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. 2018 Jul 18;41(8):1091–1096. doi: 10.1002/clc.22993

Advanced chronic kidney disease: Relationship to outcomes post‐TAVR, a meta‐analysis

Nader Makki 1, Scott M Lilly 1,✉
PMCID: PMC6490162  PMID: 29896847

Abstract

Chronic kidney disease (CKD) is associated with worse outcomes in high‐surgical‐risk patients undergoing transcatheter aortic valve replacement (TAVR). However, it is unclear whether this relationship is apparent in lower‐surgical‐risk patients. We sought to analyze existing literature to assess whether or not advanced CKD is associated with increased mortality or a greater incidence of adverse events (specifically major stroke, bleeding, and vascular complications). We searched PubMed and Embase (2008–2017) for relevant studies. Studies with <1 year follow‐up and those not evaluating advanced CKD or outcomes post‐TAVR were excluded. Our co–primary endpoints were the incidence of short‐term mortality (defined as in‐hospital or 30‐day mortality) and long‐term mortality (1 year). Our secondary endpoints included incidence of major stroke, life‐threatening bleeding, and major vascular complications. Eleven observational studies with a total population of 10709 patients met the selection criteria. Among patients with CKD there was an increased risk of short‐ and long‐term mortality in high‐surgical‐risk patients who underwent TAVR (hazard ratio [HR]: 1.51, 95% confidence interval [CI]: 1.22–1.88 and HR: 1.56, 95% CI: 1.38–1.77, respectively; P < 0.01). However, there was no association between CKD and mortality in low‐ to intermediate‐risk patients (HR: 1.35, 95% CI: 0.98–1.84, P = 0.06 in short‐term and HR: 1.08, 95% CI: 0.92–1.27, P = 0.34 in long‐term). In low‐ to intermediate‐risk TAVR patients, advanced CKD is not associated with increased mortality or poorer safety outcomes. These findings should be factored into the clinical decision‐making process regarding TAVR candidacy.

Keywords: Aortic Disease, Chronic Kidney Disease, Valvular Heart Disease

1. INTRODUCTION

Transcatheter aortic valve replacement (TAVR) has yielded outcomes comparable with surgical replacement for patients with symptomatic severe aortic stenosis at intermediate or higher surgical risk.1, 2 These patients often have multiple comorbidities, including chronic kidney disease (CKD) with a prevalence of that ranges from 1.6% to 12% in randomized trials. The presence of CKD is associated with poorer outcomes among patients undergoing surgical aortic valve replacement,3, 4, 5 although the effect of CKD on patients undergoing TAVR is less clear.5

The benefit of TAVR in patients with advanced and or end‐stage renal disease has therefore been questioned, and accurate risk stratification and prognostic tools are an unmet need. These concerns about CKD among TAVR patients have primarily been reported in patients at high or prohibitive surgical risk, and their applicability to lower‐risk populations, for whom TAVR is now a commercial option, is unclear.

We sought to analyze the existing reported literature to assess whether or not advanced CKD is associated with increased mortality or a greater incidence of adverse events (specifically major stroke, bleeding, and vascular complications) across different surgical‐risk strata.

2. METHODS

Our analysis is based on the guidelines of the Meta‐analysis of Observational Studies in the Epidemiology Group.6

2.1. Inclusion criteria and search strategies

We included both prospective and retrospective observational studies with the primary objective to analyze the association between advanced CKD and clinical outcomes post‐TAVR. Our co–primary endpoints were the incidence of short‐term mortality (defined as in‐hospital and/or 30‐day mortality) and incidence of long‐term mortality (defined as 1 year post‐TAVR). Our secondary endpoints included incidence of major stroke, life‐threatening bleeding, and major vascular complications. The Vascular Academic Research Consortium (VARC) recommendations were used for these safety endpoint definitions.7 We searched PubMed and Embase (2008–2017) to identify relevant studies. Titles and abstracts with the following terms were collated: “transcatheter aortic valve replacement,” “end‐stage renal disease,” “advanced chronic kidney disease,” “kidney disease stage 4,” “kidney disease stage 5,” “stroke,” “vascular complication,” “major bleeding or life‐threatening bleed,” and “mortality.” In addition, the “Related Articles” feature on PubMed was used and a manual search was conducted using bibliographies of review articles on this topic. Abstracts of the articles published by the American College of Cardiology, the American Heart Association, the European Society of Cardiology, and Transcatheter Cardiovascular Therapies were also searched. Titles and abstracts were evaluated independently by 2 reviewers (N.M. and S.L.). Differences were resolved by consensus. These studies were then subjected to the following exclusion criteria: (1) no control group; (2) outcomes different than our primary and/or secondary outcomes; (3) publication only in the abstract form; and (4) follow‐up duration <1 year. Figure 1 summarizes the results of the search strategy.

