Next-Day Discharge After Transcatheter Aortic Valve Implantation With the ACURATE neo/neo2 Self-Expanding Aortic Bioprosthesis

Previous studies have shown the safety of early discharge pathways in selected patients and using selected transcatheter heart valves. Hence, we sought to evaluate the safety of next-day discharge (NDD) in patients who underwent transfemoral transcatheter aortic valve implantation (TF-TAVI) with the ACURATE neo/neo2 (Boston Scientific, Marlborough, Massachusetts) self-expanding aortic bioprosthesis. Patients who underwent TF-TAVI between January 2018 and April 2023 were prospectively included. Patients were stratified into 3 groups according to discharge times within 24 hours (NDD), between 24 and 48 hours, and those discharged >48 hours after TAVI. The primary outcome was the first unplanned readmission at 30 days after TAVI. Log-rank test was used to assess the differences in the outcome of interest between the groups. A total of 368 all-comers were included in this study. According to discharge times, 204 patients followed NDD, 69 patients 24 to 48 hours discharge, and 95 patients >48 hours discharge after TAVI. The mean age was 84 ± 6.3 years and 61% were women, without differences between the groups. The mean Society of Thoracic Surgeons score was lower in those with NDD versus 24 to 48 hours and >48 hours (2.9 ± 1.0, 3.2 ± 1.2, and 3.4 ± 1.4, respectively, p = 0.014). There were no differences between the groups in terms of preprocedural right bundle branch block or pacemaker. The need for new permanent pacemaker implantation was the leading postprocedural complication; it occurred more frequently in the >48 hours group than the 24 to 48 hours, and <24 hours groups (24% vs 8.6% and 2.2%, p <0.001). There were 5 strokes (1.4%) and all of them occurred in the >48 hours group (p = 0.005). At 30 days after discharge, there were no deaths and no differences in all-cause readmissions (9.3% in <24 hours, 8.6% in 24 to 48 hours, and 19% in >48 hours, log-rank p = 0.087). The readmission rates for new permanent pacemaker implantation requirement were 3.3% (n = 6) in NDD, 0% in 24 to 48 hours, and 1.6% (n = 5) in the >48 hours groups (p = 0.27). In conclusion, in unselected patients who underwent TF-TAVI with the ACURATE neo/neo2 self-expanding bioprosthesis, the NDD pathway is feasible and appears to be safe, without an increased risk of death or all-cause rehospitalization through 30 days after hospital discharge. Previous studies have shown the safety of early discharge pathways in selected patients and using selected transcatheter heart valves. Hence, we sought to evaluate the safety of next-day discharge (NDD) in patients who underwent transfemoral transcatheter aortic valve implantation (TF-TAVI) with the ACURATE neo/neo2 (Boston Scientific, Marlborough, Massachusetts) self-expanding aortic bioprosthesis. Patients who underwent TF-TAVI between January 2018 and April 2023 were prospectively included. Patients were stratified into 3 groups according to discharge times within 24 hours (NDD), between 24 and 48 hours, and those discharged >48 hours after TAVI. The primary outcome was the first unplanned readmission at 30 days after TAVI. Log-rank test was used to assess the differences in the outcome of interest between the groups. A total of 368 all-comers were included in this study. According to discharge times, 204 patients followed NDD, 69 patients 24 to 48 hours discharge, and 95 patients >48 hours discharge after TAVI. The mean age was 84 ± 6.3 years and 61% were women, without differences between the groups. The mean Society of Thoracic Surgeons score was lower in those with NDD versus 24 to 48 hours and >48 hours (2.9 ± 1.0, 3.2 ± 