The aim of this study was to determine the influence of inhospital and post-discharge worsening renal function (WRF) on prognosis after transcatheter aortic valve replacement (TAVR). Severe chronic kidney disease and inhospital WRF are both associated with poor outcomes after TAVR. There are no data available on post-discharge WRF and outcomes. This was a single-center study evaluating all TAVR from June 1, 2008, to June 31, 2014. WRF was defined as an increase in serum creatinine of ≥0.3 mg/dl. Inhospital WRF was measured from day 0 until discharge or day 7 if the hospitalization was >7 days. Post-discharge WRF was measured at 30 days after discharge. Descriptive statistics, Kaplan-Meier time-to-event analysis, and multivariate logistic regression were used. In a series of 208 patients who underwent TAVR, 204 with complete renal function data were used in the inhospital analysis and 168 who returned for the 30-day follow-up were used in the post-discharge analysis. Inhospital WRF was seen in 28%, whereas post-discharge WRF in 12%. Inhospital and post-discharge WRF were associated with lower rates of survival; however, after multivariate analysis, only post-discharge WRF remained a predictor of 1-year mortality (hazard ratio 1.18, p = 0.030 for every 1 mg/dl increase in serum creatinine). In conclusion, the rate of inhospital WRF is higher than the rate of post-discharge WRF after TAVR, and post-discharge WRF is more predictive of mortality than inhospital WRF.
Renal dysfunction is often present in cardiovascular disease, and worsening renal function (WRF) has been associated with poor outcomes in heart failure, acute coronary syndromes, and patients who underwent cardiac surgery. Transcatheter aortic valve replacement (TAVR) is an excellent treatment option for patients with severe symptomatic aortic stenosis considered high or extreme risk for morbidity and mortality with surgical aortic valve replacement. Among the multiple co-morbidities that affect patients who underwent TAVR, chronic kidney disease graded moderate or higher is present in 29% to 34% of patients in large multicenter registries and has been demonstrated to be an independent predictor of poor outcomes after TAVR. Development of WRF during the post-procedural period after TAVR has been demonstrated to be another independent risk factor of short- and mid-term mortality. Despite this strong association between WRF and mortality after TAVR, some patients have been shown to have reversible WRF associated with favorable outcomes. The purpose of this study is to further investigate the impact of WRF on post-TAVR outcomes, to determine whether improved renal function (IRF) is associated with favorable outcomes, and to determine whether post-discharge WRF affects post-TAVR outcomes.
Methods
A database of consecutive patients who underwent TAVR at the Bluhm Cardiovascular Institute from June 1, 2008, to June 31, 2014, was reviewed. The Institutional Review Board approved analysis of all data. Data were obtained using several sources, including hemodynamic and angiographic data stored for the TAVR procedure (Calysto for Cardiology, Witt Biomedical, Melbourne, Florida; and Xcelera, Phillips Healthcare, Eindhoven, The Netherlands), available clinical information and laboratory values in the electronic medical record, echocardiographic data (Synapse Cardiovascular; Fujifilm Medical Systems, Minato, Japan), and computed tomographic data (Vital Solutions; Toshiba Medical Systems, Otawara, Japan). Outcomes were obtained by periodic monitoring through our valve clinic through telephone call and/or follow-up visit. Baseline clinical characteristics, vital signs, laboratory findings, echocardiography, and cardiac catheterization were routinely collected per institutional protocol. Inhospital laboratory, medication, transfusion, complications, and pre- and post-procedure echocardiographic data were also obtained. Valves available to the institution during the study period include the Edwards Sapien (154), Sapien XT (32), Sapien S3 (13), Medtronic CoreValve (4), and DirectFlow Medical DirectFlow Medical valve (5).
WRF was defined as an absolute increase in serum creatinine (sCr) ≥0.3 mg/ml from the baseline measurement pre-TAVR as defined in previous heart failure cohorts and based on a modification of the Valve Academic Research Consortium definition of acute kidney injury. IRF similarly was defined as an absolute decrease in sCr ≥0.3 mg/dl, and patients with stable renal function had neither WRF nor IRF. The periods of time analyzed were the inhospital period, defined by the date of the TAVR until discharge or day 7 if discharge occurred after 7 days, and the post-discharge period, occurring at the first follow-up visit, by institutional protocol scheduled 30 days after discharge. For those patients who were still in hospital at 30 days, examination and laboratory values at discharge were used. At the post-discharge visit, symptom evaluation, clinical evaluation, and laboratory analysis were obtained.
