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Mitraclip

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The MitraClip is a minimally invasive medical device used to treat mitral regurgitation, a condition where the mitral valve in the heart does not close properly. The device is designed to be delivered through a small incision in the groin and guided to the heart using imaging techniques, where it is placed to improve the function of the mitral valve.

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Lab products found in correlation

Triclip, by Abbott (2 mentions) Cardioband, by Edwards Lifesciences (1 mentions) Proglide sh closure device, by Abbott (1 mentions) Pascal ace, by Edwards Lifesciences (1 mentions) Orbis, by AGFA HealthCare (1 mentions) Mitraclip device, by Abbott (1 mentions)

19 protocols using mitraclip

1

Prospective Registry of MitraClip Procedures

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We enrolled patients after MitraClip (Abbott Vascular, Redwood City, CA) procedure into a prospective observational registry. Data were obtained from before implantation, at discharge and during the follow‐up visits, including transthoracic echocardiography and laboratory testing (including NT‐proBNP [N‐terminal pro‐B‐type natriuretic peptide]).
For this study, we included consecutive patients who were successfully treated with the MitraClip between January 2013 and December 2015 and who completed at least one follow‐up examination. Successful treatment was defined as implantation of at least one MitraClip and a degree of MR ≤2 after implantation.
Schrage B., Kalbacher D., Schwarzl M., Rübsamen N., Waldeyer C., Becher P.M., Tigges E., Burkhoff D., Blankenberg S., Lubos E., Schäfer U, & Westermann D. (2018). Distinct Hemodynamic Changes After Interventional Mitral Valve Edge‐to‐Edge Repair in Different Phenotypes of Heart Failure: An Integrated Hemodynamic Analysis. Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease, 7(6), e007963.
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2

Mitral and Tricuspid Valve Repair Techniques

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Two different approaches were used for TTVR: Trans-catheter edge-to-edge repair via MitraClip (Abbott Vascular, Santa Clara, CA, USA) or trans-catheter annuloplasty via Cardioband (Edwards Life-sciences, Irvine, CA, USA). Procedural decisions were left to the discretion of the operators. All interventions were performed under general anesthesia. During the intervention, transoesophageal echocardiography and fluoroscopy were used for guidance. Echocardiograms were analyzed in concordance with current international recommendations and involved TR grading in five stages (grade 1–5) [13 (link), 14 ]. Primary procedural success was defined as interventional reduction of at least one grade in TR severity. Regarding MR, there were 48/181 (27%) patients with moderate MR, 19/181 (11%) patients with moderate-to-severe MR, and 3/181 (2%) patients with severe MR. All three patients with concomitant severe MR got combined repair of TR and MR.
Kavsur R., Hupp-Herschel H.E., Sugiura A., Tanaka T., Öztürk C., Weber M., Nickenig G., Tiyerili V, & Becher M.U. (2021). Prognostic significance of the get with the guidelines-heart failure (GWTG-HF) risk score in patients undergoing trans-catheter tricuspid valve repair (TTVR). Heart and Vessels, 36(12), 1903-1910.
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3

Cardiac Remodeling in Severe MR Patients

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Sixty-one patients undergoing MitraClip (Abbott Vascular, Santa Clara, California) implantation at the university hospital Duesseldorf, Germany were included between 2014–2019 and underwent CMR, echocardiography and RHC prior to TMVR. Patients enrolled had severe, degenerative or functional MR and were considered at elevated surgical risk by an interdisciplinary heart team. The study was approved by the ethics committee of the Heinrich-Heine University Duesseldorf (study number 6110R) and performed in accordance with the Declaration of Helsinki. All patients gave informed written consent.
We stratified patients according to the presence/absence of RV systolic dysfunction according to the RV ejection fraction (RVEF). Similarly, patients were separated into groups according to the presence/absence of RV dilatation. For assessment of RV dilatation, the RV end-diastolic volume index (RVEDVi) assessed by CMR was matched to age and gender specific reference values for each patient.(9) In this regard, in men <60 years, RVEDVi >111 ml/m2, and in men ≥60 years RVEDVi >101 ml/m2 was defined as RV dilatation. In women <60 years, RVEDVi >96 ml/m2, and in women ≥60 years RVEDVi >84 ml/m2 was defined as RV dilatation [9 (link)].
Spieker M., Marpert J., Afzal S., Karathanos A., Scheiber D., Bönner F., Horn P., Kelm M, & Westenfeld R. (2021). Right ventricular dysfunction assessed by cardiovascular magnetic resonance is associated with poor outcome in patients undergoing transcatheter mitral valve repair. PLoS ONE, 16(1), e0245637.
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4

