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Trans-catheter valve implantation and patient outcomes: Focus on the kidney

Published:August 24, 2020DOI:https://doi.org/10.1016/j.ejim.2020.08.020

      Keywords

      In 2012 the Kidney Disease Improving Global Outcomes organization published a guideline focused on the definition and management of acute kidney injury (AKI) [
      • Ostermann M.
      • Bellomo R.
      • Burdmann E.A.
      • Doi K.
      • Endre Z.H.
      • Goldstein S.L.
      • Kane-Gill S.L.
      • Liu K.D.
      • Prowle J.R.
      • Shaw A.D.
      • Srisawat N.
      • Cheung M.
      • Jadoul M.
      • Winkelmayer W.C.
      • Kellum J.A.
      Conference Participants
      Controversies in acute kidney injury: conclusions from a Kidney Disease: improving Global Outcomes (KDIGO) Conference.
      ] which became an important reference for a correct approach to renal dysfunction in the context of critical care, as well as in case of interventional or surgical interventions. Kidney dysfunction has a major impact on cardiovascular outcomes [
      • Boriani G.
      • Savelieva I.
      • Dan G.A.
      • Deharo J.C.
      • Ferro C.
      • Israel C.W.
      • Lane D.A.
      • La Manna G.
      • Morton J.
      • Mitjans A.M.
      • Vos M.A.
      • Turakhia M.P.
      • Lip G.Y.
      Document reviewers
      Chronic kidney disease in patients with cardiac rhythm disturbances or implantable electrical devices: clinical significance and implications for decision making-a position paper of the European Heart Rhythm Association endorsed by the Heart Rhythm Society and the Asia Pacific Heart Rhythm Society.
      ] and a correct approach is needed, taking into account the current definitions of the specific forms of altered renal function, as shown in the Table 1.
      Table 1Definitions of the different forms of altered renal function. Modified from1.
      Acronym and definitionFunctional criteria for the diagnosis
      AKI= acute kidney injuryIncrease in SCr by ≥ 50% within 7 days, OR
      Increase in SCr by ≥ 0.3 mg/dL (≥26.5μmol/l) within 48 h, OR
      Oliguria (urine volume < 0.5 ml/kg/hour for 6 h, OR < 0.3 ml/kg/hour for 24 h)
      CKD= chronic kidney diseaseGFR< 60 ml/min per 1.73m2 for > 3 months
      AKD= acute kidney disease and disordersAKI, OR
      GFR < 60 ml/min per 1.73m2 for < 3 months, OR
      Decrease in GFR by ≥ 35% or increase in SCr by > 50% for < 3 months
      NKD= no kidney diseaseGFR ≥ 60 ml/min per 1.73 m2
      Stable SCr without AKI/AKD/CKD
      Legend: GFR= glomerular filtration rate; SCr= serum creatinine.
      In the last years, cardiologists became aware of the need for an accurate estimate of renal function alterations, both in chronic [
      • Malavasi V.L.
      • Pettorelli D.
      • Fantecchi E.
      • Zoccali C.
      • Laronga G.
      • Trenti T.
      • Lip G.Y.H.
      • Boriani G
      Variations in clinical management of non-vitamin K antagonist oral anticoagulants in patients with atrial fibrillation according to different equations for estimating renal function: post hoc analysis of a prospective cohort.
      ] and acute settings [
      • Ostermann M.
      • Bellomo R.
      • Burdmann E.A.
      • Doi K.
      • Endre Z.H.
      • Goldstein S.L.
      • Kane-Gill S.L.
      • Liu K.D.
      • Prowle J.R.
      • Shaw A.D.
      • Srisawat N.
      • Cheung M.
      • Jadoul M.
      • Winkelmayer W.C.
      • Kellum J.A.
      Conference Participants
      Controversies in acute kidney injury: conclusions from a Kidney Disease: improving Global Outcomes (KDIGO) Conference.
      ] and a strict collaboration with nephrologists became more and more necessary in daily practice. In the context of transcatheter aortic valve implantation (TAVI), a therapeutic technique of increasing value and implementation in daily practice for appropriately selected patients [
      • Indolfi C.
      • Bartorelli A.L.
      • Berti S.
      • Golino P.
      • Esposito G.
      • Musumeci G.
      • Petronio S.
      • Tamburino C.
      • Tarantini G.
      • Ussia G.
      • Vassanelli C.
      • Spaccarotella C.
      • Violini R.
      • Mercuro G.
      • Romeo F
      Updated clinical indications for transcatheter aortic valve implantation in patients with severe aortic stenosis: expert opinion of the Italian Society of Cardiology and GISE.
