Abstract
Background
the introduction of transcatheter aortic valve replacement (TAVR) expanded definitive therapy of aortic stenosis to many high-risk patients, but it has not been fully evaluated in the dialysis population.
Objectives
We aimed to evaluate the current trend and in-hospital outcome of Surgical aortic valve replacement (SAVR) and TAVR in the dialysis population.
Methods
Severe aortic stenosis patients on maintenance dialysis who underwent SAVR or TAVR in the Nationwide Inpatient Sample database (NIS) from January 1, 2005, through December 31, 2014, were included in our comparative analysis. The trends of SAVR and TAVR were assessed. Inhospital mortality, rates of major adverse events, hospital length of stay, cost of care and intermediate care facility utilization were compared between the two groups using both unadjusted and propensity-matched data.
Results
Utilization of aortic valve replacement in dialysis patients increased 3-fold with a total of 2,531 dialysis patients who underwent either SAVR (n=2,264) or TAVR (n=267) between 2005–2014 were identified. Propensity score matching yielded 197 matched pairs. After matching, a twofold increase in in-hospital mortality was found with SAVR compared to TAVR 13.7% vs. 6.1% (p=0.021). Patients who underwent TAVR had more permanent pacemaker implantation (13.2% vs. 5.6%, p=0.012), but less blood transfusion (43.7% vs. 56.8% p=0.02). Rates of other key morbidities were similar. Hospital length of stay (19±16 vs. 11±11 days, P<0.001) and non-home discharges (44.7% vs. 31.5%, p=0.002) were significantly higher with SAVR. Cost of hospitalization was 25% less with TAVR.
Conclusion
TAVR is associated with lower hospital mortality, resource utilization, and cost in comparison with SAVR.
Keywords: Comparative Outcomes, Dialysis, Aortic Stenosis, Transcatheter Aortic Valve Replacement, Surgical Aortic Valve Replacement
INTRODUCTION
Calcific aortic stenosis is the most common valvular pathology in patients with end-stage renal disease on maintenance dialysis 1, 2. Surgical aortic valve replacement (SAVR) for severe aortic stenosis improves survival in dialysis patients when compared to medical management 3, 4. However, many dialysis patients with severe aortic stenosis are being denied SAVR due to the significant morbidity and mortality of surgery in this population 3, 5–8. Although the availability of transcatheter aortic valve replacement (TAVR) has expanded access to definitive therapy to a larger population of patients with severe aortic stenosis, utilization in dialysis patients has been debated for a few reasons: (1) Patients with end-stage renal disease were excluded from the pivotal TAVR trials (The PARTNER, and the Medtronic CoreValve trials) 9, 10. (2) The limited comparative data on transcatheter versus surgical treatment of aortic stenosis in dialysis patients suggested no advantage of TAVR over SAVR 11. (3) TAVR has been associated with greater total cost compared with SAVR 12, 13, which may be a limitation to its utilization in a population with very resource intensive disease status 14. (4) The substantial long-term mortality in dialysis patients has called into question the futility of aortic valve replacement in this population.
We hypothesized that aortic valve replacement is being increasingly utilized in dialysis patient and that short-term outcomes of TAVR are superior to SAVR in this population. We, therefore, aimed to (1) evaluate the contemporary national trends of aortic valve replacement in dialysis patients using a nationwide database. (2) Compare in-hospital outcomes of SAVR and TAVR in a propensity-matched group of dialysis patients.
METHODS
Study Data
The Nationwide Inpatient Sample (NIS) was used to derive patient relevant information between January 2005 and December 2014. The NIS is the largest publicly available all-payer administrative claims-based database and contains information about patient discharges from approximately 1000 non-federal hospitals in 45 states. It contains clinical and resource utilization information on 5 to 8 million discharges annually, with safeguards to protect the privacy of individual patients, physicians, and hospitals. These data are stratified to represent approximately 20% of US inpatient hospitalizations across different hospital and geographic regions (random sample). National estimates of the entire US hospitalized population were calculated using the Agency for Healthcare Research and Quality sampling and weighting method.
Study Population
Dialysis patients aged 60 years and older with aortic stenosis who underwent SAVR or TAVR during the study period were identified using International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes. Aortic stenosis was identified by ICD-9-CM codes 424.1, 395.0, 395.2, 396.2, and 746.3. Maintenance dialysis status was defined as patients with ICD-9-CM code for end-stage renal disease 585.6, procedure code for hemodialysis 39.95 or peritoneal dialysis 54.98 and absence of ICD-9-CM code for acute kidney injury 584.X. ICD9-CM codes 584.X have >90% sensitivity and negative predictive value for acute kidney injury 15. Codes 35.20 and 35.21, 35.05 and 35.06, were used to identify SAVR and TAVR procedures, respectively.
