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Meta-Analysis Comparing Renal Outcomes after Transcatheter versus Surgical Aortic Valve Replacement

Meta-Analysis Comparing Renal Outcomes after Transcatheter versus Surgical Aortic Valve Replacement Hindawi Journal of Interventional Cardiology Volume 2019, Article ID 3537256, 9 pages https://doi.org/10.1155/2019/3537256 Research Article Meta-Analysis Comparing Renal Outcomes after Transcatheter versus Surgical Aortic Valve Replacement 1 2 2 1 1 Kuldeep Shah , Zakeih Chaker, Tatiana Busu, Rishita Shah , Mohammed Osman , 1 1 Fahad Alqahtani, and Mohamad Alkhouli Division of Cardiology, West Virginia School of Medicine, Morgantown, WV, USA Department of Medicine, West Virginia School of Medicine, Morgantown, WV, USA Correspondence should be addressed to Mohamad Alkhouli; mohamad.alkhouli@wvumedicine.org Received 19 November 2018; Accepted 7 April 2019; Published 24 April 2019 Academic Editor: Vasileios Panoulas Copyright © 2019 Kuldeep Shah et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Background. Acute kidney injury (AKI) is a common complication of aortic valve replacement. However, comparative on the incidence of (AKI) following transcatheter (TAVR) versus surgical valve replacement (SAVR) is sparse. Methods. We performed a meta-analysis of the randomized controlled trials (RCT) and propensity-matched observational studies comparing (A) incidence of AKI and (B) incidence of dialysis-requiring AKI at 30 days aer ft TAVR and SAVR. Results. Twenty-six studies (20 propensity- matched studies; 6 RCTs) including 19,954 patients were analyzed. eTh incidence of AKI was lower aeft r TAVR than aeft r SAVR (7.1% vs. 12.1%, OR 0.52; 95%CI, 0.39-0.68; p<0.001, I =57%), but the incidence of dialysis-requiring AKI was similar (2.8% vs. 4.1%, OR 0.78; 95%CI, 0.49-1.25; p=0.31, I =70%). Similar results were observed in a sensitivity analysis including RCTs only for both AKI ([5 RCTs; 5,418 patients], 2.0% vs. 5.0%, OR 0.39; 95%CI, 0.28-0.53; p<0.001, I =0%), and dialysis-requiring AKI ([2 RCTs; 769 patients]; 2.9% vs. 2.6%, OR 1.1; 95%CI, 0.47-2.58; p=0.83, I =0%). However, in studies including low-intermediate risk patients only, TAVR was associated with lower incidence of AKI ([10 studies; 6,510 patients], 7.6% vs. 12.4%, OR 0.55, 95%CI 0.39-0.77, p<0.001, 2 2 I =57%), and dialysis-requiring AKI, ([10 studies; 12,034 patients], 2.0% vs. 3.6%, OR 0.57, 95%CI 0.38-0.85, p=0.005, I =23%). Conclusions. TAVR is associated with better renal outcomes at 30 days in comparison with SAVR, especially in patients at low- intermediate surgical risk. Further studies are needed to assess the impact of AKI on long-term outcomes of patients undergoing TAVR and SAVR. 1. Introduction 2. Methods eTh introduction of transcatheter aortic valve replacement Our review protocol was conducted in accordance with (TAVR) and the continuous improvement in the outcomes PRISMA (Preferred Reporting Items for Systematic Reviews of surgical aortic valve replacement (SAVR) have revolu- and Meta-Analyses) reporting guidelines (Supplementary tionized the treatment of patients with severe aortic stenosis Protocol). [4] eTh literature search was conducted in in the last decade [1, 2]. However, acute kidney injury PUBMED, MEDLINE, EMBASE, EBSCO, and Cochrane (AKI) remains a common complication of both treatment (March 2, 2018) in order to identify eligible studies using modalities. Nonetheless, data on the incidence of AKI and the Medical Subject Headings search terms and text word dialysis-requiring AKI aer ft TAVR vs. SAVR remain limited search. We also did a manual search of the reference lists [3]. We performed a meta-analysis of the randomized clinical of relevant studies for additional publications and when trials (RCTs) and propensity-matched (PSM) observational multiple publications from the same study population were studies to compare renal outcomes following TAVR vs. SAVR found, data from the most inclusive report was used. eTh (a) overall and (b) in subgroups of high-risk and low- data was reviewed independently from full-text articles intermediate risk patients. by 2 of the authors (T.B. and K.S.). Disagreements were 2 Journal of Interventional Cardiology Table 1 TAVR SAVR Baseline Characteristics p-value (N=10,038) (N=9,916) Age (years) 0.528 79.1± 5.8 78.06± 5.9 Male 0.798 49.17% 50.16% Coronary artery disease 0.606 57.7% 52.99% Chronic kidney disease (GFR<60 mL/min) 0.943 25.9% 25.3% Diabetes mellitus 0.768 30.0% 31.2% Atrial bfi rillation 0.991 28.6% 28.6% Chronic obstructive pulmonary disease 0.927 23.0% 22.7% Frailty 0.957 28.4% 27.5% Left ventricular ejection fraction 0.701 56.41± 6.6 55.3± 9.0 Pulmonary hypertension 0.729 21.1% 18.7% Peripheral vascular disease 0.630 24.4% 22.6% Prior stroke or transient ischemic attack 0.838 16.5% 15.8% NYHA III or IV 0.515 71.4% 67.73% Prior coronary artery