Differences in baseline demographics, medical history, physical findings, laboratory findings, and echocardiographic findings were compared between patients with and without inhospital and post-discharge WRF. Comparison between groups was assessed using the Kruskal-Wallis test for continuous variables and the Pearson chi-square test for categorical variables. Outcomes were determined for subgroups with or without WRF inhospital and post-discharge and for IRF inhospital and post-discharge and was summarized using the Kaplan-Meier survival curves and time-to-event analysis. Predictors of 1-year mortality were determined using a multivariable regression model. The model was determined using a process of backward selection, starting with the variables that had a significance level of p <0.05. The least significant variables were removed until all remaining variables had a significance level of p <0.05. All data were analyzed using Stata MP, version 14.0 (StataCorp, College Station, Texas).
Results
A total of 208 patients underwent TAVR during the specified time period ( Figure 1 ). Of these, 1 patient had end-stage renal disease on dialysis and 3 died the day of the TAVR procedure precluding WRF analysis, leaving 204 in the inhospital analysis. Of these patients, 11 died within the 30-day post-discharge period and 25 did not follow up for their post-discharge appointment, leaving 168 in the post-discharge analysis. There were 95 patients (46%) with hospital stays from 8 to 30 days, of which 12 patients (13%) did not follow up for their post-discharge appointment, 10 patients (11%) died before their post-discharge appointment, and 3 patients (3.2%) were re-admitted. There were 5 patients (2.5%) with hospital stays >30 days whose discharge evaluation was used for the analysis. Baseline clinical characteristics are depicted in Tables 1 and 2 . There was no difference in the rate of blood transfusion in relation to access site used (data not shown).
| Yes (Δ sCr ≥ 0.3 mg/dL) (N= 57) | No (Δ sCr < 0.3 mg/dL) (N = 147) | ||
|---|---|---|---|
| Age, (years ± SD) | 82.8 ± 7.0 | 83.2 ± 7.3 | 0.74 |
| Female | 29 (51%) | 71 (48%) | 0.74 |
| Coronary artery disease | 52 (91%) | 136 (93%) | 0.76 |
| Prior myocardial infarction | 16 (28%) | 47 (32%) | 0.76 |
| Hypertension | 47 (83%) | 121 (82%) | 0.98 |
| Hyperlipidemia | 37 (65%) | 93 (63%) | 0.83 |
| COPD | 23 (40%) | 49 (33%) | 0.35 |
| Cirrhosis | 2 (3.5%) | 3 (2.0%) | 0.55 |
| STS score (% mortality ± SD) | 10.6 ± 4.9 | 8.8 ± 3.8 | 0.010 |
| LVEF (% ± SD) | 52.8 ± 14.1 | 52.4 ± 13.4 | 0.86 |
| Weight (kg ± SD) | 77.6 ± 14.0 | 78.1 ± 18.9 | 0.87 |