Trends and Outcomes of SAVR and TAVR
The trends of transcatheter and surgical aortic valve replacement in patients on dialysis during the 10-year study period were assessed using weighted numbers (national estimates). Baseline patient’s comorbidities and procedural characteristics were described. In-hospital Morbidity and Mortality of SAVR and TAVR were assessed. Predictors associated with death prior to discharge were also identified.
Comparative Outcomes Analysis of SAVR and TAVR
We aimed to perform a comparative analysis between the outcomes of TAVR and SAVR in dialysis patients. To account for potential confounding factors and reduce the effect of selection bias, a propensity score matching model was developed using logistic regression to derive two matched groups for comparative outcomes analysis (e Figure-1). After excluding patients who underwent concomitant cardiac surgery, patients who underwent “isolated” SAVR or TAVR were entered into a nearest neighbor 1:1 variable ratio, parallel, balanced propensity-matching model using a caliper of 0.1. Propensity scores were derived from 41 hospital, clinical, and demographic covariates including the Elixhauser comorbidity index (eTable-1). We performed multiple imputations to impute missing values for race (missing in 16% of observations) using the fully conditional specification (FCS) method (an iterative Markov Chain Monte Carlo algorithm) in SPSS 24. To estimate the cost of hospitalization, the NIS data were merged with cost-to-charge ratios available from the Healthcare Cost and Utilization Project. We estimated the cost of each inpatient stay by multiplying the total hospital charge with cost-to-charge ratios. The primary endpoint was inhospital death. Secondary outcomes included procedural mortality defined as death occurring on the same hospital day as SAVR or TAVR, vascular complications, pacemaker implantation, cerebrovascular accidents, acute kidney injury, blood transfusion, cardiac tamponade, length of stay, total hospitalization cost and discharge disposition.
Statistical Analysis
Descriptive statistics presented as frequencies with percentages for categorical variables and as means with standard deviations for continuous variables. Baseline characteristics were compared using a Pearson chi-squared test and Fisher’s exact test for categorical variables and an independent-samples t-test for continuous variables. Univariate and multivariate logistic regression was performed to estimate odds ratios with 95% confidence intervals to determine predictors of in-hospital death. Matched categorical variables were presented as frequencies with percentages and compared using McNemar's test. Matched continuous variables were presented as means with standard deviations and compared using a paired-samples t-test. A type I error rate of < 0.5 was considered statistically significant. All statistical analyses were performed using SPSS version 24 (IBM Corporation, Armonk, NY) and R, version 3.3.116.
Sensitivity Analysis
To further assess for residual confounding, a rule out approach to sensitivity analysis was used to illustrate how strongly a single unmeasured confounder would need to be associated with SAVR and a significant outcome endpoint to fully explain our findings (eFigure-2) 17. To fully explain the observed difference in blood transfusion rates between patients undergoing SAVR and TAVR, a confounder would have to be three times more likely to be associated with SAVR than TAVR and concurrently increase the risk of blood transfusion by nine times.
RESULTS
2531 Dialysis patients underwent aortic valve replacement between 2005–2014, representing a weighted national estimate of 12563 patients. Of these patients, 2264 (89.5%) underwent SAVR and 267 (10.5%) underwent TAVR. There was a significant upward trend in aortic valve replacement utilization in dialysis patients from 610 cases in 2005 to 2070 cases in 2014 for (p<0.001) (weighted national estimates) (Figure-1). Baseline patient-level characteristics of the unmatched groups are shown in Table-1.
Figure (1).
Temporal Trends of Dialysis Patients Undergoing Surgical (blue line) and Transcatheter (red line) Aortic Valve Replacement in the United States Between 2005 and 2014.
Table 1.