Comprehensive Preoperative Evaluation for Mitral Valve Repair

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All patients underwent preoperative left and right heart catheterization and transthoracic (TTE) and transesophageal (TEE) echocardiography before the intervention to assess MV morphology, the severity of the MR, and the anatomical suitability for edge-to-edge repair with a mitral clip device such as MitraClip® (Abbott Vascular, Santa Clara, California, USA).
Resting echocardiographic images were reviewed to obtain left atrial and left and right ventricular dimensions and functions. Mitral annular diameter was measured in end-systole in parasternal and apical long-axis views. The assessment of MR was largely dependent upon the vena contracta (severe MR ≥ 7 mm and moderate MR > 4 mm and < 7 mm). However, factors such as left ventricular function and dimensions, pulmonary artery pressure, and patient's symptoms were also considered. Stress echocardiography was performed in some cases when the vena contracta was < 7 mm to define the significance of the MR better.
Clinical assessment included recording symptoms, New York Heart Association (NYHA) Functional Class, and the risk of conventional surgical repair.
El Garhy M., Lauer B., Göbel B., Costello-Boerrigter L.C., Salomon C., Lapp H, & Ohlow M.A. (2021). Pre-procedural predictors for multiple clips in percutaneous edge-to-edge mitral valve repair. The Egyptian Heart Journal, 73, 79.
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5

Transcatheter Mitral Valve Repair Procedure

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All procedures were performed under general anaesthesia—monitored by a cardiac anaesthesiologist and transoesophageal echocardiography control as published previously.12 MitraClip™ was deployed as previously published.8, 12 Intraprocedural anticoagulation with heparin was adjusted to an activated clotting time of 250–300 s. All patients received prophylactic antibiotic therapy for 3 days after PMVR.
Access site closure was achieved by applying one ProGlide SH closure device (Abbott Vascular, Abbott Park, IL, USA) using the pre‐closure technique as described before.23 Patients were transferred to our intensive care or advanced heart failure unit after the procedure (for at least 24 h).
Geis N.A., Pleger S.T., Bekeredjian R., Chorianopoulos E., Kreusser M.M., Frankenstein L., Ruhparwar A., Katus H.A, & Raake P.W. (2018). Haemodynamic effects of percutaneous mitral valve edge‐to‐edge repair in patients with end‐stage heart failure awaiting heart transplantation. ESC Heart Failure, 5(5), 892-901.
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6

Percutaneous Mitral Valve Repair

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TEEMr was performed under general anesthesia, using fluoroscopic and 2-dimensional (2D) and 3-dimensional (3D) TEE guidance. All procedures were performed with the Mitraclip® device (Abbott Vascular, Santa Clara, CA, USA) using the standard technique previously described [1 (link)]. After the procedure, patients were transferred to an intermediate care unit or, if necessary, to the intensive cardiac care unit.
Sudarsky D., Kusniec F., Grosman-Rimon L., Lubovich A., Kinany W., Hazanov E., Gelbstein M., Birati E.Y, & Carasso S. (2021). Immediate Post-Procedural and Discharge Assessment of Mitral Valve Function Following Transcatheter Edge-to-Edge Mitral Valve Repair: Correlation and Association with Outcomes. Journal of Clinical Medicine, 10(22), 5448.
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7

MitraClip Therapy for Severe MR

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From September 2008 until April 2015, 592 consecutive patients (75 ± 8.7 years) with moderate-to-severe or severe MR underwent MitraClip therapy (Abbott Vascular, Redwood City, California) at our center. All patients (mean logistic EuroSCORE 21.0, mean Society of Thoracic Surgery mortality score 4.3) were adjudicated as not amenable to surgery by heart team consensus prior to the intervention. The study population was divided according to gender (men 61.1%, women 38.9%). All patients provided written informed consent and the study was approved by the local ethics committee.
Tigges E., Kalbacher D., Thomas C., Appelbaum S., Deuschl F., Schofer N., Schlüter M., Conradi L., Schirmer J., Treede H., Reichenspurner H., Blankenberg S., Schäfer U, & Lubos E. (2016). Transcatheter Mitral Valve Repair in Surgical High-Risk Patients: Gender-Specific Acute and Long-Term Outcomes. BioMed Research International, 2016, 3934842.
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8