1.2, and 3.4 ± 1.4, respectively, p = 0.014). There were no differences between the groups in terms of preprocedural right bundle branch block or pacemaker. The need for new permanent pacemaker implantation was the leading postprocedural complication; it occurred more frequently in the >48 hours group than the 24 to 48 hours, and <24 hours groups (24% vs 8.6% and 2.2%, p <0.001). There were 5 strokes (1.4%) and all of them occurred in the >48 hours group (p = 0.005). At 30 days after discharge, there were no deaths and no differences in all-cause readmissions (9.3% in <24 hours, 8.6% in 24 to 48 hours, and 19% in >48 hours, log-rank p = 0.087). The readmission rates for new permanent pacemaker implantation requirement were 3.3% (n = 6) in NDD, 0% in 24 to 48 hours, and 1.6% (n = 5) in the >48 hours groups (p = 0.27). In conclusion, in unselected patients who underwent TF-TAVI with the ACURATE neo/neo2 self-expanding bioprosthesis, the NDD pathway is feasible and appears to be safe, without an increased risk of death or all-cause rehospitalization through 30 days after hospital discharge. A major step forward in the management of patients who underwent transcatheter aortic valve implantation (TAVI) has been the establishment of institutional pathways for early discharge (ED).1Barbanti M Capranzano P Ohno Y Attizzani GF Gulino S Immè S Cannata S Aruta P Bottari V Patanè M Tamburino C Di Stefano D Deste W Giannazzo D Gargiulo G Caruso G Sgroi C Todaro D di Simone E Capodanno D Tamburino C Early discharge after transfemoral transcatheter aortic valve implantation.Heart. 2015; 101: 1485-1490Crossref PubMed Scopus (83) Google Scholar,2Kotronias RA Teitelbaum M Webb JG Mylotte D Barbanti M Wood DA Ballantyne B Osborne A Solo K Kwok CS Mamas MA Bagur R Early versus standard discharge after transcatheter aortic valve replacement: a systematic review and meta-analysis.JACC Cardiovasc Interv. 2018; 11: 1759-1771Crossref PubMed Scopus (66) Google Scholar However, these ED protocols were for selected patients and using selected transcatheter heart valves (THVs).1Barbanti M Capranzano P Ohno Y Attizzani GF Gulino S Immè S Cannata S Aruta P Bottari V Patanè M Tamburino C Di Stefano D Deste W Giannazzo D Gargiulo G Caruso G Sgroi C Todaro D di Simone E Capodanno D Tamburino C Early discharge after transfemoral transcatheter aortic valve implantation.Heart. 2015; 101: 1485-1490Crossref PubMed Scopus (83) Google Scholar, 2Kotronias RA Teitelbaum M Webb JG Mylotte D Barbanti M Wood DA Ballantyne B Osborne A Solo K Kwok CS Mamas MA Bagur R Early versus standard discharge after transcatheter aortic valve replacement: a systematic review and meta-analysis.JACC Cardiovasc Interv. 2018; 11: 1759-1771Crossref PubMed Scopus (66) Google Scholar, 3Wood DA Lauck SB Cairns JA Humphries KH Cook R Welsh R Leipsic J Genereux P Moss R Jue J Blanke P Cheung A Ye J Dvir D Umedaly H Klein R Rondi K Poulter R Stub D Barbanti M Fahmy P Htun N Murdoch D Prakash R Barker M Nickel K Thakkar J Sathananthan J Tyrell B Al-Qoofi F Velianou JL Natarajan MK Wijeysundera HC Radhakrishnan S Horlick E Osten M Buller C Peterson M Asgar A Palisaitis D Masson JB Kodali S Nazif T Thourani V Babaliaros VC Cohen DJ Park JE Leon MB Webb JG The Vancouver 3M (multidisciplinary, multimodality, but minimalist) clinical pathway facilitates safe next-day discharge home at low-, medium-, and high-volume transfemoral transcatheter aortic valve replacement centers: the 3M TAVR study.JACC Cardiovasc Interv. 