bypass graft 0.445 40.9% 31.8% STS score 0.590 6.6± 2.9 6.1± 2.3 Euro SCORE 0.357 17.1± 8.3 15.0± 6.3 resolved through consensus and arbitration by the senior publication bias we prepared funnel plots and Egger’s linear author (M.A.). eTh following criteria were applied for study regression test of funnel plot asymmetry (eFigures 1 and 2). inclusion: (1) randomised controlled trials and propensity- All pooled estimates are displayed with a 95% confidence matched observational studies comparing TAVR and SAVR; interval (CI). P values were considered statistically significant (2) being published in peer-reviewed journals; (3) follow- at less than 0.05. We also performed sensitivity analysis up of at least 30 days; and (4) reporting AKI or acute renal to investigate potential sources of inconsistency, including failure and/or new requirement for renal replacement therapy removal of nonrandomized studies. Forest plots were gen- (dialysis-requiring AKI) as a clinical endpoint based on the erated to show therelativeeeff ct size ofTAVR andSAVR valve replacement approach. Exclusion criteria we applied are for each clinical outcome. Potential sources of heterogeneity (1) observational studies reporting nonpropensity-matched were investigated using meta-regression techniques; factors populations and (2) nonpublished studies (abstracts). The analyzed in the metaregression included age, sex, diabetes, following study characteristics were extracted: year of pub- prior stroke, chronic renal insufficiency, vascular disease, and lication, study design, number of patients, clinical character- atrial bfi rillation (eFigure 3). We followed standard protocol istics, confounding factors, comparability between groups at for performing meta-analysis as in our previous publication. baseline, outcomes, and study follow-up. The main outcomes eTh endpoint of interest in this study is renal outcomes which of interest between the two interventions in this study were not described in our previous papers making this study included (1) incidence of AKI at 30 days and (2) incidence unique. [5, 6] of AKI requiring dialysis at 30 days. 4. Results 3. Data Synthesis and Analysis A total of 5,067 potentially relevant citations were identified eTh data supporting this meta-analysis are from previ- and screened (Figure 1). Aeft r removal of duplicated studies, ously reported studies and datasets, which have been cited. we retrieved 76 full-text articles for evaluation, of which 26 eTh processed data are reported in the article and in satisfied the selection criteria. A total of 20 PSM observational the supplementary files. We performed our meta-analyses studies and 6 RCTs were included in the meta-analysis using Comprehensive Meta-Analysis version 3.0 (Biostat, (Figure 1). All eligible studies were in the English Language. https://www.meta-analysis.com). We used the random effects The baseline characteristics of the patients in the included model with the Mantel-Haenszel (MH) method for each studies are summarized in Table 1. eTh 26 studies enrolled clinical endpoint and pooled estimates of odds ratio (OR) a total of 19,954 patients; 10,038 (50.3%) in the TAVR group with 95% confidence interval (CI) were calculated. We used I and 9,916 (49.7%) in the SAVR group. Sample sizes ranged index, tau squared, and the Q-test P value to examine hetero- from 28 to 4732 patients. Mean age was 79.1±5.8 and 78.1±5.9 geneity among individual study effect sizes. To reduce the risk years in the TAVR and SAVR groups, respectively (p=0.53). of bias, we undertook independent pooling of data from RCTs There was no significant difference in the prevalence of and PSM observational studies. In order to formally assess key morbidities between the two groups including chronic Journal of Interventional Cardiology 3 Excluded articles: 4991 1. Duplicates Total number of articles 2. Not relevant identified/screened: 5067 3. Non-propensity matched 4. Non-published 5. Diagnostic studies 6. Review articles 7. Pediatric populations Articles assessed for eligibility: 76 Studies included in analysis: 26 Propensity-score matched Randomized controlled observational studies: 20 trials: 6 TAVR: SAVR: SAVR: TAVR: 7246 7220 2792 2696 Figure 1: Flow chart of the meta-analysis. TAVR: transcatheter aortic valve replacement, SAVR: surgical aortic valve replacement. renal insufficiency (25.9% in the TAVR group vs. 25.3% 4.3. Meta-Analysis Stratiefi d by Surgical Risk. Asecondary in the SAVR group, p=0.94) (Table 1). Detailed baseline analysis was performed to compare the pooled incidence of characteristics of individual studies included in our meta- AKI and dialysis-requiring AKI among patients who are at analysis are illustrated in eTable 1. [7–32] high surgical risk and those at low-intermediate surgical risk. (A) Renal outcomes in high-surgical risk patients: seven studies including 2,787 patients reported