Hospitalization of Symptomatic Patients With Heart Failure and Moderate to Severe Functional Mitral Regurgitation Treated With MitraClip: Insights From RESHAPE-HF2 For patients with functional mitral regurgitation (FMR) and symptomatic heart failure (HF), randomized trials of mitral transcatheter edge-to-edge repair (M-TEER) have produced conflicting results. This study sought to assess the impact of M-TEER on hospitalization rates, and explore the effects of M-TEER on patients who did or did not have a history of recent HF hospitalizations before undergoing M-TEER. RESHAPE-HF2 (Randomized Investigation of the MitraClip Device in Heart Failure: 2nd Trial in Patients with Clinically Significant Functional Mitral Regurgitation) included patients with symptomatic HF and moderate to severe
In HF with functional MR, TEER with MitraClip improved HF hospitalization or CV death and health status. Transcatheter valve repair in heart failure with moderate to severe mitral regurgitation. N Engl J Med. 2024;391:1799-1809. 39216092.
Death incidents following transcatheter edge-to-edge repair (TEER) with the MitraClip device: analysis of 10-years post-marketing death reports from the Manufacturer and User Facility Device Experience (MAUDE) registry. The transcatheter edge-to-edge repair (TEER) technique, facilitated by the MitraClip device, is a minimally invasive intervention designed for high-risk patients with mitral regurgitation (MR). This study conducts a retrospective analysis of death events associated with MitraClip implantation over a ten-year decade, utilizing data from the FDA's Manufacturer and User Facility Device Experience (MAUDE) database to evaluate trends in safety outcomes. A comprehensive search of the publicly accessible MAUDE database was conducted to retrieve reports of deaths and injuries related
Randomized investigation of the MitraClip device in heart failure: Design and rationale of the RESHAPE-HF2 trial design. The safety and effectiveness of the MitraClip device to treat functional mitral regurgitation (FMR) has been tested in previous clinical trials yielding somewhat heterogeneous results in heart failure (HF) patients. Over time, the MitraClip device system has been modified and clinical practice evolved to consider also less severely diseased HF patients with FMR for this therapeutic option. The RESHAPE-HF2 trial aims to assess the safety and effectiveness of the MitraClip device system on top of medical therapy considered optimal in the treatment of clinically significant FMR in symptomatic patients with chronic HF. The RESHAPE-HF2 is an investigator-initiated, prospective
Incidence and Predictors of Cerebrovascular Accidents in Patients Undergoing Transcatheter Mitral Valve Repair with Mitraclip. Transcatheter mitral edge-to-edge repair (TEER) with transcatheter devices has become a mainstay in the minimally invasive treatment of patients with severe mitral regurgitation at increased surgical risk. Despite its apparently favorable risk profile , there is uncertainty on the risk and features of cerebrovascular accidents (CVA) early and long after TMVR. We aimed at appraising incidence and predictors of CVA in patients undergoing TEER. We explicitly queried the dataset of an ongoing multicenter prospective observational study dedicated to TEER with MitraClip (Abbott Vascular, Santa Clara, CA, USA). Incidence of CVA after TEER was formally appraised, and we
Design and Rationale of the V-Wave Shunt MitraClip Study. Patients heart failure (HF) and moderate-to-severe mitral regurgitation (MR) with residual elevations in left atrial pressure (LAP) following MitraClip may remain symptomatic and suffer subsequent HF readmissions. The V-Wave Interatrial Shunt System is a permanent interatrial septal implant that shunts blood from the left to right atrium and serves to continuously unload the left atrium. Though the V-Wave shunt has previously been studied in HF patients, the safety and feasibility of its deployment at the time of the MitraClip procedure is unknown. The V-Wave Shunt MitraClip Study (NCT04729933) is an early feasibility study which aims to demonstrate the safety and efficacy of implantation of the V-Wave shunt device at the time of MitraClip
MitraClip transcatheter mitral valve repair in patients with moderate-to-severe or severe mitral regurgitation who are not eligible for surgery The requested document is not available, or you don't have permission to view it.