2019; 12: 459-469Crossref PubMed Scopus (193) Google Scholar The ACURATE neo/neo2 (Boston Scientific, Marlborough, Massachusetts) is a self-expanding supra-annular functioning THV with relatively low rates of new conduction disorders needing permanent pacemaker implantation (PPI)4Bagur R Teefy PJ Kiaii B Diamantouros P Chu MWA First North American experience with the transfemoral ACURATE-neo™ self-expanding transcatheter aortic bioprosthesis.Catheter Cardiovasc Interv. 2017; 90: 130-138Crossref PubMed Scopus (20) Google Scholar, 5Toggweiler S Nissen H Mogensen B Cuculi F Fallesen C Veien KT Brinkert M Kobza R Rück A Very low pacemaker rate following ACURATE neo transcatheter heart valve implantation.EuroIntervention. 2017; 13: 1273-1280Crossref PubMed Scopus (59) Google Scholar, 6Kim WK Hengstenberg C Hilker M Kerber S Schäfer U Rudolph T Linke A Franz N Kuntze T Nef H Kappert U Zembala MO Toggweiler S Walther T Möllmann H The SAVI-TF Registry: 1-year Outcomes of the European Post-Market Registry Using the ACURATE neo Transcatheter Heart Valve under Real-World Conditions in 1,000 Patients.JACC Cardiovasc Interv. 2018; 11: 1368-1374Crossref PubMed Scopus (62) Google Scholar, 7Choudhury T Solomonica A Bagur R The ACURATE neo transcatheter aortic valve system.Expert Rev Med Devices. 2018; 15: 693-699Crossref PubMed Scopus (12) Google Scholar and, owing to the impact of these procedural-related complications on length of stay (LOS), the use of this valve may facilitate ED strategies. Furthermore, because the ACURATE neo/neo2 THV has been underrepresented in previous ED studies, we sought to evaluate the safety of next-day discharge (NDD) in patients who underwent TAVI with the ACURATE neo/neo2 THV. The authors declare that all supporting data are available within the article and its online supplementary files. Institutional review board and ethics committee approval was obtained from the Western University Health Science Research Ethics Board. Data from consecutive all-comers patients who underwent outpatient transfemoral TAVI (TF-TAVI) with the ACURATE neo/neo2 THV at the University Hospital, London Health Sciences Centre, Western University between January 2018 and April 2023 were prospectively collected in a dedicated local database and retrospectively analyzed. Patients who died during the index admission for TAVI were excluded from the analysis. After TAVI completion, patients recovered as per our local policies in the postanesthesia care unit for 1 hour, then transferred to a regular cardiology/cardiac surgery ward unit bed with telemetry capabilities. A 12-lead electrocardiogram (ECG) was performed while in postanesthesia care unit and repeated 4 hours after TAVI. Patient mobilization was recommended within 4 hours, and a transthoracic echocardiogram was performed either the same day (afternoon) or the next morning. All patients had a repeat ECG before discharge. Patients were deemed suitable for a NDD pathway in the absence of new-onset conduction delays on ECG or uncontrolled arrhythmia (i.e., rapid atrial fibrillation) on telemetry, chest pain secondary to cardiac ischemia, signs of congestive heart failure (CHF), fever, or ongoing infection, maintained urine output, and any signs of hemodynamic instability or major adverse events (i.e., stroke). The ED population was further divided into 2 groups: those discharged within the first 24 hours (NDD) and those discharged between 24 and 48 hours after TF-TAVI. We hypothesize that NDD is a safe strategy compared with ED after 24 to 48 hours. In addition, to provide a better understanding of the interpretation of the results, a third group comprising patients who were discharged later than 48 hours mainly because of complications is provided for comparison purposes. The primary outcome of interest was unplanned readmission at 30 days after TF-TAVI. The secondary end point was an exploratory analysis looking at the causes for readmissions, further divided into cardiovascular and noncardiovascular causes. All outcomes were reported according to the Valve Academic Research Consortium 3 definitions.8Généreux P Piazza N Alu MC Nazif T Hahn RT Pibarot P Bax JJ Leipsic JA Blanke P Blackstone EH Finn MT Kapadia S Linke A Mack MJ Makkar R Mehran R Popma JJ Reardon M Rodes-Cabau J Van Mieghem NM Webb JG Cohen DJ Leon MB VARC-3 Writing CommitteeValve Academic Research Consortium 3: updated endpoint definitions for aortic valve clinical research.J Am Coll Cardiol. 