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Commentary: Tissue is the issue—Bioprosthetic versus mechanical valves in dialysis-dependent patients

Open ArchivePublished:January 11, 2019DOI:https://doi.org/10.1016/j.jtcvs.2018.12.097
      In dialysis-dependent patients, bioprosthetic valve replacement appears safe in terms of thromboembolic events, reoperation rates, and survival, while allowing for future valve-in-valve therapy.
      See Article page 48.
      For dialysis-dependent patients requiring valve replacement, controversy remains as to whether mechanical or tissue valves are preferred. Historically, guidelines
      • Bonow R.O.
      • Carabello B.
      • de Leon A.C.
      • Edmunds Jr., L.H.
      • Fedderly B.J.
      • Freed M.D.
      • et al.
      ACC/AHA guidelines for the management of patients with valvular heart disease. Executive summary. A report of the American College of Cardiology/American Heart Association task force on practice guidelines (committee on management of patients with valvular heart disease).
      have recommended mechanical valves in patients with end-stage renal disease (ESRD) because of concern for calcific structural valve deterioration (SVD); however, limited survival of patients with ESRD requiring valve replacement
      • Thourani V.H.
      • Sarin E.L.
      • Kilgo P.D.
      • Lattouf O.M.
      • Puskas J.D.
      • Chen E.P.
      • et al.
      Short- and long-term outcomes in patients undergoing valve surgery with end-stage renal failure receiving chronic hemodialysis.
      has called such benefit into question.
      • Williams M.L.
      • Bavaria J.E.
      • Acker M.A.
      • Desai N.D.
      • Vallabhajosyula P.
      • Hargrove W.C.
      • et al.
      Valve selection in end-stage renal disease: should it always be biological?.
      In this issue of the Journal, Ikeno and colleagues
      • Ikeno Y.
      • Mukohara N.
      • Fukumura Y.
      • Tobe S.
      • Gan K.
      • Obo H.
      • et al.
      Outcomes of valve replacement with mechanical prosthesis versus bioprosthesis in dialysis patients: a 16-year multicenter experience.
      present a cohort of 312 dialysis-dependent patients across 7 Japanese centers requiring either mechanical (n = 94) or bioprosthetic (n = 218) valve replacement. Intermediate-term reoperation rates and survival were similar between mechanical and bioprosthetic groups and comparable to previous reports,
      • Williams M.L.
      • Bavaria J.E.
      • Acker M.A.
      • Desai N.D.
      • Vallabhajosyula P.
      • Hargrove W.C.
      • et al.
      Valve selection in end-stage renal disease: should it always be biological?.
      whereas thromboembolic complications were increased among patients receiving mechanical valves. On subgroup analysis by valve position, increased thromboembolic complications were seen among patients undergoing mechanical versus bioprosthetic aortic valve replacement (AVR), without differences among patients undergoing mitral valve replacement or double valve replacement. Ikeno and colleagues
      • Ikeno Y.
      • Mukohara N.
      • Fukumura Y.
      • Tobe S.
      • Gan K.
      • Obo H.
      • et al.
      Outcomes of valve replacement with mechanical prosthesis versus bioprosthesis in dialysis patients: a 16-year multicenter experience.
      conclude that bioprosthetic valve replacement in patients with ESRD may reduce thromboembolic events without increased rates of SVD, and we congratulate them for their work.
      One critique is the substantial heterogeneity of operations performed. Comparing bioprosthetic versus mechanical groups, rates for AVR (83.9% vs 47.9%; P < .001), mitral valve repair (14.2% vs 4.3%; P = .006), mitral valve replacement (10.6% vs 36.2%; P < .001), and double valve replacement (5.5% vs 16.0%; P = .004) were each different. Propensity scoring may might have helped to account for these differences, although sample size might then have proved limiting. Although the generous approach to subject inclusion of Ikeno and colleagues
      • Ikeno Y.
      • Mukohara N.
      • Fukumura Y.
      • Tobe S.
      • Gan K.
      • Obo H.
      • et al.
      Outcomes of valve replacement with mechanical prosthesis versus bioprosthesis in dialysis patients: a 16-year multicenter experience.
      increases statistical power for overall comparisons and possibly external validity to the greater dialysis-dependent population, it also imparts substantial bias, which they appropriately point out.
