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Feasibility and Safety of Early Discharge After Transfemoral Transcatheter Aortic Valve Implantation With the Edwards SAPIEN-XT Prosthesis

2015; Elsevier BV; Volume: 115; Issue: 8 Linguagem: Inglês

10.1016/j.amjcard.2015.01.546

ISSN

1879-1913

Autores

Éric Durand, Hélène Eltchaninoff, Alexandre Canville, Najime Bouhzam, Matthieu Godin, Christophe Tron, Carlos Rodríguez, Pierre‐Yves Litzler, Fabrice Bauer, Alain Cribier,

Tópico(s)

Cardiovascular Function and Risk Factors

Resumo

There is currently no consensus on the duration of hospitalization required after transfemoral transcatheter aortic valve implantation (TAVI). We report the feasibility and safety of early discharge after TAVI with the Edwards SAPIEN-XT prosthesis. From 2009 to 2013, 337 patients underwent transfemoral TAVI with the Edwards SAPIEN-XT prosthesis using local anesthesia and were discharged home either early (≤3 days, Early Discharge group, n = 121) or after 3 days (Late Discharge group, n = 216). The primary end point of the study combined death and rehospitalization from discharge to 30-day follow-up. Patients in the Early Discharge group were less symptomatic (New York Heart Association class ≥III: 64.5% vs 75.5%, p = 0.01) and had less renal failure (creatinine: 102.1 ± 41.0 vs 113.3 ± 58.9 μmol/L, p = 0.04), atrial fibrillation (33.1% vs 46.3%, p = 0.02), and previous balloon aortic valvuloplasty (11.6% vs 23.1%, p = 0.01) and were more likely to have a pacemaker before TAVI (16.5% vs 8.3%, p = 0.02). Pre-existing pacemaker (p = 0.05) and the absence of acute kidney injury (p = 0.02) were independent predictors of an early discharge, whereas previous balloon aortic valvuloplasty (p = 0.03) and post-TAVI blood transfusions (p = 0.002) were independent predictors of late discharge. The primary end point occurred in 4 patients (3.3%) in the Early Discharge group and in 11 patients (5.1%) in the Late Discharge group (p = 0.58). In conclusion, the results of our study suggest that early discharge after transfemoral TAVI using the Edwards SAPIEN-XT prosthesis is feasible and safe in selected patients. There is currently no consensus on the duration of hospitalization required after transfemoral transcatheter aortic valve implantation (TAVI). We report the feasibility and safety of early discharge after TAVI with the Edwards SAPIEN-XT prosthesis. From 2009 to 2013, 337 patients underwent transfemoral TAVI with the Edwards SAPIEN-XT prosthesis using local anesthesia and were discharged home either early (≤3 days, Early Discharge group, n = 121) or after 3 days (Late Discharge group, n = 216). The primary end point of the study combined death and rehospitalization from discharge to 30-day follow-up. Patients in the Early Discharge group were less symptomatic (New York Heart Association class ≥III: 64.5% vs 75.5%, p = 0.01) and had less renal failure (creatinine: 102.1 ± 41.0 vs 113.3 ± 58.9 μmol/L, p = 0.04), atrial fibrillation (33.1% vs 46.3%, p = 0.02), and previous balloon aortic valvuloplasty (11.6% vs 23.1%, p = 0.01) and were more likely to have a pacemaker before TAVI (16.5% vs 8.3%, p = 0.02). Pre-existing pacemaker (p = 0.05) and the absence of acute kidney injury (p = 0.02) were independent predictors of an early discharge, whereas previous balloon aortic valvuloplasty (p = 0.03) and post-TAVI blood transfusions (p = 0.002) were independent predictors of late discharge. The primary end point occurred in 4 patients (3.3%) in the Early Discharge group and in 11 patients (5.1%) in the Late Discharge group (p = 0.58). In conclusion, the results of our study suggest that early discharge after transfemoral TAVI using the Edwards SAPIEN-XT prosthesis is feasible and safe in selected patients. Since the First-In-Man transcatheter aortic valve implantation (TAVI) in 2002, our group has been proposing a progressive simplification of TAVI procedures while keeping patient safety as the main objective.1Cribier A. Eltchaninoff H. Bash A. Borenstein N. Tron C. Bauer F. Derumeaux G. Anselme F. Laborde F. Leon M.B. Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: first human case description.Circulation. 2002; 106: 3006-3008Crossref PubMed Scopus (2522) Google Scholar We soon promoted a “minimalist approach” for all transfemoral cases using local anesthesia and fluoroscopic guidance for valve implantation without intraprocedural transesophageal echocardiography.1Cribier A. Eltchaninoff H. Bash A. Borenstein N. Tron C. Bauer F. Derumeaux G. Anselme F. Laborde F. Leon M.B. Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: first human case description.Circulation. 2002; 106: 3006-3008Crossref PubMed Scopus (2522) Google Scholar, 2Cribier A. Eltchaninoff H. Tron C. Bauer F. Agatiello C. Nercolini D. Tapiero S. Litzler P.Y. Bessou J.P. Babaliaros V. Treatment of calcific aortic stenosis with the percutaneous heart valve mid-term follow-up from the initial feasibility studies: the French experience.J Am Coll Cardiol. 2006; 47: 1214-1223Abstract Full Text Full Text PDF PubMed Scopus (679) Google Scholar, 3Durand E. Borz B. Godin M. Tron C. Litzler P.Y. Bessou J.P. Bejar K. Fraccaro C. Sanchez-Giron C. Dacher J.N. Bauer F. Cribier A. Eltchaninoff H. Transfemoral aortic valve replacement with the Edwards SAPIEN and Edwards SAPIEN XT prosthesis using exclusively local anesthesia and fluoroscopic guidance: feasibility and thirty-day outcomes.JACC Cardiovasc Interv. 2012; 5: 461-467Abstract Full Text Full Text PDF PubMed Scopus (144) Google Scholar Since the launch of the SAPIEN-XT device in October 2009 and the concomitant decrease in sheath size to 16 F/20 F, most operators have switched to a pure percutaneous approach. This further strengthened the use of the “minimalist approach” for us and many other operators and early discharge progressively emerged as a reasonable option in the absence of procedural complications. There is currently no consensus on the duration of monitoring required after TAVI.4Kappetein A.P. Head S.J. Généreux P. Piazza N. van Mieghem N.M. Blackstone E.H. Brott T.G. Cohen D.J. Cutlip D.E. van Es G.A. Hahn R.T. Kirtane A.J. Krucoff M.W. Kodali S. Mack M.J. Mehran R. Rodés-Cabau J. Vranckx P. Webb J.G. Windecker S. Serruys P.W. Leon M.B. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document.J Am Coll Cardiol. 2012; 60: 1438-1454Abstract Full Text Full Text PDF PubMed Scopus (1393) Google Scholar Prolonged hospitalization often appears unnecessary, whereas shorter length of stay with early return home may be beneficial, particularly in old and frail patients, and might also be cost effective. We, therefore, aimed to evaluate the feasibility and safety of early discharge after transfemoral TAVI.MethodsWe included all consecutive patients implanted with the Edwards SAPIEN-XT valve through a transfemoral approach (Edwards Lifesciences Inc., Irvine, California) from October 2009 to November 2013. The Heart Team established the indication of TAVI according to the current guidelines. All patients were included in national or international registries, after approval