Unplanned Hospital Readmissions After Transcatheter Aortic Valve Replacement in the Era of New-Generation Devices

Abstract

Objectives. Unplanned hospital readmissions after transcatheter aortic valve replacement (TAVR) are frequent and have been associated with a poor prognosis. We sought to determine the trends in the incidence and causes of unplanned hospital readmission after TAVR in patients receiving new-generation devices (NGDs) vs early-generation devices (EGDs). Methods. The study population consisted of 1802 consecutive TAVR recipients (863 EGDs and 939 NGDs). Early and late readmissions were defined as those occurring ≤30 days and >30 days to 1-year post TAVR, respectively. Results. A total of 986 unplanned hospital readmissions (cardiac cause, 38.4%; non-cardiac cause, 61.6%) were recorded at a median time of 110 days (interquartile range [IQR], 37-217) post TAVR. The rates of early (12.3% vs 9.4%; P=.046) and late (39.1% vs 31.6%; P<.01) readmission were lower in the NGD population. In the NGD group, major/life-threatening periprocedural bleeding (hazard ratio [HR], 2.40, 95% confidence interval [CI], 1.06-5.42; P=.04) and estimated glomerular filtration rate (eGFR) <60 mL/min at hospital discharge (HR, 1.80; 95% CI, 1.15-2.83; P=.01) were associated with an increased risk of early readmission post TAVR. Chronic obstructive pulmonary disease (HR, 1.42; 95% CI, 1.07-1.88; P=.02), eGFR <60 mL/min (HR, 1.43; 95% CI, 1.11-1.84; P<.01), and combining antiplatelet and anticoagulation therapy (HR, 1.37; 95% CI, 1.01-1.85; P=.04) determined an increased risk of late readmission. Conclusions. TAVR recipients receiving NGDs exhibited a significant but modest reduction in unplanned hospital readmissions, with about one-third of patients still requiring rehospitalization at 1-year follow-up in the contemporary TAVR era. Non-cardiac comorbidities, periprocedural bleeding events, and intensive antithrombotic therapy determined an increased risk.

Key words: heart failure, hospitalization, transcatheter aortic valve replacement

The readmission burden after transcatheter aortic valve replacement (TAVR) has been as high as ~50% at 1 year, with almost one-fourth of the events occurring within 30 days after hospital discharge.¹ A higher readmission rate due to congestive heart failure has been reported following TAVR compared with surgical aortic valve replacement,² and this was associated with a poor prognosis.^3,4 About 60% of readmissions following TAVR were related to non-cardiac causes, and hospital readmission (irrespective of the cause) was associated with an increased mortality risk at follow-up.^1,5 To date, studies investigating unplanned hospital readmission after TAVR included almost exclusively patients with a very high surgical risk profile along with the use of first- and second-generation transcatheter heart valve (THV) prostheses in most cases.^1-5 TAVR patient risk profiles have progressively decreased in recent years and current THVs exhibit some specific features that could impact unplanned hospital readmissions following the procedure. New-generation devices (NGDs) are delivered through a smaller sheath (14 to 16 Fr), leading to a much higher use of the transfemoral (vs non-transfemoral) approach and a lower rate of vascular complications.⁶ Additionally, successive iterations of TAVR valves have employed technologies to reduce paravalvular leak (PVL), resulting in lower PVL rates with NGDs, although some studies have suggested an increased risk of conduction disturbances and need for permanent pacemaker implantation with these devices.^6-8 Finally, alternative transarterial access sites (subclavian, carotid) are now commonly used in non-transfemoral candidates, which in turn has been associated with improved outcomes compared with transapical and transaortic approaches.^9,10 However, the impact of NGDs and contemporary TAVR management on unplanned hospital readmission remains largely unknown. Thus, the objectives of this study were: (1) to determine the trends regarding the incidences and causes of unplanned hospital readmission after TAVR in patients receiving NGDs vs early-generation devices (EGDs); and (2) to evaluate the factors associated with unplanned hospital readmission after TAVR in NGD recipients.