      ,
      • Nai Fovino L.
      • Badawy M.R.A.
      • Fraccaro C.
      • D'Onofrio A.
      • Purita P.A.M.
      • Frigo A.C.
      • Tellaroli P.
      • Mauro A.
      • Tusa M.
      • Napodano M.
      • Gerosa G.
      • Iliceto S.
      • Bedogni F.
      • AbdelRheim A.E.R.
      • Tarantini G
      Transfemoral aortic valve implantation with new- generation devices: the repositionable Lotus vs. the balloon-expandable Edwards Sapien 3 valve.
      ,
      • Takagi H.
      • Hari Y.
      • Kawai N.
      • Kuno T.
      • Ando T.
      ALICE (All-Literature Investigation of Cardiovascular Evidence) Group
      A meta-analysis of impact of low-flow/low-gradient aortic stenosis on survival after transcatheter aortic valve implantation.
      ], AKI has become object of investigation, with evidence that it is associated with increased postoperative mortality and morbidity [
      • Sgura F.A.
      • Arrotti S.
      • Magnavacchi P.
      • Monopoli D.
      • Gabbieri D.
      • Banchelli F.
      • Tondi S.
      • Denegri A.
      • D'Amico R.
      • Guiducci V.
      • Vignali L.
      • Boriani G
      Kidney dysfunction and short term all-cause mortality after transcatheter aortic valve implantation.
      ,
      • Ma M.
      • Gao W.D.
      • Gu Y.F.
      • Wang Y.S.
      • Zhu Y.
      • He Y
      Clinical effects of acute kidney injury after transcatheter aortic valve implantation: a systematic review and meta-analysis.
      ,
      • Adamo M.
      • Provini M.
      • Fiorina C.
      • Giannini C.
      • Angelillis M.
      • Testa L.
      • Barbanti M.
      • Merlanti B.
      • Poli A.
      • Ferrara E.
      • Latib A.
      • Reimers B.
      • Maffeo D.
      • Bruschi G.
      • Montorfano M.
      • Petronio A.S.
      • Bedogni F.
      • Tamburino C.
      • Metra M.
      • Curello S
      Interaction between severe chronic kidney disease and acute kidney injury in predicting mortality after transcatheter aortic valve implantation: insights from the Italian Clinical Service Project.
      ].
      We deeply thank Dr. Adamo et al. for the interest in our study [
      • Sgura F.A.
      • Arrotti S.
      • Magnavacchi P.
      • Monopoli D.
      • Gabbieri D.
      • Banchelli F.
      • Tondi S.
      • Denegri A.
      • D'Amico R.
      • Guiducci V.
      • Vignali L.
      • Boriani G
      Kidney dysfunction and short term all-cause mortality after transcatheter aortic valve implantation.
      ], and for highlighting in their letter [
      • Adamo M.
      • Curello S.
      • Metra M
      Renal failure after trans-catheter aortic valve implantation.
      ] important points that integrate our findings, on the basis of their long-term observations on patients treated with TAVI [
      • Adamo M.
      • Provini M.
      • Fiorina C.
      • Giannini C.
      • Angelillis M.
      • Testa L.
      • Barbanti M.
      • Merlanti B.
      • Poli A.
      • Ferrara E.
      • Latib A.
      • Reimers B.
      • Maffeo D.
      • Bruschi G.
      • Montorfano M.
      • Petronio A.S.
      • Bedogni F.
      • Tamburino C.
      • Metra M.
      • Curello S
      Interaction between severe chronic kidney disease and acute kidney injury in predicting mortality after transcatheter aortic valve implantation: insights from the Italian Clinical Service Project.
      ]. We fully agree on the indication to weight the impact of AKI and chronic kidney disease (CKD) not only at 30-day follow-up, but also during long-term follow-up, in combination with other indices of potential value for outcome prediction [
      • Adamo M.
      • Provini M.
      • Fiorina C.
      • Giannini C.
      • Angelillis M.
      • Testa L.
      • Barbanti M.
      • Merlanti B.
      • Poli A.
      • Ferrara E.
      • Latib A.
      • Reimers B.
      • Maffeo D.
      • Bruschi G.
      • Montorfano M.
      • Petronio A.S.
      • Bedogni F.
      • Tamburino C.
      • Metra M.
      • Curello S
      Interaction between severe chronic kidney disease and acute kidney injury in predicting mortality after transcatheter aortic valve implantation: insights from the Italian Clinical Service Project.
      ,
      • Adamo M.
      • Curello S.
      • Metra M
      Renal failure after trans-catheter aortic valve implantation.
      ,
      • Tarro Genta F.