the incidence of 4.1. Meta-Analysis of RCT and PSM Studies. Eighteen studies AKIinhigh-surgicalriskpatientswhounderwent TAVR vs. (5 RCTs and 13 PSM observational studies; 4,633 TAVR SAVR. In these studies, TAVR was associated with lower patients; 4,724 SAVR patients) reported the incidence of AKI pooled incidence of AKI (5.5% vs. 11%, OR 0.45, 95%CI 0.25- at 30 days. eTh pooled estimated incidence of AKI among 0.83, p=0.01, I =68%) (Figure 5(a)). Seven studies including these studies was 7.1% aer ft TAVR and 12.1% aer ft SAVR 2,407 patients reported the incidence of dialysis-requiring (OR 0.52; 95%CI, 0.39-0.68; p<0.001) (I =57%) (Figure 2). AKI aer ft valve replacement in high-surgical risk patients. Seventeen studies (2 RCTs and 15 PSM observational studies; In these studies, there was no significant difference in the 7,129 TAVR patients; 7,312 SAVR patients) reported the pooled incidence of dialysis-requiring AKI between TAVR incidence of dialysis-requiring AKI at 30 days, which was and SAVR (7.4% vs. 6.2%, OR 0.95, 95%CI 0.42-2.16, p=0.91, similar between patients who underwent TAVR and those I =78%) (Figure 6(a)). who underwent SAVR (2.8% vs. 4.1%, OR 0.78; 95% CI, 0.49- (B) Renal outcomes in low-intermediate surgical risk 1.25; p=0.31) (I =70%) (Figure 3). In the meta-regression, age, patients: ten studies including 6,510 patients reported the sex, and the diabetes, prior stroke, chronic renal insufficiency, incidence of AKI following TAVR vs. SAVR in low- vascular disease, and atrial b fi rillation did not explain the intermediate surgical risk patients that compared with SAVR, observed heterogeneity between the studies (Supplementary TAVR was associated with lower pooled incidence of AKI Figures). (7.6% vs. 12.4%, OR 0.55, 95%CI 0.39-0.77, P<0.001, I =57%) (Figure 5(b)). Also, in the ten studies (n=12,034 patients) 4.2. Meta-Analysis of RCT Only. A sensitivity analysis was that reported the incidence of dialysis-requiring AKI in this performed by excluding PSM studies and restricting the cohort of patient, TAVR was associated with significantly meta-analysis to RCTs only. Similar to the original analysis, lower incidence of dialysis-requiring AKI compared with this meta-analysis showed significantly lower incidence of SAVR (2.0% vs. 3.6%, OR 0.57, 95%CI 0.38-0.85, p=0.005, AKIaeft rTAVRthanaeft rSAVR(5RCTs,5,418patients,2.0% I =23%) (Figure 6(b)). vs.5.0%, OR 0.39;95%CI,0.28-0.53;p<0.001) (Figure 4(a)), but comparable rates of dialysis-requiring AKI (2 studies; 769 5. Discussion patients; 2.9% vs. 2.6%, OR 1.1; 95% CI, 0.47-2.58; p=0.83) (Figures 4(a) and 4(b)). No heterogeneity among these trials The major findings of the current investigation are as follows. was observed (I =0%). (1) TAVR is associated with lower rates of AKI compared with 4 Journal of Interventional Cardiology Figure 2: Pooled effect estimates for 30-day acute kidney injury according to the type of aortic valve replacement procedure. TAVR: transcatheter aortic valve replacement, SAVR: surgical aortic valve replacement. Figure 3: Pooled effect estimates for 30-day renal replacement therapy according to the type of aortic valve replacement procedure. TAVR: transcatheter aortic valve replacement, SAVR: surgical aortic valve replacement. Journal of Interventional Cardiology 5 (a) (b) Figure 4: Pooled effect estimates for 30-day acute kidney injury and renal replacement therapy according to the type of aortic valve replacement procedure in the randomized controlled trials. TAVR: transcatheter aortic valve replacement, SAVR: surgical aortic valve replacement. SAVR, and this was consistent in the overall analysis, in a aer ft TAVR compared with SAVR. We hence performed a sensitivity analysis including RCTs only, and in subanalyses systematic review and a meta-analysis to synthesize the best of high-risk and low-intermediate risk patients. (2) The risk available evidence on renal outcomes following TAVR and of dialysis-requiring AKI appears to be comparable aer ft SAVR. TAVR vs. SAVR. However, the pooled incidence of dialysis- Our meta-analysis showed that TAVR is associated with requiring AKI was signicfi antly lower after TAVR than after about 50% reduction in the incidence of AKI compared with SAVR in a subgroup of low-intermediate risk patients. SAVR, but a similar rate of dialysis-requiring AKI between Patients with severe aortic stenosis are characteristically the two modalities overall. These findings have important older and have many comorbidities including a high preva- prognostic implications and deserve more scrutiny for several lence of chronic renal insufficiency. Cardiac surgery opera- reasons. (1) er Th e is ample evidence that even AKI not requir- tionsincludingSAVR areassociatedwithsignicfi antriskof ing dialysis is associated with substantial negative impact AKI and AKI requiring dialysis [33, 34]. Transcatheter aortic on long-term