| BMI (kg/m 2 ± SD) | 28.6 ± 5.1 | 28.2 ± 6.3 | 0.67 |
| Systolic BP (mmHg ± SD) | 123.7 ± 20.0 | 122.9 ± 17.9 | 0.78 |
| Diastolic BP (mmHg ± SD) | 63.1 ± 11.2 | 64.8 ± 10.1 | 0.32 |
| Heart rate (bpm ± SD) | 76.2 ± 13.8 | 74.8 ± 12.9 | 0.50 |
| sCr (mg/dL ± SD) | 1.39 ± 0.50 | 1.31 ± 0.56 | 0.35 |
| BUN (mg/dL ± SD) | 32.0 ± 15.0 | 29.6 ± 18.8 | 0.40 |
| eGFR (mL/min/1.73 m 2 ± SD) | 51.9 ± 21.1 | 56.8 ± 24.1 | 0.18 |
| Hemaglobin (g/dL ± SD) | 11.9 ± 2.0 | 12.3 ± 1.6 | 0.082 |
| Albumin (g/dL ± SD) | 3.63 ± 0.54 | 3.88 ± 0.42 | 0.0012 |
| Hospital events | |||
| Any complication | 15 (27%) | 25 (17%) | 0.14 |
| Transfemoral access | 30 (53%) | 98 (67%) | 0.063 |
| Transfusion | 20 (35%) | 18 (12%) | 0.0001 |
| Transfusion (units ± SD) | 1.43 ± 2.80 | 0.48 ± 1.61 | 0.0031 |
| Peak Systolic BP (mmHg ± SD) | 163.3 ± 23.2 | 159.9 ± 20.9 | 0.31 |
| Trough Systolic BP (mmHg ± SD) | 91.1 ± 13.2 | 94.5 ± 13.0 | 0.096 |
| Peak Diastolic BP (mmHg ± SD) | 78.9 ± 10.3 | 82.0 ± 14.5 | 0.14 |
| Trough Diastolic BP (mmHg ± SD) | 39.6 ± 8.6 | 44.3 ± 9.2 | 0.0009 |
| Peak heart rate (bpm ± SD) | 107.4 ± 19.3 | 104.3 ± 20.5 | 0.33 |
| Trough heart rate (bpm ± SD) | 61.2 ± 18.1 | 59.9 ± 11.4 | 0.53 |
| Inotrope | 24 (42%) | 31 (21%) | 0.0023 |
| Inotrope (number ± SD) | 0.54 ± 0.71 | 0.27 ± 0.57 | 0.0037 |
| Vasopressor | 42 (74%) | 73 (50%) | 0.0018 |
| Vasopressor (number ± SD) | 1.37 ± 1.17 | 0.80 ± 0.96 | 0.0005 |
| Loop diuretic during hospitalization | 56 (98%) | 128 (87%) | 0.016 |
| Loop diuretic at discharge | 38 (69%) | 93 (66%) | 0.63 |
| Pacemaker Placement | 6 (11%) | 8 (5.4%) | 0.20 |
| Procedure events | |||
| Rapid pacing (runs ± SD) | 1.09 ± 0.29 | 1.07 ± 0.25 | 0.64 |
| Contrast dose (cc ± SD) | 88.2 ± 58.5 | 84.7 ± 46.4 | 0.65 |
| Aortic regurgitation | 0.60 | ||
| None | 34 (62%) | 85 (60%) | |
| Mild | 16 (29%) | 37 (26%) | |
| Moderate | 5 (9.1%) | 19 (13%) | |
| Medications | |||
| ACE-I | 19 (33%) | 43 (46%) | 0.52 |
| ARB | 9 (16%) | 30 (20%) | 0.48 |
| Beta-blocker | 28 (49%) | 94 (64%) | 0.070 |
| Loop diuretic | 39 (68%) | 90 (61%) | 0.27 |
| Mineralcorticoid antagonist | 5 (8.8%) | 9 (6.1%) | 0.48 |
| Variable | Worsening Renal Function | P-value | |
|---|---|---|---|
| Yes (Δ sCr ≥ 0.3 mg/dL) (N= 21) | No (Δ sCr < 0.3 mg/dL) (N = 147) | ||
| Age, (years ± SD) | 82.6 ± 7.8 | 82.5 ± 7.2 | 0.99 |
| Female | 10 (48%) | 72 (49%) | 0.91 |
| Coronary artery disease | 17 (81%) | 137 (93%) | 0.058 |
| Prior myocardial infarction | 3 (14%) | 47 (32%) | 0.38 |
| Hypertension | 18 (86%) | 119 (81%) | 0.60 |
| Hyperlipidemia | 12 (57%) | 98 (67%) | 0.39 |
