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Journal ArticleDOI

Acute Kidney Injury Following Aortic Valve Replacement in Patients Without Chronic Kidney Disease

01 Jan 2021-Canadian Journal of Cardiology (Elsevier)-Vol. 37, Iss: 1, pp 37-46

TL;DR: TAVR in patients without CKD was associated with a significantly less frequent incidence of AKI compared with SAVR, and increasing severity ofAKI was incrementally associated with 5-year mortality.
Abstract: Background The data on acute kidney injury (AKI) in patients without chronic kidney disease (CKD) after transcatheter aortic valve replacement (TAVR) are limited. The study sought to compare the incidence of AKI and its impact on 5-year mortality after TAVR and surgical aortic valve replacement (SAVR) in patients without CKD. Methods This registry included data from 6463 consecutive patients who underwent TAVR or SAVR. CKD was defined as estimated glomerular filtration rate Results The study included 4555 consecutive patients (TAVR, n = 1215 and SAVR, n = 3340) without CKD. Propensity-score matching identified 542 pairs. Patients who underwent TAVR had a significantly lower incidence of AKI in comparison to those who underwent SAVR (unmatched 4.7% vs 16.4%, P Conclusions TAVR in patients without CKD was associated with a significantly less frequent incidence of AKI compared with SAVR. AKI significantly increased the risk of 5-year mortality after either TAVR or SAVR, and increasing severity of AKI was incrementally associated with 5-year mortality.

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Acute kidney injury following aortic valve replacement in
patients without chronic kidney disease
Moriyama, Noriaki
2021-01
Moriyama , N , Laakso , T , Raivio , P , Dahlbacka , S , Kinnunen , E-M , Juvonen , T ,
Valtola , A , Husso , A , Jalava , M P , Ahvenvaara , T , Tauriainen , T , Piuhola , J , Lahtinen
, A , Niemelä , M , Mäkikallio , T , Virtanen , M , Maaranen , P , Eskola , M , Savontaus , M ,
Airaksinen , J , Biancari , F & Laine , M 2021 , ' Acute kidney injury following aortic valve
replacement in patients without chronic kidney disease ' , Canadian Journal of Cardiology ,
vol. 37 , no. 1 , pp. 37-46 . https://doi.org/10.1016/j.cjca.2020.03.015
http://hdl.handle.net/10138/328204
https://doi.org/10.1016/j.cjca.2020.03.015
cc_by_nc_nd
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This is an electronic reprint of the original article.
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Journal Pre-proof
Acute kidney injury following aortic valve replacement in patients without chronic
kidney disease
Noriaki Moriyama, MD, Teemu Laakso, MD, Peter Raivio, MD, PhD, Sebastian
Dahlbacka, MD, PhD, Eeva-Maija Kinnunen, MD, PhD, Tatu Juvonen, MD, PhD, Antti
Valtola, MD, Annastiina Husso, MD, PhD, Maina P. Jalava, MD, Tuomas Ahvenvaara,
MD, Tuomas Tauriainen, MD, PhD, Jarkko Piuhola, MD, PhD, Asta Lahtinen, MD,
Matti Niemelä, MD, PhD, Timo Mäkikallio, MD, PhD, Marko Virtanen, MD, Pasi
Maaranen, MD, Markku Eskola, MD, PhD, Mikko Savontaus, MD, PhD, Juhani
Airaksinen, MD, PhD, Fausto Biancari, MD, PhD, Mika Laine, MD, PhD
PII: S0828-282X(20)30270-1
DOI: https://doi.org/10.1016/j.cjca.2020.03.015
Reference: CJCA 3670
To appear in:
Canadian Journal of Cardiology
Received Date: 16 January 2020
Revised Date: 25 February 2020
Accepted Date: 14 March 2020
Please cite this article as: Moriyama N, Laakso T, Raivio P, Dahlbacka S, Kinnunen E-M, Juvonen
T, Valtola A, Husso A, Jalava MP, Ahvenvaara T, Tauriainen T, Piuhola J, Lahtinen A, Niemelä M,
Mäkikallio T, Virtanen M, Maaranen P, Eskola M, Savontaus M, Airaksinen J, Biancari F, Laine M, Acute
kidney injury following aortic valve replacement in patients without chronic kidney disease, Canadian
Journal of Cardiology (2020), doi: https://doi.org/10.1016/j.cjca.2020.03.015.
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© 2020 Published by Elsevier Inc. on behalf of the Canadian Cardiovascular Society.