Methods

A total of 2244 consecutive patients who underwent TAVR at 2 centers were evaluated for the study. Of these, 106 patients died before hospital discharge and 153 had a follow-up of <1 year post TAVR and were therefore excluded. Among the 1985 remaining patients, the Sapien, Sapien XT, and Sapien 3 valves (Edwards Lifesciences) were implanted in 221, 533, and 669 patients, respectively, while CoreValve and Evolut R/Pro valves (Medtronic) were implanted in 109 and 270 patients, respectively, leading to a final population of 1802 patients. The EGD group received a Sapien, Sapien XT, or CoreValve device, while the NGD group received a Sapien 3 or Evolut R/Pro device. Post-TAVR clinical outcomes were defined according to Valve Academic Research Consortium-2 criteria.¹¹

Baseline, procedural, and follow-up data were prospectively collected in a dedicated database. Clinical follow-up was carried out at prescheduled outpatient clinic visits or by telephone contact at 1, 6, and 12 months post TAVR. Records from referring cardiologists, general practitioners, and other hospitals were consulted when necessary. Data were collected prospectively in a dedicated database in accordance with the ethics committee of each participating center, and all patients provided informed consent for the procedures.

Hospital readmissions up to 1 year post TAVR were recorded. Unplanned readmissions included hospital ward or intensive care unit readmission. Visits to the emergency department, admission to a day-stay hospital, and planned admissions (eg, scheduled surgery) were excluded from the current analysis. Readmission date, hospital length of stay, primary reason for hospitalization, and in-hospital death were recorded after medical record review. Causes of readmission were grouped as either cardiac or non-cardiac in origin. Cardiac causes included heart failure, acute coronary syndrome, arrhythmia, and prosthesis related (endocarditis, valve thrombosis, and prosthesis failure). Non-cardiac causes were classified as respiratory, neurologic, infection, bleeding, peripheral vascular, trauma, anemia, acute kidney injury, or other. Time to readmission was calculated as the time between the date of hospital discharge after the index TAVR procedure and the first hospital readmission day. Early and late readmission were defined as ≤30 days and >30 days to 1 year post TAVR, respectively.

Statistical analysis. Categorical variables are expressed as number (percentage) and continuous variables as mean ± standard deviation or median with interquartile range (IQR). Categorical variables were compared using the Chi-square or Fisher exact test, as appropriate. Numerical variables were compared using the Student’s t test or Mann-Whitney U non-parametric test according to their distribution (assessed by the Kolmogorov-Smirnov test). Survival curves for time-to-event variables were summarized using Kaplan-Meier estimates and log-rank tests were used for comparisons between groups. The factors associated with 30-day and 31-365 day hospital readmission were assessed in the NGD population. For this purpose, univariable Cox regression models were used. The proportional hazard assumption was tested by plotting log-minus-log survival. Variables with P≤.10 by univariable analysis were entered into a multivariable Cox regression with stepwise selection (backward elimination). Patients who died within 30 days after hospital discharge (n = 4) were not included in the analysis of factors associated with 30-365 day hospital readmission. A P<.05 was considered significant for all statistical tests. Statistical analyses were performed with SAS, version 9.4 (SAS Institute) and Prim, version 8.1.2 (GraphPad Software).

Results

The global study population consisted of 863 patients (47.9%) who received an EGD and 939 patients (52.1%) who received an NGD. Baseline clinical characteristics and procedural characteristics/in-hospital outcomes according to device generation are presented in Table 1 and Table 2, respectively. As compared with EGD recipients, patients who received a NGD were less severely symptomatic (70.6% EGD vs 59.5% NGD in New York Heart Association functional class III or IV; P<.001) and exhibited a lower burden of comorbidities, leading to a lower Society of Thoracic Surgeons (STS) risk score (7.0 ± 4.6% EGD vs 6.0 ± 4.9% NGD; P<.001). Rates of non-transfemoral approach (33.5% EGD vs 21.8% NGD; P<.001) and balloon predilation (75.2% EGD vs 20.0% NGD; P<.001) decreased with the use of NGD devices. Alternative access sites were transapical/transaortic and transubclavian/transcarotid in 95.8% and 4.2% in the EGD population, respectively, whereas subclavian/carotid approaches represented 73.7% of all alternative approaches in the NGD population (P<.001). Self-expanding devices were more frequently used during NGD procedures (12.6% EGD vs 28.8% NGD; P<.001). Rates of serious in-hospital complications (stroke, life-threatening bleeding, major vascular complication, and acute kidney injury) decreased in the NGD population (P<.05 for all). Conversely, the rate of permanent pacemaker implantation increased among NGD patients (12.1% EGD vs 15.7% NGD; P=.03) and a numerically lower rate of moderate to severe aortic regurgitation post TAVR was observed (4.1% EGD vs 2.7% NGD; P=.10).

