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      Monitoring of mitral‐ and tricuspid valve interventions with CardioMEMS: Insights beyond imaging

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          Abstract

          Background

          Mitral‐ and tricuspid regurgitation are associated with significant morbidity and mortality and are increasingly treated interventionally. CardioMEMS is a transcutaneously implanted pressure sensor placed in the pulmonary artery that allows invasive measurement of pulmonary artery pressure and cardiac output.

          Methods

          This proof‐of‐concept study aimed to observe hemodynamic changes as determined by CardioMEMS after transcatheter atrioventricular valve interventions, assess the additional value of CardioMEMS on top of echocardiography, and investigate a potential effect of CardioMEMS on outcome. Patients treated with transcatheter mitral‐ or tricuspid valve interventions (mitral: TMVR, tricuspid: TTVR) or bicaval valve implantation (bi‐CAVI) were recruited. All patients were followed for 12 months.

          Results

          Thirty‐six patients were included (4 with CardioMEMS, 32 controls). Patients with CardioMEMS were monitored prior to intervention and 3–12 months thereafter (one received TMVR, one bi‐CAVI, one both TMVR and TTVR, and one isolated TTVR). CardioMEMS group: In both patients with TMVR and in the patient with bi‐CAVI, mean pulmonary artery pressures decreased (all p < .001) and cardiac output increased significantly (both TMVR p < .001 and bi‐CAVI p = .006) while functional parameters, echocardiography, and NT‐proBNP were difficult to interpret, unreliable, or both. Changes after TTVR remained inconclusive.

          Conclusion

          Invasive monitoring using CardioMEMS provides important information after mitral‐ and tricuspid valve interventions. Such data pave the way for a deeper understanding of the prerequisites for optimal patient selection and management for catheter‐based interventions.

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          Most cited references27

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          Transcatheter Mitral-Valve Repair in Patients with Heart Failure

          Among patients with heart failure who have mitral regurgitation due to left ventricular dysfunction, the prognosis is poor. Transcatheter mitral-valve repair may improve their clinical outcomes.
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            Wireless pulmonary artery haemodynamic monitoring in chronic heart failure: a randomised controlled trial.

            Results of previous studies support the hypothesis that implantable haemodynamic monitoring systems might reduce rates of hospitalisation in patients with heart failure. We undertook a single-blind trial to assess this approach. Patients with New York Heart Association (NYHA) class III heart failure, irrespective of the left ventricular ejection fraction, and a previous hospital admission for heart failure were enrolled in 64 centres in the USA. They were randomly assigned by use of a centralised electronic system to management with a wireless implantable haemodynamic monitoring (W-IHM) system (treatment group) or to a control group for at least 6 months. Only patients were masked to their assignment group. In the treatment group, clinicians used daily measurement of pulmonary artery pressures in addition to standard of care versus standard of care alone in the control group. The primary efficacy endpoint was the rate of heart-failure-related hospitalisations at 6 months. The safety endpoints assessed at 6 months were freedom from device-related or system-related complications (DSRC) and freedom from pressure-sensor failures. All analyses were by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00531661. In 6 months, 83 heart-failure-related hospitalisations were reported in the treatment group (n=270) compared with 120 in the control group (n=280; rate 0·31 vs 0·44, hazard ratio [HR] 0·70, 95% CI 0·60-0·84, p<0·0001). During the entire follow-up (mean 15 months [SD 7]), the treatment group had a 39% reduction in heart-failure-related hospitalisation compared with the control group (153 vs 253, HR 0·64, 95% CI 0·55-0·75; p<0·0001). Eight patients had DSRC and overall freedom from DSRC was 98·6% (97·3-99·4) compared with a prespecified performance criterion of 80% (p<0·0001); and overall freedom from pressure-sensor failures was 100% (99·3-100·0). Our results are consistent with, and extend, previous findings by definitively showing a significant and large reduction in hospitalisation for patients with NYHA class III heart failure who were managed with a wireless implantable haemodynamic monitoring system. The addition of information about pulmonary artery pressure to clinical signs and symptoms allows for improved heart failure management. CardioMEMS. Copyright © 2011 Elsevier Ltd. All rights reserved.
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              Percutaneous Repair or Medical Treatment for Secondary Mitral Regurgitation

              In patients who have chronic heart failure with reduced left ventricular ejection fraction, severe secondary mitral-valve regurgitation is associated with a poor prognosis. Whether percutaneous mitral-valve repair improves clinical outcomes in this patient population is unknown.
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                Author and article information

                Contributors
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                Journal
                European Journal of Clinical Investigation
                Eur J Clin Investigation
                Wiley
                0014-2972
                1365-2362
                June 2023
                February 08 2023
                June 2023
                : 53
                : 6
                Affiliations
                [1 ] Department of Internal Medicine II, Division of Cardiology Medical University of Vienna Vienna Austria
                [2 ] Department of Internal Medicine and Cardiology, Campus Virchow Klinikum Charité ‐ Universitätsmedizin Berlin Berlin Germany
                [3 ] Department of Internal Medicine 3, University Hospital St. Pölten Karl Landsteiner University of Health Sciences Krems Austria
                Article
                10.1111/eci.13961
                b1cc3418-5232-4303-956c-0712efe95cf0
                © 2023

                http://creativecommons.org/licenses/by/4.0/

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