Characteristics of Dialysis Patients Undergoing Transcatheter and Surgical Aortic Valve Replacement Between 2005–2014
| Characteristic | All Patients (n=2531) | TAVR (n=267) | SAVR (n= 2264) | P value |
|---|---|---|---|---|
| Age- mean (SD), y | 64 (14) | 75 (10) | 63 (13) | <0.0001 |
| Male- no (%) | 1689 (66.7) | 172 (64.4) | 1517 (67) | 0.396 |
| Teaching Hospital- no (%) | 1856 (73.3) | 240 (89.9) | 1616 (71.4) | <0.0001 |
| Race- no. (%) | <0.0001 | |||
| Caucasian | 1530 (60.5) | 195 (73) | 1335 (59) | |
| African American | 583 (23) | 41 (15.4) | 542 (23.9) | |
| Hispanic | 255 (10.1) | 13 (4.9) | 242 (10.7) | |
| Non-elective Admission Status | 1154 (45.6) | 99 (37.1) | 1272 (56.3) | <0.0001 |
| Medical Comorbidity- no (%) | ||||
| Hypertension | 2250 (88.9) | 229 (85.8) | 2021 (89.3) | 0.085 |
| Diabetes | 1061 (41.9) | 126 (47.2) | 935 (41.3) | 0.065 |
| Prior Sternotomy | 161 (6.4) | 52 (19.5) | 109 (4.8) | <0.0001 |
| Chronic Pulmonary Disease | 551 (21.8) | 82 (30.7) | 469 (20.7) | <0.0001 |
| Chronic Renal Failure | 1021 (40.3) | 113 (42.3) | 908 (40.1) | 0.485 |
| Atrial Fibrillation/Flutter | 139 (5.5) | 5 (1.9) | 134 (5.9) | 0.006 |
| Cardiogenic Shock | 1380 (54.5) | 15 (5.6) | 249 (11) | 0.007 |
| Anemia | 850 (33.6) | 163 (61) | 1217 (53.8) | 0.024 |
| Coagulopathy | 95 (3.8) | 77 (28.8) | 773 (34.1) | 0.083 |
| Conduction Abnormalities | 530 (20.9) | 28 (10.5) | 67 (3) | <0.0001 |
| Peripheral Vascular Disease | 1228 (48.5) | 99 (37.1) | 431 (19) | <0.0001 |
| Coronary Artery Disease | 2250 (88.9) | 125 (46.8) | 1103 (48.7) | 0.556 |
| Chronic Liver Disease | 114 (4.5) | 16 (6) | 98 (4.3) | <0.0001 |
| Metastatic Cancer | 0 (0) | 1 (0.4) | 0 (0) | 0.004 |
| Congestive Heart Failure | 183 (7.2) | 41 (15.4) | 142 (6.3) | <0.0001 |
| Procedure Access | ||||
| Transfemoral | 211(8.3) | 211 (79) | NA | NA |
| Transapical | 56 (2.2) | 56 (21) | NA | NA |
| Concomitant Procedures- no (%) | ||||
| Coronary artery bypass | 848 (33.5) | 0 (0) | 848 (37.5) | <0.0001 |
| Percutaneous Coronary Intervention | 20 (0.8) | 10 (3.7) | 10 (0.4) | <0.0001 |
| Mitral Valve Valvuloplasty | 94 (3.7) | 0 (0) | 94 (4.2) | 0.001 |
| Mitral Valve Replacement | 328 (13) | 1 (0.4) | 327 (14.4) | <0.0001 |
| Annuloplasty | 124 (4.9) | 1 (0.4) | 123 (5.4) | <0.0001 |
| Open ASD\VSD Repair | 54 (2.1) | 1 (0.4) | 327 (14.4) | <0.0001 |
| IABP*/LV† Assist Device Use | 198 (7.8) | 10 (3.7) | 188 (8.3) | 0.009 |
Intra-aortic balloon pump
Left ventricular
Outcomes of SAVR and TAVR prior to propensity matching
Patients who underwent TAVR were older than those who underwent SAVR (75±10 vs. 63±13 years) and had higher prevalence of key comorbidities (Table-1). Despite that, in-hospital death was significantly higher in the SAVR group compared TAVR group (11.8 vs. 5.6% p<0.002). Dialysis patients undergoing SAVR demonstrated higher rates of the adverse events compared to patients undergoing TAVR (Table-2). In a multivariate regression model of the overall population, age, need for left ventricular assist device, cardiogenic shock, concomitant cardiac surgery, fluid and electrolyte imbalance, chronic liver disease and male gender were all independently associated with increased risk of in-hospital death (eTables-2 and 3).
Table 2.
In-Hospital Outcomes of Dialysis Patients Undergoing Transcatheter and Surgical Aortic Valve Replacement Between 2005–2014
| All Patients (n=2531) | TAVR (n=267) | SAVR (n=2264) | P value | |
|---|---|---|---|---|
| Clinical Outcome- no (%) | ||||
| In-Hospital Death | 283 (11.2) | 15 (5.6) | 268 (11.8) | 0.002 |
| Procedural Death | 15 (0.6) | 0 (0) | 15 (0.7) | 0.182 |
| Vascular Complications | 222 (8.8) | 29 (10.9) | 193 (8.5) | 0.202 |
| Vascular Complications Requiring Surgery | 233 (9.2) | 14 (5.2) | 108 (4.8) | 0.733 |
| Permanent Pacemaker Implantation | 122 (4.8) | 39 (14.6) | 194 (8.6) | 0.001 |
| Transient Ischemic Attack | 12 (0.5) | 2 (0.7) | 10 (0.4) | 0.489 |
| Clinical Stroke | 139 (5.5) | 5 (1.9) | 134 (5.9) | 0.006 |
| Blood Transfusion | 1346 (53.2) | 119 (44.6) | 1227 (54.2) | 0.003 |
| Cardiac Tamponade | 4 (0.2) | 1 (0.4) | 56 (2.5) | 0.029 |
| Discharge Status- no (%) | <0.0001 | |||
| Discharged Home | 1232 (48.7) | 163 (61) | 1069 (47.2) | |
| Discharged SNF*/NH†/IC‡ | 1009 (39.9) | 89 (33) | 920 (40.60) | |
| Length of Stay- mean (SD), d | 19 (18) | 12 (11) | 20 (18) | <0.0001 |
| Cost of Hospitalization (SD), $ | 94263 (75960) | 72149 (47820) | 96870 (78213) | <0.0001 |
Skilled nursing facility
Nursing home
Intermediate care
Comparative outcomes of SAVR and TAVR in the propensity-matched cohorts
