Infolding of the Venus P-Valve After Transcatheter Pulmonary Valve Implantation

HomeCirculation: Cardiovascular InterventionsVol. 11, No. 4Infolding of the Venus P-Valve After Transcatheter Pulmonary Valve Implantation Free AccessCase ReportPDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissionsDownload Articles + Supplements ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toSupplemental MaterialFree AccessCase ReportPDF/EPUBInfolding of the Venus P-Valve After Transcatheter Pulmonary Valve Implantation Mounir Riahi, MD, Hak Lee Ang, MD, MMED, Matthew Jones, MD, Pimpak Prachasilchai, MD, Alban-Elouan Baruteau, MD, PhD, Worakan Promphan, MD, Eric Rosenthal, MD and Shakeel Ahmed Qureshi, MBChB Mounir RiahiMounir Riahi From the Department of Pediatric and Adult Cardiology, Evelina London Children's Hospital and Guy's and St Thomas' NHS Foundation Trust, United Kingdom (M.R., M.J., A.-E.B., E.R., A.S.Q.); Department of Cardiology, St. Paul's Hospital, Vancouver, BC, Canada (M.R.); Department of Cardiology, University Malaya Medical Centre, University of Malaya, Kuala Lumpur, Malaysia (H.L.A., W.P.); and Queen Sirikit National Institute of Child Health, Rangsit University, Bangkok, Thailand (P.P.). , Hak Lee AngHak Lee Ang From the Department of Pediatric and Adult Cardiology, Evelina London Children's Hospital and Guy's and St Thomas' NHS Foundation Trust, United Kingdom (M.R., M.J., A.-E.B., E.R., A.S.Q.); Department of Cardiology, St. Paul's Hospital, Vancouver, BC, Canada (M.R.); Department of Cardiology, University Malaya Medical Centre, University of Malaya, Kuala Lumpur, Malaysia (H.L.A., W.P.); and Queen Sirikit National Institute of Child Health, Rangsit University, Bangkok, Thailand (P.P.). , Matthew JonesMatthew Jones From the Department of Pediatric and Adult Cardiology, Evelina London Children's Hospital and Guy's and St Thomas' NHS Foundation Trust, United Kingdom (M.R., M.J., A.-E.B., E.R., A.S.Q.); Department of Cardiology, St. Paul's Hospital, Vancouver, BC, Canada (M.R.); Department of Cardiology, University Malaya Medical Centre, University of Malaya, Kuala Lumpur, Malaysia (H.L.A., W.P.); and Queen Sirikit National Institute of Child Health, Rangsit University, Bangkok, Thailand (P.P.). , Pimpak PrachasilchaiPimpak Prachasilchai From the Department of Pediatric and Adult Cardiology, Evelina London Children's Hospital and Guy's and St Thomas' NHS Foundation Trust, United Kingdom (M.R., M.J., A.-E.B., E.R., A.S.Q.); Department of Cardiology, St. Paul's Hospital, Vancouver, BC, Canada (M.R.); Department of Cardiology, University Malaya Medical Centre, University of Malaya, Kuala Lumpur, Malaysia (H.L.A., W.P.); and Queen Sirikit National Institute of Child Health, Rangsit University, Bangkok, Thailand (P.P.). , Alban-Elouan BaruteauAlban-Elouan Baruteau From the Department of Pediatric and Adult Cardiology, Evelina London Children's Hospital and Guy's and St Thomas' NHS Foundation Trust, United Kingdom (M.R., M.J., A.-E.B., E.R., A.S.Q.); Department of Cardiology, St. Paul's Hospital, Vancouver, BC, Canada (M.R.); Department of Cardiology, University Malaya Medical Centre, University of Malaya, Kuala Lumpur, Malaysia (H.L.A., W.P.); and Queen Sirikit National Institute of Child Health, Rangsit University, Bangkok, Thailand (P.P.). , Worakan PromphanWorakan Promphan From the Department of Pediatric and Adult Cardiology, Evelina London Children's Hospital and Guy's and St Thomas' NHS Foundation Trust, United Kingdom (M.R., M.J., A.-E.B., E.R., A.S.Q.); Department of Cardiology, St. Paul's Hospital, Vancouver, BC, Canada (M.R.); Department of Cardiology, University Malaya Medical Centre, University of Malaya, Kuala Lumpur, Malaysia (H.L.A., W.P.); and Queen Sirikit National Institute of Child Health, Rangsit University, Bangkok, Thailand (P.P.). , Eric RosenthalEric Rosenthal From the Department of Pediatric and Adult Cardiology, Evelina London Children's Hospital and Guy's and St Thomas' NHS Foundation Trust, United Kingdom (M.R., M.J., A.-E.B., E.R., A.S.Q.); Department of Cardiology, St. Paul's Hospital, Vancouver, BC, Canada (M.R.); Department of Cardiology, University Malaya Medical Centre, University of Malaya, Kuala Lumpur, Malaysia (H.L.A., W.P.); and Queen Sirikit National Institute of Child Health, Rangsit University, Bangkok, Thailand (P.P.). and Shakeel Ahmed QureshiShakeel Ahmed Qureshi From the Department of Pediatric and Adult Cardiology, Evelina London Children's Hospital and Guy's and St Thomas' NHS Foundation Trust, United Kingdom (M.R., M.J., A.