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Impact of Severity of Chronic Kidney Disease on Management and Outcomes Following Transcatheter Aortic Valve Replacement With Newer-Generation Transcatheter Valves
Abstract: Background. The association between chronic kidney disease (CKD) and outcomes following transcatheter aortic valve replacement (TAVR) in the setting of newer-generation transcatheter heart valves (THVs) is not well known. Accordingly, we sought to assess the impact of CKD severity on outcomes in adults undergoing TAVR with newer-generation THVs. Methods. The study population included 298 consecutive patients who underwent TAVR with a newer-generation THV (Sapien 3 [Edwards Lifesciences] or CoreValve Evolut R or Evolut Pro [Medtronic]) from December 2015 to June 2018 at an academic tertiary medical center. Patients were classified into three groups: group I, defined as creatinine clearance (CrCl) ≥60 mL/min (n = 133); group II, defined as CrCl ≥30 mL/min and <60 mL/min (n = 128); and group III, defined as CrCl <30 mL/min (n = 37). Results. Median length of stay was longer in groups II and III (2.0 days in group I vs 3.0 days in group II vs 4.0 days in group III; P<.01). While rates of 30-day readmission were significantly higher in groups II and III compared with group I (14.5% in group I vs 26.6% in group II vs 37.1% in group III; P<.01), rates of in-hospital and 30-day mortality and disabling stroke were similar. In multivariable analysis, CKD was independently associated with higher 30-day readmission rates (group II: odds ratio, 2.10; 95% confidence interval 1.02-4.32; group III: odds ratio, 3.52; 95% confidence interval, 1.40-8.87; group I: referent). Conclusions. In this prospective study of adults undergoing TAVR with newer-generation THVs, moderate and severe CKD was associated with a nearly 2-fold and 3-fold higher risk of 30-day readmission, respectively.
Key words: chronic kidney disease, transcatheter aortic valve replacement
Transcatheter aortic valve replacement (TAVR) has become the standard of care to treat patients with severe symptomatic aortic stenosis (AS).1-3 The contemporary TAVR era has introduced more frequent use of periprocedural conscious sedation, the inclusion of patients with lower surgical risk, and newer-generation transcatheter heart valves (THVs) with smaller sheath size, less frequent paravalvular regurgitation, and ability for valve retrievability (in the case of self-expanding valves). Chronic kidney disease (CKD) commonly coexists in patients with AS and has been linked to impaired outcomes following balloon aortic valvuloplasty and TAVR.4-15 With a prevalence of CKD >30% in adults undergoing TAVR,5-15 it is of high importance to investigate the risk profile, management, and outcomes of this population, especially in the contemporary era of newer-generation THVs, to provide further optimization of care. Accordingly, we evaluated the impact of presence and severity of renal dysfunction on clinical presentation, management, and outcomes in adults with severe symptomatic AS undergoing TAVR with newer-generation THVs at an academic tertiary medical center.
Methods
We conducted a prospective cohort study examining differences in outcomes in men and women undergoing TAVR at an academic tertiary medical center. All adults (age ≥18 years) with severe symptomatic AS and/or failure of a bioprosthetic valve and undergoing TAVR with a newer-generation THV (Sapien 3 valve [Edwards Lifesciences] or CoreValve Evolut R or Evolut Pro [Medtronic]) at Stony Brook University Medical Center from December 2015 to June 2018 were included in this study. Patients were classified into three groups: group I, defined as creatinine clearance (CrCl) of ≥60 mL/min; group II, defined as CrCl ≥30 mL and <60 mL/min; and group III, defined as CrCl <30 mL/min.
Demographic and baseline medical history data extracted included age, sex, weight, height, body mass index (BMI), prior coronary artery bypass graft (CABG) surgery, prior myocardial infarction (MI), prior aortic valve replacement (AVR), prior balloon aortic valvuloplasty (BAV), prior mitral valve surgery, prior pacemaker/defibrillator, atrial fibrillation (AF), chronic obstructive pulmonary disease (COPD), obstructive sleep apnea, prior stroke/transient ischemic attack, carotid disease, peripheral artery disease, diabetes mellitus, and CrCl.
Clinical data extracted included echocardiographic data (eg, aortic valve area [AVA] and aortic valve area index [AVAI], left ventricular ejection fraction [LVEF]), gated computed tomography angiography (CTA) data (eg, aortic annulus area and perimeter), procedural information (eg, the use of conscious sedation, transfemoral access, predilation, THV type, postdilation), discharge data (eg, discharge location and length of stay [LOS]), in-hospital outcomes (all-cause mortality and disabling stroke), and 30-day outcomes (all-cause mortality, disabling stroke, and all-cause hospital readmission). This study was approved by our institutional review board. A waiver of consent to use data prospectively was obtained for all patients.
Statistical analysis. Categorical variables were presented as percentages and compared with the Chi-square test or Fisher’s exact test, where applicable. Continuous variables were presented as mean ± standard deviation (SD) and compared using one-way ANOVA. Multivariable logistic regression was utilized to determine the association between CKD and 30-day readmission. Predictors for the logistic regression were selected based on previous clinical data and statistical significance in the univariate analysis (P<.10) and included age, sex, diabetes mellitus, postdilation, and hospital LOS. SPSS, version 23.0 (SPSS) was used for data analysis and a two-tailed P-value of .05 was regarded as statistically significant.