of the corresponding Ethics Committee, and provided signed informed consent.The technique of transfemoral SAPIEN-XT valve implantation using local anesthesia has been previously described and reported by our group.3Durand E. Borz B. Godin M. Tron C. Litzler P.Y. Bessou J.P. Bejar K. Fraccaro C. Sanchez-Giron C. Dacher J.N. Bauer F. Cribier A. Eltchaninoff H. Transfemoral aortic valve replacement with the Edwards SAPIEN and Edwards SAPIEN XT prosthesis using exclusively local anesthesia and fluoroscopic guidance: feasibility and thirty-day outcomes.JACC Cardiovasc Interv. 2012; 5: 461-467Abstract Full Text Full Text PDF PubMed Scopus (144) Google Scholar After the procedure, all the patients were monitored in the intensive care unit (ICU) for at least 24 hours. Electrocardiography was recorded daily until discharge, and transthoracic echocardiography was performed before discharge. Patients were eligible for early discharge if the procedure was not performed in emergency and if there were no major complications during the procedure and the first 24 hours of monitoring in ICU (i.e., stroke, myocardial infarction, major vascular complication requiring transfusions, life-threatening bleeding, acute kidney injury stage 2 or 3). Careful electrocardiographic monitoring in ICU allowed for early conduction disturbances detection. A pacemaker was systematically implanted in patients with persistent complete atrioventricular block 24 hours after TAVI. Patients with persistent de novo complete left bundle branch block were also closely monitored and were not eligible for early discharge. At discharge, patients were advised to return to our department in case of worsening of dyspnea, syncope, or any abnormal symptom. Thirty-day outpatient visit and echocardiography were systematically performed in all patients at our institution.Baseline, procedural, and in-hospital data were entered prospectively in the Rouen TAVI registry. Complications and procedural outcomes were defined according to the Valvular Academic Research Consortium-2 consensus statement.4Kappetein A.P. Head S.J. Généreux P. Piazza N. van Mieghem N.M. Blackstone E.H. Brott T.G. Cohen D.J. Cutlip D.E. van Es G.A. Hahn R.T. Kirtane A.J. Krucoff M.W. Kodali S. Mack M.J. Mehran R. Rodés-Cabau J. Vranckx P. Webb J.G. Windecker S. Serruys P.W. Leon M.B. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document.J Am Coll Cardiol. 2012; 60: 1438-1454Abstract Full Text Full Text PDF PubMed Scopus (1393) Google Scholar Clinical and transthoracic echocardiographic parameters were obtained at baseline, discharge, and 1 month.The study population was divided into 2 groups based on tertile length of stay values. Length of stay was calculated from TAVI procedure (day 0) to discharge. Patients in the lowest tertile (length of stay ≤3 days, n = 121) constituted the Early Discharge group, and patients with a length of stay >3 days (n = 216) constituted the Late Discharge group. Qualitative variables were expressed as percentage, and quantitative variables as mean ± SD or median (25th to 75th interquartile range). Comparison of numerical variables was performed with the Student t test or Wilcoxon rank-sum test, depending on variable distribution. The chi-square test or Fisher's exact test was used to compare qualitative variables. A logistic regression multivariable analysis was used to assess independent correlates of early discharge. The model was built on the basis of the univariate association between the variable and early discharge with a p = 0.05 and an