Propensity score matching yielded 197 matched pairs. Baseline characteristics were well matched between the two groups as detailed in Table-1 and eFigure-3. After propensity matching, logistic regression analysis consistently showed that SAVR was associated with a significant two-fold increase in in-hospital death (13.7 % vs. 6.1%, p=<0.021). This mortality benefit was mainly seen in patients who underwent transfemoral TAVR vs. SAVR (5.1% vs. 13.8%, p=0.007). Patients who underwent transapical TAVR had similar in-hospital mortality with patients who underwent SAVR (10% vs. 14%, p=0.52) (Figure-2). Blood transfusion rates were higher after SAVR (56.8% vs. 43.7%, p=0.02), while permanent pacemaker implantation was more frequent after TAVR (13.2% vs. 5.6%, p=0.012). There was no statistically significant difference in the rates of vascular complications or stroke between the two groups (Table-2). Resource utilization was higher in the SAVR group compared with patients who underwent TAVR, those who underwent SAVR had longer hospital length of stay (19±16 vs. 11±11 days, p<0.001) and were more likely to be discharged to an intermediate care facility or nursing home (44.7% vs. 31.5%, p=0.002) (Table-2). The total cost of hospitalization was 25% higher with SAVR compared to TAVR (95784±83739 $ vs. 73048±52323 $, p=0.001).
Figure (2).
In-Hospital Mortality in Propensity Matched Patients on Maintenance Dialysis Following Surgical or Transcatheter Aortic Valve. (a) In-hospital mortality in the overall TAVR vs. SAVR groups (b) In-hospital mortality in the transapical TAVR vs. SAVR groups (c) In-hospital mortality in the transfemoral TAVR vs. SAVR groups TAVR; transcatheter aortic valve replacement SAVR; surgical aortic valve replacement
DISCUSSION
The principal findings of the present investigation are: (1) SAVR and TAVR are being utilized more frequently in dialysis patients over the last decade in the United States. (2) In propensity-matched cohorts of dialysis patients undergoing SAVR or TAVR, in-hospital mortality, and resource utilization were significantly higher in the SAVR group.
Cardiovascular diseases are highly prevalent among dialysis patients, with aortic stenosis being the most common valvular disease affecting them 18–20. The management of aortic stenosis in dialysis patients is becoming an increasingly relevant topic for two reasons: (1) The prevalence, risk profile and longevity of patients on dialysis have changed in the past two decades 21. In 2013, there were 661,648 patients receiving maintenance dialysis in the United States. Although the incidence of end-stage renal disease has plateaued, the dialysis population is growing by about 21,000 additional patients annually due to the decline in mortality rate among end-stage renal disease patients 22. With the rising number and declining mortality of patients receiving maintenance dialysis, the number of dialysis patients with aortic stenosis in need for valve replacement is projected to increase. (2) The introduction of TAVR has revolutionized the treatment of aortic stenosis for a wide range of aortic stenosis patients but, has not yet adequately addressed the unmet need in certain at-risk population (such as the dialysis population) in whom surgical replacement has been associated with substantial morbidity and mortality 4, 7, 8, 23. Our study showed a significant upward trend in the utilization of both SAVR and TAVR in dialysis patients between 2005–2014 (Figure-1), this may be explained by the growing number of dialysis patients needing aortic valve replacement though it may also be related to increasing trends to treat higher risk patients with aortic stenosis in the TAVR era.
Outcome data on TAVR in dialysis patients are limited. Several small studies assessed the outcomes of TAVR in dialysis patients compared to those with normal renal function and found maintenance dialysis to be an independent predictor of in-hospital and long-term mortality 18, 24–29. Dialysis status has now become a standard element in the TAVR risk prediction tool derived from large-scale data available in the ACC/TVT registry 30, 31. To our knowledge, only one comparative study has assessed the outcomes of SAVR versus TAVR in dialysis patients 11. In a propensity-matched analysis, Kobrin et al. found no difference in 30-day mortality between dialysis patients who underwent SAVR compared to TAVR (8% vs. 10%, respectively. P=0.47). However, this study was conducted in the very early experience with TAVR in the United States (January 1, 2011, and November 30, 2012). The lack of advantage of TAVR over SAVR in this study might have been related to issues pertaining to the extreme risk population treated in the early TAVR experience, the learning curve of the procedure, the use of first-generation transcatheter heart valves, and the utilization of transapical access in up to one-fifth of the patients. Data from the ACC/TVT Registry have shown continuous improvement in TAVR outcomes overall between 2011–2015 30, 32. In our study, compared to SAVR, TAVR was associated with less than half of the in-hospital mortality rate in propensity-matched pairs (13.7% vs. 6.1%, p=<0.021), driven mostly by a substantial reduction in in-hospital mortality in patients who underwent transfemoral TAVR (5.1% vs. 13.8%, p=0.007) (Figure 2). Additional studies are needed to assess long-term outcomes of contemporary TAVR in comparison with SAVR in the dialysis population.