Results
The study population included 298 consecutive patients who underwent TAVR and received a contemporary THV from December 2015 to June 2018 at an academic tertiary medical center. Of the 298 patients, a total of 133 patients (44.6%) were classified as group I (CrCl ≥60 mL/min), while 128 patients (43.0%) were classified as group II (CrCl ≥30 mL/min and <60 mL/min), and 37 patients (12.4%) were classified as group III (CrCl <30 mL/min). Table 1 highlights the baseline medical history. Compared with group I, groups II and III were noted to be older, with lower BMI, higher rates of prior BAV, and lower rates of COPD. Group III patients had the highest rates of prior mitral valve surgery and prior pacemaker/defibrillator.
No significant difference was noted between the three groups in echocardiographic AVA (0.76 cm2 in group I vs 0.71 cm2 in group II vs 0.76 cm2 in group III; P=.14) or AVAI (0.38 cm2/m2 in group I vs 0.43 cm2/m2 in group II vs 0.44 cm2/m2 in group III; P=.18). Compared with groups I and II, group III patients had significantly lower echocardiographic LVEF (57% in group I vs 58% in group II vs 47% in group III; P<.001). Aortic annular perimeter obtained from gated CTA was significantly smaller in groups II and III (79 mm in group I vs 75 mm in group II vs 76 mm in group III; P=.03), while aortic annular areas were similar among the three groups (455 mm2 in group I vs 431 mm2 in group II vs 454 mm2 in group III; P=.12).
Table 2 presents the procedural management during TAVR. No difference in rates of conscious sedation, transfemoral access, THV type, or postdilation were noted. Group III patients had a trend toward lower rates of predilation. Rates of discharge to a skilled nursing facility were significantly lower in group I (15.2% in group I vs 21.4% in group II vs 17.1% in group III; P=.03), while median hospital LOS was significantly longer in groups II and III (Figure 1A). Rates of in-hospital and 30-day all-cause mortality and disabling stroke remained low and were similar between the groups (Figure 1B). Rates of all-cause readmission were significantly higher in groups II and III (14.5% in group I vs 26.6% in group II vs 37.1% in group III; P<.01).
In multivariable analysis, CKD was independently associated with higher rates of 30-day readmission (group II: odds ratio, 2.10; 95% confidence interval, 1.02-4.32; group III: odds ratio, 3.52; 95% confidence interval, 1.40-8.87; group I: referent) (Table 3). Other independent predictors of all-cause 30-day readmission included absence of diabetes mellitus (odds ratio, 0.42; 95% confidence interval, 0.22-0.82), postdilation (odds ratio, 4.08; 95% confidence interval, 1.23-13.46), and hospital LOS (odds ratio, 1.05; 95% confidence interval, 1.00-1.11).
Discussion
Several findings are noteworthy in this contemporary observational study of adults undergoing TAVR with newer-generation THVs. First, nearly 55% of patients undergoing TAVR were noted to have CKD. Second, patients with severe CKD were older and had lower BMI, lower LVEF, higher rates of prior BAV, and a trend toward less frequent predilation during TAVR. Third, while no differences in in-hospital or 30-day death or disabling stroke were noted among the three groups, the presence of moderate and severe CKD were both independently associated with higher rates of all-cause 30-day readmission.
Advanced CKD is widely prevalent in patients with severe AS undergoing TAVR, with an incidence of 38%-70%.5-12 While advanced CKD has been associated with higher rates of early and late mortality and bleeding events following TAVR,5,6,8,10,11,13-15 there has been limited reporting of its impact of hospital readmission. Thirty-day readmission rates post TAVR have ranged between approximately 10%-22%.16-20 Patients with severe renal disease had the highest incidence of 30-day readmission in the inoperable cohort of the PARTNER (Placement of Aortic Transcatheter Valves) study.11 Data from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry (2011-2015) reported that glomerular filtration rate was independently associated with 30-day readmission.16 Data from the 2013 National Readmission Database noted that renal failure was significantly associated with 30-day readmission (odds ratio, 1.43; 95% confidence interval, 1.24-1.65), alongside with transapical access, chronic lung disease, diabetes mellitus, discharge to skilled nursing facilities, and prolonged hospital LOS.18 Data on the impact of renal function on hospital readmission for heart failure has yielded conflicting results.21,22
Study limitations. Our study had a number of limitations. First, our findings are based on observational data, which was internally validated, but not centrally adjudicated. Second, the majority of the devices implanted during the study period were balloon-expandable in nature and nearly all cases were performed via transfemoral approach. Third, we did not assess rates of post-TAVR acute kidney injury, which has been associated with impaired postprocedural outcomes.8,23-29 Finally, we did not assess post-TAVR improvement in kidney function, which has been associated with improved outcomes in this population.30-32
Conclusion
In this observational, prospective study of adults undergoing TAVR with newer-generation THVs, patients with moderate and severe CKD have a nearly 2-fold and 3-fold higher risk of 30-day readmission, respectively.
References
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From the 1Division of Cardiovascular Medicine, Department of Medicine, State University of New York at Stony Brook, Stony Brook, New York; and 2Division of Cardiothoracic Surgery, Department of Medicine, State University of New York at Stony Brook, Stony Brook, New York.
Disclosure: The authors have completed and returned the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Parikh reports consultant income from Medtronic; scientific advisory board for AstraZeneca. The remaining authors report no conflicts of interest regarding the content herein.
Manuscript submitted July 11, 2019, provisional acceptance given July 17, 2019, final version accepted July 24, 2019.
Address for correspondence: Puja B. Parikh, MD, MPH, Division of Cardiology, Stony Brook University Medical Center, Health Sciences Center T16, Room 080, Stony Brook, NY 11794-8160. Email: puja.parikh@stonybrookmedicine.edu