elimination p = 0.10. All statistical tests were 2 sided. Differences were considered statistically significant at a p value ≤0.05. All data were analyzed using SPSS software (version 17.0; IBM, Armonk, New York).ResultsA total of 424 consecutive patients underwent TAVI using the SAPIEN-XT prosthesis at our center in the specified period. We excluded 65 patients implanted through transapical or transaortic routes, 14 transfemoral patients who died before 72 hours after implantation, and 8 patients who did not return home directly but were transferred to a rehabilitation center or another hospital. The final study population comprised 337 patients who returned home after discharge. The distribution of length of stay after TAVI is shown in Figure 1. One hundred twenty-one (36%) patients were discharged within 3 days (Early Discharge group), whereas 216 (64%) were discharged >3 days after TAVI (Late Discharge group). The proportion of patients with a length of stay ≤3 days over the years is shown in Figure 2. Interestingly, the incidence of early discharge gradually increased from 0% in 2009 to 53.2% in 2013. In parallel, the mean length of stay gradually decreased from 2009 to 2013 (Figure 3).Figure 2Bar graph representation of the proportion of early discharge from 2009 to 2013.View Large Image Figure ViewerDownload Hi-res image Download (PPT)Figure 3Bar graph representation of the mean length of stay from 2009 to 2013.View Large Image Figure ViewerDownload Hi-res image Download (PPT)Baseline characteristics of the studied population are listed in Tables 1 and 2. Patients in the Early Discharge group had less renal failure and were more likely to have a history of pacemaker. Moreover, they had less history of atrial fibrillation and balloon aortic valvuloplasty and were less symptomatic. Other variables were comparable between the 2 groups.Table 1Baseline characteristicsVariablesOverallpopulation(n=337)Earlydischarge(n=121)Latedischarge(n=216)PAge (years)84.0 ± 6.883.7 ± 6.984.2 ± 6.20.46Men145 (43.0%)58 (47.9%)87 (40.3%)0.17Body mass index (kg/m2)26.6 ± 5.126.8 ± 5.126.5 ± 5.10.61Hypertension240 (71.2%)89 (73.6%)151 (69.9%)0.56Diabetes mellitus101 (30.0%)32 (26.4%)69 (31.9%)0.32Previous myocardial infarction34 (10.1%)12 (9.9%)22 (10.2%)0.94Previous percutaneous coronary intervention75 (22.2%)25 (20.7%)50 (23.1%)0.60Previous coronary bypass31 (9.2%)11 (9.1%)20 (9.3%)0.96Sinus rhythm238 (70.6%)94 (77.6%)144 (66.6%)0.04History of atrial fibrillation140 (41.5%)40 (33.1%)100 (46.3%)0.02Right bundle branch block43 (12.8%)19 (15.7%)24 (11.1%)0.22Pacemaker38 (11.3%)20 (16.5%)18 (8.3%)0.02Previous balloon aortic valvuloplasty64 (18.9%)14 (11.6%)50 (23.1%)0.01Peripheral artery disease35 (10.4%)15 (6.8%)20 (9.3%)0.37Porcelain aorta11 (3.3%)5 (4.1%)6 (2.8%)0.50Previous stroke19 (5.6%)7 (5.8%)12 (5.6%)0.93Creatinine (μmol/l)109.4 ± 53.5102.1 ± 41.0113.3 ± 58.90.04Creatinine clearance (ml/min)47.0 ± 22.450.9 ± 24.744.9 ± 20.80.02Chronic obstructive pulmonary disease59 (17.5%)20 (16.5%)39 (18.1%)0.72Chest irradiation18 (5.3%)8 (6.6%)10 (4.6%)0.44Neoplasia55 (16.3%)19 (15.7%)36 (16.7%)0.80NYHA III or more241 (72.6%)78 (64.5%)163 (75.5%)0.01Logistic EuroSCORE (%)16.9 ± 9.615.6 ± 9.617.6 ± 9.50.07 Open table in a new tab Table 2Baseline echocardiographic characteristicsVariablesOverallpopulation(n=337)Earlydischarge(n=121)Latedischarge(n=216)PAnnulus diameter (mm)21.5 ± 2.321.6 ± 2.021.5 ± 2.50.93Mean aortic gradient (mm Hg)47.0 ± 17.947.0 ± 17.147.1 ± 18.80.96Aortic valve area (cm2)0.64 ± 0.240.61 ± 0.250.65 ± 0.240.12Pulmonary