Figure 1.

Figure 1

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Flowchart representing the search strategy of our analysis. The literature search yielded 20 potential studies. Of these, a total of 11 observational studies were included in final analysis. Abbreviations: TIA, transient ischemic attack

2.2. Quality assessment and data extraction

Studies were rated according to the Newcastle‐Ottawa Scale used for assessing nonrandomized observational studies.8 Two reviewers (N.M. and S.L.) extracted the following data elements: (1) publication details, including first author's last name and year; (2) study design; (3) characteristics of the study population, including sex, race, mean patient age, and comorbidities including hypertension and diabetes; (4) variables included in the multivariate analyses; and (5) adjusted hazard ratio (HR) with 95% confidence interval (CI) from the multivariate analyses.

2.3. Definitions

Advanced CKD was defined as stage 4 (severe CKD: glomerular filtration rate 15–29 mL/min/1.73 m2) and stage 5 (severe CKD and/or dialysis: glomerular filtration rate < 15 mL/min/1.73 m2).9 Short‐term mortality and long‐term mortality (primary endpoints) were defined as in‐hospital/30‐day mortality and 1 year post‐TAVR, respectively.

Our secondary endpoints including major stroke, bleeding, and major vascular complications, defined as per the VARC recommendations.7 These secondary endpoints were defined primarily at 30 days post‐TAVR.

2.4. Data synthesis and analysis

The degree of association between advanced CKD and outcomes in TAVR patients was represented in terms of HR. Summary HR and 95% CI were calculated for all clinical outcomes by pooling published results available for each study. For all studies, multivariate regression analysis was performed to adjust for potential confounders (age, sex, and history of atrial fibrillation, hypertension, diabetes, peripheral arterial disease, prior stroke/transient ischemic attack, coronary artery disease, and prior myocardial infarction). Calculated HRs were transformed logarithmically. We assessed heterogeneity of the studies by calculating a Q statistic (significance defined as P < 0.05), which we compared with the I 2 index (I 2 ≥ 25% defined as significant).10, 11 Data were collected and analyzed using a random‐ and fixed‐effect model approach with inverse‐variance weighting.10 The underlying heterogeneity further prompted us to perform meta‐regression analysis to investigate if our study endpoints were affected by factors other than our primary risk factor (advanced CKD). We adopted a weighted regression random‐effect model and estimated between study variance (s2) using empirical Bayes estimate. A 2‐sided P value <0.05 was regarded as significant for all analyses. All statistical calculations were performed using RevMan software, version 5.0 (The Cochrane Collaboration, The Nordic Cochrane Centre, Copenhagen, Denmark). Potential publication bias was represented graphically with Begg funnel plots of the natural log of the HR vs its standard error.

3. RESULTS

The literature search yielded 20 potential studies. Of these, 11 observational studies with a total population of 10709 patients met our selection criteria (Table 1). The mean age of this cohort was 81 years, and approximately 58% of the population was male. Procedural characteristics and main outcomes are represented in Table 2. Based on the Newcastle‐Ottawa Scale, all included studies scored high in terms of selection, comparability, and outcome assessment (see Supporting Information, Table 1, in the online version of this article).

Table 1.