outcomes [35–41]. (2) The risk of AKI and valve replacement was introduced as an effective alternative dialysis-requiring AKI may be more modifiable in patients to surgery in high-prohibitive risk patients but later expanded undergoing TAVR. The advances in 3D echocardiography into young and lower risk patient cohorts. Nonetheless, both and the refinements in TAVR techniques have allowed the thepreoperativework-up andthe TAVR procedureitself introduction of the ‘Reno-protective TAVR’ concept [42– carry a significant risk of AKI due to contrast medium usage, 46]. This concept along with the wide adoption of moderate and the high prevalence of atherosclerotic risk factors among sedation in TAVR procedures has the potential to further patients submitted for TAVR. Whether TAVR is associated reduce postprocedural renal insucffi iency although this has with lower risk of AKI and AKI requiring dialysis than SAVR not yet been studied in a prospective fashion [47]. In contrast, has not been well studied. In the pivotal PARTNER-1 trial, theriskofAKIaeft r SAVRmaybemorerelatedto the no difference in the rate of AKI was observed between TAVR patient risk profile than to modifiable procedural factors as and SAVR. [7] Subsequent RCTs showed lower rates of AKI surgical techniques in SAVR have not differed significantly 6 Journal of Interventional Cardiology (a) (b) Figure 5: Pooled effect estimates for 30-day acute kidney injury according to the type of aortic valve replacement procedure in the randomized controlled trials. TAVR: transcatheter aortic valve replacement, SAVR: surgical aortic valve replacement. in the last decade. (3) In our subanalysis of patients who propensity score matched comparisons. While this can intro- are at low-intermediate surgical risk, TAVR was associated duce heterogeneity into our analysis, our sensitivity analysis withasignicfi antreduction notonlyinAKIbutalsoinAKI including RCTs only yielded similar results to the overall requiring dialysis. In light of the continuous expansion of meta-analysis. (2) eTh definition of AKI varies among the TAVR to lower risk populations, the impact of the TAVR on studies, but those definitions were maintained the same in the improving renal outcomes in these patients warrants more same study for comparison between TAVR and SAVR, and investigation [48]. hence the results are comparable. 6. Limitations 7. Conclusions Our study has several limitations: (1) there are only few TAVR procedure has significantly lower rates of AKI com- RCTs comparing TAVR with SAVR. Hence, we included paredtoSAVRbutsimilarratesofAKIrequiring renal observational studies in our meta-analysis. However, we limited our inclusion of observational studies to those with replacement therapy. AKI has short and long-term effects on Journal of Interventional Cardiology 7 (a) (b) Figure 6: Pooled effect estimates for 30-day renal replacement therapy according to the type of aortic valve replacement procedure and surgical risk. TAVR: transcatheter aortic valve replacement, SAVR: surgical aortic valve replacement. outcomes andsurvival; henceevery eoff rtshouldbemadeto Authors’ Contributions reduce the incidence of AKI. Dr. Shah and Dr. Chaker contributed equally to this manuscript. Data Availability ed Th ata usedtosupportthefindingsofthisstudy are Supplementary Materials available from the corresponding author upon request. eFigure 1: Funnel plot of the meta-analysis of the published Disclosure studies reporting 30-day acute kidney injury in patients undergoing TAVR versus SAVR. TAVR: transcatheter aor- All authors listed meet the authorship criteria according tic valve replacement; SAVR: surgical aortic valve replace- to the latest guidelines of the International Committee of ment. eFigure 2: Funnel plot of the meta-analysis of the Medical Journal Editors, and all authors are in agreement published studies reporting 30-day renal replacement ther- with the manuscript. eTh article is processing charges to be apy in patients undergoing TAVR versus SAVR. TAVR: covered in the institutional membership at West Virginia transcatheter aortic valve replacement; SAVR: surgical aor- University. tic valve replacement. eFigure 3: Meta regression for age, gender, previous stroke, peripheral arterial disease, dia- Conflicts of Interest betes, chronic kidney disease, atrial bfi rillation, and acute eTh authors declare that they have no conflicts of interest. kidney injury and renal replacement therapy in patients 8 Journal of Interventional Cardiology undergoing TAVR versus SAVR. TAVR: transcatheter aortic factors, prognostic value, and comparison with surgical aortic valve replacement,” European Heart Journal,vol.31, no.7,pp. valve replacement; SAVR: surgical aortic valve replacement. 865–874, 2010. (Supplementary Materials) [14] M. Fusari, V. Bona, M. 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Meta-Analysis Comparing Renal Outcomes after Transcatheter versus Surgical Aortic Valve Replacement