Overall, 986 unplanned hospital readmissions within the year following TAVR were recorded. Of these, 204 were early readmissions (≤30 days). Details of the causes of early readmission are presented in Table 3. The proportion of cardiac readmission (44.6% EGD vs 38.0% NGD; P=.34) and in-hospital death at readmission (2.6% EGD vs 1.1% NGD; P=.63) did not significantly differ between the 2 periods. At a patient level, 194 patients (10.8%) were readmitted within 30 days, with 10 patients (0.6%) exhibiting 2 distinct early readmission events (0.7% EGD vs 0.4% NGD; P=.53). An early readmission occurred less frequently in patients receiving an NGD (88 patients; 9.4%) compared with EGD (106 patients; 12.3%; P=.046) (Figure 1). The rate of early readmission for cardiac (5.5% EGD vs 3.7% NGD; P=.08) and non-cardiac causes (7.1% EGD vs 5.9% NGD; P=.30) did not differ between EGD and NGD recipients. However, a higher rate of readmissions due to advanced conduction disturbances requiring permanent pacemaker implantation was observed in NGD patients (0.9% EGD vs 8.7% NGD; P<.01), with no significant differences regarding the rate of heart failure hospitalization (34.8% EGD vs 27.2% NGD; P=.24).

A total of 782 late readmissions (at 31-365 days) were recorded. The proportion of cardiac readmissions (36.8% EGD vs 38.5% NGD; P=.63) as well as in-hospital death at readmission (9.3% EGD vs 9.4% NGD; P=.94) were similar in the two groups. A comparison of causes of late hospital readmission according to device generation is presented in Table 4. At a patient level, 635 patients (35.2%) were hospitalized at least 1 time within the year post TAVR, with a median time to rehospitalization of 110 days (IQR, 37 to 217) post discharge. Multiple readmissions occurred in 232 patients (7.2% EGD vs 5.7% NGD; P<.01), ranging from 2 to 7 hospitalization events. Globally, the rate of unplanned hospital readmission was significantly lower in the NGD population (P<.01). The risk of non-cardiac rehospitalization was also lower in the NGD population (P=.01), while a trend toward a lower risk of cardiac readmission was observed (P=.06) (Figure 2). Rates of hospital readmission related to heart failure (20.0% EGD vs 21.6% NGD; P=.81) and cardiac arrhythmia (7.1% EGD vs 8.3% NGD; P=.54) did not significantly differ between the 2 groups.

The factors associated with early readmission (≤30 days) in the NGD population are presented in Table 5. By multivariable analysis, major/life-threatening bleeding (hazard ratio [HR], 2.40; 95% confidence interval [CI], 1.06-5.42; P=.04) and estimated glomerular filtration rate (eGFR) <60 mL/min at hospital discharge (HR, 1.80; 95% CI, 1.15-2.83; P=.01) were associated with an increased risk of unplanned hospital readmission within 30 days post TAVR. Conversely, age (P=.32), left ventricular ejection fraction (P=.08), arterial approach (P=.07), and antithrombotic medication at discharge (P=.26) were not associated with an increased risk of early hospital readmission.

The factors associated with late (31-365 days) hospital readmission in the NGD population are shown in Table 6. By multivariable analysis, chronic obstructive pulmonary disease (COPD; HR, 1.42; 95% CI, 1.07-1.88; P=.02), eGFR <60 mL/min at hospital discharge (HR, 1.43; 95% CI, 1.11-1.84; P<.01), and the combination of antiplatelet and anticoagulation therapy (HR, 1.37; 95% CI, 1.01-1.85; P=.04) determined an increased risk of late hospital readmission. Device type (self-expanding or balloon-expandable valve; P=.19), permanent pacemaker implantation (P=.87), and new-onset left bundle-branch block (P=.17) were not associated with an increased risk of hospital readmission.

Discussion

The main findings of this study can be summarized as follows: (1) a significant but modest reduction in both early and late post-TAVR readmission rates was observed in the NGD group vs the EGD group; (2) the proportion of readmissions related to cardiac causes as well as in-hospital mortality rates remained steady, but a higher incidence of early readmission related to conduction issues requiring permanent pacemaker implantation was observed among TAVR recipients receiving NGDs; (3) periprocedural major/life-threatening bleeding and renal dysfunction determined an increased risk of early readmission, whereas COPD, renal dysfunction, and a more aggressive antithrombotic therapy (anticoagulation + antiplatelet) were associated with an increased risk of late readmission.

