Feasibility and Safety of Adopting Next-Day Discharge as First-Line Option After Transfemoral Transcatheter Aortic Valve Replacement

Abstract: Objectives. Data on next-day discharge (NDD) after transcatheter aortic valve replacement (TAVR) are limited. This study investigated the feasibility and safety of NDD as a first-line option (the very-early discharge [VED] strategy) compared with the early-discharge (ED) strategy (2-3 days as a first-line option) after TAVR. Methods. We reviewed 611 consecutive patients who had minimalist TAVR (transfemoral approach under conscious sedation) and no in-hospital mortality; a total of 418 patients underwent ED strategy (since December 2013) and 193 patients underwent VED strategy (as part of a hospital initiative to reduce length of stay, since August 2016). NDD in the VED strategy was performed with heart team consensus in patients without significant complications. The primary outcome was a composite of 30-day all-cause mortality/rehospitalization. Results. Sixty-five patients (33.7%) in the VED strategy and 10 patients (2.4%) in the ED strategy were discharged the next day (P<.001). NDD patients had received balloon-expandable (n = 30) or self-expanding valves (n = 45) and showed a similar primary outcome rate compared with non-NDD patients. After adjustment using propensity score matching (172 pairs), post-TAVR length of stay was significantly shorter in the VED group (3.2 ± 3.1 days) than in the ED group (3.5 ± 2.7 days; P<.01). The primary outcome did not differ between the two groups (7.0% vs 11.6%; P=.14), with comparable 30-day mortality rate (1.2% vs 2.3%; P=.68) and rehospitalization rate (5.8% vs 11.1%; P=.08). Conclusions. Utilization of NDD as a first-line option after minimalist TAVR is feasible and safe, and leads to further reduction in length of stay compared with an ED strategy.

J INVASIVE CARDIOL 2019;31(3):64-72.

Key words: aortic stenosis, early discharge, minimalist approach, next-day discharge, transcatheter aortic valve replacement

Transcatheter aortic valve replacement (TAVR) has been accepted as an alternative therapeutic option to surgical aortic valve replacement (SAVR) in severe aortic stenosis patients who have moderate or higher surgical risk.^1,2 Ongoing improvements in devices and techniques have contributed to better TAVR outcomes, including decreased intraprocedural complication rate, postprocedural aortic regurgitation, and 30-day mortality rate.^3,4 These improvements also support the current adoption (initially by European and more recently by United States centers) of less invasive transfemoral TAVR, performed with local anesthesia and conscious sedation without transesophageal echocardiographic (TEE) guidance (ie, minimalist TAVR).^5,6 Recent reports suggest that while a minimalist TAVR approach delivers similar results compared with a conventional approach performed with general anesthesia and TEE, it also enables shorter postprocedural hospital length of stay (LOS).⁷

Our group and others have shown that early discharge (ED), where patients are discharged within 3 days after transfemoral TAVR, is safe and feasible.^8-11 Accordingly, more centers have increasingly adopted ED after TAVR, provided that patients have no major complications or conduction abnormalities requiring longer postprocedural observation. ED has the potential to reduce longer hospital-stay decline in elderly patients, and to mitigate the high costs associated with TAVR.

The concept of next-day discharge (NDD), barring any complications requiring more than 24-hour therapy or observation, is an attractive option to further minimize system costs while optimally maintaining the patient’s functional capacity post TAVR. However, the feasibility and safety of NDD are still unclear in this setting. This study investigated the feasibility and safety of routine NDD as a first-line option (the very-early discharge [VED] strategy) after minimalist transfemoral TAVR, compared with routine ED as a first-line option (the ED strategy).

Methods

Study population. This single-center study evaluated the outcomes of utilizing VED vs ED strategies in a tertiary-care setting. We reviewed 624 consecutive patients who underwent transfemoral TAVR with minimalist approach at our institution between December 2013 and September 2017. Of these, patients with in-hospital mortality (n = 13) were excluded from analysis. Driven by the implementation of minimalist TAVR in December 2013, we transitioned from a conventional discharge approach (since the initiation of TAVR in March 2011) to an ED strategy, with a goal of discharge on postprocedural day 2 to 3 as the first-line option. In August 2016, we further adopted a VED strategy as part of a hospital initiative to reduce LOS, with the goal of discharge on postprocedural day 1 as the first-line option, provided there were no complications requiring more than 24-hour observation.

