therapy, and no delirium or relevant bleeding. Uni- and multivariable logistic regression analyses were used to identify independent predictors of the need for ICU treatment. Results: In total, 33% of patients (62/183) had an indication for ICU treatment after M-TEER. Patients with an indication for ICU treatment had significantly lower survival rates three years after M-TEER (37.4% [23/62] vs. 61.6% [75/121], p < 0.001) than patients without an ICU indication. A EuroSCORE II of >10% (OR 2.6, 95% CI 1.3–5.4, p = 0.006), a MitraScore of >3 (OR 2.5, 95% CI 1.2–5.2, p = 0.02), and a hospital stay of >5 days before M-TEER (OR 3.2, 95% CI 1.6–6.4, p < 0.001) were independently associated with the need for ICU treatment. Conclusions: One-third of the patients were indicated for ICU treatment, which was associated with a high mortality rate. On the basis of these predictors of required ICU care, tailored treatment strategies can be developed to improve treatment outcomes. Full article

Background/Objectives: Over the past two decades, MitraClip™ therapy has proven to be an effective and safe treatment for severe mitral regurgitation (MR), with more than 200,000 patients treated globally through continuous advancements in device design and implantation techniques. This retrospective, observational, single-center study aimed to assess the safety and efficacy of the latest generation of MitraClip compared to earlier models in the Real-World MitraClip Florence Registry. The primary efficacy endpoint was a comparison in terms of the rate of successful procedures, the time to device deployment and the duration of the hospital stay. The secondary safety endpoint regarded long-term all-cause mortality and hospitalization for heart failure. Methods: Patients treated at our center from January 2016 to June 2022 were included. They were divided into two groups: those receiving early-generation devices (G1–G3) and those treated with the last-generation device (G4). All patients underwent a comprehensive preoperative echocardiographic assessment, with a re-evaluation before hospital discharge and after 12 months. A long-term follow-up focusing on all-cause mortality and hospitalization for heart failure was conducted. Results: Of 131 patients, 81 received the last-generation device. The mean age was 79.4 years. Both groups exhibited a high burden of comorbidities (overall mean n = 2.85). Procedural success was high (97%) across groups, with a significantly better MR reduction (Grade ≤ 1) in the G4 group (47% vs. 70%, p = 0.009). The time to device deployment was significantly shorter with the G4 system (72 vs. 135 min, p < 0.001), and there was a trend towards shorter hospital stays (6.1 vs. 7.9 days, p = 0.08). Kaplan–Meier analysis demonstrated better 5-year survival rates for the last-generation device group (p = 0.019), with no significant difference in rehospitalization rates (p = 0.186). Conclusions: The MitraClip G4 system in the real world for the treatment of severe MR is safe and effective, achieving immediate and durable procedural success, accompanied by an improved NYHA functional class. Moreover, a better long-term survival rate was observed, along with a comparable high rate of recurrent HF hospitalization, reflecting a high comorbidity burden in this frail population. Full article

Mitral regurgitation (MR) is a common valvular disorder often seen in a severely dilated left ventricle (LV) and reduced LV function. In chronic heart failure (HF), severe functional MR increases preload, wall tension, LV workload, and worsening prognosis. The MitraClip device offers a percutaneous treatment option in HF, although its safety and efficacy in advanced and acute HF remain a gray zone. We present a successful case of the emergent MitraClip intervention in a patient with advanced HF and review the relevant literature. Full article

Background: Mitral regurgitation (MR) is a common valvular disorder linked to high morbidity and mortality. For patients unsuitable for surgery, transcatheter mitral edge-to-edge repair (TEER) with the MitraClip^® G4 system offers an alternative. This study aims to evaluate procedural, echocardiographic, functional, and quality of life (QoL) outcomes in patients who underwent TEER with the MitraClip^® G4 system, along with possible predictors of New York Heart Association (NYHA) class I at 30 days and at 1 year. Methods: Patients with moderate-to-severe (3+) or severe (4+) degenerative MR (DMR) or functional MR (FMR), classified as NYHA class III or IV, and who underwent TEER with the MitraClip^® G4 system at our center between January 2021 and December 2023 were included. Results: A total of 83 patients [71% FMR, 66% male, median (IQR) age 70 (11) years] underwent TEER, with 100% procedural success. MR ≤ 2+ was achieved in 100% and 98% of patients at 30 days and 1 year, respectively. NYHA class I or II was achieved in 100% and 96.8% of patients at 30 days and 1 year, respectively. The Kansas City Cardiomyopathy Questionnaire (KCCQ) score improved from 51 ± 20 at baseline to 69 ± 15 at 30 days (p < 0.001) and 70.5 ± 15 at 1 year (p < 0.001). Lower baseline N-terminal pro-brain natriuretic peptide (NT-proBNP) predicted achieving NYHA class I at 30 days (HR: 0.63, 95% CI: 0.41–0.95, p = 0.030), while lower European System for Cardiac Operative Risk Evaluation II (EuroSCORE II) and NT-proBNP predicted it at 1 year [(HR: 0.50, 95% CI: 0.28–0.89, p = 0.019), (HR: 0.67, 95% CI: 0.44–0.99, p = 0.049), respectively]. Conclusions: The MitraClip^® G4 system provides significant improvements in MR severity, functional class, and QoL. Lower NT-proBNP and EuroSCORE II were strong predictors of achieving optimal functional status (NYHA class I). Full article