Baseline characteristics of included studiesa

Study N Male Sex Mean Age, y DM HTN CAD Advanced CKD, Stage 4 Advanced CKD, Stage 5 STS Score LVEF
LR/IR HR
Allende et al21 2075 56.5 81.9 ±6.2 29.5 81.5 59.5 134 (6.4) 67 (3.2) 805 (38.8) 1265 (61.2) 56 ±12
Codner et al22 1204 70.4 82.1 ±6.0 24.3 90.4 22.5 398 (33.1) 66 (5.5) Excl 1204 (100) 62 ± 16
Conrotto et al23 1904 56.5 79.4 ±7.5 26.8 87.8 45.5 347 (18.2) 74 (3.9) 570 (29.8) 1334 (70.1) 51.4 ± 12.6
D'Acenszo et al6 364 42.3 82.4 ± 5.3 31.5 86.5 42.3 73 (21.2) Excl Excl 364 (100) 52.4 ± 11.9
Dumontello et al14 942 53.8 81.0 ±7.0 28.5 69.5 45.2 72 (7.6) 33 (3.5) 269 (28.4) 673 (71.6) 50.4 ± 1.6
Ferro et al7 3696 60.4 81.1 ± 10.2 17.6 69.5 22.0 315 (8.5) 99 (2.7) 925 (25) 2771 (75) 52.4 ± 11.9
Levi at al24 1204 56.9 82.8 ±6.1 29.4 86.1 16.0 464 (38.5) Excl 331 (27.5) 873 (72.5) 52.4 ± 11.9
Nguyen et al25 321 61.5 81.7 ± 9.1 43.3 93.1 32.5 139 (43.3) 23 (7.2) Excl 321 (100) 52 ± 16
Rahman et al26 118 57.6 81.3 ±7.7 22.0 91.1 25.4 63 (53.4) Excl 33 (39) 85 (61) 52.4 ± 11.9
Thourani et al27 2531 51.1 84.9 ±6.8 36.2 92 83.3 291 (11.5) Excl Excl 2531 (100) 52.4 ± 11.9
Wessely et al5 42 72.1 76.4 ± 11.0 48.8 90.7 35.5 33 (76) Excl Excl 42 (100) 52.4 ± 11.9
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Abbreviations: CAD, coronary artery disease; CKD, chronic kidney disease; DM, diabetes mellitus; Excl, excluded; HR, high‐risk STS score; HTN, hypertension; IR, intermediate‐risk STS score; LR, low‐risk STS score; LVEF, left ventricular ejection fraction; SD, standard deviation; STS, Society of Thoracic Surgeons.

Data are presented as %, n (%), or mean ± SD as appropriate.

a

There were a total of 11 studies with a total population of 10 709 patients, the majority of whom were male and had known HTN and CAD.

Table 2.

Procedural characteristics and main outcomes

Study Valve Type Death at 30 Days Death at 1 Year Major Bleeding Major Vascular Complications Stroke
Allende et al21 CoreValve (51.4), Edwards (48.6) 16.6 20.5 21.5 10 4.1
Codner et al22 CoreValve (59), Edwards XT (36), Edwards S3 (5.0) 11.8 18.5 2.6 N/A N/A
Conrotto et al23 Edwards XT (68.6), Edwards S3 (31.4) 20.4 N/A 23.5 7 1.8
D'Acenszo et al6 CoreValve (51.4), Edwards (48.6) N/A 17.6 21.5 10 4.1
Dumontello et al14 CoreValve (53.7), Edwards (46.3) 18.8 22.5 22.5 9.6 6.1
Ferro et al7 CoreValve (51.7), Edwards (49.3) 15.8 25.5 25.8 11.5 4.4
Levi at al24 NS N/A 26.5 25.5 8.5 4.4
Nguyen et al25 NS N/A 31.4 N/A 7.6 4.4
Rahman et al26 CoreValve (90.7), Edwards (9.3) 13.4 18.4 17.6 12.6 6.1
Thourani et al27 Edwards (100) 12.5 17.5 N/A N/A N/A
Wessely et al5 CoreValve (51.7), Edwards (49.3) 11.8 16.7 N/A N/A N/A
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Abbreviations: N/A, not applicable; NS, not specified; SD, standard deviation.

Data are presented as %.

3.1. Primary outcome

Ten out of 11 studies evaluated the association of advanced CKD with long‐term mortality. We evaluated this relationship at 1‐year post‐TAVR. Advanced CKD was associated with an increased risk of long‐term mortality in high‐risk TAVR patients (HR: 1.94, 95% CI: 1.76–2.14, P < 0.001) but not in the low‐ to intermediate‐risk group (HR: 1.08, 95% CI: 0.93–1.25, P = 0.29; Figure 2A). Results were similar with regard to short‐term mortality; advanced CKD was associated with an increased risk of short‐term mortality in high‐risk TAVR patients (HR: 1.97, 95% CI: 1.72–2.26, P < 0.001) but not in the low‐ to intermediate‐risk group (HR: 1.31, 95% CI: 1.01–1.71, P = 0.06; Figure 2B).

Figure 2.

Figure 2

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Forest plot of our primary endpoint. (2A) Advanced CKD was associated with an increased risk of long‐term mortality in high‐risk TAVR patients, but not in the low‐ to intermediate‐risk group. Similarly (2B), advanced CKD was associated with an increased risk of short‐term mortality in high‐risk TAVR patients but not in the low‐ to intermediate‐risk group. Abbreviations: CI, confidence interval; CKD, chronic kidney disease; df, degrees of freedom; SE, standard error; TAVR, transcatheter aortic valve replacement

Meta‐regression analysis showed that the effect size of short‐ and long‐term mortality in the studies did not significantly interact with the independent variable: patients with advanced CKD (see Supporting Information, Figure 1A, in the online version of this article).