Resource utilization is becoming an extremely relevant issue in the current era. Medicare spending for end stage renal disease patients continues to rise, in 2013 it accounted for 7.1% of the overall paid claims costs in the fee-for-service system 21. In our study, compared to SAVR, TAVR was associated with significant cost saving in the dialysis population; (1) The total cost of hospitalization for SAVR was 25% more than the cost of hospitalization for TAVR (95784±83739 p=0.001). (2) Patients were more likely to need intermediate care/long term facility following SAVR than following TAVR (44.7% vs. 31.5%, p=0.002). In the era of health care reform, and the increasing pressure to reduce costs, these data have important implications for health care delivery systems especially to certain populations with resource intensive morbidities.
The discussion of our findings would not be complete without alluding to the important issue of utility and futility of high-risk interventions in the dialysis population. Several studies have shown a substantial intermediate and long-term mortality in dialysis patients with aortic stenosis despite definitive treatment11, 33. In the TVT registry, patients undergoing TAVR who were on dialysis had a 41% one-year mortality compared with 24% in the overall TAVR cohort33. Similarly, in a multicenter study by Allende et al. one-year mortality was 44% in dialysis patients compared with 21% in patients with normal renal function25. In another study, Kobrin et al. found that in dialysis patients, one-year mortality was 40% after TAVR and 36.4% after SAVR11. These findings raised the question of whether these high-risk patients do indeed benefit from TAVR. However, these studies included extreme risk patients in the early TAVR experience and were underpowered to identify subgroups of dialysis patients in whom valve replacement might be futile (patients with atrial fibrillation, pulmonary hypertension, or those who are not suitable for transfemoral access, etc.)25. Dialysis patients who survive TAVR have similar improvement in New York Heart Association heart failure class, and similar valve hemodynamics at 1-year compared with patients with normal renal function25. Therefore, efforts to identify predictors of poorer short and long-term outcomes of TAVR (and possibly SAVR) in the dialysis population are key to allow appropriate risk stratification and avoid denying treatment to patients who may have substantial benefit. Further studies are needed to investigate the impact of other factors (length of dialysis, frailty, pulmonary hypertension, low ejection fraction, etc.) on the long-term survival of dialysis patients to identify the best candidate for transcatheter or surgical intervention.
LIMITATIONS
The NIS is derived from hospital claims data without access to individual medical records and subject to the shortcomings of other administrative datasets. Inconsistencies related to diagnosis coding may overestimate or underestimate secondary adverse events. However, we believe our data is reflective of the true data because (a) ICD-9-CM codes for dialysis have been validated and have very high sensitivity and specificity values 15 and (b) Hard clinical end points such as death, stroke, pacemaker implantation, length of stay, discharge status, and hospital charges, etc., are subject to rigorous HCUP quality control and are difficult to miscode 17.
Baseline, procedural and post-procedural hemodynamic data, prosthesis performance, laboratory data, and patient’s functional status, as well as long-term outcomes beyond hospital discharge, are not available in NIS. Other factors such as the underlying cause leading to dialysis and the duration of dialysis are also not captured in NIS. This limitation may markedly impede our ability to draw solid conclusions on the utility of TAVR in a population that is inherently known to have significant long-term morbidity and mortality. However, our findings of substantial inpatient mortality following SAVR in these patients provide important insight to the heart team upon evaluating these patients especially that it is extremely unlikely to conduct a randomized trial of SAVR versus TAVR in this cohort of patients.
The potential for unmeasured confounders may bias outcomes results. However, we believe that our vigorous propensity matching and sensitivity analysis (eFigure-2 and 3) helped to mitigate these issues as much as possible.
CONCLUSION
Despite the poor long-term prognosis of patients on maintenance dialysis, aortic valve replacement utilization has increased 3-fold over the last decade. In these patients, transcatheter aortic valve replacement is associated with significantly lower in-hospital mortality and cost in comparison to standard surgical aortic valve replacement. However, our data does not address the question of long-term utility versus futility of valve replacement in dialysis patients, and further studies are needed to address this.
Supplementary Material
Table 3.