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Copyright © 2019 Kuldeep Shah et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
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Hindawi Journal of Interventional Cardiology Volume 2019, Article ID 3537256, 9 pages https://doi.org/10.1155/2019/3537256 Research Article Meta-Analysis Comparing Renal Outcomes after Transcatheter versus Surgical Aortic Valve Replacement 1 2 2 1 1 Kuldeep Shah , Zakeih Chaker, Tatiana Busu, Rishita Shah , Mohammed Osman , 1 1 Fahad Alqahtani, and Mohamad Alkhouli Division of Cardiology, West Virginia School of Medicine, Morgantown, WV, USA Department of Medicine, West Virginia School of Medicine, Morgantown, WV, USA Correspondence should be addressed to Mohamad Alkhouli; mohamad.alkhouli@wvumedicine.org Received 19 November 2018; Accepted 7 April 2019; Published 24 April 2019 Academic Editor: Vasileios Panoulas Copyright © 2019 Kuldeep Shah et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Background. Acute kidney injury (AKI) is a common complication of aortic valve replacement. However, comparative on the incidence of (AKI) following transcatheter (TAVR) versus surgical valve replacement (SAVR) is sparse. Methods. We performed a meta-analysis of the randomized controlled trials (RCT) and propensity-matched observational studies comparing (A) incidence of AKI and (B) incidence of dialysis-requiring AKI at 30 days aer ft TAVR and SAVR. Results. Twenty-six studies (20 propensity- matched studies; 6 RCTs) including 19,954 patients were analyzed. eTh incidence of AKI was lower aeft r TAVR than aeft r SAVR (7.1% vs. 12.1%, OR 0.52; 95%CI, 0.39-0.68; p<0.001, I =57%), but the incidence of dialysis-requiring AKI was similar (2.8% vs. 4.1%, OR 0.78; 95%CI, 0.49-1.25; p=0.31, I =70%). Similar results were observed in a sensitivity analysis including RCTs only for both AKI ([5 RCTs; 5,418 patients], 2.0% vs. 5.0%, OR 0.39; 95%CI, 0.28-0.53; p<0.001, I =0%), and dialysis-requiring AKI ([2 RCTs; 769 patients]; 2.9% vs. 2.6%, OR 1.1; 95%CI, 0.47-2.58; p=0.83, I =0%). However, in studies including low-intermediate risk patients only, TAVR was associated with lower incidence of AKI ([10 studies; 6,510 patients], 7.6% vs. 12.4%, OR 0.55, 95%CI 0.39-0.77, p<0.001, 2 2 I =57%), and dialysis-requiring AKI, ([10 studies; 12,034 patients], 2.0% vs. 3.6%, OR 0.57, 95%CI 0.38-0.85, p=0.005, I =23%). Conclusions. TAVR is associated with better renal outcomes at 30 days in comparison with SAVR, especially in patients at low- intermediate surgical risk. Further studies are needed to assess the impact of AKI on long-term outcomes of patients undergoing TAVR and SAVR. 1. Introduction 2. Methods eTh introduction of transcatheter aortic valve replacement Our review protocol was conducted in accordance with (TAVR) and the continuous improvement in the outcomes PRISMA (Preferred Reporting Items for Systematic Reviews of surgical aortic valve replacement (SAVR) have revolu- and Meta-Analyses) reporting guidelines (Supplementary tionized the treatment of patients with severe aortic stenosis Protocol). [4] eTh literature search was conducted in in the last decade [1, 2]. However, acute kidney injury PUBMED, MEDLINE, EMBASE, EBSCO, and Cochrane (AKI) remains a common complication of both treatment (March 2, 2018) in order to identify eligible studies using modalities. Nonetheless, data on the incidence of AKI and the Medical Subject Headings search terms and text word dialysis-requiring AKI aer ft TAVR vs. SAVR remain limited search. We also did a manual search of the reference lists [3]. We performed a meta-analysis of the randomized clinical of relevant studies for additional publications and when trials (RCTs) and propensity-matched (PSM) observational multiple publications from the same study population were studies to compare renal outcomes following TAVR vs. SAVR found, data from the most inclusive report was used. eTh (a) overall and (b) in subgroups of high-risk and low- data was reviewed independently from full-text articles intermediate risk patients. by 2 of the authors (T.B. and K.S.). Disagreements were 2 Journal of Interventional Cardiology Table 1 TAVR SAVR Baseline Characteristics p-value (N=10,038) (N=9,916) Age (years) 0.528 79.1± 5.8 78.06± 5.9 Male 0.798 49.17% 50.16% Coronary artery disease 0.606 57.7% 52.99% Chronic kidney disease (GFR<60 mL/min) 0.943 25.9% 25.3% Diabetes mellitus 0.768 30.0% 31.2% Atrial bfi rillation 0.991 28.6% 28.6% Chronic obstructive pulmonary disease 0.927 23.0% 22.7% Frailty 0.957 28.4% 27.5% Left ventricular ejection fraction 0.701 56.41± 6.6 55.3± 9.0 Pulmonary hypertension 0.729 21.1% 18.7% Peripheral vascular disease 0.630 24.4% 22.6% Prior stroke or transient ischemic attack 0.838 16.5% 15.8% NYHA III or IV 0.515 71.4% 67.73% Prior