We report on a 72 years old male patient with recurrent heart failure hospitalizations caused by severe mitral regurgitation due to severe restriction of the posterior mitral leaflet treated with the transfemoral mitral valve replacement (TMVR) system Cardiovalve. Immediate interventional success was obtained resulting in a quick mobilization and discharge

Mai, Gunther

Maisano, Francesco

Pieske-Kraigher, Elisabeth

Reinthaler, Markus

Riess, Juliane

Sherif, Mohammad

Sündermann, Simon H.

Trippel, Tobias Daniel

English

PubMed

PubMed Central

Cardiovalve in mitral valve position—Additional solution for valve replacement

Institutional Repository of the Freie Universität Berlin

TYPE PerspectivePUBLISHED 06 September 2022DOI 10.3389/fcvm.2022.960849OPEN ACCESSEDITED BYGiuseppe Tarantini,University of Padua, ItalyREVIEWED BYAlessandro Iadanza,Siena University Hospital, Italy*CORRESPONDENCEMohammad Sherifmohammad.sherif@charite.deSPECIALTY SECTIONThis article was submitted toHeart Valve Disease,a section of the journalFrontiers in Cardiovascular MedicineRECEIVED 03 June 2022ACCEPTED 08 August 2022PUBLISHED 06 September 2022CITATIONSherif M, Sündermann SH, Maisano F,Pieske-Kraigher E, Riess J,Reinthaler M, Mai G and Trippel TD(2022) Cardiovalve in mitral valveposition—Additional solution for valvereplacement.Front. Cardiovasc. Med. 9:960849.doi: 10.3389/fcvm.2022.960849COPYRIGHT© 2022 Sherif, Sündermann, Maisano,Pieske-Kraigher, Riess, Reinthaler, Maiand Trippel. This is an open-accessarticle distributed under the terms ofthe Creative Commons AttributionLicense (CC BY). The use, distributionor reproduction in other forums ispermitted, provided the originalauthor(s) and the copyright owner(s)are credited and that the originalpublication in this journal is cited, inaccordance with accepted academicpractice. No use, distribution orreproduction is permitted which doesnot comply with these terms.Cardiovalve in mitral valveposition—Additional solution forvalve replacementMohammad Sherif1,2*, Simon H. Sündermann2,3,4,Francesco Maisano5, Elisabeth Pieske-Kraigher1,2,Juliane Riess2,6, Markus Reinthaler2,6, Gunther Mai7 andTobias Daniel Trippel1,21Department of Cardiology, Charité – Universitätsmedizin Berlin, Campus Virchow Klinikum, Berlin,Germany, 2German Centre for Cardiovascular Research (DZHK), Partner Site Berlin, Berlin, Germany,3Department of Cardiovascular Surgery, Charité – Universitätsmedizin Berlin, Berlin, Germany,4Department of Cardiothoracic- and Vascular Surgery, German Heart Center Berlin, Berlin,Germany, 5Department of Cardiac Surgery, Istituto di Ricovero e Cura a Carattere Scientifico(IRCCS) San Ra aele University Hospital, Milan, Italy, 6Department of Cardiology, Charité –Universitätsmedizin Berlin, Berlin, Germany, 7Department of Cardiac Anesthesia, Charité –Universitätsmedizin Berlin, Berlin, GermanyWe report on a 72 years old male patient with recurrent heart failurehospitalizations caused by severe mitral regurgitation due to severe restrictionof the posterior mitral leaflet treated with the transfemoral mitral valvereplacement (TMVR) system Cardiovalve. Immediate interventional successwas obtained resulting in a quick mobilization and discharge.KEYWORDSmitral insuciency, heart valvular disease, heart failure, TMVR, comput(eriz)edtomographyIntroductionMitral Regurgitation (MR) is a major risk factor for future morbidity and mortality.Patients with left ventricular (LV) dysfunction who have concurrent MR have a nearlytwo-fold increased risk of death or hospitalization (1). The current standard is to improvesignificant MR with surgical mitral valve replacement (MVR) or transcatheter edge-to-edge repair (TEER) (2). Transcatheter mitral valve replacement (TMVR) has emerged asa less invasive approach potentially surmounting some of the current hurdles associatedwith transcatheter edge-to-edge repair and high-risk mitral valve surgery (3).Case reportWe describe the case of a 72 years old male patient with preserved ejectionfraction a recurrent history of decompensated heart failure caused by severe mitralregurgitation due to severe restriction of the posterior mitral leaflet by calcifications(Figure 1,1a) with a consecutive severe excentric posterior