The study was approved by the Institutional Review Board with a waiver of consent. Clinical data were collected from electronic medical records and entered into the REDCap (Research Electronic Data Capture) tool hosted at the University Hospitals Cleveland Medical Center.¹²

Treatment protocols. Minimalist TAVR procedures were performed in a standard cardiac catheterization laboratory with transthoracic echocardiography assistance, under local anesthesia and conscious sedation using commercially available valves, ie, self-expanding valves (CoreValve, Evolut R, Evolut PRO; Medtronic) or balloon-expandable valves (Sapien XT, Sapien 3; Edwards Lifesciences) via transfemoral approach, as previously described by our group.⁸ Vascular access was obtained percutaneously followed by double-ProGlide sutures (Abbott Vascular). In the ED strategy, patients were routinely discharged 2 or 3 days after the procedure, unless there were major complications or conduction abnormalities requiring longer postprocedural observation. Major complications included myocardial infarction, stroke, New York Heart Association (NYHA) class IV heart failure or postprocedural deterioration of heart failure, and complications that required long-term therapy or observation. Electrocardiograms were obtained systematically at baseline, immediately after the procedure, and daily until discharge. Temporary pacemaker was removed after 24 hours of the procedure if no worsening conduction disturbances were observed. In the event of persistent high-degree atrioventricular block (AVB) necessitating permanent pacing, patients underwent permanent pacemaker (PPM) implantation 1 day post procedure. Patients with new onset left bundle-branch block (LBBB), first-degree AVB, or Mobitz I AVB remained eligible for ED, barring any further progression in conduction disturbance during the observation period. In the VED strategy, patients who met ED criteria were further encouraged to be discharged the next day if they did not have any complications including conduction abnormalities that required more than 24-hour postprocedural therapy or observation.

A multidisciplinary team of physicians, nurses, and social workers, along with the patient and family members, decided together on the appropriateness for discharge on an individualized basis for each patient. We prioritized patient safety and carefully selected candidates for NDD. Patients with significant deconditioning were referred to skilled nursing facility or short rehabilitation prior to discharge home. Per our protocol, patients who were discharged 1 day post procedure as part of the VED strategy were required to have a family member or friend present with them for the first 24 hours after discharge. Furthermore, patients were contacted by phone the following day by a critical care nurse knowledgable with post-TAVR complications, and within 1 week by an advanced practice provider at an outpatient clinic.  

Baseline, follow-up data, and study endpoints. Baseline clinical, echocardiographic and procedural details, and LOS post TAVR were recorded for all patients. Adverse events up to 30 days were obtained from chart review of inpatient admission documentation and outpatient follow-up notes, which were judged according to Valve Academic Research Consortium (VARC)-2 criteria¹³ during the TAVR procedure, in-hospital, and at 30-day follow-up. The rate and causes of rehospitalization during the follow-up period were also investigated. Transthoracic echocardiography was performed to assess implanted valve function prior to discharge. Clinical outcomes were compared between ED and VED strategies, and the primary endpoint of this study was the composite of all-cause mortality or rehospitalization at 30 days post TAVR.

Statistical analysis. Continuous variables are expressed as mean ± standard deviation. Categorical variables are expressed as absolute number and percentage. The Student’s t-test or Wilcoxon rank-sum test was used to compare continuous variables, and the Chi-square test or Fisher’s exact test was used to compare categorical variables, as appropriate. To control for confounding variables on the estimation of outcomes, we performed a propensity-score matched analysis. The propensity-score model included the following data based on the clinically important covariates: age, sex, race, Society of Thoracic Surgeons (STS) scores, NYHA classification, chronic obstructive pulmonary disease (COPD), diabetes, hypertension, peripheral arterial disease, previous stroke, dialysis status, creatinine, previous myocardial infarction, previous coronary artery bypass surgery, atrial fibrillation, baseline LBBB, left ventricular ejection fraction, aortic valve area, prosthesis type, transfusion, minor vascular complications, new PPM, new LBBB, and post-TAVR moderate/severe aortic regurgitation. The one-to-one pair matching was performed with a caliper width equal to 0.2. The rate of freedom from the primary composite endpoint was calculated by the Kaplan-Meier method with log-rank test. All analyses were two-sided, and significance was judged at P<.05. All statistical analyses were performed with JMP software (SAS Institute).