artery systolic pressure (mm Hg)44.8 ± 14.944.4 ± 12.945.0 ± 15.80.77Pulmonary artery systolic pressure ≥ 60 mm Hg37 (11.0%)8 (6.6%)29 (13.4%)0.19Left ventricular ejection fraction (%)59.0 ± 16.359.7 ± 16.358.7 ± 16.30.61Left ventricular ejection fraction < 30%14 (4.2%)2 (1.6%)12 (5.6%)0.10 Open table in a new tab Procedural and in-hospital outcomes are listed in Table 3, Table 4, Table 5. Valve size and proportion of valve-in-valve procedures were similar in the 2 groups. Procedural duration and contrast volume were significantly lower in the Early Discharge group, whereas x-ray time was not significantly different. None of the patients in the Early Discharge group had stroke, life-threatening bleeding, acute myocardial infarction, or acute kidney injury stages 2 or 3 before discharge. Furthermore, patients in the Early Discharge group had less major bleeding/vascular complications and transfusions. Other variables were not significantly different between the 2 groups. ICU stay was significantly shorter in the Early Discharge group. Postprocedural echocardiographic characteristics are listed in Table 4. Mean aortic gradient and aortic valve area were similar, whereas the proportion of patients with an aortic regurgitation ≥grade 2 was significantly lower in the Early Discharge group.Table 3Procedural outcomesVariablesOverallpopulation(n=337)Earlydischarge(n=121)Latedischarge(n=216)PValve size (mm)0.2323154 (45.7%)52 (43.0%)102 (47.2%)26153 (45.4%)54 (44.6%)99 (45.8%)2930 (8.9%)15 (12.4%)15 (6.9%)Valve-in-valve5 (1.5%)1 (0.8%)4 (1.8%)0.66Procedural duration (minutes)102.4 ± 46.483.4 ± 43.8110.6 ± 45.50.02X-ray time (minutes)19.6 ± 9.019.0 ± 11.720.0 ± 6.90.38Contrast volume (ml)194.4 ± 74.5183.7 ± 63.7200.6 ± 79.50.05 Open table in a new tab Table 4Post-procedural echocardiographic characteristicsVariablesOverallpopulation(n=337)Earlydischarge(n=121)latedischarge(n=216)PMean aortic gradient (mm Hg)10.3 ± 4.510.3 ± 4.410.2 ± 4.50.78Aortic valve area (cm2)1.72 ± 0.641.73 ± 0.641.71 ± 0.650.69Aortic regurgitation ≥ Grade 278 (23.1%)20 (16.5%)58 (26.8%)0.03Pulmonary artery systolic pressure (mm Hg)29.6 ± 21.227.0 ± 19.731.0 ± 21.90.10Left ventricular ejection fraction (%)59.0 ± 16.360.7 ± 15.262.0 ± 14.50.47 Open table in a new tab Table 5In-hospital outcomesVariablesOverallpopulation(n=337)Earlydischarge(n=121)Latedischarge(n=216)PStroke Major stroke4 (1.2%)04 (1.9%)0.14 Minor stroke2 (0.5%)02 (0.9%)0.32 Transient ischemic attack2 (0.5%)02 (0.9%)0.32Bleeding Life-threatening22 (6.5%)022 (10.2%)<0.0001 Major36 (10.7%)6 (4.9%)30 (13.8%)0.01 Minor25 (7.4%)7 (5.8%)18 (8.3%)0.39 Transfusions61 (18.1%)3 (2.4%)58 (26.8%)<0.0001Acute kidney injury0.01 Stage 32 (0.5%)02 (0.9%) Stage 21 (0.3%)01 (0.4%) Stage 150 (14.8%)8 (6.6%)42 (19.4%)Vascular complications Major52 (15.4%)7 (5.8%)45 (20.8%)<0.0001 Minor25 (7.4%)8 (6.6%)17 (7.8%)0.70 Urgent vascular surgery4 (1.2%)04 (1.9%)0.30 Failure of closure device16 (4.7%)1 (0.8%)15 (6.9%)0.002 Covered stent28 (8.3%)4 (3.3%)24 (11.1%)0.01Peri-procedural myocardial infarction2 (0.6%)02 (0.9%)1Pacemaker20 (5.9%)4 (3.3%)15 (6.9%)0.13Days from procedure to Intensive Care Unit dischargeMedian (interquartile range)1 (1)1 (1)2 (2)<0.0001Days from procedure to dischargeMedian (interquartile range)5 (4)3 (1)6 (4)<0.0001 Open table in a new tab Univariate and multivariable analyses were performed to identify predictive factors of early discharge and are listed in Tables 6 and 7. Pre-existing pacemaker before TAVI and absence of acute kidney injury were independent predictors of an