Fracturing the Ring of Small Mitroflow Bioprostheses by High-Pressure Balloon Predilatation in Transcatheter Aortic Valve-in-Valve Implantation
2015; Lippincott Williams & Wilkins; Volume: 8; Issue: 8 Linguagem: Inglês
10.1161/circinterventions.115.002667
ISSN1941-7632
AutoresJens Erik Nielsen‐Kudsk, Evald Høj Christiansen, Christian Juhl Terkelsen, Bjarne Linde Nørgaard, Kaare Jensen, Lars Romer Krusell, Mariann Tang, Kim Terp, Kaj-Erik Klaaborg, Henning Andersen,
Tópico(s)Cardiac pacing and defibrillation studies
ResumoHomeCirculation: Cardiovascular InterventionsVol. 8, No. 8Fracturing the Ring of Small Mitroflow Bioprostheses by High-Pressure Balloon Predilatation in Transcatheter Aortic Valve-in-Valve Implantation Free AccessResearch ArticlePDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissionsDownload Articles + Supplements ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toSupplemental MaterialFree AccessResearch ArticlePDF/EPUBFracturing the Ring of Small Mitroflow Bioprostheses by High-Pressure Balloon Predilatation in Transcatheter Aortic Valve-in-Valve Implantation Jens Erik Nielsen-Kudsk, MD, DMSc, Evald Høj Christiansen, MD, PhD, Christian Juhl Terkelsen, MD, DMSc, Bjarne Linde Nørgaard, MD, PhD, Kaare Troels Jensen, MD, PhD, Lars Romer Krusell, MD, Mariann Tang, MD, Kim Terp, MD, Kaj-Erik Klaaborg, MD and Henning Rud Andersen, MD, DMSc Jens Erik Nielsen-KudskJens Erik Nielsen-Kudsk From Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark; and Department of Cardiothoracic Surgery, Aarhus University Hospital, Aarhus, Denmark. , Evald Høj ChristiansenEvald Høj Christiansen From Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark; and Department of Cardiothoracic Surgery, Aarhus University Hospital, Aarhus, Denmark. , Christian Juhl TerkelsenChristian Juhl Terkelsen From Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark; and Department of Cardiothoracic Surgery, Aarhus University Hospital, Aarhus, Denmark. , Bjarne Linde NørgaardBjarne Linde Nørgaard From Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark; and Department of Cardiothoracic Surgery, Aarhus University Hospital, Aarhus, Denmark. , Kaare Troels JensenKaare Troels Jensen From Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark; and Department of Cardiothoracic Surgery, Aarhus University Hospital, Aarhus, Denmark. , Lars Romer KrusellLars Romer Krusell From Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark; and Department of Cardiothoracic Surgery, Aarhus University Hospital, Aarhus, Denmark. , Mariann TangMariann Tang From Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark; and Department of Cardiothoracic Surgery, Aarhus University Hospital, Aarhus, Denmark. , Kim TerpKim Terp From Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark; and Department of Cardiothoracic Surgery, Aarhus University Hospital, Aarhus, Denmark. , Kaj-Erik KlaaborgKaj-Erik Klaaborg From Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark; and Department of Cardiothoracic Surgery, Aarhus University Hospital, Aarhus, Denmark. and Henning Rud AndersenHenning Rud Andersen From Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark; and Department of Cardiothoracic Surgery, Aarhus University Hospital, Aarhus, Denmark. Originally published24 Jul 2015https://doi.org/10.1161/CIRCINTERVENTIONS.115.002667Circulation: Cardiovascular Interventions. 