2021; 77: 2717-2746Crossref PubMed Scopus (503) Google Scholar Procedural aspects have been previously described.4Bagur R Teefy PJ Kiaii B Diamantouros P Chu MWA First North American experience with the transfemoral ACURATE-neo™ self-expanding transcatheter aortic bioprosthesis.Catheter Cardiovasc Interv. 2017; 90: 130-138Crossref PubMed Scopus (20) Google Scholar,7Choudhury T Solomonica A Bagur R The ACURATE neo transcatheter aortic valve system.Expert Rev Med Devices. 2018; 15: 693-699Crossref PubMed Scopus (12) Google Scholar,9Bagur R Chu MWA Ordoñez S Valdis M Gelinas J Chaumont G Teefy PJ Diamantouros P Single Access for transfemoral transcatheter Aortic Valve Implantation with the Acurate neo/neo 2 Self-Expanding Valve.Can J Cardiol. 2023; 39: 35-37Abstract Full Text Full Text PDF PubMed Google Scholar Continuous variables are reported as mean ± SD or median (interquartile range), whereas dichotomous parameters are reported as frequencies and percentages. Comparisons were carried out using a chi-square test for categorical data, and the Student's t test or analysis of variance for continuous variables, as appropriate. To assess the occurrence of the primary outcome, survival analysis was conducted using the Kaplan–Meier method, and the distribution of time-to-event occurrence was compared with the log-rank test. A 2-step analysis was used to assess factors associated with the outcome of interest. First, a single logistic regression was performed. Variables judged, a priori, clinically relevant along with those with a p <0.10 were entered into a multivariable logistic regression analysis. The results are reported as odds ratio (OR) with a 95% confidence interval (CI). All statistical analyses are 2-tailed, and a p value of <0.05 was considered statistically significant. The statistical software STATA, Version 14.1 (StataCorp, College Station, Texas) was used for all the statistical analyses. Of 372 patients who underwent TF-TAVI with ACURATE neo/neo2 THV, 4 patients died during the index hospitalization and were excluded from the analysis. The study population comprised 368 patients who were discharged at home after TF-TAVI. The mean age was 84 ± 6.3 years, 61% were women, and the mean preprocedural risk profile, as assessed by the Society of Thoracic Surgeons Predicted Risk of Mortality and European System for Cardiac Operative Risk Evaluation II, were 3.1 ± 1.1 and 2.7 ± 1.8, respectively. A total of 204 patients (55.4%) followed an NDD pathway, 69 patients (18.8%) were discharged between 24 and 48 hours and 95 patients (25.8%) after 48 hours. The mean preprocedural Society of Thoracic Surgeons Predicted Risk of Mortality score was similar in those who followed NDD versus 24 to 48 hours but higher in those discharged >48 hours (2.9 ± 1.0, 3.2 ± 1.2, and 3.4 ± 1.4, p = 0.28 and p = 0.014, respectively). There were no differences between the groups in terms of preexisting right bundle branch block (RBBB), preprocedural pacemaker, or the proportion of patients presenting with left ventricular ejection fraction (LVEF) <35% (p = no significant [NS] comparing the NDD versus 24 to 48 hours groups and between the 3 groups) (Table 1).Table 1Baseline