Results

Baseline characteristics, procedural outcomes, and in-hospital outcomes. After excluding 13 patients who had in-hospital mortality, a total of 611 patients were analyzed. Patients treated between December 2013 and July 2016 were allocated to ED strategy (n = 418) and those treated between August 2016 and September 2017 were allocated to VED strategy (n = 193).

Baseline preprocedural patient characteristics are found in Table 1. The mean patient age was 81.7 ± 8.6 years, and 53% of patients were male. Patients in the VED strategy had lower rates of NYHA class III or IV heart failure, COPD, and atrial fibrillation, while having a higher serum creatinine level. A significantly higher proportion of patients received a self-expanding bioprosthesis in the VED strategy (68.4% for VED vs 51.0% for ED; P<.001) as shown in Table 2. During hospitalization, there were no differences between the strategies in terms of complications including stroke, bleeding, and vascular complications, as well as the rates of new PPM implantation and post-TAVR moderate/severe aortic regurgitation.

Distribution of Post-TAVR LOS. The distribution of LOS after TAVR is shown in Figure 1. NDD was performed in 75 patients. Mean LOS was significantly shorter in the VED strategy (3.1 ± 3.1 days) than in the ED strategy (4.1 ± 3.9 days; P<.01) (Table 3). The VED strategy had more patients discharged the next day and within 3 days compared with the ED strategy (33.7% vs 2.4%, respectively, for next day [P<.001] and 73.6% vs 60.3%, respectively,  for ≤3 days [P=.001]).

Characteristics of patients with NDD. In the VED strategy, sixty-five patients with NDD had a lower STS score than 128 patients with non-NDD (5.5 ± 3.7% vs 7.8 ± 5.4%, respectively; P<.01), and were more likely to have prior PPM implantation (21.5% vs 10.2%, respectively; P=.03). Regarding periprocedural outcomes, transfusion (0.0% vs 12.5%; P<.01), new PPM implantation (4.6% vs 21.1%; P<.01), and new LBBB (9.2% vs 29.7%; P<.01) were less common in patients with NDD. Of note, none of the patients with NDD experienced stroke, myocardial infarction, life-threatening or major bleeding complications, transfusion, major vascular complications, or acute kidney injury (stage 2 or 3) during hospitalization.

Thirty-day outcomes. Adverse event rates at 30 days are presented in Table 4. During 30-day follow-up, a total of 11 deaths (1.8%) and 52 rehospitalizations (8.5%) occurred. At 30 days, there were no differences in the rates of the primary composite endpoint between the two strategies (6.7% for VED strategy vs 11.0% for ED strategy; P=.10) or other adverse outcomes, such as all-cause mortality, rehospitalization, and postdischarge new PPM implantation, as well as freedom from the primary composite endpoint, as calculated with the use of Kaplan-Meier analysis (P=.10) (Figure 2A). Heart failure was the most common reason for rehospitalization (2.9%) and the frequency was similar between the two strategies, whereas the rate of rehospitalization due to access-related complications was low (0.8%) in both strategies.

The propensity-score matching extracted a total of 172 pairs. Baseline characteristics, procedural outcomes, and in-hospital outcomes were well balanced after propensity-score matching, as shown by standardized differences. The VED strategy still had a greater proportion of patients with NDD compared with the ED strategy (33.1% vs 4.1%, respectively; P<.001), with consistently shorter post-TAVR LOS in the VED strategy (3.2 ± 3.1 days vs 3.5 ± 2.7 days; P<.01). There was no difference between the two strategies in the rates of the primary composite endpoint (7.0% for VED strategy vs 11.6% for ED strategy; P=.14), or in the rates of all-cause mortality (1.2% vs 2.3%; P=.68), rehospitalization (5.8% vs 11.1%; P=.08), and post-discharge new PPM implantation (0.6% vs 2.3%; P=.37) (Table 4). Additionally, time-to-event data (Kaplan-Meier analysis) also showed that rates of freedom from the primary composite endpoint during 30 days did not differ between the strategies (P=.14) (Figure 2B).

