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Expanding Indications for Bioprosthetic Valve Fracture and Bioprosthetic Valve Remodeling

2018; Lippincott Williams & Wilkins; Volume: 11; Issue: 8 Linguagem: Inglês

10.1161/circinterventions.118.007017

1941-7632

Adnan K. Chhatriwalla, Paul Sorajja,

Cardiac Structural Anomalies and Repair

HomeCirculation: Cardiovascular InterventionsVol. 11, No. 8Expanding Indications for Bioprosthetic Valve Fracture and Bioprosthetic Valve Remodeling Free AccessEditorialPDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toFree AccessEditorialPDF/EPUBExpanding Indications for Bioprosthetic Valve Fracture and Bioprosthetic Valve RemodelingWho Is Most Likely to Benefit? Adnan K. Chhatriwalla, MD and Paul Sorajja, MD Adnan K. ChhatriwallaAdnan K. Chhatriwalla Saint Luke's Mid America Heart Institute, Kansas City, MO (A.K.C.). and Paul SorajjaPaul Sorajja Paul Sorajja, MD, Roger L. and Lynn C. Headrick Chair, Valve Science Center, Minneapolis Heart Institute Foundation, Abbott Northwestern Hospital, 920 E 28th St, Suite 200, Minneapolis, MN 55407. Email E-mail Address: [email protected] Abbott Northwestern Hospital, Minneapolis, MN (P.S.). Originally published3 Aug 2018https://doi.org/10.1161/CIRCINTERVENTIONS.118.007017Circulation: Cardiovascular Interventions. 2018;11:e007017This article is a commentary on the followingIntentional Fracture of Bioprosthetic Valve Frames in Patients Undergoing Valve-in-Valve Transcatheter Pulmonary Valve ReplacementSee Article by Shahanavaz et alPatient prosthesis mismatch is associated with increased morbidity and mortality and has become an increasing concern for both surgical and transcatheter valve replacement (TVR).1,2 Patients undergoing valve in valve (VIV) TVR are at particular risk for patient prosthesis mismatch given that the expansion of the transcatheter heart valve (THV) is limited by the sewing ring of the prior surgical valve. As a result, there has been much recent interest in the techniques of bioprosthetic valve fracture (BVF) and bioprosthetic valve remodeling (BVR), in which a high-pressure balloon inflation is performed to intentionally fracture (in BVF) or stretch (in BVR) the sewing ring of a bioprosthetic surgical valve (BSV), thus allowing for further expansion of the implanted THV and leading to an increased valve area and lower residual transvalvular gradients.3–5 Although the majority of published data to this point has centered on the use of BVF to facilitate VIV transcatheter aortic valve replacement, the current report by Shahanavaz et al6 is an important step in increasing our understanding of which patients stand to benefit from BVF and BVR.In this study, the authors report outcomes of BVF in 37 patients undergoing transcatheter pulmonary valve replacement. BVF was successful in 28 cases and unsuccessful in 4 cases, and in 5 cases, the high-pressure balloon inflation resulted in BVR. The procedural results in this series were outstanding, with a decrease in the mean right ventricular outflow tract gradient in this cohort from 40 to 8 mm Hg and few complications. Importantly, the median final internal diameter (ID) of the THV was 2 mm larger than the ID of the surgical valve being treated while, in a cohort of 70 matched control patients who did not undergo BVF or BVF, the median final ID was 2 mm smaller than the ID of the surgical valve. Moreover, even though not statistically significant, the increase in THV expansion achieved with BVF/BVR was associated with an incremental improvement in final hemodynamics as the final mean right ventricular outflow tract gradient in the BVF/BVR cohort was 8.3 mm Hg as compared with 11.8 mm Hg (P=0.07) in the control group.These findings build on those from bench studies and clinical experience, which have demonstrated that while many BSVs can be fractured, others cannot.5 However, the current report adds to the prior literature in several notable ways. First, the prior bench studies were performed in small (19- and 21-mm) surgical valves, and the fracture thresholds of larger sized BSVs have not systematically been tested. However, 22 patients in the current