Introduction: Clinically significant severe tricuspid regurgitation (TR) is a common untreated pathology associated with increased mortality. Even though surgical valve replacement has been the mainstay option, transcatheter intervention is a novel and potentially effective tool. To the best of our knowledge, this is the first systematic review that assessed and compared clinical and echocardiographic outcomes of coaptation and annuloplasty devices in patients with clinically significant TR. Methods: PubMed, the Cochrane Central Register of Controlled Trials, and EMBASE were searched for articles published from August 2016 until February 2023. Primary endpoints were technical and procedural successes. Secondary endpoints were TR grade, NYHA, change in 6 min walk distance (6MWD), and echocardiographic parameters at 30-day follow-up. Results: We included thirty-eight studies consisting of 2273 patients with severe symptomatic TR (NYHA III-IV 77% and severe/massive/torrential TR 83.3%) and high surgical risk (mean EUROSCORE of 7.54). The technical success for the annuloplasty devices was 96.7% and for the coaptation device was 94.8%. The procedural success for the annuloplasty devices was 64.6% and for the coaptation device was 81.4%. The 6MWD increased by 17 m for the coaptation devices and increased by 44 m after 30 days for the annuloplasty devices. A reduction in TR grade to <2 was seen in 70% of patients with coaptation and 59% of patients with annuloplasty devices. Conclusions: Transcatheter tricuspid valve intervention appears to be feasible and is associated with favorable outcomes. Full article

Background: Patients with cardiogenic shock (CS) and mitral regurgitation (MI) have a prohibitive risk that contraindicates surgical treatment. Although the feasibility of transcatheter edge-to-edge therapy (TEER) has been demonstrated in this setting, the benefit of the combined use of TEER with mechanical circulatory support devices (MCS) has not been studied. The aim of this study was to evaluate the clinical outcomes of TEER in patients with MCS. Methods: The MITRA-ASSIST study is a retrospective multicentre Spanish registry that included patients with MR and CS who underwent TEER in combination with MCS. The primary endpoint was death from any cause at 12 months. The secondary endpoint was a composite of death from any cause or hospitalisation for heart failure at 12 months. Results: A total of twenty-four patients in nine high-volume Spanish centres (66.2 (51–82) years, 70.8% female, EuroSCORE II 20.4 ± 17.8) were included. Acute ST-elevation myocardial infarction was the main CS aetiology (56%), and the most implanted MCS was the intra-aortic balloon pump (82.6%), followed by ECMO (8.7%), IMPELLACP^® (4.3%), or a combination of both (4.3%). Procedural success was 95.8%, with 87.5% in-hospital survival. At 12-month follow-up, 25.0% of patients died, and 33.3% had a composite event of death from any cause or hospitalisation for heart failure. Conclusions: TEER in patients with concomitant CS and MR who require MCS appears to be a promising therapeutic alternative with a high device procedural success rate and acceptable mortality and heart failure readmission rates at follow-up. Full article