early discharge, whereas previous balloon aortic valvuloplasty and post-TAVI blood transfusions were independent predictors of a late discharge.Table 6Predictive factors of early discharge using univariate analysisVariablesUnivariate analysisOddratio95%Confidence IntervalPvalueTransfusions0.070.02-0.23<0.0001Major vascular complication0.240.10-0.540.001Covered stent0.280.09-0.830.02Left ventricular ejection fraction ≤ 30%0.300.06-1.350.19Life-threatening or major bleeding0.320.13-0.800.01Previous balloon aortic valvuloplasty0.430.23-0.810.01Atrial fibrillation0.530.35-0.980.04NYHA ≥ 30.530.33-0.880.01Aortic regurgitation ≥ grade 2 post TAVI0.540.31-0.950.03Delta haemoglobin0.580.47-1.720.11Haemoglobin before TAVI0.900.77-1.040.15Creatinine clearance before TAVI0.990.98-1.000.02Delta creatinine0.990.98-1.00<0.0001NT-pro brain natriuretic peptide1.001.00-1.000.86Age1.010.98-1.040.46Logistic EuroSCORE1.021.00-1.050.07Diabetes mellitus1.320.81-2.170.27Man1.370.87-2.130.17Sinus rhythm1.721.03-2.860.04Previous pacemaker2.171.10-4.350.02Delta haemoglobin was defined as the difference between the haemoglobin levels before the procedure and the nadir value after the procedure.Delta creatinine was defined as the difference between the creatinine levels before the procedure and the highest value after the procedure. Open table in a new tab Table 7Predictive factors of early discharge using multivariable analysisVariablesOddratio95%Confidence IntervalPvalueTransfusions0.100.03-0.420.002Previous balloon aortic valvuloplasty0.440.22-0.910.03NYHA ≥30.590.33-1.050.07Atrial fibrillation0.650.35-1.190.16Aortic regurgitation ≥ grade 2 post TAVI0.660.33-1.330.24Major vascular complication0.850.26-2.780.79Delta creatinine0.990.98-0.990.02Creatinine clearance before TAVI1.010.99-1.020.10Logistic EuroSCORE1.010.98-1.040.60Previous pacemaker2.271.01-5.260.05Delta creatinine was defined as the difference between the creatinine levels before the procedure and the highest value after the procedure. Open table in a new tab The primary end point occurred similarly between the 2 groups (Figure 4). No patient died in the Early Discharge group. Two deaths occurred in the Late Discharge group related to life-threatening bleeding and acute kidney injury stage 3 in 1 case and to major stroke in the other case. The proportion of patients readmitted within 30 days was low and not significantly different between the 2 groups. Importantly, none of the patients discharged early presented with delayed high degree atrioventricular block, whereas 1 patient in the Late Discharge group was readmitted for symptomatic bradycardia requiring pacemaker.Figure 4Bar graph representation of the combined primary end point including death and rehospitalization from discharge to 30-day follow-up in the Early (black) and Conventional (white) Discharge groups.View Large Image Figure ViewerDownload Hi-res image Download (PPT)DiscussionThe results of this study lead to the following conclusions: (1) in an uncomplicated planned transfemoral procedure using Edwards SAPIEN-XT valve and local anesthesia, early discharge is feasible and safe in selected patients and its incidence increased gradually during the study period, to reach eventually about half of our patients; and (2) previous pacemaker, absence of previous balloon aortic valvuloplasty, and transfusions after TAVI were independent predictors of early discharge after TAVI.There is no consensus on the duration of monitoring required after transfemoral TAVI and no published studies evaluating the feasibility and safety of early discharge. 