The changes in patient characteristics and procedural features between EGDs and NGDs observed in the present study are a mirror of the well-known temporal changes between early and current TAVR recipients, with device generation being directly related to the year of implantation.¹² Both early and late readmission burden modestly decreased in the NGD population. The risk of late non-cardiac rehospitalization was also lower, while early cardiac/non-cardiac readmission and late cardiac readmission rates were not significantly different between the 2 groups. In fact, the proportion of cardiac vs non-cardiac readmissions (among all readmissions) remained steady between EGD and NGD groups, suggesting that the 2 main readmission causes decreased in the same magnitude over time. Interestingly, the decrease in readmission burden was achieved in parallel with a reduction in the length of stay during the index hospitalization. This is in keeping with previous studies showing no increased risk of 30-day readmissions with the implementation of an early-discharge strategy.^13,14 However, the rate of early readmission related to permanent pacemaker implantation was much higher in the NGD group, and this may be related to the shorter length of stay in this population along with device characteristics and implantation techniques (particularly in the early stages of NGDs) leading to an increased risk of conduction disturbances in NGD recipients.⁸ The impact of recently developed valve implantation techniques—leading to much higher (aortic) valve implants—on early hospital readmission rates should be evaluated in future studies.

The progressive expansion of TAVR toward the treatment of intermediate- and low-risk patients, as evidenced by the lower comorbidity burden and STS risk score in the NGD population, likely explains the decrease in readmissions from non-cardiac causes observed in our study. On the other hand, several factors may have resulted in the lower rate of cardiac readmissions. Significant residual aortic regurgitation after TAVR has been associated with poorer outcomes, including an increased risk of unplanned rehospitalization.⁵ The tendency toward a lower incidence of significant PVLs in the NGD group, likely secondary to the anti-PVL features of NGDs, may have contributed to these findings.^6,7 Also, acute coronary syndrome occurs in about 10% of TAVR recipients after a mean follow-up of 2 years, with prior coronary artery disease determining an increased risk of coronary events.¹⁶ The lower prevalence of prior coronary artery disease in the NGD population, along with advances in coronary artery disease management before TAVR and the increasing use of hemodynamic functional assessment of coronary lesions, may have also contributed to decreased readmissions for cardiac causes.¹⁷

Major/life-threatening bleeding and renal dysfunction at hospital discharge predicted an increased risk of early unplanned hospital readmission. This finding is in line with previous reports in this field and highlights the importance of continuous efforts to reduce bleeding events and prevent renal dysfunction in the periprocedural TAVR period.^1,18 Alternative access sites for TAVR have been associated with poorer outcomes compared with transfemoral approach.¹⁹ However, this was mainly related to transaortic and transapical access, and new alternative arterial approaches (subclavian and carotid) have been associated with improved outcomes.¹⁰ In fact, adjusted data analyses have shown that subclavian and carotid approaches are associated with early clinical outcomes similar to those of transfemoral TAVR.²⁰ In our study, no relationship was found between vascular access site and early hospital readmission, which was likely related to the fact that most alternative accesses were trans-subclavian/transcarotid in the NGD population.

Patients with COPD and renal dysfunction were at higher risk for late hospital readmission, and this finding is consistent with prior studies.^1,4 The relatively high rate of readmission for respiratory causes (accounting for ~20% of all non-cardiac readmissions) is explained by the detrimental impact of COPD on readmissions. Also, patients receiving a combination of antiplatelet and anticoagulation therapy at discharge were at higher risk for late readmission. In fact, bleeding was the primary cause of 10% of non-cardiac late readmissions, which may explain the relation between aggressive antithrombotic regimen post TAVR and late hospital readmission. Altisent et al suggested an increased risk of bleeding complications and no benefit regarding ischemic events in patients receiving combined antithrombotic therapies vs warfarin alone²¹ and these results were confirmed by the randomized POPULAR-TAVI trial, which showed a higher risk of bleeding as well as cardiovascular death, non–procedure-related bleeding, stroke, or myocardial infarction in patients receiving oral anticoagulation plus clopidogrel vs oral anticoagulation alone.²² Our findings further emphasize the detrimental effect of combining antiplatelet and anticoagulation therapies following TAVR. Interestingly, while new-onset left bundle-branch block and permanent pacemaker implantation post TAVR have been associated with an increased risk of cardiac rehospitalization,²³ these 2 covariates were not associated with an increased risk of hospital readmission in the present study. The fact that readmission for heart failure represented only 20% of late readmissions suggests that the above-mentioned relation has likely been offset by the other causes of readmission.