1
Acute kidney injury following aortic valve replacement in patients without
chronic kidney disease
Noriaki Moriyama,
a
MD; Teemu Laakso,
a
MD; Peter Raivio,
a
MD, PhD; Sebastian Dahlbacka,
a
MD,
PhD; Eeva-Maija Kinnunen,
a
MD, PhD; Tatu Juvonen,
a
MD, PhD; Antti Valtola,
b
MD; Annastiina
Husso,
b
MD, PhD; Maina P. Jalava,
c
MD; Tuomas Ahvenvaara,
d
MD; Tuomas Tauriainen,
d
MD, PhD;
Jarkko Piuhola,
e
MD, PhD; Asta Lahtinen,
e
MD; Matti Niemelä,
e
MD, PhD; Timo Mäkikallio,
e
MD,
PhD; Marko Virtanen,
f
MD; Pasi Maaranen,
f
MD; Markku Eskola,
f
MD, PhD; Mikko Savontaus,
c
MD,
PhD; Juhani Airaksinen,
c
MD, PhD; Fausto Biancari,
c,d
MD, PhD; Mika Laine,
a
MD, PhD
a
Heart and Lung Center, Helsinki University Hospital, Helsinki;
b
Heart Center, Kuopio University
Hospital, Kuopio;
c
Heart Center, Turku University Hospital and University of Turku, Turku;
d
Department of Surgery, Oulu University Hospital and University of Oulu, Oulu;
e
Department of
Internal Medicine, Oulu University Hospital, Oulu;
f
Heart Hospital, Tampere University Hospital and
University of Tampere, Tampere, Finland.
Short title: AKI in patients without CKD following TAVR and SAVR
Word counts: 5497
Address for correspondence:
Mika Laine, MD, PhD, Adjunct Professor of Cardiology
Heart and Lung Center, Helsinki University and Helsinki University Central Hospital,
Haartmaninkatu 4, 00290, Helsinki, Finland.
Telephone: +358504279008, Fax: +358504270352, E-mail: Mika.Laine@hus.fi

2
Abstract
Backgrounds: The data on acute kidney injury (AKI) in patients without chronic kidney disease
(CKD) after transcatheter aortic valve replacement (TAVR) are limited. The study sought to compare
the incidence of AKI and its impact on 5-year mortality following TAVR and surgical aortic valve
replacement (SAVR) in patients without CKD.
Methods: This registry included data from 6463 consecutive patients who underwent TAVR or SAVR.
CKD was defined as estimated glomerular filtration rate (eGFR)<60 ml/min/1.73m
2
. AKI was defined
according to the Kidney Disease Improving Global Outcomes criteria. For sensitivity analysis,
propensity-score (PS) matching between TAVR and SAVR was performed.
Results: The study included 4555 consecutive patients (TAVR, n=1215 and SAVR, n=3340) without
CKD. PS matching identified 542 pairs. Patients who underwent TAVR had a significantly lower
incidence of AKI in comparison to those who underwent SAVR (unmatched 4.7% vs 16.4%, P<0.001,
multivariable analysis: OR 0.29, 95% CI 0.20-0.41; matched 5.9% vs 19.0%, P<0.001). Patients with
AKI had significantly increased 5-year mortality compared to those without AKI (unmatched 36.0%
vs 19.1%, log-rank P<0.001; matched 36.3% vs 24.0%, log-rank P<0.001). The adjusted hazard ratios
for 5-year mortality were 1.58 (95%CI 1.20-2.08) for AKI grade 1, 3.27 (95%CI 2.09-5.06) for grade 2
and 4.82 (95%CI 2.93-8.04) for grade 3.