Mitral valve infective endocarditis in a dialysis patient with a tunneled dialysis catheter and prior MitraClip® implantation: an autopsy case. The number of patients with heart disease who can benefit from treatment is continuing to increase due to the widespread use of cardiac implantable devices. Accordingly, the number of cardiac device-related infective endocarditis (CDRIE) cases has been increasing year by year. We report a very rare experience of performing an autopsy on a patient who died of CDRIE at the site of MitraClip ® implantation, which has recently been developed as a treatment option for severe mitral regurgitation. In addition to hematoxylin-eosin (H-E) staining, Elastica-Masson staining in the present case revealed destruction of all of the atrial, trabecular, fiber
Safety and efficacy of MitraClip in acutely ill (NYHA Class IV) patients with mitral regurgitation: Results from the global EXPAND study. Patients with severe mitral regurgitation (MR) and acute heart failure (HF) have refractory symptoms without adequate response to medical therapy. The objective of this analysis was to assess the impact of the MitraClip device in acutely ill HF patients , characterized by NYHA Class IV at baseline, in a real-world, contemporary setting. EXPAND was a prospective, multicenter, international study enrolling patients with MR who consented to receive the MitraClip System at 57 sites globally. The study outcomes included acute procedural success (APS), quality of life, heart failure hospitalizations (HFH), and all-cause mortality. The study population comprised
Cost-effectiveness of the MitraClip device in German heart failure patients with secondary mitral regurgitation. To evaluate the cost-effectiveness of the MitraClip device (MitraClip) in addition to optimal medical therapy (OMT) in patients with heart failure and secondary mitral regurgitation in Germany. A model-based economic evaluation was performed to estimate the incremental cost per quality-adjusted life-years (QALYs) for patients with a moderate-to-severe or severe secondary mitral regurgitation receiving MitraClip plus OMT compared with OMT alone from the statutory health insurance (SHI) perspective. Transition probabilities, data on survival rates, and hospitalization rates were obtained from the COAPT trial, a randomized-controlled multicenter trial. Data on health utility
Percutaneous MitraClip Device or Surgical Mitral Valve Repair in Patients With Primary Mitral Regurgitation Who Are Candidates for Surgery: Design and Rationale of the REPAIR MR Trial. Background The current standard of care for the treatment of patients with primary mitral regurgitation (MR) is surgical mitral valve repair. Transcatheter edge-to-edge repair with the MitraClip device provides a less invasive treatment option for patients with both primary and secondary MR. Worldwide, >150 000 patients have been treated with the MitraClip device. However, in the United States, MitraClip is approved for use only in primary patients with MR who are at high or prohibitive risk for mitral valve surgery. The REPAIR MR (Percutaneous MitraClip Device or Surgical Mitral Valve Repair in Patients
Comparison of costs associated with transcatheter mitral valve repair: PASCAL vs MitraClip in a real-world setting. We aimed to conduct a clinical process cost analysis to evaluate all upcoming costs of mitral valve transcatheter edge-to-edge repair (M-TEER) treatment using the MitraClip and the PASCAL repair system. First, we prospectively enrolled 107 M-TEER patients treated with either the PASCAL or MitraClip system and compared all upcoming costs during the M-TEER procedure and the associated in-hospital stay. Second, we retrospectively analysed 716 M-TEER procedures with regard to the occurrence of complications and their associated costs. All materials used in the catheterization laboratory for the procedures were evaluated. The cost analysis considered various expenses
Increased Left Ventricular End-diastolic Volume Index is associated with increased Adverse Events following MitraClip Implantation. This study investigated the association between the left ventricular end-diastolic volume index (LVEDVI) and the incidence of adverse clinical events in patients following MitraClip implantation. In this retrospective observational study, 123 patients who underwent the MitraClip procedure were enrolled. Participants were divided into 2 groups according to the LVEDVI cut-off level, calculated using receiver operating characteristic (ROC) curve analysis, to predict the primary endpoint, and the occurrence of cardiovascular events was compared between the groups. The primary endpoint was all-cause mortality and hospitalization due to heart failure. ROC curve analysis