| COPD | 8 (38%) | 49 (33%) | 0.67 |
| Cirrhosis | 3 (14%) | 1 (0.68%) | 0.0001 |
| STS score (% mortality ± SD) | 10.2 ± 3.7 | 8.9 ± 3.8 | 0.18 |
| LVEF (% ± SD) | 54.8 ± 15.3 | 52.3 ± 13.4 | 0.44 |
| Weight (kg ± SD) | 80.7 ± 19.0 | 78.3 ± 18.1 | 0.57 |
| BMI (kg/m 2 ± SD) | 29.2 ± 6.7 | 28.4 ± 5.8 | 0.55 |
| Systolic BP (mmHg ± SD) | 114.0 ± 16.8 | 125.3 ± 18.9 | 0.012 |
| Diastolic BP (mmHg ± SD) | 59.1 ± 8.7 | 64.2 ± 10.2 | 0.033 |
| Heart rate (bpm ± SD) | 74.0 ± 13.4 | 75.5 ± 13.0 | 0.62 |
| sCr (mg/dL ± SD) | 1.32 ± 0.54 | 1.30 ± 0.50 | 0.83 |
| BUN (mg/dL ± SD) | 27.6 ± 13.0 | 29.6 ± 16.7 | 0.63 |
| eGFR (mL/min/1.73 m 2 ± SD) | 56.8 ± 22.3 | 56.2 ± 23.7 | 0.92 |
| Hemaglobin (g/dL ± SD) | 11.2 ± 1.5 | 12.3 ± 1.8 | 0.012 |
| Albumin (g/dL ± SD) | 3.7 ± 0.53 | 3.8 ± 0.44 | 0.10 |
| Hospital events | |||
| Any complication | 21 (14%) | 4 (19%) | 0.58 |
| Transfemoral access | 14 (67%) | 92 (63%) | 0.72 |
| Transfusion | 5 (25%) | 27 (18%) | 0.49 |
| Transfusion (units ± SD) | 0.95 ± 1.86 | 0.48 ± 1.63 | 0.22 |
| Peak Systolic BP (mmHg ± SD) | 160.8 ± 24.4 | 159.7 ± 19.3 | 0.81 |
| Trough Systolic BP (mmHg ± SD) | 87.4 ± 11.8 | 95.2 ± 12.9 | 0.0094 |
| Peak Diastolic BP (mmHg ± SD) | 79.2 ± 11.5 | 81.1 ± 13.5 | 0.54 |
| Trough Diastolic BP (mmHg ± SD) | 39.0 ± 9.2 | 43.7 ± 9.4 | 0.034 |
| Peak heart rate (bpm ± SD) | 110.4 ± 20.0 | 103.2 ± 19.8 | 0.12 |
| Trough heart rate (bpm ± SD) | 59.2 ± 8.0 | 59.8 ± 10.7 | 0.80 |
| Inotrope | 6 (29%) | 34 (23%) | 0.59 |
| Inotrope (number ± SD) | 0.38 ± 0.67 | 0.29 ± 0.57 | 0.49 |
| Vasopressor | 12 (57%) | 78 (53%) | 0.73 |
| Vasopressor (number ± SD) | 0.90 ± 1.04 | 0.86 ± 0.96 | 0.86 |
| Loop diuretic during hospitalization | 19 (91%) | 132 (90%) | 0.92 |
| Loop diuretic at discharge | 15 (71%) | 99 (67%) | 0.71 |
| Pacemaker Placement | 1 (4.8%) | 11 (7.5%) | 0.65 |
| In-hospital Worsening Renal Function | 14 (67%) | 33 (22%) | <0.0001 |
| In-hospital max sCr (mg/dL ± SD) | 1.86 ± 0.86 | 1.59 ± 1.57 | 0.43 |
| Procedure events | |||
| Rapid pacing (runs ± SD) | 1.19 ± 0.40 | 1.05 ± 0.23 | 0.024 |
| Contrast dose (cc ± SD) | 92.4 ± 61.02 | 81.9 ± 42.3 | 0.32 |
| Aortic regurgitation | 0.17 | ||
| None | 12 (57%) | 93 (65%) | |
| Mild | 4 (19%) | 38 (26%) | |
| Moderate | 5 (24%) | 13 (9.0%) | |
| Medications, n (%) | |||
| ACE-I | 9 (43%) | 44 (30%) | 0.24 |
| ARB | 3 (14%) | 28 (19%) | 0.60 |
| Beta-blocker | 11 (52%) | 89 (61%) | 0.48 |
| Loop diuretic | 16 (76%) | 89 (61%) | 0.17 |
| Mineralcorticoid antagonist | 1 (4.8%) | 9 (6.1%) | 0.81 |
Stay updated, free articles. Join our Telegram channel
Full access? Get Clinical Tree