and procedural characteristics of the study populationVariablesOverall n=368<24h n=20424-48h n=69>48h n=95P-value*For differences between the <24h versus 24-48h groups.P-value†For overall differences between the three groups.Baseline characteristicsAge, years84±6.384±5.883±6.184±7.50.570.58Female sex225 (61)124 (61)36 (52)65 (68)0.200.11Hypertension326 (89)179 (88)60 (87)87 (92)0.860.72Diabetes89 (24)45 (22)17 (25)27 (28)0.650.18Coronary artery disease109 (30)59 (29)20 (29)30 (32)0.990.23 Previous PCI59 (16)32 (16)10 (14)17 (18)0.810.71 Previous CABG50 (14)27 (13)10 (14)13 (14)0.790.32Peripheral artery disease49 (13)25 (12)9 (13)15 (16)0.860.89Porcelain aorta21 (5.6)11 (5.4)5 (7.2)5 (5.2)0.570.85Atrial fibrillation110 (30)50 (25)22 (32)36 (38)0.220.25Any conduction delay64 (17)32 (16)13 (19)19 (20)0.540.51 Right bundle branch block42 (11)19 (9.3)9 (13)14 (15)0.370.60Previous pacemaker41 (11)19 (9.3)11 (16)11 (12)0.120.25STS-PROM score3.1±1.12.9±1.03.2±1.23.4±1.40.280.014EuroSCORE II score2.7±1.82.5±1.22.9±2.03.2±2.60.390.007Echocardiographic dataAortic valve area (cm2)0.60±0.150.60±0.160.60±0.160.60±0.140.990.97Mean gradient (mmHg)46±1345±1147±1348±150.260.16Ejection Fraction (%)57±1358±1258±1256±150.990.37 Ejection Fraction <35%31 (8.4)14 (6.8)5 (7.2)12 (13)0.910.30Procedural dataSingle access178 (48)144 (70)14 (20)20 (21)<0.001<0.001General anesthesia110 (30)18 (8.8)31 (45)61 (64)<0.001<0.001Surgical cutdown access45 (12)8 (3.9)6 (8.6)31 (33)0.12<0.001Valve sizeSmall (23 mm)72 (20)40 (20)17 (25)15 (16)0.460.35Medium (25 mm)136 (37)73 (36)21 (30)42 (44)Large (27 mm)153 (42)82 (40)30 (43)41 (43)Postdilatation120 (33)55 (29)24 (37)41 (43)0.210.05Right ventricular pacing‡Right ventricular as opposed to left ventricular stimulation for rapid pacing. Data are presented as mean±SD or n (%). Some percentages may not add up to 100% owing to rounding.183 (50)53 (26)57 (83)73 (77)<0.001<0.001ProGlide/Style closure device260 (71)138 (67)61 (88)61 (64)0.0010.001AngioSeal closure devise31 (8.4)22 (11)1 (1.4)8 (8.4)0.010.09Manta vascular closure devise63 (17)58 (28)2 (2.8)3 (3.1)<0.001<0.001Procedure duration46±2142±1046±1362±260.18<0.001CABG =coronary artery bypass graft; EuroSCORE = European System for Cardiac Operative Risk Evaluation; PCI = percutaneous coronary intervention; STS-PROM = Society of Thoracic Surgeons Predicted Risk of Mortality. For differences between the <24h versus 24-48h groups.† For overall differences between the three groups.‡ Right ventricular as opposed to left ventricular stimulation for rapid pacing.Data are presented as mean±SD or n (%). Some percentages may not add up to 100% owing to rounding. Open table in a new tab CABG =coronary artery bypass graft; EuroSCORE = European System for Cardiac Operative Risk Evaluation; PCI = percutaneous coronary intervention; STS-PROM = Society of Thoracic Surgeons Predicted Risk of Mortality. Higher rates of general anesthesia were observed comparing the NDD and 24 to 48 hours groups and the 3 groups (8.8%, 45%, and 64%, p <0.001 for both comparisons). Surgical cutdown for vascular access tended to be higher in the 24 to 48 hours group versus NDD but did not reach statistical significance, whereas it did when comparing the 3 groups, being higher in those discharged >48 hours (3.9%, 8.6%, and 33%, p = 0.12 and p <0.001, respectively). Patients who followed a NDD pathway had higher proportion of single- vascular access (pigtail through the same large-bore sheath, 70% vs 20% in the 24 to 48 hours and 21% in the >48 hours groups, p <0.001 for both comparisons), use of the TAVI wire for left ventricular pacing (as opposed to venous access for right ventricular pacing, 74% vs 17% in the 24 to 48 hours and 13% in >48 hours groups, p <0.001 for both comparisons), and Manta (Teleflex, Teleflex Inc., Malvern, Pennsylvania) vascular closure device (28% vs 2.8% in the 24 to 48 hours and 3.1% in >48 hours groups, p <0.001 for both comparisons). Procedural duration time was comparable between the NDD and 24 to 48 hours groups but significantly longer in those discharged >48 hours (42 ± 10 minutes vs 46 ± 13 minutes in the 24 to 48 hours and 62 ± 26 minutes in the >48 hours groups, p = 0.18 and p <0.001, respectively). This is most likely the translation of the previously mentioned higher use of surgical cutdown in this group. The remaining baseline clinical, electrocardiographic, echocardiographic, and procedural characteristics of the study population are listed in Table 1. Postprocedural echocardiographic data were similar between groups, except for a slightly but significantly higher mean gradient in 24 to 48 hours group (9.7 ± 5.3 vs 8.3 ± 3.2 mm Hg in the NDD p = 0.03 and 8.5 ± 4.3 mm Hg in the 48 hours groups, p = 0.04) and this may be explained by a numerically higher proportion of small-sized THVs that were implanted in this group. As expected, patients who had procedural-related complications were more often discharged >48 hours (p <0.001) but no difference was found between the NDD and 24 to 48 hours groups (p = 0.58). The need for new PPI was the leading postprocedural complication (n = 29, 8.9%) and occurred more frequently in those discharged >48 hours than the 24 to 48 hours and NDD groups (24%, 8.6%, and 2.2%, respectively, p <0.001 for the overall comparison and p = 0.02 comparing the NDD and 24 to 48 hours groups). In patients who required PPI, baseline RBBB was present in 11 patients, 3 in the NDD group, 3 in the 24 to 48 hour groups, and 5 in the >48 hours group. There were a total of 5 strokes (1.4%) and all of them occurred in the >48 hours group (p = 0.01). No significant differences were found in terms of vascular complications, bleeding, and infections (p = NS for all comparisons) (Table 2).Table 2Post-procedural data and 30-day unplanned readmissionsVariablesOverall n=368<24h n=20424-48h n=69>48h n=95P-value*For differences between the <24h versus 24-48h groups.P-value†For overall differences between the three groups.Echocardiographic dataAortic valve area, cm21.68±0.381.70±0.371.71±0.441.61±0.330.320.16Mean gradient, mmHg8.7±4.08.3±3.29.7±5.38.5±4.30.030.04Ejection fraction (%)61±1162±1061±1159±130.520.14 Ejection Fraction <35%27 (7.3)18 (8.8)2 (2.8)7 (7.3)0.100.12Paravalvular leakage None/trace176 (48)92 (45)32 (46)52 (56)0.850.13 Mild162 (44)94 (47)32 (49)36 (38)0.960.25 Moderate27 (7.3)18 (8.8)2 (2.8)7 (7.3)0.100.11 Severe1 (0.2)0 (0)0 (0)1 (1.0)1.000.89In-hospital adverse events69 (19)19 (9.3)8 (12)42 (44)0.58<0.001Major vascular complications16 (4.3)8 (3.9)1 (1.4)7 (7.3)0.320.30Bleeding18 (4.9)7 (3.4)2 (2.8)9 (9.4)0.830.09 Minor13 (3.5)6 (2.9)1 (1.4)6 (6.3)0.490.26 Major4 (1.1)1 (0.6)1 (1.4)2 (2.1)0.410.51 Life Threatening1 (0.2)0 (0)0 (0)1 (1.0)1.000.89Stroke5 (1.4)0 (0)0 (0)5 (5.2)1.000.01 Minor1 (0.2)0 (0)0 (0)1 (1.0)1.000.89 Major2 (0.5)0 (0)0 (0)2 (2.1)1.000.89 Disabling2 (0.5)0 (0)0 (0)2 (2.1)1.000.12New permanent pacemaker‡Out of patients without preprocedural pacemakers (n=41).29 (8.9)4 (2.2)5 (8.6)20 (24)0.02<0.001Infections1 (0.2)0 (0)0 (0)1 (1.1)1.000.2730-day readmissions43 (12)19 (9.3)6 (8.6)18 (19)0.870.08Cardiovascular causes25 (6.8)12 (6.3)4 (5.7)9 (9.4)0.970.09 New permanent pacemaker§Out of patients without pre- and post-procedural pacemakers (n=70). Data are presented as mean±SD, median (interquartile range) or n (%). Some percentages may not add up to 100% owing to rounding.7 (2.3)6 (3.3)0 (0)1 (1.6)0.570.27 Congestive heart Failure12 (3.2)5 (2.4)1 (1.4)6 (6.3)0.620.26 Stroke/TIA3 (0.8)0 (0)2 (3.0)1 (1.0)0.090.06 Acute coronary syndrome1 (0.3)0 (0)1 (1.4)0 (0)0.260.20 Arrhythmias2 (0.5)1 (0.5)0 (0)1 (1.0)0.961.00Non-cardiovascular causes18 (4.9)7 (3.4)2 (2.8)9 (9.4)0.830.15 Infections10 (2.7)4 (1.9)1 (1.4)5 (5.3)0.780.20 Access site complication3 (0.8)1 (0.5)1 (1.4)1 (1.0)0.410.76Length of stay (on readmission)6.5 (3-12)4.5 (2-8)9 (6-12)6 (3-10)0.240.38TIA = transient ischemic attack. For differences between the <24h versus 24-48h groups.