Characteristics of Propensity Matched Dialysis Patients Undergoing Transcatheter and Surgical Aortic Valve Replacement Between 2005–2014
| Characteristic | TAVR (n= 197) | SAVR (n= 197) | P Value |
|---|---|---|---|
| Age- mean (SD), y | 73 (10) | 72 (10) | 0.233 |
| Male- no (%) | 128 (65) | 126 (64) | 0.907 |
| Teaching Hospital- no (%) | 172 (87.3) | 174 (88.3) | 0.874 |
| Race- no. (%) | 0.917 | ||
| Caucasian | 136 (69) | 132 (67) | |
| African American | 35 (17.8) | 41 (20.8) | |
| Hispanic | 11 (5.6) | 8 (4.1) | |
| Non-elective Admission Status | 120 (60.9) | 122 (61.9) | 0.917 |
| Medical Comorbidity- no (%) | |||
| Hypertension | 171 (86.8) | 172 (87.3) | 0.99 |
| Diabetes | 90 (45.7) | 89 (45.2) | 0.99 |
| Prior Sternotomy | 27 (13.7) | 26 (13.2) | 0.99 |
| Chronic Pulmonary Disease | 55 (27.9) | 49 (24.9) | 0.576 |
| Atrial Fibrillation/Flutter | 84 (42.6) | 79 (40.1) | 0.678 |
| Cardiogenic Shock | 15 (7.6) | 18 (9.1) | 0.719 |
| Anemia | 116 (58.9) | 105 (53.3) | 0.324 |
| Coagulopathy | 62 (31.5) | 62 (31.5) | 0.99 |
| Conduction Abnormalities | 10 (5.1) | 13 (6.6) | 0.678 |
| Peripheral Vascular Disease | 62 (31.5) | 53 (26.9) | 0.356 |
| Coronary Artery Disease | 93 (47.2) | 87 (44.2) | 0.614 |
| Chronic Liver Disease | 13 (6.6) | 13 (6.6) | 0.99 |
| Congestive Heart Failure | 23 (11.7) | 25 (12.7) | 0.877 |
| Procedure Access | |||
| Transfemoral | 155 (78.6) | NA | NA |
| Transapical | 42 (21.4) | NA | NA |
| Concomitant Procedures- no (%) | |||
| Percutaneous Coronary Intervention | 7 (3.6) | 1 (0.5) | 0.07 |
| Coronary artery bypass | 0 (0) | 0 (0) | 0.99 |
| Other Cardiac Surgery | 0 (0) | 0 (0) | 0.99 |
| IABP6/LV7 Assist Device Use | 8 (4.1) | 17 (8.6) | 0.064 |
Intra-aortic balloon pump
Left ventricular
Table 4.
In-Hospital Outcomes of Propensity-Matched Patients Undergoing Aortic Valve Replacement Between 2005–2014
| TAVR (n= 197) | SAVR (n= 197) | P Value | |
|---|---|---|---|
| Clinical Outcome- no (%) | |||
| In-Hospital Death | 12 (6.1) | 27 (13.7) | 0.021 |
| Procedural Death | 0 (0) | 0 (0) | 0.99 |
| Vascular Complications | 23 (11.7) | 22 (11.2) | 0.99 |
| Vascular Complications Requiring Surgery | 10 (5.1) | 14 (7.1) | 0.523 |
| Pacemaker Implantation | 26 (13.2) | 11 (5.6) | 0.012 |
| Transient Ischemic Attack | 2 (1) | 0 (0) | 0.5 |
| Clinical Stroke | 4 (2) | 7 (3.6) | 0.549 |
| Blood Transfusion | 86 (43.7) | 112 (56.8) | 0.02 |
| Cardiac Tamponade | 1 (0.5) | 4 (2) | 0.375 |
| Discharge Status- no (%) | 0.002 | ||
| Discharged Home | 123 (62.4) | 82 (41.1) | |
| Discharged SNF8/NH9/IC10 | 62 (31.5) | 87 (44.7) | |
| Length of Stay- mean (SD), d | 11 (11) | 19 (16) | <0.0001 |
| Cost of Hospitalization (SD), $ | 73048 (52323) | 95784(83739) | 0.001 |
Skilled nursing facility
Nursing home
Intermediate care
Utilization of aortic valve replacement in dialysis patients with aortic stenosis increased 3-fold between 2005–2014.
In propensity matched patients, in-hospital mortality was two-fold higher following surgical versus transcatheter aortic valve replacement.
Rates of major morbidities, mean hospital length of stay and cost of hospitalization were also higher after surgical vs. transcatheter valve replacement.
Transcatheter aortic valve replacement offers significant advantages over surgical replacement in dialysis patients.
Acknowledgments
Funding sources: none.
Footnotes
Disclosures: none
All authors had access to the data and a role in writing the manuscript FA, SA reviewed the literature and performed the initial analysis. SA also created the figures and illustrations. KB, AS, EM performed secondary analyses, sensitivity analysis and ensured authenticity of the data. MA reviewed the data, verified the analysis, and wrote the manuscript. CSR and DRH reviewed the manuscript and provided editorial comments/changes, and made significant changes to the discussion.
Conflicts of interest: none.