Transcatheter Tricuspid Valve Repair

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The procedures were performed using MitraClip, TriClip (Abbott Vascular), PASCAL P10, PASCAL Ace (Edwards Lifesciences) devices, or Cardioband device (Edwards Lifesciences), as previously described [6, 26, 27] . As direct annuloplasty is more complex than TEER, both regarding patient screening including computed tomography as well as longer and more complex procedure, TEER is the first treatment choice in daily clinical practice. In general, every patient which showed a tricuspid valve anatomy with difficulty in leaflet grasping (e.g., extremely large coaptation gap, short leaflets, or multiple-scallop leaflets) was evaluated for direct annuloplasty. Technical success was defined as successful device implantation without conversion to emergent TV surgery or re-intervention and absence of mortality, as well as successful deployment and correct positioning of the device. Additionally, procedural success was confirmed if the postprocedural TR grade at discharge was moderate or less (≤ II°).
Ehrenfels M.A., Fretter C., von Stein J., Körber M.I., Wienemann H., Baldus S., Pfister R, & Iliadis C. (2024). Role of preexisting right ventricular remodeling in symptoms and prognosis after transcatheter tricuspid valve repair. Clinical research in cardiology : official journal of the German Cardiac Society.
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9

Retrospective Analysis of TMTVR Patients

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We conducted a retrospective analysis using our single centre database. All consecutive patients who underwent TMTVR for valve regurgitation at the Heart Centre of the University Hospital of Cologne, Germany, between May 2014 and December 2019 were eligible for inclusion in our registry. Patients who refused consent or had significant language barrier were excluded. All patients had an indication for treatment of mitral or tricuspid regurgitation according to current guidelines at the time [6, (link)7] (link) and were discussed in a multidisciplinary heart team. Only patients at high or prohibitive surgical risk and amenable to the appropriate catheter techniques were treated. Valve repair with Cardioband, Pascal (both Edwards Lifesciences), MitraClip or TriClip (both Abbott Vascular) was performed as previously described [8] (link)[9] (link)[10] (link)[11] (link). Patients with acute cardiac decompensation were excluded from the study.
Baseline demographic and clinical characteristics were obtained from medical records or the automated information system (ORBIS, Agfa Healthcare, Bonn, Germany).
Schäfer M., Nöth H., Metze C., Iliadis C., Körber M.I., Halbach M., Baldus S, & Pfister R. (2024). Frailty, periinterventional complications and outcome in patients undergoing percutaneous mitral and tricuspid valve repair. Clinical research in cardiology : official journal of the German Cardiac Society.
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10

Mitral TEER with MitraClip Outcomes

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We reviewed the records of 298 consecutive patients with moderate–severe or severe MR who underwent mitral TEER with MitraClip (Abbott Vascular, Santa Clara, CA) at Houston Methodist Hospital (Houston, TX) from March 2014 to September 2022. As determined by a multidisciplinary heart team based on current guidelines, patients with symptomatic primary MR at high surgical risk and those with secondary MR on optimized guideline‐directed medical therapy underwent the procedure. Among 298 patients who had successful MitraClip implantation, 291 patients had satisfactory color Doppler MR evaluation on echocardiography before, during, and after the procedure and comprised the primary study cohort. All study procedures were conducted in accordance with the Declaration of Helsinki. Informed consent was obtained from all patients before the procedure. This observational study was approved by the Houston Methodist Institutional Review Board.
Hatab T., Samimi S., Bou Chaaya R.G., Qamar F., Kharsa C., Wessly P., Faza N., Little S.H., Atkins M.D., Reardon M.J., Kleiman N.S., Zoghbi W.A., Nagueh S.F., Zaid S, & Goel S.S. (2024). Echocardiographic Profiling Predicts Clinical Outcomes After Mitral Transcatheter Edge‐to‐Edge Repair. Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease, 13(5), e032784.
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