series with intermediate sized surgical valves (ie, with a true ID of >18.5–21 mm) and 1 patient with a large sized surgical valve (ie, with a true ID ≥21 mm) underwent successful BVF, suggesting that BVF is feasible even in larger surgical bioprostheses. Furthermore, the prior bench studies were limited in that the BSVs tested were those that were clinically available at the time. As a result, data on the fracturability of older generation BSVs have been limited. It now seems that some valves that cannot be fractured can be significantly remodeled to allow THV expansion (Table).Table. Bioprosthetic Valves That Can Be Fractured or Remodeled With a High-Pressure Balloon InflationValves That Can Be FracturedValves That Can Be RemodeledValves That Cannot Be Fractured or RemodeledBiocor EpicInspirisAvalusMagnaCarpentier-Edwards StandardHancock IIMagna EaseCarpentier-Edwards SAVMitroflowPerimount (older generation)MosaicTrifectaPerimount (newer generation)Now that we have a greater knowledge of which BSVs are amenable to BVF and BVR, we need to better understand which patients are likely to benefit from the procedure. The current study is important in that it establishes the feasibility and safety of these techniques in patients undergoing transcatheter pulmonary valve replacement. However, one limitation of the current report is that BVF and BVR were performed before the transcatheter pulmonary valve replacement implant, and as a result, it is difficult to estimate the benefit of BVF and BVR without knowing what the hemodynamic results would have been if transcatheter pulmonary valve replacement had been performed without BVF or BVR. The comparison of the 2 groups is limited by matching only on 2 clinical variables: body weight and the true ID of the BSV. As a result, significant differences between the study and control groups were likely present, including a significant difference in baseline mean gradient, as the authors note. Nevertheless, the fact that a hemodynamic benefit of BVF and BVR was not proven in this study raises the possibility of a threshold effect beyond which patients with larger sized BSVs may not benefit from these techniques.Patients with larger BSVs undergoing VIV TVR have a lower risk of patient prosthesis mismatch and high residual gradients, compared with patients with small BSVs. However, THVs deployed in larger BSVs remain constrained by the BSV sewing ring, and there is evidence that suboptimal expansion of THVs can impair leaflet motion, alter leaflet stress, and result in early leaflet degeneration.7 In fact, case reports in which patients who have undergone VIV TVR and a subsequent reoperation have demonstrated that THV underexpansion is associated with leaflet delamination, calcification, and dysfunction.8 Accordingly, interest has been raised in performing BVF or BVR for patients with larger BSVs undergoing VIV TVR even when patient prosthesis mismatch is not a concern to optimize THV expansion, preserve leaflet architecture, and to potentially improve the long-term durability of the procedure; however, data on the use of these techniques in patients with larger BSVs remain limited to date.Larger studies are needed to better define the optimal techniques to perform BVF and BVR and to characterize complications related to the procedure. Further research is also needed to evaluate the long-term impact of BVF and BVR on hemodynamic and clinical outcomes in patients undergoing VIV TVR. Comprehensive examinations of flow dynamics with and without BVF and BVR, both acutely and long-term, are needed to understand whether these techniques are beneficial only for patients with small BSVs undergoing VIV TVR or whether all patients stand to benefit. Last, as new BSVs become commercially available, it will be important for manufacturers to report whether they can or cannot be fractured or remodeled, and at what pressures, to guide our clinical practice.DisclosuresDr Chhatriwalla serves on the speakers bureau for Edwards Lifesciences, Medtronic Inc, and Abbott Vascular and proctor for Medtronic Inc. Dr Sorajja is a consultant for Edwards Lifesciences, Medtronic Inc, Boston Scientific, Abbott Structural, Admedus Inc, and Pipeline Technologies; and he serves on speakers bureau for Edwards Lifesciences, Medtronic Inc, Boston Scientific, Abbott Structural.FootnotesThe opinions expressed in this article are not necessarily those of the editors or of the American Heart Association.https://www.ahajournals.org/journal/circinterventionsPaul Sorajja, MD, Roger L. and Lynn C. Headrick Chair, Valve Science Center, Minneapolis Heart Institute Foundation, Abbott Northwestern Hospital, 920 E 28th St, Suite 200, Minneapolis, MN 55407. Email paul.