† For overall differences between the three groups.‡ Out of patients without preprocedural pacemakers (n=41).§ Out of patients without pre- and post-procedural pacemakers (n=70).Data are presented as mean±SD, median (interquartile range) or n (%). Some percentages may not add up to 100% owing to rounding. Open table in a new tab TIA = transient ischemic attack. In the >48 hours group, these patients were discharged on day 3 after TAVI (n = 35), day 4 (n = 17), day 5 (n = 6), day 6 (n = 5), day 7 (n = 10), day 8 (n = 8), day 9 (n = 3), day 10 (n = 1), day 11 (n = 1), day 13 (n = 3), day 15 (n = 3), day 16 (n = 1), day 20 (n = 1), and day 28 (n = 1). The overall LOS for this group was a median of 4 (interquartile range of 3 to 7) days. The leading reasons for a prolonged LOS in this group were complications inherent to the procedure, such as the need for PPI 20 (21%), vascular 7 (7.4%), stroke/TIA 5 (5.2%), CHF 8 (8.4%), delirium 6 (6.3%), deconditioning/rehabilitation 7 (7.4%), and urological/gastrointestinal bleeding 4 (4.2%). After discharge, there were no deaths through 30 days of follow-up, and there were no statistical differences in the primary outcome, all-cause readmissions (log-rank p = 0.087, Figure 1); however, those discharged >48 hours group doubled the proportion of readmissions at 30 days (19% in >48 hours vs 8.7% in 24 to 48 hours and 9.3% in NDD, Table 2). Overall, half of the readmissions occurred within 7 days of discharge (Figure 2). Cardiovascular causes of readmissions occurred in 5.9% in the NDD group, 5.8% in the 24 to 48 hours group, and 9.5% in >48 hours group (p = 0.97 between NDD and 24 to 48 hours and p = 0.09 for the overall comparison, Figure 2), whereas readmissions for noncardiovascular causes were 4.0% in the NDD group, 3.0% in the 24 to 48 hours group, and 9.6% in the >48 hours group (p = 0.83 between NDD and 24 to 48 hours and p = 0.15 for the overall comparison, Figure 2). The median LOS for the readmission was 6.5 (3 to 12) days, 4.5 (2 to 8) days in the <24 hours group, 9 (6 to 12) in the 24 to 48 hours group, and 6 (3 to 10) days in the >48 hours group (p = 0.24 between NDD and 24 to 48 hours and p = 0.38 for the overall comparison).Figure 2(A) Overall time to first readmission. (B) Time to readmission for cardiovascular causes. (C) Time to readmission for noncardiovascular causes.View Large Image Figure ViewerDownload Hi-res image Download (PPT) The readmission rates for new PPI requirement were 3.3% (n = 6), 0%, and 1.6% (n = 5) in the NDD group, 24 to 48 hours, and >48 hours groups, respectively (p = 0.57 between NDD and 24 to 48 hours and p = 0.27 for the overall comparison). In the patients who followed an NDD pathway, those who required new PPI were readmitted on days 1 (n = 1), 3 (n = 2), 4 (n = 2), and 6 (n = 1) after discharge. Of these, 1 patient presented with baseline RBBB and was readmitted with a complete atrioventricular block (CAVB) on day 3 after discharge. No patient was readmitted for new PPI requirement within 30 days in the 24 to 48 hours group, and only 1 patient in the >48 hours group was readmitted with CAVB and this admission occurred 4 days after discharge (Figure 3). Readmissions for CHF