-E.B., E.R., A.S.Q.); Department of Cardiology, St. Paul's Hospital, Vancouver, BC, Canada (M.R.); Department of Cardiology, University Malaya Medical Centre, University of Malaya, Kuala Lumpur, Malaysia (H.L.A., W.P.); and Queen Sirikit National Institute of Child Health, Rangsit University, Bangkok, Thailand (P.P.). Originally published4 Apr 2018https://doi.org/10.1161/CIRCINTERVENTIONS.117.005923Circulation: Cardiovascular Interventions. 2018;11:e005923IntroductionWe report 2 cases of postdeployment infolding of the Venus P-valve after percutaneous pulmonary valve implantation.Both patients had tetralogy of Fallot and underwent surgical repair in childhood comprising transannular patch enlargement of the right ventricular (RV) outflow tract. They developed severe RV dilatation and dysfunction with reduced exercise capacity at ages of 31 and 18 years, respectively. Both were deemed suitable for percutaneous pulmonary valve implantation using the Venus P-valve system (Venus Medtech, Hangzhou, China) via transfemoral venous access. The optimal device diameter was determined by adding 3 to 4 mm to the maximal diameter of the waist of the sizing balloon (Figures 1A and 2A). A detailed description of the landing zone anatomy is provided in the Table. The procedures followed the standard Venus P-valve implantation steps, which have been described in detail previously.1–3 The valve was deployed gradually by opening the distal flare in the distal main pulmonary artery and the proximal flare in the RV outflow tract (Video I and Video IV in the Data Supplement). In both cases, the fully deployed valve stent frame had an abnormal appearance on fluoroscopy with distinct lines corresponding to infolded struts (Figures 1B, 1C, 2B, and 2C). The complete valve infolding could be demonstrated with a steep caudal and shallow left anterior oblique en face view (Figure 1D). Both patients remained hemodynamically stable. In case number 1, the stent frame was successfully expanded using a 34 mm Amplatzer atrial septal defect sizing balloon (St Jude Medical, Saint Paul, MN; Video II in the Data Supplement; Figure 1E through 1G). However, postexpansion angiography showed persistent severe valvar pulmonary regurgitation (Video III in the Data Supplement). Transthoracic echocardiogram confirmed severe pulmonary regurgitation secondary to leaflet dysfunction. In case number 2, a Coda 32 mm semicompliant balloon (Cook Medical, Bloomington, IN) was used to expand the valve with a good result and without any sign of leaflet dysfunction on both angiography and transthoracic echocardiogram (Video V and Video VI in the Data Supplement; Figure 2D through 2F).Table. Procedural and Anatomic DetailsPatient No.IndicationRVEF, %RVEDVi, mL/m2RVOT Maximum Diameter, mmMPA Maximum Diameter, mmLanding Zone Length, mmDevice Size Used*1Severe PR2615835×3630×314536–302Severe PR5614033×3730×335036–30MPA indicates main pulmonary artery; PR, pulmonary regurgitation; RVEDVi, right ventricular end-diastolic volume index; RVEF, right ventricular ejection fraction; and RVOT, right ventricular outflow tract.*Diameter length.Download figureDownload PowerPointFigure 1. Series of fluoroscopic images of case No. 1. A, Pulmonary angiography in the 30° right anterior oblique/30° cranial view. A2, Inflation of an Amplatzer sizing balloon in the right ventricular outflow tract (RVOT) with simultaneous RV angiography in the 90° left anterior oblique view; B and C, Postdeployment aspect of the infolded P-valve stents in the left anterior oblique 90° views and right anterior oblique/cranial views. The white arrows indicate the folding lines. D, En face view of the infolded valve in patient 1. E and F, Postballoon dilatation of the P-valve stents in the left anterior oblique 90° views and right oblique/cranial views. G, En face view of the stent frame after balloon dilatation.Download figureDownload PowerPointFigure 2. Series of fluoroscopic images of case No. 2. A1, Pulmonary angiography in the 30° right anterior oblique/30° cranial view. A2, Inflation of an Amplatzer sizing balloon in the right ventricular outflow tract (RVOT) with simultaneous RV angiography in the 90° left anterior oblique view. B and C, Postdeployment aspect of the infolded P-valve stents in the left anterior oblique 90° views and right anterior oblique/cranial views. The white arrows indicate the folding lines. D and E, Postballoon dilatation of the P-valve stents in the left anterior oblique 90° views and right oblique/cranial views. F, En face view of the stent frame after balloon dilatation.At 41 and 18 days, respectively, the patients remained well. Patient number 1 is still waiting for a repeat magnetic resonance imaging assessment before proceeding with a further elective valve-in-valve procedure