Author + information
- Received October 4, 2018
- Revision received November 13, 2018
- Accepted November 14, 2018
- Published online March 4, 2019.
- Siddharth A. Wayangankar, MDa,∗ (, )
- Islam Y. Elgendy, MDa,
- Qun Xiang, MSb,
- Hani Jneid, MDc,
- Sreekanth Vemulapalli, MDb,
- Tigran Khachatryan, MDd,
- Don Pham, MDe,
- Anthony A. Hilliard, MDd and
- Samir R. Kapadia, MDf
- aDivision of Cardiovascular Medicine, Department of Medicine, University of Florida, Gainesville, Florida
- bDuke Cardiovascular Research Institute, Durham, North Carolina
- cDivision of Cardiovascular Medicine, Baylor College of Medicine, Houston, Texas
- dDivision of Cardiovascular Medicine, Loma Linda University, Loma Linda, California
- eMemorial Hermann Hospital, Houston, Texas
- fDepartment of Cardiology, Cleveland Clinic, Cleveland, Ohio
- ↵∗Address for correspondence:
Dr. Siddharth A. Wayangankar, Division of Cardiovascular Medicine, Department of Medicine, University of Florida, 7919 SW 79th Drive, Gainesville, Florida 32610.
Objectives The goal of this study was to investigate the trends, predictors, and outcomes of delayed discharge (>72 h) after transcatheter aortic valve replacement.
Background Length of stay post–transcatheter aortic valve replacement may have significant clinical and administrative implications.
Methods Data from the Transcatheter Valve Therapy Registry were used to identify patients undergoing nonaborted transfemoral transcatheter aortic valve replacement who survived to discharge, and data linked from the Centers for Medicare & Medicaid Services were used to provide 1-year events. Patients were categorized to early discharge (≤72 h) versus delayed discharge (>72 h). The trends, predictors, and adjusted 1-year outcomes were compared in both groups.
Results From 2011 to 2015, a total of 13,389 patients (55.1%) were discharged within 72 h, whereas 10,896 patients (44.9%) were discharged beyond 72 h. There was a significant decline in rates of delayed discharge across the study period (62% vs. 34%; p < 0.01). This remained unchanged when stratified by Transcatheter Valve Therapy risk scores. Several factors were identified as independent predictors of early and delayed discharge. After adjustment for in-hospital complications, delayed discharge was an independent predictor of 1-year all-cause mortality (hazard ratio: 1.45; 95% confidence interval: 1.30 to 1.60; p < 0.01).
Conclusions Rates of delayed discharge have declined from 2011 to 2015. Delayed discharge is associated with a significant increase in mortality even after adjusting for in-hospital complications. Further work is necessary to determine if predictors of early discharge could be used to develop length of stay scores that might be instrumental in administrative, financial, or clinical policy development.
Transcatheter aortic valve replacement (TAVR) has emerged as a suitable alternative for surgical aortic valve replacement for intermediate- to high-risk patients with severe aortic stenosis (1–5). Recent enhancement in techniques, devices, and improved operator experience has largely contributed to the improved outcomes and lower procedure-related complications with TAVR (6). These improvements have led to a more widespread adoption of a “minimalist” approach using monitored anesthesia care/local anesthesia and avoidance of post-procedure intensive care stay for selective transfemoral (TF) TAVRs (7). The biggest push behind this “minimalist approach” has been to limit direct procedural costs, but more importantly to abbreviate the length of stay (LOS) thereby minimizing post-procedure costs; the latter being a large contributor to total TAVR costs. Because the procedures are becoming less invasive, the LOS after the procedure is expected to become shorter. Several single-center studies have suggested that an early discharge strategy (<72 h) is safe and feasible after TF-TAVR (8–10). A strategy of early discharge is important from administrative and financial viewpoints. Thus, the aim of this study was to investigate the trends, predictors, and outcomes of delayed discharge (≥72 h) after TAVR using a nationally representative dataset.
The Society of Thoracic Surgery/American College of Cardiology Transcatheter Valve Therapy (STS/ACC TVT) Registry was founded in 2011. Facilities performing TAVR procedures are required to submit commercial cases to the registry for Medicare reimbursement. The data are linked with inpatient Medicare administrative claims by the Centers for Medicare and Medicaid Services using directed patient identifiers. The TVT Registry contains clinical information including patient baseline demographics, comorbidities, functional status, and procedural details, and 1-year outcomes using standardized definitions on all patients undergoing TAVR at a participating facility. This approach of acquiring the data and ascertainment of events in the STS/ACC TVT Registry has been previously published (6,11). The Duke University School of Medicine institutional review board granted a waiver of informed consent for this study.