2015;8IntroductionEarly deterioration of Mitroflow aortic bioprostheses (Sorin Group Inc), particularly small sizes 19 and 21 mm, has been reported.1 Treatment of failing bioprostheses by transcatheter valve-in-valve (VIV) therapy has become an alternative to repeat surgery.2,3 However, VIV treatment is problematic with small surgical bioprostheses because of a further reduction in the effective valve orifice. One way to overcome this challenge may be to fracture the ring of the surgical valve by high-pressure balloon dilatation before implanting a larger size transcatheter valve. The feasibility of this approach was recently reported for an Edwards Perimount bioprosthesis (19 mm) in the pulmonic position.4 We report the first cases in vitro and in man of high-pressure balloon dilatation to fracture the ring of small dysfunctional Mitroflow aortic bioprostheses followed by transcatheter VIV implantation.The Mitroflow bioprosthesis is build from a bovine pericardial sheet sutured to the outside of an acetyl stent to form the leaflets. The sewing ring is made from soft radiopaque silicone covered by a Dacron mesh. Mitroflow 19 and 21 mm prostheses have internal stent ring diameters of 15.4 and 17.3 mm, respectively. In vitro, we gradually inflated a 22 mm high-pressure balloon (ATLAS Gold, Bard, Temple) in an unused 21 mm Mitroflow valve. On fluoroscopy, there was a waist in the balloon from the bioprosthesis, and at a pressure of 11 atm, the ring of the Mitroflow valve fractured with an audible click followed by expansion of the balloon to its full diameter of 22 mm (Figure 1). The Dacron ring was intact with no irregularities or sharp edges and only by palpation a fracture line could be recognized in the stent ring. Dissecting the Mitroflow bioprosthesis revealed a single regular thin fracture line in the inner acetyl stent ring of the valve (Figure 1). The experiment was repeated twice giving the same findings. With a 23 mm Z-MED balloon, we subsequently implanted a SAPIEN XT (Edwards Lifesciences, Irvine) transcatheter heart valve in vitro in one of the fractured 21 mm Mitroflow bioprostheses.Download figureDownload PowerPointFigure 1. An ATLAS Gold 22 mm high-pressure balloon was gradually inflated inside a 21 mm Mitroflow valve. At a balloon pressure of 11 atm, the acetyl stent ring of the valve fractured with a load click. At the same time, the waist in the balloon disappeared, balloon pressure dropped suddenly, and the balloon did fully expand to a diameter of 22 mm. The outer Dacron ring of the bioprosthesis was intact and no sharp elements did protrude (A). A fracture line could be appreciated by palpation and was visualized by dissection of the valve ring (B and C, arrow).After in vitro testing and informed consent, we performed this procedure in 2 patients with small Mitroflow bioprostheses (19 and 21 mm) and high risk to redo surgery (Table). High-pressure balloon predilatation by an ATLAS Gold balloon led to fracturing of the stent ring of the Mitroflow valves with subsequent successfully VIV with an SAPIEN XT valve 20 mm (19 mm Mitroflow) and a SAPIEN III 23 mm valve (21 mm Mitroflow; Table). The procedures were performed in general anesthesia guided by fluoroscopy and TEE. Rapid right ventricular pacing (180 bpm) and cardiopulmonary support (CPS 2 l/min; right atrium to left femoral artery) were used during the high-pressure balloon predilatation and at the time of VIV implantation. The Mitroflow valve ring fractured at a pressure of 16 atm (Mitroflow 19 mm) and 11 atm (Mitroflow 21 mm) evident by a sudden drop in inflation pressure and resolution of the waist in the balloon with expansion to its full diameter (Figure 2; Movies I and II in the Data Supplement). The 2 cases were successful without any complications. There were no signs of damage to the aortic root or paravalvular leaks on follow-up TEE or cardiac CT. In both patients, there was a marked reduction in the pressure gradient across the Mitroflow valve and an increase in the aortic valve area as evaluated by echocardiography. The Mitroflow ring circumference measured by computed tomography was increased 17% to 18% as an indirect proof of stent ring fracture (Table; Figure 3).Table. Two Patients Treated by Transcatheter Aortic Valve-in-Valve Implantation After Fracturing the Ring of Small Mitroflow Bioprostheses by High-Pressure Balloon PredilatationCase 1Case 