coronary artery bypass graft 0.445 40.9% 31.8% STS score 0.590 6.6± 2.9 6.1± 2.3 Euro SCORE 0.357 17.1± 8.3 15.0± 6.3 resolved through consensus and arbitration by the senior publication bias we prepared funnel plots and Egger’s linear author (M.A.). eTh following criteria were applied for study regression test of funnel plot asymmetry (eFigures 1 and 2). inclusion: (1) randomised controlled trials and propensity- All pooled estimates are displayed with a 95% confidence matched observational studies comparing TAVR and SAVR; interval (CI). P values were considered statistically significant (2) being published in peer-reviewed journals; (3) follow- at less than 0.05. We also performed sensitivity analysis up of at least 30 days; and (4) reporting AKI or acute renal to investigate potential sources of inconsistency, including failure and/or new requirement for renal replacement therapy removal of nonrandomized studies. Forest plots were gen- (dialysis-requiring AKI) as a clinical endpoint based on the erated to show therelativeeeff ct size ofTAVR andSAVR valve replacement approach. Exclusion criteria we applied are for each clinical outcome. Potential sources of heterogeneity (1) observational studies reporting nonpropensity-matched were investigated using meta-regression techniques; factors populations and (2) nonpublished studies (abstracts). The analyzed in the metaregression included age, sex, diabetes, following study characteristics were extracted: year of pub- prior stroke, chronic renal insufficiency, vascular disease, and lication, study design, number of patients, clinical character- atrial bfi rillation (eFigure 3). We followed standard protocol istics, confounding factors, comparability between groups at for performing meta-analysis as in our previous publication. baseline, outcomes, and study follow-up. The main outcomes eTh endpoint of interest in this study is renal outcomes which of interest between the two interventions in this study were not described in our previous papers making this study included (1) incidence of AKI at 30 days and (2) incidence unique. [5, 6] of AKI requiring dialysis at 30 days. 4. Results 3. Data Synthesis and Analysis A total of 5,067 potentially relevant citations were identified eTh data supporting this meta-analysis are from previ- and screened (Figure 1). Aeft r removal of duplicated studies, ously reported studies and datasets, which have been cited. we retrieved 76 full-text articles for evaluation, of which 26 eTh processed data are reported in the article and in satisfied the selection criteria. A total of 20 PSM observational the supplementary files. We performed our meta-analyses studies and 6 RCTs were included in the meta-analysis using Comprehensive Meta-Analysis version 3.0 (Biostat, (Figure 1). All eligible studies were in the English Language. https://www.meta-analysis.com). We used the random effects The baseline characteristics of the patients in the included model with the Mantel-Haenszel (MH) method for each studies are summarized in Table 1. eTh 26 studies enrolled clinical endpoint and pooled estimates of odds ratio (OR) a total of 19,954 patients; 10,038 (50.3%) in the TAVR group with 95% confidence interval (CI) were calculated. We used I and 9,916 (49.7%) in the SAVR group. Sample sizes ranged index, tau squared, and the Q-test P value to examine hetero- from 28 to 4732 patients. Mean age was 79.1±5.8 and 78.1±5.9 geneity among individual study effect sizes. To reduce the risk years in the TAVR and SAVR groups, respectively (p=0.53). of bias, we undertook independent pooling of data from RCTs There was no significant difference in the prevalence of and PSM observational studies. In order to formally assess key morbidities between the two groups including chronic Journal of Interventional Cardiology 3 Excluded articles: 4991 1. Duplicates Total number of articles 2. Not relevant identified/screened: 5067 3. Non-propensity matched 4. Non-published 5. Diagnostic studies 6. Review articles 7. Pediatric populations Articles assessed for eligibility: 76 Studies included in analysis: 26 Propensity-score matched Randomized controlled observational studies: 20 trials: 6 TAVR: SAVR: SAVR: TAVR: 7246 7220 2792 2696 Figure 1: Flow chart of the meta-analysis. TAVR: transcatheter aortic valve replacement, SAVR: surgical aortic valve replacement. renal insufficiency (25.9% in the TAVR group vs. 25.3% 4.3. Meta-Analysis Stratiefi d by Surgical Risk. Asecondary in the SAVR group, p=0.94) (Table 1). Detailed baseline analysis was performed to compare the pooled incidence of characteristics of individual studies included in our meta- AKI and dialysis-requiring AKI among patients who are at analysis are illustrated in eTable 1. [7–32] high surgical risk and those at low-intermediate surgical risk. (A) Renal outcomes in high-surgical risk patients: seven studies including 