For the purpose of this study, we included all patients ≥18 years who underwent TF-TAVR from November 1, 2011 to September 30, 2015, from the TVT Registry. Patients were excluded if: 1) they died during the hospitalization; 2) the procedure was aborted or canceled; or 3) they were transferred or discharged to any facility other than home (because some institutions might choose to discharge patients to another facility as a method to artificially lower the LOS). Based on the hospital LOS, patients were categorized into early discharge group (i.e., discharge within ≤72 h) or delayed discharge group (i.e., discharge beyond 72 h).
The 1-year individual outcomes included time to event occurrence of all-cause mortality, myocardial infarction (MI), and stroke. The composite endpoint included a composite of major adverse cardiac events, defined as the composite of all-cause mortality, MI, stroke, or major bleeding. The data for these outcomes were obtained through Medicare administrative claims records for rehospitalization for these events using International Classification of Diseases-9th Revision (n = 12,479)-Clinical Modification codes for MI (410.x0 and 410.x1) and stroke (433.x1, 434.x1, 997.02, 436, 437.1, 437.9, 430, 431, and 432.x).
Baseline characteristics and in-hospital complications were presented for the early discharge versus the delayed discharge groups. Categorical variables were reported as percentages. The baseline characteristics and in-hospital complications of the early discharge group and delayed discharge group were compared using Pearson chi-square test for categorical variables. Multivariable logistic regression models with generalized estimating equation were constructed to estimate odds ratios and corresponding 95% confidence intervals for early or delayed discharge. A robust covariance matrix estimator was used to account for the effect of cluster between the hospitals. We calculated the incidence of the delayed discharges in each quarter across the study period, with the total number of TF-TAVR procedures as the denominator. The Cochran-Armitage test was used to show the probability of delayed discharge rates over time. The trend analyses were stratified based on the STS Predicted Risk of Operative Mortality score.
Kaplan-Meier analyses were used to compute the incidences of death and nonfatal outcomes at 1-year post-TAVR for patients in the early discharge and delayed discharge groups. For the survival analyses of the nonfatal outcomes, such as stroke and MI, we incorporated the competing effect of death on the risk of these outcomes using Gray test (12). A Cox proportional hazards model was applied to examine the association of LOS and the outcomes at 1 year. The model was adjusted for variables listed in Online Table 1. The risk of outcomes of interest for those in the early discharge versus delayed discharge groups were reported using hazard ratios with 95% confidence interval. All statistical analyses were conducted using SAS version 9.4 (SAS Institute Inc., Cary, North Carolina), and a p < 0.05 was considered statistically significant for all analyses.
During the study period from November 1, 2011, to September 30, 2015, a total of 24,285 patients underwent nonaborted TF-TAVR and survived to discharge: 13,389 patients (55.1%) were discharged within 72 h (i.e., early discharge group), whereas 10,896 patients (44.9%) were discharged beyond 72 h (i.e., delayed discharge group). Data for Centers for Medicare & Medicaid Services linkage for the 1-year outcomes were available for 12,479 patients (51.4% of the entire cohort). The median follow-up estimate was 365 days (Q1, 217; Q3, 365). Table 1 summarizes the baseline characteristics of patients in both groups. Patients in the early discharge group were older, men, white, had diabetes, had a history of MI, prior revascularization (percutaneous coronary intervention or coronary artery bypass surgery), and were more likely to have a history of prior pacemaker or defibrillator and a previous history of aortic valve procedure. Patients in the late discharge group were likely to have underlying severe lung disease, or history of mitral valve procedure.
Temporal trends of delayed discharge
During the study period, there was a significant decline in the rates of delayed discharge (62.2% in the 2012 Q1 vs. 34.4% 2015 Q3; p < 0.01) (Figure 1). This decline in the rates of delayed discharge was noted during the study period across every STS Predicted Risk of Operative Mortality score subgroup (Figure 2).
Predictors of early and delayed discharge
Table 2 depicts the predictors of delayed discharge after multivariate analyses. Age ≥85 years, African Americans, Hispanics, patients with prior mitral valve procedures, presence of diabetes, home oxygen, New York Heart Association functional class IV, cardiogenic shock, need for ionotropes, need for mechanical support, atrial fibrillation, dialysis, glomerular filtration rate <30, right ventricular systolic pressure >60 mm Hg, institutional volume 200 to 399 cases/year, cut down access technique, >10 s on walk test, and use of self-expanding valve were independent predictors for delayed discharge. In contrast, presence of prior intracardiac devices, prior coronary artery bypass surgery, smokers, prior MI, valve-in-valve, and percutaneous access were independent predictors of early discharge.