jet (Figure 1,1a). Thepatient has a > 10 years history of coronary heart disease with CABG LIMA/LAD,Vene/RIVP, Vene/D1, and Vene/M1 with preserved left ventricular ejection fraction, ahistory of stroke, atrial fibrillation, severe chronic obstructive pulmonary disease andFrontiers inCardiovascularMedicine 01 frontiersin.orgSherif et al. 10.3389/fcvm.2022.960849FIGURE 1Cardiovalve in Mitral Valve Position. (1a) 2D posterior mitral leaflet by calcification; (1b) consecutive severe excentric posterior jet; (2)Pre-procedural computed tomography scan with valve sizing and predicted neo-LVOT; (3a) Fluoroscopy of device delivery; (3b) Fluoroscopy ofdevice with closure of ASD; (3c) 3D transesophageal echocardiography of delivered Device; (4a) post-interventional result; (4b) Post-proceduralCT scan with actual neo-LVOT.pulmonary hypertension as well as chronic kidney disease witha eGFR of 48 ml/min/1.73 m2 (by CKD-EPI) resulting in aEuro Score II of 19.40% and STS for Morbidity and Mortality of33.223% (Version 4.2). Given the clinical condition and patienthistory he was deemed inoperable for conventional MVR,minimal-invasive right thoracotomy surgical treat treatmentor TEER by our institutions interdisciplinary heart team inAugust 2021.On March 11th, 2022 he was admitted to our institutionwith New York Heart Association (NYHA) functional classIV, peripheral edema, pleural effusions and jugular veindistension. His NT-proBNP was 2,894 ng/L and recompensationwith intravenous diuretic therapy was initiated. Screeningcomputed tomography scan confirmed anatomic suitabilityfor Cardiovalve prosthesis (Figure 1,2) and projected a neoleft ventricular outflow tract (LVOT) of ∼2.3 cm². Afterapproval by AHEAD screening committee patient has beenenrolled in the AHEAD-Trial (ClinicalTrials.gov, Identifier:NCT03339115) and scheduled for transcatheter mitral valvereplacement (TMVR) with the Cardiovalve (Cardiovalve, Or-Yehuda, Israel).The Cardiovalve is based on a low-profile design ofthree scallop-shaped bovine pericardial leaflets designed to bedelivered through a transfemoral transseptal approach usinga 32-F capsule with a 24-F shaft (4). Three valve sizes areavailable, covering an intracommissural annular size from 36to 53mm (4). The patient underwent the procedure on March16th, 2022 in our hybrid operation theater under guidancewith fluoroscopy and transesephageal echocardiography in fullanesthesia. A surgical vascular access of the right femoral veinwas established. Transeptal puncture was performed employingthe VersaCrossR©Transseptal (Baylis Medical, München,Germany) System under balloon dilatation of the intraatrialseptum with a 10mm balloon. The delivery system was insertedFrontiers inCardiovascularMedicine 02 frontiersin.orgSherif et al. 10.3389/fcvm.2022.960849into the left atrium and centered with respect to the mitralannulus before final deployment and stabilized with a 300 cmLunderquist in over the wire technique under fluoroscopicguidance (Figure 1,3a). We implanted a 45mm CardiovalveMitral Valve replacement in a stepwise procedure. Meantransvalvular gradient was < 4 mmHg. The procedure relatedatrial septum defect was closed using a 12mmAmplatz Occluder(Abbott, Abbott Park, IL, USA) (Figure 1,3b). Transesophagealechocardiography showed the correct positioning of the valve,with no leak, and no LVOT (Figure 1,3c). The patientwas extubated in the hybrid operation theater immediatelyafter the procedure, transferred to our intermediate careward for 24 h for surveillance and hence transferred to ournormal care ward for another 5 days of recompensationand mobilization.Post-procedural echocardiography showed a satisfactoryresult (Figure 1,4a), CT scan confirmed prosthesis stability, noevidence of left ventricular outflow tract (LVOT) obstruction(Figure 1,4b) with an actual neo-LVOT of ∼3.2 cm² beforedischarge. We did observe a clinical improvement to NYHAfunctional class II and rapid recompensation. The patient wasdischarged on 25th of March 2022 and the 30 day post-discharge timeframe was event free. Given the pre-existingindication for oral anticoagulation due to atrial fibrillation, thepatient continued to take warfarin after discharge. The presentreport shows the feasibility