      Reduced thrombotic complications also contradict the findings of Nakatsu and colleagues,
      • Nakatsu T.
      • Minakata K.
      • Tanaka S.
      • Minatoya K.
      PROGRESS-Kyoto Investigators
      Intermediate-term outcomes of aortic valve replacement with bioprosthetic or mechanical valves in patients on hemodialysis.
      who recently examined 491 dialysis-dependent patients requiring mechanical versus bioprosthetic AVR across 18 Japanese centers and found no difference in thromboembolic events at 5-year follow-up. In contrast to Ikeno and colleagues
      • Ikeno Y.
      • Mukohara N.
      • Fukumura Y.
      • Tobe S.
      • Gan K.
      • Obo H.
      • et al.
      Outcomes of valve replacement with mechanical prosthesis versus bioprosthesis in dialysis patients: a 16-year multicenter experience.
      and colleagues, Nakatsu and colleagues
      • Nakatsu T.
      • Minakata K.
      • Tanaka S.
      • Minatoya K.
      PROGRESS-Kyoto Investigators
      Intermediate-term outcomes of aortic valve replacement with bioprosthetic or mechanical valves in patients on hemodialysis.
      focused on patients requiring AVR, and their larger sample size may have allowed them better to capture a representative sample of this specific subpopulation, without necessarily offering generalizability to patients requiring mitral valve replacement or double valve replacement.
      One caveat not addressed in either publication is the possibility for valve-in-valve (ViV) transcatheter aortic and/or mitral valve replacement for postoperative SVD. ViV therapy is an option in high-risk patients, and ESRD was present in approximately half of patients treated with ViV aortic
      • Dvir D.
      • Webb J.
      • Brecker S.
      • Bleiziffer S.
      • Hildick-Smith D.
      • Colombo A.
      • et al.
      Transcatheter aortic valve replacement for degenerative bioprosthetic surgical valves: results from the global valve-in-valve registry.
      and mitral
      • Cheung A.
      • Webb J.G.
      • Barbanti M.
      • Freeman M.
      • Binder R.K.
      • Thompson C.
      • et al.
      5-year experience with transcatheter transapical mitral valve-in-valve implantation for bioprosthetic valve dysfunction.
      valve replacement in studies affirming the safety and efficacy of these techniques. Thinking ahead, an added benefit of initial bioprosthetic valve replacement in patients with ESRD is that ViV options remain available should evidence of SVD arise. Conversely, mechanical valve dysfunction after replacement compels patients with ESRD to undergo a high-risk open reoperation.
      Ikeno and colleagues
      • Ikeno Y.
      • Mukohara N.
      • Fukumura Y.
      • Tobe S.
      • Gan K.
      • Obo H.
      • et al.
      Outcomes of valve replacement with mechanical prosthesis versus bioprosthesis in dialysis patients: a 16-year multicenter experience.
      add to the growing body of literature that bioprosthetic valve replacement in dialysis-dependent patients is safe,
      • Williams M.L.
      • Bavaria J.E.
      • Acker M.A.
      • Desai N.D.
      • Vallabhajosyula P.
      • Hargrove W.C.
      • et al.
      Valve selection in end-stage renal disease: should it always be biological?.
      • Ikeno Y.
      • Mukohara N.
      • Fukumura Y.
      • Tobe S.
      • Gan K.
      • Obo H.
      • et al.
      Outcomes of valve replacement with mechanical prosthesis versus bioprosthesis in dialysis patients: a 16-year multicenter experience.
      • Nakatsu T.
      • Minakata K.
      • Tanaka S.
      • Minatoya K.
      PROGRESS-Kyoto Investigators
      Intermediate-term outcomes of aortic valve replacement with bioprosthetic or mechanical valves in patients on hemodialysis.
      also suggesting reduced thromboembolic complications with this approach, and we commend them for their work. In patients with ESRD, when tissue is the issue, perhaps bioprosthetic valves should be favored at the time of initial replacement and this issue revisited for ViV treatment of postoperative bioprosthetic SVD. It appears that tissue should be the issue when dealing with patients with ESRD requiring valve replacements.

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