      • Tidu M.
      • Corbo P.
      • Bertolin F.
      • Salvetti I.
      • Bouslenko Z.
      • Giordano A.
      • Dalla Vecchia L
      Predictors of survival in patients undergoing cardiac rehabilitation after transcatheter aortic valve implantation.
      ]. This may allow to better define the determinants of outcome after TAVI, considering the full spectrum of co-morbidities and with the potential to provide hints for an improved patient targeting. Moreover, the improvement in renal function that Adamo et al. found in patients treated with TAVI not developing AKI [
      • Adamo M.
      • Provini M.
      • Fiorina C.
      • Giannini C.
      • Angelillis M.
      • Testa L.
      • Barbanti M.
      • Merlanti B.
      • Poli A.
      • Ferrara E.
      • Latib A.
      • Reimers B.
      • Maffeo D.
      • Bruschi G.
      • Montorfano M.
      • Petronio A.S.
      • Bedogni F.
      • Tamburino C.
      • Metra M.
      • Curello S
      Interaction between severe chronic kidney disease and acute kidney injury in predicting mortality after transcatheter aortic valve implantation: insights from the Italian Clinical Service Project.
      ,
      • Adamo M.
      • Curello S.
      • Metra M
      Renal failure after trans-catheter aortic valve implantation.
      ], becomes of major clinical significance and is another proof of the strict bi-directional relationships linking the kidney and the heart [
      • Boriani G.
      • Savelieva I.
      • Dan G.A.
      • Deharo J.C.
      • Ferro C.
      • Israel C.W.
      • Lane D.A.
      • La Manna G.
      • Morton J.
      • Mitjans A.M.
      • Vos M.A.
      • Turakhia M.P.
      • Lip G.Y.
      Document reviewers
      Chronic kidney disease in patients with cardiac rhythm disturbances or implantable electrical devices: clinical significance and implications for decision making-a position paper of the European Heart Rhythm Association endorsed by the Heart Rhythm Society and the Asia Pacific Heart Rhythm Society.
      ].
      We fully agree that in daily practice, a careful assessment of the severity of CKD before the TAVI procedure, of the type of sedation/anesthesia, of the type of interventional approach (trans-femoral, trans-apical or trans-axillary) and of the amount of contrast medium during the procedure may improve prediction of the occurrence of post-procedural AKI in patients treated with TAVI [
      • Sgura F.A.
      • Arrotti S.
      • Magnavacchi P.
      • Monopoli D.
      • Gabbieri D.
      • Banchelli F.
      • Tondi S.
      • Denegri A.
      • D'Amico R.
      • Guiducci V.
      • Vignali L.
      • Boriani G
      Kidney dysfunction and short term all-cause mortality after transcatheter aortic valve implantation.
      ,
      • Adamo M.
      • Provini M.
      • Fiorina C.
      • Giannini C.
      • Angelillis M.
      • Testa L.
      • Barbanti M.
      • Merlanti B.
      • Poli A.
      • Ferrara E.
      • Latib A.
      • Reimers B.
      • Maffeo D.
      • Bruschi G.
      • Montorfano M.
      • Petronio A.S.
      • Bedogni F.
      • Tamburino C.
      • Metra M.
      • Curello S
      Interaction between severe chronic kidney disease and acute kidney injury in predicting mortality after transcatheter aortic valve implantation: insights from the Italian Clinical Service Project.
      ]. In view of the impact of AKI on the length of hospitalization, on morbidity and short-term outcome, as well as on long-term outcomes, it is of great importance to assess what can be the ways to minimize, or even prevent, post-procedural AKI in patients treated with TAVI. Unfortunately, the results of a single-center, prospective, randomized, double-blind sham-controlled clinical trial (REDUCE-AKI) that evaluated whether forced diuresis with matched intravenous hydration could reduce AKI in patients undergoing TAVI were not positive, since AKI was not significantly reduced, and a significant increase in long-term mortality for the active intervention group was found [
      • Arbel Y.
      • Ben-Assa E.
      • Puzhevsky D.
      • Litmanowicz B.
      • Galli N.
      • Chorin E.
      • Halkin A.
      • Sadeh B.
      • Konigstein M.
      • Bassat O.K.
      • Steinvil A.
      • Bazan S.
      • Banai S.
      • Finkelstein A
      Forced diuresis with matched hydration during transcatheter aortic valve implantation for Reducing Acute Kidney Injury: a randomized, sham-controlled study (REDUCE-AKI).
      ]. These findings even more highlight the complexity that characterizes the clinical management of TAVI patients and the need for further prospective evaluations, with specific focus on kidney function.

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