3.2. Secondary outcomes

Advanced CKD was associated with an increased risk of major bleeding in the high‐risk TAVR group (adjusted HR: 2.43, 95% CI: 2.06–2.87, P < 0.001) but not in the low‐ to intermediate‐risk group (adjusted HR: 1.04, 95% CI: 0.90–1.20, P = 0.59; Figure 3A). However, we did not find an increased risk of major vascular complications in the high‐risk group (adjusted HR: 1.14, 95% CI: 0.98–1.32, P = 0.08) or the low‐ to intermediate‐risk group (adjusted HR: 1.11, 95% CI: 0.95–1.30, P = 0.17; Figure 3B). In regard to risk of major stroke, we found that advanced CKD was associated with a significant increase in high‐risk TAVR patients (adjusted HR: 1.17, 95% CI: 1.01–1.35, P < 0.05) but not in the low‐ to intermediate‐risk group (adjusted HR: 1.11, 95% CI: 0.95–1.30, P = 0.07; Figure 3C).

Figure 3.

Figure 3

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Forest plot of our secondary endpoints. (3A) Advanced CKD was associated with an increased risk of major bleeding in the high‐risk TAVR group but not in the low‐ to intermediate‐risk group. (3B) Advanced CKD was not associated with an increased risk of major vascular complications in the high‐risk group or the low‐ to intermediate‐risk group. (3C) Advanced CKD was associated with an increased risk of major vascular complications in high‐risk TAVR patients (adjusted HR: 1.17, 95% CI: 1.01–1.35, P < 0.05) but not in the low‐ to intermediate‐risk group (adjusted HR: 1.11, 95% CI: 0.95–1.30, P = 0.07). Abbreviations: CI, confidence interval; CKD, chronic kidney disease; df, degrees of freedom; SE, standard error; TAVR, transcatheter aortic valve replacement

Meta‐regression of major vascular complications by advanced CKD patients in these studies failed to show any significant interaction (see Supporting Information, Figure 1B, in the online version of this article).

There was no evidence of publication bias for the included studies by visual inspection of the funnel plot and using the Egger test (P = 0.20; see Supporting Information, Figure 2, in the online version of this article).

4. DISCUSSION

Our meta‐analysis and systematic review represents the largest dataset to date demonstrating the relationship between advanced CKD and outcomes with TAVR, stratified by surgical risk. Our analysis demonstrates the following findings: (1) advanced CKD is associated with increased mortality (short and long term) in high‐surgical‐risk groups; (2) advanced CKD is associated with increased major bleeding and stroke in the high‐surgical‐risk groups; and (3) advanced CKD is not associated with increased mortality, vascular complications, or bleeding in lower‐ or intermediate‐surgical‐risk groups undergoing TAVR.

The concept that advanced CKD might be associated with poorer outcomes is a reasonable one. Patients with advanced CKD are generally older and frailer and have higher baseline surgical risk scores than do patients without renal disease.12, 13, 14, 15, 16 Comorbidities are more common, and it is established that advanced CKD modified the natural history of aortic stenosis, presumably through the same pathophysiological mechanisms that underlie calcium deposition on the leaflets.17 Additionally, there are likely a number of phenomena that accompany CKD not captured in surgical risk scores, such as disorders of primary hemostasis,18 which might contribute to the rate of periprocedural bleeding.

In the present study, advanced CKD was associated with worse outcomes (mortality, bleeding, and stroke) in high‐risk TAVR patients. This is in line with previous studies demonstrating that advanced CKD is an independent risk factor for mortality, stroke, and bleeding events in TAVR patients.12, 19, 20, 21, 22, 23 The findings herein corroborate these earlier reports and the observation that mortality, bleeding events, and stroke cluster in this cohort. If it is the occurrence of bleeding or stroke that underlies the mortality difference in high‐surgical‐risk patients, bleeding‐avoidance strategies (less aggressive anticoagulant or antiplatelet therapy) or technological advancements (smaller sheaths, routine closure device utilization) might have particular merit in this cohort. Additionally, there is now a commercially available device for stroke prophylaxis during TAVR, and the renal disease population might represent a population for routine use.24 Whether bleeding events are of greater consequence or strokes are more profound in patients with advanced renal disease remains an area of inquiry.