Publisher's Disclaimer: This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
References
- 1.Ohara T, Hashimoto Y, Matsumura A, Suzuki M, Isobe M. Accelerated progression and morbidity in patients with aortic stenosis on chronic dialysis. Circ J. 2005;69:1535–1539. doi: 10.1253/circj.69.1535. [DOI] [PubMed] [Google Scholar]
- 2.London GM, Pannier B, Marchais SJ, Guerin aP. Calcification of the aortic valve in the dialyzed patient. Journal of the American Society of Nephrology : JASN. 2000;11:778–783. doi: 10.1681/ASN.V114778. [DOI] [PubMed] [Google Scholar]
- 3.Herzog CA, Ma JZ, Collins AJ. Long-Term Survival of Dialysis Patients in the United States With Prosthetic Heart Valves Should. Circulation. 2002 doi: 10.1161/hc1102.100075. [DOI] [PubMed] [Google Scholar]
- 4.Kaplon RJ, Cosgrove DM, 3rd, Gillinov AM, Lytle BW, Blackstone EH, Smedira NG. Cardiac valve replacement in patients on dialysis: influence of prosthesis on survival. Ann Thorac Surg. 2000;70:438–441. doi: 10.1016/s0003-4975(00)01544-7. [DOI] [PubMed] [Google Scholar]
- 5.Horst M, Mehlhorn U, Hoerstrup SP, Suedkamp M, de Vivie ER. Cardiac surgery in patients with end-stage renal disease: 10-year experience. Ann Thorac Surg. 2000;69:96–101. doi: 10.1016/s0003-4975(99)01133-9. [DOI] [PubMed] [Google Scholar]
- 6.Brinkman WT, Williams WH, Guyton RA, Jones EL, Craver JM. Valve replacement in patients on chronic renal dialysis: implications for valve prosthesis selection. The Annals of Thoracic Surgery. 2002;74:37–42. doi: 10.1016/s0003-4975(02)03692-5. [DOI] [PubMed] [Google Scholar]
- 7.Thourani VH, Keeling WB, Sarin EL, et al. Impact of Preoperative Renal Dysfunction on Long-Term Survival for Patients Undergoing Aortic Valve Replacement. The Annals of Thoracic Surgery. 2011;91:1798–1807. doi: 10.1016/j.athoracsur.2011.02.015. [DOI] [PubMed] [Google Scholar]
- 8.Thourani VH, Sarin EL, Keeling WB, et al. Long-Term Survival for Patients With Preoperative Renal Failure Undergoing Bioprosthetic or Mechanical Valve Replacement. The Annals of Thoracic Surgery. 2011;91:1127–1134. doi: 10.1016/j.athoracsur.2010.12.056. [DOI] [PubMed] [Google Scholar]
- 9.Leon MB, Smith CR, Mack M, et al. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010;363:1597–1607. doi: 10.1056/NEJMoa1008232. [DOI] [PubMed] [Google Scholar]
- 10.Popma JJ, Adams DH, Reardon MJ, et al. Transcatheter aortic valve replacement using a self-expanding bioprosthesis in patients with severe aortic stenosis at extreme risk for surgery. J Am Coll Cardiol. 2014;63:1972–1981. doi: 10.1016/j.jacc.2014.02.556. [DOI] [PubMed] [Google Scholar]
- 11.Kobrin DM, McCarthy FH, Herrmann HC, et al. Transcatheter and Surgical Aortic Valve Replacement in Dialysis Patients: A Propensity-Matched Comparison. The Annals of Thoracic Surgery. 2015;100:1230–1237. doi: 10.1016/j.athoracsur.2015.05.039. [DOI] [PubMed] [Google Scholar]
- 12.Ailawadi G, LaPar DJ, Speir AM, et al. Contemporary Costs Associated With Transcatheter Aortic Valve Replacement: A Propensity-Matched Cost Analysis. Ann Thorac Surg. 2016;101:154–160. doi: 10.1016/j.athoracsur.2015.05.120. discussion 160. [DOI] [PubMed] [Google Scholar]
- 13.Reynolds MR, Lei Y, Wang K, et al. Cost-Effectiveness of Transcatheter Aortic Valve Replacement With a Self-Expanding Prosthesis Versus Surgical Aortic Valve Replacement. J Am Coll Cardiol. 2016;67:29–38. doi: 10.1016/j.jacc.2015.10.046. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 14.Klarenbach SW, Tonelli M, Chui B, Manns BJ. Economic evaluation of dialysis therapies. Nat Rev Nephrol. 2014;10:644–652. doi: 10.1038/nrneph.2014.145. [DOI] [PubMed] [Google Scholar]
- 15.Waikar SS, Wald R, Chertow GM, et al. Validity of International Classification of Diseases, Ninth Revision, Clinical Modification Codes for Acute Renal Failure. J Am Soc Nephrol. 2006;17:1688–1694. doi: 10.1681/ASN.2006010073. [DOI] [PubMed] [Google Scholar]
- 16.Team RC. R: A Language and Environment for Statistical Computing. R Foundation for Statistical Computing; 2014. [Google Scholar]