to correct the residual leak.DiscussionThe Venus P-valve is a new generation device consisting of porcine pericardium leaflets mounted in a self-expanding nitinol stent, specifically designed for use in large native RV outflow tracts. To date, >100 Venus P-valves have been implanted worldwide with favorable procedural and short-term outcomes.1–3 Distortion and infolding of the stent frame have not been seen with Venus P-valve but has been reported with CoreValve device (Medtronic Inc, MN) used for transcatheter aortic valve implantation, which is also mounted in a self-expanding nitinol stent.4 It may be because of asymmetrical crimping during the valve preparation and mounting or to the intrinsic mechanical properties of this large and long Nitinol stent. Another hypothesis is that the observed posterior infolding was related to the mechanics of deployment around a curvature and tension on the system. In both cases, the infolding occurred along the inferior curvature, which could be consistent with a mechanism of constrained frame architecture. This may happen if the valves were oversized in relation to the main pulmonary artery diameter or if there was severe RV outflow tract angulation, both of which may increase the mechanical tension on the frame.ConclusionsWe report the occurrence of postdeployment stent infolding and distortion in 2 cases of percutaneous pulmonary valve implantation using a 36 mm Venus P-valve. In both instances, stent geometry was reestablished using postimplantation balloon dilation. The mechanism causing this phenomenon is not well-understood. It could be related to constrained stent frame architecture or an asymmetrical crimping.DisclosuresA.S. Qureshi is a consultant for Venus Medtech and a Principal Investigator for the CE study. Dr Promphan is a consultant for Venus Medtech.FootnotesThe Data Supplement is available at http://circinterventions.ahajournals.org/lookup/suppl/doi:10.1161/CIRCINTERVENTIONS.117.005923/-/DC1.Correspondence to Shakeel Ahmed Qureshi, Department of Pediatric and Adult Cardiology, Evelina London Children's Hospital, 4th Floor Becket House, Evelina London Children's Hospital, Westminster Bridge Rd, London SE1 7EH, United Kingdom. E-mail [email protected]References1. Promphan W, Prachasilchai P, Siripornpitak S, Qureshi SA, Layangool T. Percutaneous pulmonary valve implantation with the Venus P-valve: clinical experience and early results.Cardiol Young. 2016; 26:698–710. doi: 10.1017/S1047951115001067.CrossrefMedlineGoogle Scholar2. Garay F, Pan X, Zhang YJ, Wang C, Springmuller D. Early experience with the Venus p-valve for percutaneous pulmonary valve implantation in native outflow tract.Neth Heart J. 2017; 25:76–81. doi: 10.1007/s12471-016-0932-5.CrossrefMedlineGoogle Scholar3. Cao QL, Kenny D, Zhou D, Pan W, Guan L, Ge J, Hijazi ZM. Early clinical experience with a novel self-expanding percutaneous stent-valve in the native right ventricular outflow tract.Catheter Cardiovasc Interv. 2014; 84:1131–1137. doi: 10.1002/ccd.25544.CrossrefMedlineGoogle Scholar4. Wiper A, Chauhan A, More R, Roberts D. CoreValve frame distortion: the importance of meticulous valve loading.JACC Cardiovasc Interv. 2014; 7:222–223. doi: 10.1016/j.jcin.2013.05.032.CrossrefMedlineGoogle Scholar Previous Back to top Next FiguresReferencesRelatedDetailsCited By Shahanavaz S, Balzer D, Babaliaros V, Kim D, Dimas V, Veeram Reddy S, Leipsic J, Blanke P, Shirali G, Parthiban A, Gorelick J and Zahn E (2020) Alterra Adaptive Prestent and SAPIEN 3 THV for Congenital Pulmonic Valve Dysfunction, JACC: Cardiovascular Interventions, 10.1016/j.jcin.2020.06.039, 13:21, (2510-2524), Online publication date: 1-Nov-2020. Ou-Yang W, Qureshi S, Ge J, Hu S, Li S, Yang K, Zhang G, Zhou D, Chen M, Wang S, Zhang F and Pan X (2020) Multicenter Comparison of Percutaneous and Surgical Pulmonary Valve Replacement in Large RVOT, The Annals of Thoracic Surgery, 10.1016/j.athoracsur.2020.01.009, 110:3, (980-987), Online publication date: 1-Sep-2020. Ben-Dor I, Rogers T, Satler L and Waksman R (2018) A word of caution using self-expanding transcatheter aortic valve-frame infolding, Catheterization and Cardiovascular Interventions, 10.1002/ccd.27870, 93:3, (555-558), Online publication date: 15-Feb-2019. April 2018Vol 11, Issue 4 Advertisement Article InformationMetrics © 2018 American Heart Association, Inc.https://doi.org/10.1161/CIRCINTERVENTIONS.117.005923PMID: 29618579 Originally publishedApril 4, 2018 Keywordsnitinolfluoroscopypulmonary valvetetralogy of Fallotaortic valvePDF download Advertisement SubjectsCatheter-Based Coronary and Valvular InterventionsCongenital Heart DiseaseValvular Heart Disease