of TMVR with a fully percutaneousantegrade system in the setting of a severe restriction of theposterior mitral leaflet.DiscussionThe case we report here focuses on a patient with clinicalsigns and symptoms of heart failure with recurrent heartfailure hospitalizations due to significant mitral valve disease.Despite his young age, he was deemed inoperable. Severe leafletrestriction and calcification hindered the option of TEER. Theongoing interventional revolution in the field of structural heartdisease brought a novel treatment option to the hybrid operationtable: Cardiovalve.Thanks to the rapidly evolving field, we were able to treat thispatient within the European Feasibility Study of the CardiovalveTransfemoral Mitral Valve System (AHEAD) and obtained fineshort term clinical, structural and imaging results. Of specialnote, the actually obtained neo-LVOT was greater than thepredicted neo-LVOT. The low-profile design of three scallop-shaped bovine pericardial leaflets employed in the Cardiovalveenabled a considerate treatment in a patient deemed clinicallyunfit for conventional MVR as well as anatomically unfit forminimal-invasive right thoracotomy surgical treat treatmentor TEER.Yet, structured outcome data on short and long-termmorbidity and mortality remain lacking. Safety, performanceand outcome data of TMVR devices such as CepheaR©,EvoqueR©, IntrepidR©, SapienM3R©, and NaviGateR©competingwith CardiovalveR©in some aspects will have to be takeninto account.TMVR will further advance the field oftranscatheter treatments of mitral valve diseaseand allow promising treatment options formany patients.Data availability statementThe raw data supporting the conclusions of this article willbe made available by the authors, without undue reservation.Ethics statementThe studies involving human participants were reviewedand approved by LAGESO, BfArM. The patients/participantsprovided their written informed consent to participate inthis study.Author contributionsMS and TT conceptionalized, drafted, and wrote thearticle. SS, FM, GM, MR, JR, and EP-K reviewed the articlefor important intellectual content. All participated in patientcare. All authors contributed to the article and approved thesubmitted version.Conflict of interestAuthor MS reports to be principal investigator of theAHEAD trial at the respective site and received honorariafrom Edwards Lifesciences, Abbott and Cardiovalve. AuthorFM reports honoraria from Edwards Lifesciences, Abbottand Cardiovalve.The remaining authors declare that the research wasconducted in the absence of any commercial or financialrelationships that could be construed as a potential conflictof interest.Publisher’s noteAll claims expressed in this article are solely those of theauthors and do not necessarily represent those of their affiliatedorganizations, or those of the publisher, the editors and thereviewers. Any product that may be evaluated in this article, orclaim that may be made by its manufacturer, is not guaranteedor endorsed by the publisher.Frontiers inCardiovascularMedicine 03 frontiersin.orgSherif et al. 10.3389/fcvm.2022.960849References1. Baskett RJ, Exner DV, Hirsch GM, Ghali WA. Mitral insufficiencyand morbidity and mortality in left ventricular dysfunction.Can J Cardiol. (2007) 23:797–800. doi: 10.1016/S0828-282X(07)70830-92. Vahanian A, Beyersdorf F, Praz F, Milojevic M, Baldus S, Bauersachs J, et al.2021 ESC/EACTS Guidelines for the management of valvular heart disease. EurHeart J. (2022) 43:561–632. doi: 10.1093/ejcts/ezac2093. Sá MP, Ramlawi B, Gray WA, Malin JH, Van den Eynde J, Sicouri S, et al.Transcatheter mitral valve implantation in the ongoing structural heart revolution.J Card Surg. (2022) 37:1691–704. doi: 10.1111/jocs.164314. Maisano F, Benetis R, Rumbinaite E, Unikas R, Mizariene V,Jakuska P, et al. 2-year follow-up after transseptal transcatheter mitralvalve replacement with the cardiovalve. JACC Cardiovasc Interv. (2020)13:e163–4. doi: 10.1016/j.jcin.2020.05.032Frontiers inCardiovascularMedicine 04 frontiersin.org

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Cardiovalve in mitral valve position—Additional solution for valve replacement

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