Effect of clinical factors on the association between discharge strategy and the primary composite endpoint. The primary composite endpoints of the two strategies were further analyzed for subgroups according to LOS, age, body mass index, NYHA, COPD, and prosthesis type. There were no significant interactions between the discharge strategy and these factors in either the overall cohort (Figure 3A) or the propensity-matched cohort (Figure 3B).    

Thirty-day outcomes of NDD. There were no differences between NDD patients (n = 75) and non-NDD patients (n = 536) in the rates of the primary composite endpoint (8.0% vs 9.9%, respectively; P=.60), all-cause mortality (0.0% vs 2.1%, respectively; P=.38), rehospitalization (8.0% vs 8.6%, respectively; P=.87), and post-discharge new PPM implantation (0.0% vs 1.5%, respectively; P=.60) (Supplementary Table S1. Patients with NDD were further divided into two groups by the transcatheter valve type; a total of 30 patients had balloon-expandable valves, while 45 patients had self-expanding valves. The primary composite endpoint and other adverse outcomes did not differ between the two groups (Supplementary Table S2).  

Discussion

The main findings of the present study are as follows. First, similar clinical outcomes in terms of 30-day mortality and rehospitalization rates were observed for two different discharge strategies after minimalist TAVR. Second, the VED strategy had significantly shorter mean LOS than the ED strategy after TAVR. Finally, low rates of 30-day mortality and rehospitalization were achieved with the VED strategy. These results were consistent after propensity-score matching and ultimately support the feasibility and safety of the VED strategy in patients undergoing minimalist transfemoral TAVR. In addition, NDD patients underwent TAVR using both balloon-expandable (n = 30) and self-expanding valves (n = 45) and showed a similar primary outcome rate compared with non-NDD patients.

Several reports have shown that ED (within 3 days) after transfemoral TAVR does not compromise safety,^8-11,14 while it does offer the advantage of reduced hospitalization costs.^15,16 However, in these studies, a very low percentage of NDD patients was included in the ED group. The safety of NDD has been directly evaluated in only a few studies with a very small number of patients.¹⁷ Recently, Kamioka et al¹⁸ showed similar 30-day mortality and rehospitalization rates between NDD and non-NDD patients in a retrospective observational study (n = 150 for NDD). However, patient selection bias was a potential caveat for NDD (ie, patients with better baseline characteristics and favorable results after TAVR would likely be selected for NDD and have better outcomes after discharge). Thus, it was difficult to draw a clear conclusion in terms of the safety of NDD from these results. In the current study, we significantly reduced the selection bias by comparing two different strategies defined by the study period according to our first-line approach, and included 65 patients (33.7%) with NDD in the VED strategy. We also showed the outcomes of NDD in 45 patients with self-expanding valves. In the previous reports, Rathore et al¹⁷ included only 2 patients with self-expanding valves (out of 22 patients) in the NDD cohort, and Kamioka et al¹⁸ studied only those with balloon-expandable valves. Thus, this study provides practical information in a clinical setting. Approximately one-third of patients underwent self-expanding valve implantation during TAVR in data from the Society of Thoracic Surgeons (STS)/American College of Cardiology (ACC) Transcatheter Valve Therapy (TVT) registry.¹⁹ The primary composite endpoint at 30 days did not differ between patients who had received balloon-expandable and self-expanding valves, and no patients with self-expanding valves experienced post-discharge new PPM implantation. Of note, our 30-day rehospitalization rates for ED and VED were both lower than the national benchmark rehospitalization rate of TAVR (17.9%).²⁰ Other previous studies have also reported higher rates of rehospitalization, with a range between 17.4%-20.9%.^21,22

TAVR in the inoperable or high surgical-risk patient has been demonstrated to provide good cost-effectiveness with favorable outcomes compared with SAVR or medical management.^23-25 In these studies, the shorter LOS was an important factor to offset the high costs of expensive transcatheter valve systems. From large clinical trial reports,^24,25 TAVR reduced LOS an average of 4.4-6.2 days relative to SAVR. When applying TAVR to patients at intermediate surgical risk, reduction in the LOS may be even more meaningful in terms of cost-effectiveness, as the survival and quality-of-life benefit of TAVR compared with SAVR may be reduced in these patients. Although we did not analyze cost-effectiveness of the VED strategy in the current study, average LOS after TAVR was 3.1 days, while in the latest report from SURTAVI trial of intermediate surgical-risk patients, the LOS after TAVR was 5.8 days on average.² Data from the STS/ACC TVT registry showed a mean post-TAVR LOS of 6.2 days;²⁶ substantially shorter LOS was successfully achieved with our VED strategy. Additionally, for elderly patients, who are the majority of the TAVR population, shorter LOS is beneficial considering the potential reduction in known negative outcomes of hospitalization (eg, reduced functional status, infection, or delirium).^27,28