occurred in 2.4% (n = 5), 1.4% (n = 1), and 6.3% (n = 6) in the NDD, 24 to 48 hours, and >48 hours groups, respectively (p = 0.62 between NDD and 24 to 48 hours and p = 0.26 for the overall comparison). In patients who followed an NDD pathway, readmissions for CHF were on days 2, 7, 10, 12, and 23 after discharge. Only one patient in the 24 to 48 hours group (discharged on post-TAVI day 2) was readmitted for CHF and this occurred 11 days after discharge. This patient died because of end-stage CHF and failure to thrive 32 days after readmission (43 days after discharge for TAVI). In the >48 hours group, readmissions for CHF occurred on days 4, 5, 7, 10, 12, and 25 after discharge (Figure 3). Older age (per year increase, OR 1.05, 95% CI 1.00 to 1.11, p = 0.044), paravalvular leakage > mild (OR 2.75, 95% CI 1.04 to 7.28, p = 0.007), and prolonged LOS (per day increase, OR 1.10, 95% CI 1.01 to 1.21, p = 0.030) were the factors that were found to be independently associated with 30-day readmissions (Figure 4). The present analysis of ED pathways after TF-TAVI with the ACURATE neo/neo2 self-expanding valve demonstrates that NDD is feasible and appears to be safe in unselected patients, without an increased risk of death or all-cause rehospitalization through 30 days after hospital discharge. Patients discharged within 24 hours did not require more PPI than those patients discharged 24 to 48 hours or later. Older age, paravalvular leakage > mild, and prolonged LOS were the factors strongly associated with a higher probability of 30-day readmissions. A strategy that has contributed to our local decrease in LOS was the change of TAVI days from Thursdays to Tuesdays. As a result of this change, should a PPI be needed, this can be performed the day after (Wednesday) or, in the worst-case scenario, on day 2 (Thursday) after TAVI. Patients who underwent TAVI on Thursdays may have waited until Monday (sometimes Tuesdays) to have their PPI if the pacemaker laboratory could not do so on day 0 or day 1 after TAVI. In this regard, 20 patients that required post-TAVI PPI in the >48 hours group were discharged on day 3 (n = 3), day 4 (n = 2), day 5 (n = 1), day 6 (n = 2), day 7 (n = 5), day 8 (n = 3), day 9 (n = 1), day 11 (n = 1), and day 15 (n = 2). It is also important to note that patients with high-risk futures on baseline ECG (i.e., RBBB) are scheduled for TAVI in the morning and, should a PPI be needed, this is arranged to be done in the afternoon, allowing the patients to be discharged the next day. Importantly, despite an all-comer population with a mean age of 84 years, we had 0% mortality after hospital discharge through 30 days, and the overall all-cause readmission rate at 30 days was 9.3% after an NDD pathway. A total of 60% of the readmissions were for cardiovascular causes, which were evenly distributed in those presenting with conduction disturbances requiring PPI and CHF. This study also shows the absence of significant differences in overall all-cause unplanned readmissions across the groups; however, those who were discharged >48 hours experienced almost twice as high the proportion of readmissions at 30 days, highlighting, therefore, the safety of NDD and ED at 24 to 48 hours after TAVI. Hence, our results are relevant because the study was carried out in patients who underwent TF-TAVI with the ACURATE neo/neo2 self-expanding valve, which has been underrepresented in most of the previous studies and, again, we did not incorporate any selection criteria. Our overall in-hospital and 30-day new PPI rates were 8.9% and 11.2%, respectively, and this is in line with previous reports with the ACURATE neo/neo2.10Pagnesi M Kim WK Conradi L Barbanti M Stefanini GG Zeus T