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Commentary: Our patients deserve our patience

      Figure thumbnail fx1
      Left to right: William C. Frankel, MD, Michael Z. Tong, MD, MBA, and Aaron J. Weiss, MD
      In this single-center retrospective study, long-term outcomes after surgical aortic valve replacement were excellent and remained stable over time in the face of increasing case complexity.
      See Article page 1742.
      In this single-center retrospective study from the Netherlands, Çelik and colleagues
      • Çelik M.
      • Durko A.P.
      • Bekkers J.A.
      • Oei F.B.S.
      • Mahtab E.A.F.
      • Bogers A.J.J.C.
      Outcomes of surgical aortic valve replacement over three decades.
      report the outcomes over 3 decades of 4404 patients who underwent surgical aortic valve replacement (SAVR). The mean survival for the overall cohort was 13.8 years, and survival relative to an age-, sex-, and year-matched population was 85.8% and 60.4% for the overall cohort and 92.4% and 73.8% for the isolated SAVR cohort at 10 and 20 years, respectively. The authors argue that the latter 2 rates in particular should serve as benchmarks for future long-term transcatheter aortic valve replacement (TAVR) studies. Furthermore, despite increasing rates of comorbidities and concomitant procedures, operative mortality decreased from 2.7% (first decade) to 1.8% (final decade), and long-term survival remained stable. The authors should be commended for their results and requisite commitment to continuous improvement across all phases of cardiovascular care in the face of increasing patient and case complexity.
      Although these results may not dramatically affect the current paradigm for aortic valve replacement, they are a welcome addition to the existing literature further demonstrating the excellent durability and long-term survival of contemporary SAVR.
      • Jamieson W.R.E.
      • Burr L.H.
      • Miyagishima R.T.
      • Germann E.
      • Macnab J.S.
      • Stanford E.
      • et al.
      Carpentier-Edwards supra-annular aortic porcine bioprosthesis: clinical performance over 20 years.
      • David T.E.
      • Armstrong S.
      • Maganti M.
      Hancock II bioprosthesis for aortic valve replacement: the gold standard of bioprosthetic valves durability?.
      • Forcillo J.
      • Pellerin M.
      • Perrault L.P.
      • Cartier R.
      • Bouchard D.
      • Demers P.
      • et al.
      Carpentier-Edwards pericardial valve in the aortic position: 25-years experience.
      • Johnston D.R.
      • Soltesz E.G.
      • Vakil N.
      • Rajeswaran J.
      • Roselli E.E.
      • Sabik III, J.F.
      • et al.
      Long-term durability of bioprosthetic aortic valves: implications from 12,569 implants.
      • Holmgren A.
      • Enger T.B.
      • Näslund U.
      • Videm V.
      • Valle S.
      • Evjemo K.J.D.
      • et al.
      Long-term results after aortic valve replacement for bicuspid or tricuspid valve morphology in a Swedish population.
      This is in stark contrast to a paucity of rigorous data regarding intermediate- and long-term outcomes for TAVR. Nevertheless, over the last decade, TAVR has incrementally secured approval from the Food and Drug Administration for patients with severe aortic stenosis from extreme to low surgical risk. Moreover, the most recent American College of Cardiology/American Heart Association guidelines endorse both TAVR and SAVR as reasonable options for low- and intermediate-risk patients between 65 and 80 years old.
      • Otto C.M.
      • Nishimura R.A.
      • Bonow R.O.
      • Carabello B.A.
      • Erwin III, J.P.
      • Gentile F.
      • et al.
      2020 ACC/AHA guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Joint Committee on clinical practice guidelines.
      There are several important limitations to the American College of Cardiology/American Heart Association guidelines and implied equipoise between TAVR and SAVR. First, the age range included in this recommendation is not supported by any evidence and extends almost 10 years below the mean patient age in the landmark low-risk TAVR trials. The aforementioned trials were also constructed based on surgical risk rather than age or life expectancy, rendering further expansion of TAVR to younger patients based on a false equivalency. Second, no randomized clinical trial to date has reported the outcomes of low- or intermediate-risk patients after TAVR beyond 5 years, and it remains unclear the extent to which complications such as a permanent pacemaker or paravalvular leak may adversely impact long-term outcomes. In fact, initial studies comparing outcomes in TAVR versus SAVR for low-risk patients—including a patient-level meta-analysis from the same author—have even signaled an increased risk of mortality associated with TAVR beyond 2 years.
      • Çelik M.
      • Milojevic M.M.
      • Durko A.P.
      • Oei F.B.S.
      • Bogers A.J.J.C.
      • Mahtab E.A.F.
      Mortality in low-risk patients with aortic stenosis undergoing transcatheter or surgical aortic valve replacement: a reconstructed individual patient data meta-analysis.
      In addition, younger patients with a reasonable life expectancy may require subsequent aortic valve interventions during their lifetime. An initial strategy of TAVR may increase the likelihood of future SAVR, particularly in patients with small annular diameters. Albeit in a greater-risk population, initial studies have reported an early mortality of ∼20% following TAVR explantation,
      • Fukuhara S.
      • Brescia A.A.
      • Deeb G.M.
      Surgical explantation of transcatheter aortic bioprostheses: an analysis from the Society of Thoracic Surgeons Database.
      far exceeding the risk of reoperative SAVR.
      • Naji P.
      • Griffin B.P.
      • Sabik J.F.
      • Kusunose K.
      • Asfahan F.
      • Popovic Z.B.
      • et al.
      Characteristics and outcomes of patients with severe bioprosthetic aortic valve stenosis undergoing redo surgical aortic valve replacement.
      In summary, this manuscript is an important reminder to continue to be patient and measured while awaiting more rigorous long-term comparative data before further expansion of TAVR, especially to low-risk patients with a greater projected life expectancy.

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