Imaging for Transcatheter Tricuspid Annuloplasty Using the K-Clip Device.

HomeCirculation: Cardiovascular ImagingVol. 16, No. 6Imaging for Transcatheter Tricuspid Annuloplasty Using the K-Clip Device Free AccessCase ReportPDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissionsDownload Articles + Supplements ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toSupplemental MaterialFree AccessCase ReportPDF/EPUBImaging for Transcatheter Tricuspid Annuloplasty Using the K-Clip Device Alex Pui-Wai Lee, Yiming Ni and Yat-yin Lam Alex Pui-Wai LeeAlex Pui-Wai Lee Correspondence to: Alex Lee, MBChB, MD, Rm 114037, 9/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, 30-32 Ngan Shing St, Shatin, N.T., Hong Kong. Email E-mail Address: [email protected] https://orcid.org/0000-0002-4120-155X Li Ka Shing Institute of Health Science, The Chinese University of Hong Kong, China (A.P.L.). Search for more papers by this author , Yiming NiYiming Ni The First Affiliated Hospital, College of Medicine, Zhejiang University, China (Y.N.). Search for more papers by this author and Yat-yin LamYat-yin Lam Hong Kong Asia Heart Center, Hong Kong, China (Y.-y.L.). Search for more papers by this author Originally published8 Feb 2023https://doi.org/10.1161/CIRCIMAGING.122.015033Circulation: Cardiovascular Imaging. 2023;16Other version(s) of this articleYou are viewing the most recent version of this article. Previous versions: February 8, 2023: Ahead of Print An 86-year-old woman with chronic atrial fibrillation presented with right-sided heart failure and torrential tricuspid valve regurgitation (TR) secondary to right atrial remodeling and tricuspid annulus dilatation (Figure 1A left; Video S1). Despite optimal medical therapy, she had refractory peripheral edema. Heart team deemed open heart surgery high risk (age, lung disease) and assessed her for transcatheter therapy. Transesophageal echocardiography (Figure 1A; right) revealed anatomy unfavorable for transcatheter edge-to-edge repair, including a 4-leaflet morphology, a stellate-shaped regurgitant orifice, and an 8 mm coaptation gap. Transcatheter tricuspid valve replacement was considered undesirable given patient’s bleeding history (gross hematuria) while on oral anticoagulation. Furthermore, echocardiography showed severe tricuspid annular dilatation favoring the choice of an annuloplasty approach. Therefore, compassionate transcatheter annuloplasty using the K-Clip system (Huihe Medical) was offered (Figure 1B).1 Evaluation included cardiac computed tomography (CT) to assess tricuspid annulus proximity to right coronary artery (RCA; Figure 1C). Cardiac CT was performed using a 384 slice dual source multidetector CT scanner (Somatom Force, Siemens, Germany). The tube current was 200 to 580 mA at 100 to 135 kV, and the slice thickness was 0.6 mm. The scan coverage ranged from the neck to the diaphragmatic surface of the heart. Retrospective ECG gating was used with acquisition of the entire cardiac cycle. Nonionic iodinated contrast agent (Ultravist, Bayer, Germany; 370 mg/mL) was intravenously administered at a flow rate of 4ml/s. Contrast agent tracking technology (bolus tracking) was used to monitor opacification of the right ventricle, and data acquisition was automatically triggered at a threshold value of 200 Hounsfield units with a 6-second delay. Acquisition was performed during an inspiratory breath-hold. Triphasic bolus injection technique (contrast, followed by contrast:saline 30:70 mixture, and then saline) was performed to minimize artifacts and improve biventricular opacification. Analysis of CT datasets was performed on dedicated CT workstations (3-mensio, Pie Medical Imaging, the Netherlands; Mimics, Materialise, Belgium) in mid-diastole (60%–80% of R-R interval) using multiplanar reformatted images and semiautomated segmentation of the coronary arteries. The course of the RCA in the right atrioventricular groove in relation to the tricuspid annulus was evaluated. The distance between the tricuspid annulus and RCA was measured at multiple points, with a distance of ≥4 mm considered safe for K-Clip implantation without causing RCA injury.Download figureDownload PowerPointFigure 1. Preprocedural imaging. A Baseline echocardiography. B, The K-Clip system. C, Preprocedural computed tomography. AL indicates anterior leaflet; Ao, aorta; PL1, first posterior leaflet; PL2, second posterior leaflet; RCA, right coronary artery; SL, septal leaflet; TR, tricuspid valve regurgitation; and TVA, tricuspid valve annulus.The K-Clip procedure was guided by echocardiography and fluoroscopy. During the procedure (Figure 2), the K-clip system was inserted percutaneously via right jugular vein (Video S2) and steered towards the posterior tricuspid annulus (Video S3); the anchor inside the clip was screwed into the midposterior annulus (Video S4). Under live 3-dimensional echocardiographic guidance with live 3-dimensional multiplanar reconstruction, the clip (16 mm) was opened and oriented tangentially to the annulus; the