Our finding that advanced CKD does not portend worse outcomes in lower‐surgical‐risk strata is interesting and provides support for ongoing consideration of therapy in this cohort of patients. The consistent observations that TAVR is less efficacious in high‐risk patients with CKD has been employed to encourage alternative pathways aimed at “renal protection”25 or in some cases not offering TAVR to patients with end‐stage renal disease. Our findings, however, suggest that perhaps it is not renal disease per se that limits clinical benefit, but the accompanying comorbidities (both overt and occult) that drive outcome differences. Nevertheless, low‐contrast (or noncontrast) pre‐ and intraprocedural guidance are likely of merit in this group.

4.1. Study limitations

There are several potential limitations of the present analysis. First, it is based only on published studies, and the possibility of publication bias cannot be excluded. Additionally, although careful screening was undertaken, the possibility of overlapping study populations could result in similar estimates. As with most meta‐analyses, there is potential discrepancy in outcomes as well as potential search and selection biases and differences in study protocols and definitions. Further, this meta‐analysis was performed on study‐level data, not data at the individual patient level. This meta‐analysis included only observational studies, and unmeasured confounding is an important limitation that should be acknowledged. Finally, the adjusted prognostic value of different degrees of kidney disease on outcomes after TAVI was not assessed due to the scarcity of study data.

5. CONCLUSION

In low‐ to intermediate‐risk TAVR patients, advanced CKD is not associated with increased mortality or worse safety outcomes. These findings should be factored into the clinical decision‐making process regarding TAVR candidacy of these patients.

Conflicts of interest

The authors declare no potential conflicts of interest.

Supporting information

Supplementary Figure 1 Plot representing results of our meta‐regression analysis of primary endpoint (1A) and secondary endpoint (1B) as an effect of the independent variable (percent patients with advanced CKD) .The independent variable (percent patients with advanced CKD) is plotted on the horizontal axis against effect size (log HR). The data points are then plotted according to original data input. However, the size of the circular dot is calculated as follows: (i) as the area of the dot represents the weight, the radius of the dot is calculated as sqrt (wt); (ii) the size of the dot therefore represents the multiple of the smallest effect size in the meta‐analysis dataset

Click here for additional data file. (209.6KB, jpg)

Supplementary Figure 2 Plot representing results of our meta‐regression analysis of primary endpoint (1A) and secondary endpoint (1B) as an effect of the independent variable (percent patients with advanced CKD) .The independent variable (percent patients with advanced CKD) is plotted on the horizontal axis against effect size (log HR). The data points are then plotted according to original data input. However, the size of the circular dot is calculated as follows: (i) as the area of the dot represents the weight, the radius of the dot is calculated as sqrt (wt); (ii) the size of the dot therefore represents the multiple of the smallest effect size in the meta‐analysis dataset

Click here for additional data file. (115.7KB, jpg)

Appendix Table 1 New‐castle Ottawa Scale for evaluating the quality of cohort studies

Click here for additional data file. (95.9KB, docx)

Makki N, Lilly SM. Advanced chronic kidney disease: Relationship to outcomes post‐TAVR, a meta‐analysis. Clin Cardiol. 2018;41:1091–1096. 10.1002/clc.22993

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Associated Data

This section collects any data citations, data availability statements, or supplementary materials included in this article.

Supplementary Materials

Supplementary Figure 1 Plot representing results of our meta‐regression analysis of primary endpoint (1A) and secondary endpoint (1B) as an effect of the independent variable (percent patients with advanced CKD) .The independent variable (percent patients with advanced CKD) is plotted on the horizontal axis against effect size (log HR). The data points are then plotted according to original data input. However, the size of the circular dot is calculated as follows: (i) as the area of the dot represents the weight, the radius of the dot is calculated as sqrt (wt); (ii) the size of the dot therefore represents the multiple of the smallest effect size in the meta‐analysis dataset

Click here for additional data file. (209.6KB, jpg)

Supplementary Figure 2 Plot representing results of our meta‐regression analysis of primary endpoint (1A) and secondary endpoint (1B) as an effect of the independent variable (percent patients with advanced CKD) .The independent variable (percent patients with advanced CKD) is plotted on the horizontal axis against effect size (log HR). The data points are then plotted according to original data input. However, the size of the circular dot is calculated as follows: (i) as the area of the dot represents the weight, the radius of the dot is calculated as sqrt (wt); (ii) the size of the dot therefore represents the multiple of the smallest effect size in the meta‐analysis dataset

Click here for additional data file. (115.7KB, jpg)

Appendix Table 1 New‐castle Ottawa Scale for evaluating the quality of cohort studies

Click here for additional data file. (95.9KB, docx)

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