One of the concerns to be discussed in the implementation of the VED strategy is the incidence of conduction disturbances after TAVR. PPM implantation still remains one of the most frequent complications of TAVR.^29,30 However, until now, an evidence-based strategy has not been established regarding the duration of continuous electrocardiogram monitoring required after TAVR.³¹ From these backgrounds, conduction abnormalities should be assessed with discretion during and after the procedure using continuous rhythm monitoring and electrocardiogram. If there is a possibility of advancing to high-degree AVB, such as persistent new-onset LBBB, or deterioration of PR or QRS interval, monitoring should be continued over 24 hours after the procedure. Moreover, other complications such as groin complications and heart failure symptoms should also be carefully followed during hospitalization and after discharge. In the current study, patients with NDD were followed by phone on the second day after the procedure (the next day after discharge), and at an outpatient clinic within 1 week. Finally, a multifaceted approach to the patient, including assessment of daily-life activity, family support, and accessibility to the hospital, is key for final decision-making regarding NDD.

Study limitations. This study has several limitations that warrant mention. The present study is limited by its observational, non-randomized design; however, comparison based on the two different study periods can minimize the selection bias that has been observed in previous reports where patients were divided according to the LOS. Propensity-score matching was used to reduce differences in baseline and procedural characteristics, given the fact that indication for TAVR was expanded to include intermediate surgical risk patients after the initiation of the VED strategy. The propensity-score model also included in-hospital complications to reduce performance bias related to operator experience. However, clinical characteristics that were difficult to quantify may have existed between the two strategies, eg, a difference in decision-making for PPM implantation. In the VED strategy, less than half of patients were discharged the next day. The final decision of discharge for an individual patient was made by a multidisciplinary team discussion, and patients were carefully selected for NDD.

Conclusion

We conclude that the VED strategy, which is characterized by NDD as a first-line option, is feasible and can be safely performed in patients undergoing minimalist transfemoral TAVR. Use of this strategy further reduced LOS compared with the ED strategy, which may ultimately mitigate high costs associated with TAVR and improve patient experience.

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From the ¹Valve & Structural Heart Disease Intervention Center, Division of Cardiovascular Medicine, Harrington Heart and Vascular Institute, University Hospitals Cleveland Medical Center, Cleveland, Ohio; ²Department of Medicine, Case Western Reserve University School of Medicine, Cleveland, Ohio; ³Interventional Cardiology, Heart Specialists of St. Rita’s, St. Rita’s Medical Center, Mercy Health, Lima, Ohio; ⁴Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine, Osaka, Japan; and ⁵The Valve & Structural Heart Disease Intervention Center, Division of Cardiovascular Surgery, Harrington Heart and Vascular Institute, University Hospitals Cleveland Medical Center, Cleveland, Ohio.

Disclosure: The authors have completed and returned the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Sandeep Patel reports honoraria and personal fees from Abbott Vascular, Boston Scientific, and Medtronic. Dr Li serves as a consultant for Medtronic and Abbott Vascular. Dr Bezerra is a consultant for Edwards Lifesciences, Medtronic, and Abbott Vascular. Dr Kalra reports personal fees from Medtronic and Philips. Dr Attizzani is a consultant and proctor for Edwards Lifesciences and Medtronic; consultant for Abbott Vascular. The remaining authors report no conflicts of interest regarding the content herein.

Manuscript submitted November 19, 2018, provisional acceptance given November 28, 2018, final version accepted December 3, 2018.

Address for correspondence: Yasuhiro Ichibori, MD, PhD, Division of Cardiovascular Medicine University Hospitals Cleveland Medical Center, 11100 Euclid Avenue, Cleveland, OH 44106. Email: yasuhiro11ichibom@gmail.com