2,787 patients reported the incidence of 4.1. Meta-Analysis of RCT and PSM Studies. Eighteen studies AKIinhigh-surgicalriskpatientswhounderwent TAVR vs. (5 RCTs and 13 PSM observational studies; 4,633 TAVR SAVR. In these studies, TAVR was associated with lower patients; 4,724 SAVR patients) reported the incidence of AKI pooled incidence of AKI (5.5% vs. 11%, OR 0.45, 95%CI 0.25- at 30 days. eTh pooled estimated incidence of AKI among 0.83, p=0.01, I =68%) (Figure 5(a)). Seven studies including these studies was 7.1% aer ft TAVR and 12.1% aer ft SAVR 2,407 patients reported the incidence of dialysis-requiring (OR 0.52; 95%CI, 0.39-0.68; p<0.001) (I =57%) (Figure 2). AKI aer ft valve replacement in high-surgical risk patients. Seventeen studies (2 RCTs and 15 PSM observational studies; In these studies, there was no significant difference in the 7,129 TAVR patients; 7,312 SAVR patients) reported the pooled incidence of dialysis-requiring AKI between TAVR incidence of dialysis-requiring AKI at 30 days, which was and SAVR (7.4% vs. 6.2%, OR 0.95, 95%CI 0.42-2.16, p=0.91, similar between patients who underwent TAVR and those I =78%) (Figure 6(a)). who underwent SAVR (2.8% vs. 4.1%, OR 0.78; 95% CI, 0.49- (B) Renal outcomes in low-intermediate surgical risk 1.25; p=0.31) (I =70%) (Figure 3). In the meta-regression, age, patients: ten studies including 6,510 patients reported the sex, and the diabetes, prior stroke, chronic renal insufficiency, incidence of AKI following TAVR vs. SAVR in low- vascular disease, and atrial b fi rillation did not explain the intermediate surgical risk patients that compared with SAVR, observed heterogeneity between the studies (Supplementary TAVR was associated with lower pooled incidence of AKI Figures). (7.6% vs. 12.4%, OR 0.55, 95%CI 0.39-0.77, P<0.001, I =57%) (Figure 5(b)). Also, in the ten studies (n=12,034 patients) 4.2. Meta-Analysis of RCT Only. A sensitivity analysis was that reported the incidence of dialysis-requiring AKI in this performed by excluding PSM studies and restricting the cohort of patient, TAVR was associated with significantly meta-analysis to RCTs only. Similar to the original analysis, lower incidence of dialysis-requiring AKI compared with this meta-analysis showed significantly lower incidence of SAVR (2.0% vs. 3.6%, OR 0.57, 95%CI 0.38-0.85, p=0.005, AKIaeft rTAVRthanaeft rSAVR(5RCTs,5,418patients,2.0% I =23%) (Figure 6(b)). vs.5.0%, OR 0.39;95%CI,0.28-0.53;p<0.001) (Figure 4(a)), but comparable rates of dialysis-requiring AKI (2 studies; 769 5. Discussion patients; 2.9% vs. 2.6%, OR 1.1; 95% CI, 0.47-2.58; p=0.83) (Figures 4(a) and 4(b)). No heterogeneity among these trials The major findings of the current investigation are as follows. was observed (I =0%). (1) TAVR is associated with lower rates of AKI compared with 4 Journal of Interventional Cardiology Figure 2: Pooled effect estimates for 30-day acute kidney injury according to the type of aortic valve replacement procedure. TAVR: transcatheter aortic valve replacement, SAVR: surgical aortic valve replacement. Figure 3: Pooled effect estimates for 30-day renal replacement therapy according to the type of aortic valve replacement procedure. TAVR: transcatheter aortic valve replacement, SAVR: surgical aortic valve replacement. Journal of Interventional Cardiology 5 (a) (b) Figure 4: Pooled effect estimates for 30-day acute kidney injury and renal replacement therapy according to the type of aortic valve replacement procedure in the randomized controlled trials. TAVR: transcatheter aortic valve replacement, SAVR: surgical aortic valve replacement. SAVR, and this was consistent in the overall analysis, in a aer ft TAVR compared with SAVR. We hence performed a sensitivity analysis including RCTs only, and in subanalyses systematic review and a meta-analysis to synthesize the best of high-risk and low-intermediate risk patients. (2) The risk available evidence on renal outcomes following TAVR and of dialysis-requiring AKI appears to be comparable aer ft SAVR. TAVR vs. SAVR. However, the pooled incidence of dialysis- Our meta-analysis showed that TAVR is associated with requiring AKI was signicfi antly lower after TAVR than after about 50% reduction in the incidence of AKI compared with SAVR in a subgroup of low-intermediate risk patients. SAVR, but a similar rate of dialysis-requiring AKI between Patients with severe aortic stenosis are characteristically the two modalities overall. These findings have important older and have many comorbidities including a high preva- prognostic implications and deserve more scrutiny for several lence of chronic renal insufficiency. Cardiac surgery opera- reasons. (1) er Th e is ample evidence that even AKI not requir- tionsincludingSAVR areassociatedwithsignicfi antriskof ing dialysis is associated with substantial negative impact AKI and AKI requiring dialysis [33, 34]. Transcatheter