Outcomes at 1 year
Figure 3A shows the comparison of outcomes based on LOS. The composite of death, stroke, MI, or bleeding was significantly higher in patients who had delayed discharge compared with early discharge. This was mainly driven by increased mortality in the former group. Delayed discharge post-TAVR was significantly associated with higher 1-year all-cause mortality with separation of curves noted immediately post-procedure (Figure 3B). The results of survival analysis (adjusted and unadjusted data) on mortality and cumulative incidence of nonfatal outcomes at 1-year without, and with in-hospital complication are shown in Table 3. As observed from the tables, even after adjusting for in-hospital complications, delayed discharge was an independent predictor of 1-year all-cause mortality (hazard ratio: 1.45; 95% confidence interval: 1.30 to 1.60; p < 0.01).
This is the first large-scale study looking into LOS post-TF-TAVR. Our study showed that from 2011 to 2015 around 55% of the patients were discharged within 72 h. There was a significant decline in rates of delayed discharge across the study period (62% vs. 34%; p < 0.01). Regardless of whether patients had post-procedural complications or not, delayed discharge was an independent predictor of increased 1-year all-cause mortality (hazards ratio: 1.45; 95% confidence interval: 1.30 to 1.60; p < 0.01).
Decline in delayed discharge
Our study showed that on an average, more than one-half of the TF-TAVRs end up having delayed discharge during the study period. However, it is encouraging to note that the prevalence of delayed discharge has shown a consistent decline from 2011 to 2015 (62% to 34%). The biggest drop was noted across 2014 Q2 (about 10%). Although the financial feasibility of TAVR was always questioned since its inception, it was during 2014 to 2016 that the concept of “minimalistic TAVR” gained wider acceptance. Appropriate patient selection, modified monitored anesthesia care, post-procedure care in post-anesthesia care units, and lower threshold to remove temporary pacemaker post-procedure have all significantly helped institutions curtail operating costs. More importantly, this trend persisted when patients were analyzed stratified based on the STS risk (Figure 2). This speaks to the nationwide system-based changes aiming to optimize TAVRs that have been universally adopted by all TAVR programs across the country. These changes that were designed to optimize TAVR (and improve financial and administrative feasibility of TAVR programs) have had an indirect effect in negating the effect of high TVT scores on LOS in patients undergoing TF-TAVR.
Predictors of delayed discharge
Advanced age (≥85 years) was found to be an independent predictor for delayed discharge. Advanced age is usually associated with advanced frailty, lower functional capacity, increased burden of comorbidities, and higher risk for periprocedural vascular and nonvascular complications, all factors that can delay discharge to home (13). A testimony to this fact that is that >10 s on walk test (a surrogate marker for frailty) was independently associated with delayed discharge in our study. Also, our study excluded patients discharged to nursing homes, a feature common in octogenarians and nonagenarians post-surgery or advanced procedures. Hence the impact of age on discharge to home may actually be underestimated in our study. As observed in many other cardiovascular studies (14), racial disparity in outcomes was observed in our study as well. African American and Hispanic race were associated with delayed discharge. Whether this was caused by increased disease burden in certain races or related to differential demographic and clinical variables among different races remains a matter of speculation. Our study shows interesting phenomena with respect to LOS and institutional volume. Institutions performing 200 to 399 cases per year were associated with delayed discharge. This phenomenon was not observed when institutions performed <100 cases per year or >400 cases per year. A combination of patient selection and proficiency of TAVR programs may be responsible for this observed effect. The institutions performing <100 cases per year are relatively lower volume centers who prefer to super-select certain straightforward TAVR cases or might chose more appropriate cases and therefore have minimal impact on delayed discharge. However, institutions >400 cases per year despite potentially receiving high-risk case referrals have years of experience and have therefore streamlined their TAVR programs, which effectively blunts the effect of high-risk cases on delayed discharge. Institutions who are in between are in a transition phase where they are trying to increase their institutional volumes but have not yet perfected the art of careful patient selection; hence the strong association with delayed discharge. Interestingly, the use of self-expanding valves was found to be a predictor for delayed discharge. We believe this may have been related to the practice of keeping temporary pacemakers for >48 h post-procedure in every patient with core-valve, a mandated requirement in some of the self-expanding valve trials. In addition, some centers still practice surgical cut down when using self-expanding valves, which might be another contributor for the delayed discharge seen with this type of device.