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CoreValve United States Clinical InvestigatorsTranscatheter aortic valve replacement using a self-expanding bioprosthesis in patients with severe aortic stenosis at extreme risk for surgery.J Am Coll Cardiol. 2014; 63: 1972-1981Crossref PubMed Scopus (772) Google Scholar In the French National Transcatheter Aortic-Valve Implantation (FRANCE-2) registry, the mean length of stay was 10.5 ± 8.1 days.8Gilard M. Eltchaninoff H. Iung B. Donzeau-Gouge P. Chevreul K. Fajadet J. Leprince P. Leguerrier A. Lievre M. Prat A. Teiger E. Lefevre T. Himbert D. Tchetche D. Carrié D. Albat B. Cribier A. Rioufol G. Sudre A. Blanchard D. Collet F. Dos Santos P. Meneveau N. Tirouvanziam A. Caussin C. Guyon P. Boschat J. Le Breton H. Collart F. Houel R. Delpine S. Souteyrand G. Favereau X. Ohlmann P. Doisy V. Grollier G. Gommeaux A. Claudel J.P. Bourlon F. Bertrand B. Van Belle E. Laskar M. FRANCE 2 InvestigatorsRegistry of transcatheter aortic-valve implantation in high-risk patients.N Engl J Med. 2012; 366: 1705-1715Crossref PubMed Scopus (1032) Google Scholar Using a step-by-step simplification of transfemoral TAVI procedures, early discharge has emerged in our group as a reasonable option considering the reduction of required sheath size, a careful selection of patients avoiding compassionate cases, and the growing experience of the operators. Obviously, the occurrence of any major complication after TAVI and TAVI performed in hemodynamically unstable patients require prolonged recovery and do not allow an early discharge. In our experience, most of the major complications after Edwards SAPIEN-XT transfemoral TAVI occurred within the first 48 hours. Indeed, in our study, only 3 patients presented with a delayed major complication (occurring from discharge to 30 days): 1 case of transient ischemic attack and 1 case of acute kidney injury stage 3 in the Early Discharge group and 1 case of life-threatening gastrointestinal bleeding in the Late Discharge group. Moreover, occurrence of conduction disturbances including complete atrioventricular block are immediate and more often temporary using the Edwards Sapien-XT prosthesis. Our group and others previously reported a low incidence of persistent complete atrioventricular block requiring permanent pacemaker using the Edwards SAPIEN-XT prosthesis.15Godin M. Eltchaninoff H. Furuta A. Tron C. Anselme F. Bejar K. Sanchez-Giron C. Bauer F. Litzler P.Y. Bessou J.P. Cribier A. Frequency of conduction disturbances after transcatheter implantation of an Edwards Sapien aortic valve prosthesis.Am J Cardiol. 2010; 106: 707-712Abstract Full Text Full Text PDF PubMed Scopus (68) Google Scholar, 16Laynez A. Ben-Dor I. Barbash I.M. Hauville C. Sardi G. Maluenda G. Xue Z. Satler L.F. Pichard A.D. Lindsay J. Waksman R. Frequency of conduction disturbances after Edwards SAPIEN percutaneous valve implantation.Am J Cardiol. 2012; 110: 1164-1168Abstract Full Text Full Text PDF PubMed Scopus (40) Google Scholar, 17Franzoni I. Latib A. Maisano F. Costopoulos C. Testa L. Figini F. Giannini F. Basavarajaiah S. Mussardo M. Slavich M. Taramasso M. Cioni M. Longoni M. Ferrarello S. Radinovic A. Sala S. Ajello S. Sticchi A. Giglio M. Agricola E. Chieffo A. Montorfano M. Alfieri O. Colombo A. Comparison of incidence and predictors of left bundle branch block after transcatheter aortic valve implantation using the CoreValve versus the Edwards valve.Am J Cardiol. 2013; 112:

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