Mortality Associated With Proportionality of Secondary Mitral Regurgitation After Transcatheter Mitral Valve Repair: North American Mitraclip for Functional Mitral Regurgitation Registry. The association, if any, between the effective regurgitant orifice (EROA) to left ventricular end-diastolic volume (LVEDV) ratio and 1-year mortality is controversial in patients undergoing mitral transcatheter edge-to-edge repair (m-TEER) with the MitraClip™ system. This study's objective was to determine the association between EROA/LVEDV and 1-year mortality among patients undergoing m-TEER with MitraClip™.In patients with severe secondary (functional) mitral regurgitation, we analyzed registry data from 11 centers using generalized linear models with the generalized estimating equations approach. We
Temporal trends and procedural safety of transcatheter mitral valve repair with mitraclip in patients with hypertrophic cardiomyopathy: Insights from the national inpatient sample. Data on utilization and safety of mitral Transcatheter Edge-to-Edge Repair (TEER) among hypertrophic cardiomyopathy (HCM) patients is limited. Our study aimed to assess the national utilization, safety, and clinical
Impact of Frailty on Outcomes After Transcatheter Edge-to-Edge Repair With MitraClip (from the National Inpatient Sample Database). Transcatheter edge-to-edge repair (TEER) with MitraClip (Abbott, Santa Clara, California) is a frequently chosen method for mitral valve repair for patients at high surgical risk. We investigated the impact of frailty on outcomes of patients who underwent TEER. We reviewed the National Inpatient Sample to identify patients that underwent TEER with MitraClip. Frailty was defined using the Johns Hopkins Adjusted Clinical Groups frailty-defining diagnoses indicator. The primary end point was in-hospital mortality. The secondary end points included blood transfusion, respiratory failure, sepsis, length of stay, and total hospitalization cost. Univariate
Real-world anticoagulatory treatment after percutaneous mitral valve repair using MitraClip: a retrospective, observational study on 1300 patients. This study sought to investigate current anticoagulatory treatment patterns and clinical outcome in patients undergoing transcatheter mitral valve repair (MitraClip). In a retrospective study of a German claims database (InGef research database ), anticoagulatory treatment regimens were assessed using any drug prescription post discharge within the first 90 days after MitraClip procedure. Clinical events between 30 days and 6 months were examined by treatment regime. The study population comprised 1342 patients undergoing MitraClip procedure between 2014 and 2018. 22.4% received antiplatelet monotherapy, 20.8% oral anticoagulation (OAC) plus antiplatelet
Target-controlled infusion during MitraClip procedures in deep-sedation with spontaneous breathing. Percutaneous mitral valve repair with the MitraClip system is an alternative procedure for high-risk patients not suitable for conventional surgery. The MitraClip can be safely performed under general anesthesia (GA) or deep sedation (DS) with spontaneous breathing using a combination of propofol and remifentanil. This study aimed to evaluate the benefits of target-controlled infusion (TCI) of remifentanil and administration of propofol during DS compared with manual administration of total intravenous anesthesia (TIVA) medication during GA in patients undergoing MitraClip. We assessed the impact of these procedures in terms of remifentanil dose, hemodynamic profile, adverse events, and days of hospital
Effect of Chronic Kidney Disease on 5-Year Outcome in Patients With Heart Failure and Secondary Mitral Regurgitation Undergoing Percutaneous MitraClip Insertion. Chronic kidney disease (CKD) is strongly related to outcomes in cardiovascular diseases. Limited data are available regarding the independent prognostic role of CKD after transcatheter mitral valve repair with MitraClip. We sought to evaluate the real impact of CKD in a large series of patients with heart failure (HF) and secondary mitral regurgitation (SMR) who underwent MitraClip treatment. The study included 565 patients with severe SMR from a multicenter international registry. Patients were stratified into 3 groups according to estimated glomerular filtration rate (eGFR) assessment before MitraClip implantation: normal eGFR (≥60
Mitral Valve Transcatheter Edge-to-Edge Repair Using MitraClip or PASCAL: A Multicenter Propensity Score-Matched Comparison. Since its introduction in 2003, Abbott's MitraClip (MC) has become the most established catheter-based treatment for mitral regurgitation (MR). Recent approval of Edwards Lifescience's PASCAL device has extended the field of TEER. The aim of this retrospective multicenter