Predictors of early discharge
Interestingly, patients with prior MI or prior coronary artery bypass surgery were found to be independent predictors for early discharge. The reason for this paradox is unknown but favorable outcomes within the same subgroup have been noted in prior studies with cardiogenic shock patients undergoing percutaneous coronary intervention (15). In the latter study, it seemed that patients with prior coronary artery disease and revascularization did better than naive patients when they underwent percutaneous coronary intervention for cardiogenic shock and the authors in that study attributed to the benefit to ischemic pre-conditioning and better integration of these patients into local medical systems because of their prior coronary artery disease. It is hence possible that a similar benefit may have accrued in our study patients. Another group of patients who seemed to have had an impact on the early discharge favorably were the patients with prior intracardiac devices. This may have been driven by lesser need for prolonged in-hospital electrical monitoring favoring expedited discharge. An early discharge in patients with moderate-severe aortic insufficiency may be explained by dual hemodynamic benefit of treating 2 coexisting valvular lesions. A smoker’s paradox was also noted with regards to LOS. This has been noted in a few cardiovascular outcome studies; however, the exact mechanism for this effect remains speculative at best. Valve-in-valve therapies seem to do better because the native heart (electrical, circulatory, and annular structure) is relatively protected by the prior surgical valve and most common reasons for delay in discharge are therefore mitigated (16). Finally, percutaneous access to TF-TAVR has allowed efficient optimization of TF-TAVR procedures and helped by obviating general anesthesia, expedited early recovery, mobilization, and hence early discharge post-procedure. These predictors (of delayed and early discharge) could be used to develop risk scores that could be used by clinicians for appropriate patient selection and use of resources by administrators, insurance companies, and policy makers to formulate stratified bundle payments for TAVR procedures in future.
One of the most clinically significant finding in our study is that the LOS does have significant association with short- and long-term outcomes. The Kaplan-Meier curves demonstrated that patients with delayed discharge had significantly worse 1-year outcomes compared with early discharge cohort. Although this could be as a result of residual uncaptured difference in terms of patients' risk profile, the adjusted analyses also demonstrated that early discharge is associated with a lower 1-year mortality. Delayed discharge portends a significantly higher risk of composite of death, stroke, MI, and bleeding compared with early discharge. This effect was mainly driven by increased mortality and bleeding (requiring hospitalization) in the former group. Because procedural complications have huge implications on LOS and morbidity and mortality, we analyzed our data for outcomes with/without adjusting for occurrence of complications and found similar results. This is significant and indicates that regardless of the occurrence of procedural complications, delayed discharges are a group of TF-TAVR patients who are at higher risk for mortality compared with the early discharge group. Development of pre-procedural and post-procedural risk scores would help in proper patient selection and more importantly post-procedurally help in planning closer follow-up and more rigorous risk factor modification in the delayed discharge to mitigate the risk of higher mortality.
First, this study is observational in nature. Despite applying statistical analyses to adjust for the differences in the baseline characteristics and in-hospital complications, the risk of residual confounding could not be entirely excluded. Second, although there is standardization and uniformity in the TVT Registry, the data are only internally validated at sites and not centrally adjudicated. Third, the field of TF-TAVR had rapid changes in patient selection, techniques, and post-procedural care; hence, our study results may not entirely be representative of the current practice standards. Finally, the 1-year outcome data were driven from an administrative database, thus the outcomes might have been overestimated. However, this approach has been adopted in previous studies from the TVT Registry (6,11) and other National Cardiovascular Data Registry databases.
This is the first study that describes the patterns of LOS post-TAVR from a large nationwide database. LOS post-TF-TAVR has significantly decreased from 2011 to 2015; and with continued refinement in techniques and patient selection, we anticipate this trend would continue. Predictors of delayed discharge and early discharge could be used by clinicians, administrators, and third-party payers to better serve this ever-expanding field of percutaneous valve therapies. Finally, regardless of the presence of procedure-related complications, delayed discharge is associated with a significant risk of mortality at 1 year.
WHAT IS KNOWN? LOS post-TAVR may have significant clinical and administrative implications.
WHAT IS NEW? LOS for patients undergoing transfemoral TAVR has significantly decreased from 2011 to 2015. Delayed discharge is associated with a significant increase in mortality even after adjusting for in-hospital complications.
WHAT IS NEXT? Predictors of early/delayed discharge could be used to develop LOS scores, which might be instrumental in administrative, financial, or clinical policy development.
Dr. Wayangankar is a proctor for Medtronic Valve therapies. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Abbreviations and Acronyms
- length of stay
- myocardial infarction
- STS/ACC TVT
- Society of Thoracic Surgery/American College of Cardiology Transcatheter Valve Therapy Registry
- transcatheter aortic valve replacement
- Received October 4, 2018.
- Revision received November 13, 2018.
- Accepted November 14, 2018.
- 2019 American College of Cardiology Foundation
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