- 17.Schneeweiss S. Sensitivity analysis and external adjustment for unmeasured confounders in epidemiologic database studies of therapeutics. Pharmacoepidemiol Drug Saf. 2006;15:291–303. doi: 10.1002/pds.1200. [DOI] [PubMed] [Google Scholar]
- 18.Szerlip M, Kim RJ, Adeniyi T, et al. The outcomes of transcatheter aortic valve replacement in a cohort of patients with end-stage renal disease. Catheter Cardiovasc Interv. 2016;87:1314–1321. doi: 10.1002/ccd.26347. [DOI] [PubMed] [Google Scholar]
- 19.Buttner S, Weiler H, Zoller C, et al. Aortic Valve Stenosis in a Dialysis Patient Waitlisted for Kidney Transplantation. Ann Thorac Surg. 2016;102:e437–e438. doi: 10.1016/j.athoracsur.2016.04.033. [DOI] [PubMed] [Google Scholar]
- 20.Kim D, Shim CY, Hong GR, et al. Effect of End-Stage Renal Disease on Rate of Progression of Aortic Stenosis. Am J Cardiol. 2016;117:1972–1977. doi: 10.1016/j.amjcard.2016.03.048. [DOI] [PubMed] [Google Scholar]
- 21.2015 USRDS Annual Data Report Volume 2: ESRD in the United States. 2015. [Google Scholar]
- 22.Saran RRB, Shahinian V. United States Renal Data System. 2016 USRDS annual data report: Epidemiology of kidney disease in the United States. Am J Kidney Dis. doi: 10.1053/j.ajkd.2016.12.004. (in press) [DOI] [PMC free article] [PubMed] [Google Scholar]
- 23.Tanaka K, Tajima K, Takami Y, et al. Early and Late Outcomes of Aortic Valve Replacement in Dialysis Patients. The Annals of Thoracic Surgery. 2010;89:65–70. doi: 10.1016/j.athoracsur.2009.10.026. [DOI] [PubMed] [Google Scholar]
- 24.Dumonteil N, van der Boon RM, Tchetche D, et al. Impact of preoperative chronic kidney disease on short- and long-term outcomes after transcatheter aortic valve implantation: a Pooled-RotterdAm-Milano-Toulouse In Collaboration Plus (PRAGMATIC-Plus) initiative substudy. Am Heart J. 2013;165:752–760. doi: 10.1016/j.ahj.2012.12.013. [DOI] [PubMed] [Google Scholar]
- 25.Allende R, Webb JG, Munoz-Garcia AJ, et al. Advanced chronic kidney disease in patients undergoing transcatheter aortic valve implantation: insights on clinical outcomes and prognostic markers from a large cohort of patients. Eur Heart J. 2014;35:2685–2696. doi: 10.1093/eurheartj/ehu175. [DOI] [PubMed] [Google Scholar]
- 26.Ferro CJ, Chue CD, de Belder MA, et al. Impact of renal function on survival after transcatheter aortic valve implantation (TAVI): an analysis of the UK TAVI registry. Heart. 2015;101:546–552. doi: 10.1136/heartjnl-2014-307041. [DOI] [PubMed] [Google Scholar]
- 27.Walther T, Hamm CW, Schuler G, et al. Perioperative Results and Complications in 15,964 Transcatheter Aortic Valve Replacements: Prospective Data From the GARY Registry. J Am Coll Cardiol. 2015;65:2173–2180. doi: 10.1016/j.jacc.2015.03.034. [DOI] [PubMed] [Google Scholar]
- 28.Ohno Y, Attizzani GF, Barbanti M, et al. Transcatheter Aortic Valve Replacement for Severe Aortic Stenosis Patients Undergoing Chronic Dialysis. Journal of the American College of Cardiology. 2015;66:93–94. doi: 10.1016/j.jacc.2015.03.598. [DOI] [PubMed] [Google Scholar]
- 29.Yamashita K, Taniguchi S. Transcatheter Aortic Valve Implantation for Chronic Dialysis Patients in Japan. Circ J. 2015;79:2557–2559. doi: 10.1253/circj.CJ-15-1104. [DOI] [PubMed] [Google Scholar]
- 30.Holmes DR, Jr, Nishimura RA, Grover FL, et al. Annual Outcomes With Transcatheter Valve Therapy: From the STS/ACC TVT Registry. J Am Coll Cardiol. 2015;66:2813–2823. doi: 10.1016/j.jacc.2015.10.021. [DOI] [PubMed] [Google Scholar]
- 31.STS/ACC. adjusted TAVR in-hospital mortality risk. [Google Scholar]
- 32.Grover FL, Vemulapalli S, Carroll JD, et al. 2016 Annual Report of the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry. J Am Coll Cardiol. 2016
- 33.Holmes DR, Jr, Brennan JM, Rumsfeld JS, et al. Clinical outcomes at 1 year following transcatheter aortic valve replacement. JAMA. 2015;313:1019–1028. doi: 10.1001/jama.2015.1474. [DOI] [PubMed] [Google Scholar]
Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.