[email protected]comReferences1. Dvir D, Webb JG, Bleiziffer S, Pasic M, Waksman R, Kodali S, Barbanti M, Latib A, Schaefer U, Rodés-Cabau J, Treede H, Piazza N, Hildick-Smith D, Himbert D, Walther T, Hengstenberg C, Nissen H, Bekeredjian R, Presbitero P, Ferrari E, Segev A, de Weger A, Windecker S, Moat NE, Napodano M, Wilbring M, Cerillo AG, Brecker S, Tchetche D, Lefèvre T, De Marco F, Fiorina C, Petronio AS, Teles RC, Testa L, Laborde JC, Leon MB, Kornowski R; Valve-in-Valve International Data Registry Investigators. Transcatheter aortic valve implantation in failed bioprosthetic surgical valves.JAMA. 2014; 312:162–170. doi: 10.1001/jama.2014.7246.CrossrefMedlineGoogle Scholar2. Head SJ, Mokhles MM, Osnabrugge RL, Pibarot P, Mack MJ, Takkenberg JJ, Bogers AJ, Kappetein AP. The impact of prosthesis-patient mismatch on long-term survival after aortic valve replacement: a systematic review and meta-analysis of 34 observational studies comprising 27 186 patients with 133 141 patient-years.Eur Heart J. 2012; 33:1518–1529. doi: 10.1093/eurheartj/ehs003.CrossrefMedlineGoogle Scholar3. Chhatriwalla AK, Allen KB, Saxon JT, Cohen DJ, Aggarwal S, Hart AJ, Baron SJ, Dvir D, Borkon AM. Bioprosthetic valve fracture improves the hemodynamic results of valve-in-valve transcatheter aortic valve replacement.Circ Cardiovasc Interv. 2017; 10:e005216. doi: 10.1161/CIRCINTERVENTIONS.117.005216.LinkGoogle Scholar4. Nielsen-Kudsk JE, Andersen A, Therkelsen CJ, Christensen EH, Jensen KT, Krusell LR, Tang M, Terp KA, Klaaborg KE, Greisen JR, Nørgaard BL, Andersen HR. High-pressure balloon fracturing of small dysfunctional Mitroflow bioprostheses facilitates transcatheter aortic valve-in-valve implantation.EuroIntervention. 2017; 13:e1020–e1025. doi: 10.4244/EIJ-D-17-00244.CrossrefMedlineGoogle Scholar5. Allen KB, Chhatriwalla AK, Cohen DJ, Saxon JT, Aggarwal S, Hart A, Baron S, Davis JR, Pak AF, Dvir D, Borkon AM. Bioprosthetic valve fracture to facilitate transcatheter valve-in-valve implantation.Ann Thorac Surg. 2017; 104:1501–1508. doi: 10.1016/j.athoracsur.2017.04.007.CrossrefMedlineGoogle Scholar6. Shahanavaz S, Asnes JD, Grohmann J, Qureshi AM, Rome JJ, Tanase D, Crystal MA, Latson LA, Morray BH, Hellenbrand W, Balzer DT, Gewillig M, Love JC, Berdjis F, Gillespie MJ, McElhinney DB. Intentional fracture of bioprosthetic valve frames in patients undergoing valve-in-valve transcatheter pulmonary valve replacement.Circ Cardiovasc Interv. 2018; 11:e006453. doi: 10.1161/CIRCINTERVENTIONS.118.006453.LinkGoogle Scholar7. Abbasi M, Azadani AN. Leaflet stress and strain distributions following incomplete transcatheter aortic valve expansion.J Biomech. 2015; 48:3663–3671. doi: 10.1016/j.jbiomech.2015.08.012.CrossrefMedlineGoogle Scholar8. Grubitzsch H, Galloni M, Falk V. Wrinkles, folds and calcifications: reduced durability after transcatheter aortic valve-in-valve replacement.J Thorac Cardiovasc Surg. 2017; 153:266–268. doi: 10.1016/j.jtcvs.2016.08.018.CrossrefMedlineGoogle Scholar Previous Back to top Next FiguresReferencesRelatedDetailsRelated articlesIntentional Fracture of Bioprosthetic Valve Frames in Patients Undergoing Valve-in-Valve Transcatheter Pulmonary Valve ReplacementShabana Shahanavaz, et al. Circulation: Cardiovascular Interventions. 2018;11 August 2018Vol 11, Issue 8 Advertisement Article InformationMetrics © 2018 American Heart Association, Inc.https://doi.org/10.1161/CIRCINTERVENTIONS.118.007017PMID: 30354791 Originally publishedAugust 3, 2018 Keywordsheart valve prosthesisaortic valvetranscatheter aortic valve replacementEditorialspulmonary valvePDF download Advertisement