Background/Objectives: Previous trials reported comparable results with PASCAL and earlier MitraClip generations. Limited comparative data exist for more contemporary MitraClip generations, particularly the large MitraClip XT(R/W). We aimed to evaluate acute and 30-day outcomes in patients undergoing mitral valve transcatheter edge-to-edge repair (M-TEER) with one of the large devices, either PASCAL P10 or MitraClip XT(R/W) (3rd/4th generation). Methods: A total of 309 PASCAL-treated patients were matched by propensity score to 253 MitraClip-treated patients, resulting in 200 adequately balanced pairs. Procedural, clinical, and echocardiographic outcomes were collected for up to 30 days, including subgroup analysis for mitral regurgitation (MR) etiologies. Results: PASCAL and MitraClip patients were comparable regarding age (80 vs. 79 years), sex (female: 45.5% vs. 50.5%), and MR etiology (degenerative MR: n = 94, functional MR [FMR]: n = 96, mixed MR: n = 10 in each group). Technical success rates were comparable (96.5% vs. 96.0%; p > 0.999). At discharge, the mean gradient was higher (3.3 mmHg vs. 3.0 mmHg; p = 0.038), and the residual mitral valve orifice area was smaller in MitraClip patients (3.0 cm² vs. 2.3 cm²; p < 0.001). At discharge, the reduction to MR ≤ 2+ was comparable (92.4% vs. 87.8%; p = 0.132). However, reduction to MR ≤ 1+ was more frequently observed in PASCAL patients (67.7% vs. 56.6%; p = 0.029), driven by the FMR subgroup (74.0% vs. 60.0%; p = 0.046). No difference was observed in 30-day mortality (p = 0.204) or reduction in NYHA-FC to ≤II (p > 0.999). Conclusions: Both M-TEER devices exhibited high and comparable rates of technical success and MR reduction to ≤2+. PASCAL may be advantageous in achieving MR reduction to ≤1+ in patients with FMR. Full article

(1) Objective: We aimed to assess whether the candidate profile, the long-term outcomes and the predictors for long-term mortality after transcatheter edge-to-edge mitral valve repair (M-TEER) have changed over the last decade; (2) Methods: Long-term follow-up data (median time of 1202 days) including mortality, MACCE and functional status were available for 677 consecutive patients enrolled in the prospective MiTra Ulm registry from January 2010 to April 2019. The initial 340 patients treated in our institution before January 2016 were compared with the following 337 patients; (3) Results: Patients treated after 2016 showed significantly less ventricular dilatation (left ventricular end-systolic diameter of 43 ± 13 mm vs. 49 ± 16 mm, p < 0.007), lower systolic pulmonary pressures (50 ± 15 mmHg vs. 57 ± 21 mmHg, p = 0.01) and a lower prevalence of severe tricuspid regurgitation (27.2% vs. 47.3%, p < 0.001) at baseline than patients treated before 2016. Compared to the cohort treated before 2016, patients treated afterwards showed a significantly lower all-cause 3-year mortality (29.4% vs. 43.8%, p < 0.001) and lower MACCE (38.6% vs. 54.1%, p < 0.001), without differences for MR etiology. While severe tricuspid regurgitation and NYHA class IV remained independently associated with an increased long-term mortality over the last decade, severe left ventricular dilatation (hazard ratio, HR 2.12, p = 0.047) and severe pulmonary hypertension (HR 2.18, p = 0.047) were predictors of long-term mortality only in patients treated before 2016. (4) Conclusions: The M-TEER candidates are currently treated earlier in the course of disease and benefit significantly in terms of a better long-term survival than patients treated at the beginning of the M-TEER era. Full article

Both the MitraClip and PASCAL systems offer transcatheter edge-to-edge repair (TEER) solutions for mitral regurgitation. Evidence indicates a lower technical success rate for TEER in complex degenerative mitral regurgitation (DMR) cases. We conducted a retrospective analysis of patients who underwent transcatheter edge-to-edge therapy for primary mitral regurgitation with advanced anatomy, defined as mitral regurgitation effective regurgitant orifice area (MR-EROA) ≥0.40 cm² or large flail gap (≥5 mm) or width (≥7 mm) or Barlow’s disease, that completed follow-up after 1 year. Our criteria were met by 27 patients treated with PASCAL and 18 with MitraClip. All patients exhibited a significant, equivalent short-term reduction in MR-EROA, mitral regurgitation vena contracta diameter (MR-VCD), regurgitant volume, and clinical status. At 1 year follow-up, reductions in MR-VCD, regurgitant volume, and MR-EROA remained significant for both groups without significant differences between groups. MR-Grade ≤ 1+ was achieved in 18 (66.7%) and 10 (55.6%) patients, respectively. At follow-up, no difference in hospitalization for cardiac decompensation was observed. Overall death was similar in both groups. Our study suggests that both the PASCAL and MitraClip systems significantly reduce mitral regurgitation even in advanced degenerative diseases. Within our limited data, we found no evidence of inferior performance of the PASCAL system. Full article