Although both early and late readmission rates decreased in the contemporary NGD era, about one-tenth and one-third of NGD recipients still experienced an unplanned hospital readmission within 30 days and 1 year, respectively. Hospital readmission negatively impacts patient prognosis and is associated with increased health care costs.^1,4,24 Consequently, further measures should be implemented in order to reduce the burden of cardiac readmission post TAVR. First, cardiac amyloidosis is supposed to affect up to 15% of patients with aortic stenosis and is associated with increased risk of heart failure.²⁵ A better screening of cardiac amyloidosis in TAVR candidates and the implementation of recently developed pharmacological therapies dedicated to transthyretin amyloidosis could potentially reduce hospitalizations for heart failure and improve the prognosis of some TAVR recipients. Second, incomplete coronary revascularization before TAVR is associated with more frequent death, myocardial infarction, and stroke post TAVR in patients undergoing pre-TAVR percutaneous coronary intervention.²⁶ Targeting a complete coronary revascularization before TAVR (when reasonably feasible) could therefore help to reduce hospitalization for acute coronary syndrome and improve post-TAVR prognosis. Third, conduction disturbances remain the most frequent drawback of TAVR.⁸ Both new-onset left bundle-branch block and permanent pacemaker implantation are associated with increased risk of all-cause death and heart failure hospitalization,²³ and the arrival of NGDs was not associated with a reduction in the rate of conduction disturbances.⁸ Continuous electrocardiographic monitoring before and after TAVR allows for the identification of unknown arrhythmic events, leading to prompt therapeutic measures in a substantial proportion of patients, and its implementation in daily practice should reduce unplanned readmission for arrhythmic events in the future.^27,28 In addition, depth of valve implantation is associated with new-onset left bundle-branch block and permanent pacemaker implantation post TAVR,⁸ and a tailored valve implantation depth based on membranous septum measurement on cardiac computed tomography could positively affect the burden of readmission for arrhythmic causes.²⁹

Study limitations. The present study had the limitations inherent to an observational study without an external adjudication event committee. There is an inverse association between hospital TAVR volume and readmissions, and the 2 participating centers had relatively high TAVR volumes.³⁰ Thus, our findings may not necessarily apply to centers with lower TAVR volumes.

Conclusion

A significant, but modest, decrease in early and late readmission burden after TAVR was observed among patients receiving NGDs compared with their EGD counterparts. However, up to one-third of TAVR-NGD recipients required at least 1 unplanned hospital readmission within the year following the procedure (close to one-third of them within the initial 30 days). Non-cardiac conditions (kidney dysfunction, COPD), periprocedural bleeding events, and intensive antithrombotic therapy determined an increased risk, and further strategies to reduce periprocedural bleeding events (such as reduced antithrombotic therapy and improvement in vascular access hemostasis) and to prevent renal dysfunction should be implemented in order to reduce the risk of rehospitalization. Also, improving the management of coexisting cardiac conditions (such as coronary artery disease, arrhythmia, heart failure, and cardiac amyloidosis) before and after TAVR may be required to further reduce the burden of readmission post TAVR, along with its associated negative clinical consequences and socioeconomic impact.

Affiliations and Disclosures

From the ¹Quebec Heart and Lung Institute, Laval University, Quebec City, Quebec, Canada; and the ²Cardiovascular Institute, Hospital Clinico San Carlos, Madrid, Spain.

Disclosure: The authors have completed and returned the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Faroux reports fellowship support from Institut Servier and the Associ- ation Régionale de Cardiologie de Champagne-Ardenne (ARCCA); research grant support from Biotronik, Edwards Lifesciences, and Medtronic. Dr Nombela-Franco has served as a proctor for Abbott and reports speaker honoraria from Abbott and Edwards Lifesciences. Dr Rodés-Cabau reports institutional research grants from Edwards Lifesciences, Medtronic, and Boston Scientific. The remaining authors report no conflicts of interest regarding the content herein.

Manuscript accepted June 8, 2021.

Address for correspondence: Josep Rodés-Cabau, MD, Quebec Heart & Lung Institute, Laval University, 2725 chemin Ste-Foy. G1V4G5, Quebec City, Quebec, Canada. Email: Josep.rodes@ criucpq.ulaval.ca

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• The Prognostic Utility of Invasive Right Heart Catheterization in Patients Prior to Transcatheter Aortic Valve Replacement