3
Conclusions: TAVR in patients without CKD was associated with significantly less frequent
incidence of AKI compared with SAVR. AKI significantly increased the risk of 5-year mortality after
either TAVR or SAVR and increasing severity of AKI was incrementally associated with 5-year
mortality.
Clinical Trial Registration: ClinicalTrials.gov, Identifier: NCT03385915.
(URL https://clinicaltrials.gov/ct2/show/NCT03385915)

Citations
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Journal ArticleDOI
Michele Pighi1, Simone Fezzi1, Gabriele Pesarini1, Gabriele Venturi1  +6 moreInstitutions (1)
Abstract: Background In this study we sought to determine the differences in incidence of acute kidney injury (AKI) and acute kidney recovery (AKR) among patients undergoing transcatheter aortic valve implantation (TAVI), according to the degree of extravalvular cardiac damage (EVCD). Methods From the Verona Valvular Heart Disease Registry, 674 symptomatic severe aortic stenosis (AS) patients were selected and retrospectively analysed. Using echocardiographic data, patients were classified based on the degree of EVCD. Results After dichotomized analysis, patients in EVCD stage 3 or 4 reported a significantly higher rate of AKI (29.5% vs 11.2%; P Conclusions Increase in EVCD stage was associated with a higher rate of AKI after TAVI. AKI had a negative impact on long-term clinical outcomes but only in patients with advanced cardiac damage. AKR did not reduce adverse clinical outcomes but was associated with improved renal function at 12 months.

3 citations



References
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Journal ArticleDOI
TL;DR: In patients with severe aortic stenosis who were not suitable candidates for surgery, TAVI, as compared with standard therapy, significantly reduced the rates of death from any cause, the composite end point of deathFrom any cause or repeat hospitalization, and cardiac symptoms, despite the higher incidence of major strokes and major vascular events.
Abstract: Background Many patients with severe aortic stenosis and coexisting conditions are not candi dates for surgical replacement of the aortic valve. Recently, transcatheter aortic-valve implantation (TAVI) has been suggested as a less invasive treatment for high-risk patients with aortic stenosis. Methods We randomly assigned patients with severe aortic stenosis, whom surgeons considered not to be suitable candidates for surgery, to standard therapy (including balloon aortic valvuloplasty) or transfemoral transcatheter implantation of a balloon-expandable bovine pericardial valve. The primary end point was the rate of death from any cause. Results A total of 358 patients with aortic stenosis who were not considered to be suitable candidates for surgery underwent randomization at 21 centers (17 in the United States). At 1 year, the rate of death from any cause (Kaplan–Meier analysis) was 30.7% with TAVI, as compared with 50.7% with standard therapy (hazard ratio with TAVI, 0.55; 95% confidence interval [CI], 0.40 to 0.74; P<0.001). The rate of the composite end point of death from any cause or repeat hospitalization was 42.5% with TAVI as com pared with 71.6% with standard therapy (hazard ratio, 0.46; 95% CI, 0.35 to 0.59; P<0.001). Among survivors at 1 year, the rate of cardiac symptoms (New York Heart Association class III or IV) was lower among patients who had undergone TAVI than among those who had received standard therapy (25.2% vs. 58.0%, P<0.001). At 30 days, TAVI, as compared with standard therapy, was associated with a higher incidence of major strokes (5.0% vs. 1.1%, P = 0.06) and major vascular complications (16.2% vs. 1.1%, P<0.001). In the year after TAVI, there was no deterioration in the functioning of the bioprosthetic valve, as assessed by evidence of stenosis or regurgitation on an echocardiogram. Conclusions In patients with severe aortic stenosis who were not suitable candidates for surgery, TAVI, as compared with standard therapy, significantly reduced the rates of death from any cause, the composite end point of death from any cause or repeat hospitalization, and cardiac symptoms, despite the higher incidence of major strokes and major vascular events. (Funded by Edwards Lifesciences; ClinicalTrials.gov number, NCT00530894.)

5,625 citations


Journal ArticleDOI
Andrew S. Levey1, Josef Coresh2, Tom Greene3, Lesley A. Stevens1  +4 moreInstitutions (4)
TL;DR: The MDRD Study equation has now been reexpressed for use with a standardized serum creatinine assay, allowing GFR estimates to be reported in clinical practice by using standardized serumcreatinine and overcoming this limitation to the current use of GFR estimating equations.
Abstract: Using standardized creatinine assays, the authors remeasured serum creatinine levels in 1628 patients whose glomerular filtration rate (GFR) had been measured by urinary clearance of 125I-isothalam...