aortic on long-term outcomes [35–41]. (2) The risk of AKI and valve replacement was introduced as an effective alternative dialysis-requiring AKI may be more modifiable in patients to surgery in high-prohibitive risk patients but later expanded undergoing TAVR. The advances in 3D echocardiography into young and lower risk patient cohorts. Nonetheless, both and the refinements in TAVR techniques have allowed the thepreoperativework-up andthe TAVR procedureitself introduction of the ‘Reno-protective TAVR’ concept [42– carry a significant risk of AKI due to contrast medium usage, 46]. This concept along with the wide adoption of moderate and the high prevalence of atherosclerotic risk factors among sedation in TAVR procedures has the potential to further patients submitted for TAVR. Whether TAVR is associated reduce postprocedural renal insucffi iency although this has with lower risk of AKI and AKI requiring dialysis than SAVR not yet been studied in a prospective fashion [47]. In contrast, has not been well studied. In the pivotal PARTNER-1 trial, theriskofAKIaeft r SAVRmaybemorerelatedto the no difference in the rate of AKI was observed between TAVR patient risk profile than to modifiable procedural factors as and SAVR. [7] Subsequent RCTs showed lower rates of AKI surgical techniques in SAVR have not differed significantly 6 Journal of Interventional Cardiology (a) (b) Figure 5: Pooled effect estimates for 30-day acute kidney injury according to the type of aortic valve replacement procedure in the randomized controlled trials. TAVR: transcatheter aortic valve replacement, SAVR: surgical aortic valve replacement. in the last decade. (3) In our subanalysis of patients who propensity score matched comparisons. While this can intro- are at low-intermediate surgical risk, TAVR was associated duce heterogeneity into our analysis, our sensitivity analysis withasignicfi antreduction notonlyinAKIbutalsoinAKI including RCTs only yielded similar results to the overall requiring dialysis. In light of the continuous expansion of meta-analysis. (2) eTh definition of AKI varies among the TAVR to lower risk populations, the impact of the TAVR on studies, but those definitions were maintained the same in the improving renal outcomes in these patients warrants more same study for comparison between TAVR and SAVR, and investigation [48]. hence the results are comparable. 6. Limitations 7. Conclusions Our study has several limitations: (1) there are only few TAVR procedure has significantly lower rates of AKI com- RCTs comparing TAVR with SAVR. Hence, we included paredtoSAVRbutsimilarratesofAKIrequiring renal observational studies in our meta-analysis. However, we limited our inclusion of observational studies to those with replacement therapy. AKI has short and long-term effects on Journal of Interventional Cardiology 7 (a) (b) Figure 6: Pooled effect estimates for 30-day renal replacement therapy according to the type of aortic valve replacement procedure and surgical risk. TAVR: transcatheter aortic valve replacement, SAVR: surgical aortic valve replacement. outcomes andsurvival; henceevery eoff rtshouldbemadeto Authors’ Contributions reduce the incidence of AKI. Dr. Shah and Dr. Chaker contributed equally to this manuscript. Data Availability ed Th ata usedtosupportthefindingsofthisstudy are Supplementary Materials available from the corresponding author upon request. eFigure 1: Funnel plot of the meta-analysis of the published Disclosure studies reporting 30-day acute kidney injury in patients undergoing TAVR versus SAVR. TAVR: transcatheter aor- All authors listed meet the authorship criteria according tic valve replacement; SAVR: surgical aortic valve replace- to the latest guidelines of the International Committee of ment. eFigure 2: Funnel plot of the meta-analysis of the Medical Journal Editors, and all authors are in agreement published studies reporting 30-day renal replacement ther- with the manuscript. eTh article is processing charges to be apy in patients undergoing TAVR versus SAVR. TAVR: covered in the institutional membership at West Virginia transcatheter aortic valve replacement; SAVR: surgical aor- University. tic valve replacement. eFigure 3: Meta regression for age, gender, previous stroke, peripheral arterial disease, dia- Conflicts of Interest betes, chronic kidney disease, atrial bfi rillation, and acute eTh authors declare that they have no conflicts of interest. kidney injury and renal replacement therapy in patients 8 Journal of Interventional Cardiology undergoing TAVR versus SAVR. TAVR: transcatheter aortic factors, prognostic value, and comparison with surgical aortic valve replacement,” European Heart Journal,vol.31, no.7,pp. valve replacement; SAVR: surgical aortic valve replacement. 865–874, 2010. (Supplementary Materials) [14] M. Fusari, V. Bona, M. 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