2Age, sex, BSA84 y, male, 1.88 m280 y, female, 1.43 m2Mitroflow, year since implant21 mm, stenotic, 11 y19 mm, stenotic, 10 yPostsurgical peak gradientNA40 mm HgATLAS Gold balloon22 mm20 mmThreshold for ring fracture11 atm16 atmEdwards SapienIII 23 mm, transapicalXT 20 mm, transfemoralNYHA class (pre/FU)II/IIII/IILVEF (pre/FU)35%/35%60%/60%Peak gradient (pre/FU)65/26 mm Hg127/38 mm HgMean gradient (pre/FU)41/17 mm Hg81/27 mm HgAVA (pre/FU)0.8/1.0 cm2 (25% increase)0.3/0.9 cm2 (200% increase)Mitroflow circumference CT (pre/post)57.5/67.2 mm (17% increase)49.6/58.7 mm (18% increase)Clinical and echocardiography parameters were obtained preprocedural and at follow-up (FU) 4 weeks (Case 1) and 6 weeks (Case 2) after the procedure. AVA indicates aortic valve area; BSA, body surface area; LVEF, left ventricular ejection fraction; and NYHA, New York Heart Association.Download figureDownload PowerPointFigure 2. A 20 mm ATLAS Gold balloon was used to predilate the 19 mm Mitroflow valve. With gradual inflation, there was a waist in the balloon (waist diameter 8 mm) first from the thickened stenotic valve leaflets (A) and second from the stent ring of the bioprosthesis (waist diameter 15 mm; B). At a balloon pressure of 16 atm, the Mitroflow stent ring fractured and the balloon expanded to its full diameter of 20 mm (C). Subsequently, a SAPIEN XT 20 mm valve was implanted inside the fractured Mitroflow prosthesis at an optimal position (D). Cardiopulmonary support (CPS) was used from balloon dilatation to valve implantation to avoid hemodynamic instability. The CPS outflow cannula was in the right atrium (seen on the images) and the inflow cannula in the left femoral artery.Download figureDownload PowerPointFigure 3. Cardiac computed tomography performed after transcatheter valve-in-valve (VIV) with insertion of a SAPIEN XT 20 mm valve into a Mitroflow 19 mm prosthesis (internal diameter 15.4 mm) preceded by high-pressure ballon predilation to fracture the ring of the surgical bioprosthesis. Note the small indentation in the radiopaque silicone band (arrow), which most likely represents the fracture site in the acetyl stent of the valve.The surgical valve ring will normally protect against aortic root rupture or dissection in VIV therapy, but this advantage may not apply after balloon-induced fracturing of the ring. Moreover, coronary ostial compression is a serious complication to VIV therapy, such that only patients with coronary ostia distant to the upper part of the bioprosthesis or those having well-functioning bypass grafts will be suitable. Until more experience is gained, repeat surgery remains the standard treatment for dysfunctional small bioprostheses, and the described novel technique should only be performed in highly selected patients.DisclosuresDr Christiansen is Proctor for Edwards Lifescienses; and Dr Klaaborg is Proctor for Edwards Lifescienses. The other authors report no conflicts.FootnotesThe Data Supplement is available at http://circinterventions.ahajournals.org/lookup/suppl/doi:10.1161/CIRCINTERVENTIONS.115.002667/-/DC1.Correspondence to Jens Erik Nielsen-Kudsk, MD, DMSc, Department of Cardiology, Aarhus University Hospital, Skejby, Palle Juul-Jensens Boulevard 99, DK-8200 Aarhus N, Denmark. E-mail [email protected]References1. 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August 2015Vol 8, Issue 8 Advertisement Article InformationMetrics © 2015 American Heart Association, Inc.https://doi.org/10.1161/CIRCINTERVENTIONS.115.002667PMID: 26208503 Manuscript receivedMarch 31, 2015Manuscript acceptedJune 25, 2015Originally publishedJuly 24, 2015 Keywordsaortic valvebioprosthesistranscatheter valve-in-valve implantationdilatationtranscatheter aortic valve implantationPDF download Advertisement SubjectsCatheter-Based Coronary and Valvular InterventionsValvular Heart Disease
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