anchor was withdrawn, pulling the annulus tissue into the clip which was then closed, sandwiching the annulus within the toothed clip arms, achieving plication (Video S5). Coronary angiogram confirmed patent RCA flow (Video S6). The clip was released, resulting in annular and TR reduction (Figure 3A. Video S7). At 3-month follow-up, the patient was clinically improved (resolved edema) with sustained TR reduction and clip stability (Figure 3B).Download figureDownload PowerPointFigure 2. Procedural imaging. A indicates anchor component; AL, anterior leaflet; C, clip component; DS, delivery sheath; FW, right ventricular free wall; GS, guide sheath; GW, guidewire; IAS, interatrial septum; PL, posterior leaflet; RCA, right coronary artery; SL, septal leaflet; SVC, superior vena cava; and TVO, tricuspid valve orifice. *Annular tissue; dotted lines=tricuspid annulus.Download figureDownload PowerPointFigure 3. Postprocedural imaging. A, Intraprocedural echocardiography showing immediate reduction of the annular dimensions, coaptation gap, and tricuspid valve regurgitation (TR) severity; the P1 leaflet was excluded resulting in a 3-leaflet morphology (tricuspidization of the 4-leaflet valve). B, Three-month follow-up echocardiography showing mild residual TR and secure device position. yellow arrow=endothelialized K-Clip; dotted lines=tricuspid annulus. AL indicates anterior leaflet; Ao, aorta; circ, annular circumference; PL1, first posterior leaflet; PL2, second posterior leaflet; RCA, right coronary artery; SL, septal leaflet; and SLd, septolateral annular diameter.The K-Clip is a transcatheter tricuspid annuloplasty system using a clip-based annular plication approach. It is introduced via transjugular venous access with an outer guide (18F) and a steerable inner delivery catheter (15F). Refinement of the system for transfemoral access is under development. The anchor can be screwed into tricuspid annulus for a controlled depth of <4 mm to avoid coronary perforation. The toothed clip arms can open to 120° to facilitate wide annulus capture. Four clip sizes (arm length 12, 14, 16, 18 mm) are available. Potential contraindications to K-Clip implantation include RCA proximity with RCA-to-annulus distance <4 mm and poor-quality imaging.This first-in-human case demonstrates the feasibility of K-Clip to reduce tricuspid annular dimensions through clip-based annuloplasty. It has the advantages of having few procedural steps, being retrievable, and sutureless, with no need to cross valve or penetrate leaflets. With minimal distortion of the tricuspid anatomy after K-Clip implantation, the options of subsequent/concomitant transcatheter repair or replacement with other devices remain viable. Isolated tricuspid valve surgery has a high operative mortality; this transcatheter procedure may offer a feasible option for treating functional TR with acceptable safety and simplicity. The use of multimodality imaging in procedural planning and monitoring is crucial to procedural success. Echocardiography provides important information regarding TR severity, mechanism, leaflet morphology, and annular dimensions. CT enables detailed characterization of the spatial relationship between the RCA and the tricuspid valve and is important for patient selection and procedure planning. During the procedure, live 3-dimensional multiplanar reconstruction echocardiographic imaging complements 2-dimensional imaging to visualize with superior spatial orientation device and cardiac structures for confirmation of clip anchoring at the atrioventricular junction, clip-arm orientation along the annulus, and capturing of adequate annular tissues. Fluoroscopic angiogram enhances safety by detection of RCA obstruction.Article InformationSources of FundingNone.Supplemental MaterialVideos S1–S7Disclosures Drs Lee and Lam are consultants for Huihe Medical Technology.FootnotesFor Sources of Funding and Disclosures, see page 520.Supplemental Material is available at https://www.ahajournals.org/doi/suppl/10.1161/CIRCIMAGING.122.015033.Correspondence to: Alex Lee, MBChB, MD, Rm 114037, 9/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, 30-32 Ngan Shing St, Shatin, N.T., Hong Kong. Email [email protected]edu.hkReferences1. Pan W, Long Y, Zhang X, Chen S, Li W, Pan C, Guo Y, Zhou D, Ge J. Feasibility study of a novel transcatheter tricuspid annuloplasty system in a porcine model.JACC Basic Transl Sci. 2022; 7:600–607. doi: 10.1016/j.jacbts.2022.02.022CrossrefMedlineGoogle Scholar Previous Back to top Next FiguresReferencesRelatedDetails June 2023Vol 16, Issue 6 Advertisement Article InformationMetrics © 2023 American Heart Association, Inc.https://doi.org/10.1161/CIRCIMAGING.122.015033PMID: 36752091 Manuscript receivedOctober 28, 2022Manuscript acceptedDecember 23, 2022Originally publishedFebruary 8, 2023 Keywordswomenatrial remodelingtricuspid valveatrial fibrillationdilatationPDF download Advertisement SubjectsCatheter-Based Coronary and Valvular InterventionsComputerized Tomography (CT)EchocardiographyImaging