4,644 citations


Journal ArticleDOI
TL;DR: This VARC-2 document has provided further standardization of endpoint definitions for studies evaluating the use of TAVI, which will lead to improved comparability and interpretability of the study results, supplying an increasingly growing body of evidence with respect to TAVi and/or surgical aortic valve replacement.
Abstract: Objectives The aim of the current Valve Academic Research Consortium (VARC)-2 initiative was to revisit the selection and definitions of transcatheter aortic valve implantation (TAVI) clinical endpoints to make them more suitable to the present and future needs of clinical trials. In addition, this document is intended to expand the understanding of patient risk stratification and case selection. Background A recent study confirmed that VARC definitions have already been incorporated into clinical and research practice and represent a new standard for consistency in reporting clinical outcomes of patients with symptomatic severe aortic stenosis (AS) undergoing TAVI. However, as the clinical experience with this technology has matured and expanded, certain definitions have become unsuitable or ambiguous. Methods and Results Two in-person meetings (held in September 2011 in Washington, DC, and in February 2012 in Rotterdam, The Netherlands) involving VARC study group members, independent experts (including surgeons, interventional and noninterventional cardiologists, imaging specialists, neurologists, geriatric specialists, and clinical trialists), the US Food and Drug Administration (FDA), and industry representatives, provided much of the substantive discussion from which this VARC-2 consensus manuscript was derived. This document provides an overview of risk assessment and patient stratification that need to be considered for accurate patient inclusion in studies. Working groups were assigned to define the following clinical endpoints: mortality, stroke, myocardial infarction, bleeding complications, acute kidney injury, vascular complications, conduction disturbances and arrhythmias, and a miscellaneous category including relevant complications not previously categorized. Furthermore, comprehensive echocardiographic recommendations are provided for the evaluation of prosthetic valve (dys)function. Definitions for the quality of life assessments are also reported. These endpoints formed the basis for several recommended composite endpoints. Conclusions This VARC-2 document has provided further standardization of endpoint definitions for studies evaluating the use of TAVI, which will lead to improved comparability and interpretability of the study results, supplying an increasingly growing body of evidence with respect to TAVI and/or surgical aortic valve replacement. This initiative and document can furthermore be used as a model during current endeavors of applying definitions to other transcatheter valve therapies (for example, mitral valve repair).

3,174 citations


Journal ArticleDOI
Martin B. Leon1, Craig R. Smith1, Michael J. Mack2, Michael J. Mack1  +30 moreInstitutions (15)
TL;DR: In intermediate-risk patients, TAVR was similar to surgical aortic-valve replacement with respect to the primary end point of death or disabling stroke; surgery resulted in fewer major vascular complications and less paravalvular aorta regurgitation.
Abstract: BackgroundPrevious trials have shown that among high-risk patients with aortic stenosis, survival rates are similar with transcatheter aortic-valve replacement (TAVR) and surgical aortic-valve replacement. We evaluated the two procedures in a randomized trial involving intermediate-risk patients. MethodsWe randomly assigned 2032 intermediate-risk patients with severe aortic stenosis, at 57 centers, to undergo either TAVR or surgical replacement. The primary end point was death from any cause or disabling stroke at 2 years. The primary hypothesis was that TAVR would not be inferior to surgical replacement. Before randomization, patients were entered into one of two cohorts on the basis of clinical and imaging findings; 76.3% of the patients were included in the transfemoral-access cohort and 23.7% in the transthoracic-access cohort. ResultsThe rate of death from any cause or disabling stroke was similar in the TAVR group and the surgery group (P=0.001 for noninferiority). At 2 years, the Kaplan–Meier event...

2,975 citations


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Michael J. Mack1, Martin B. Leon2, Vinod H. Thourani3, Raj Makkar  +21 moreInstitutions (14)
TL;DR: Among patients with severe aortic stenosis who were at low surgical risk, the rate of the composite of death, stroke, or rehospitalization at 1 year was significantly lower with TAVR than with surgery.
Abstract: Background Among patients with aortic stenosis who are at intermediate or high risk for death with surgery, major outcomes are similar with transcatheter aortic-valve replacement (TAVR) an...

1,852 citations


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