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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.
We soon promoted a “minimalist approach” for all transfemoral cases using local anesthesia and fluoroscopic guidance for valve implantation without intraprocedural transesophageal echocardiography.
Treatment of calcific aortic stenosis with the percutaneous heart valve mid-term follow-up from the initial feasibility studies: the French experience.
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.
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.
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.
Methods
We 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.
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.
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.
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).
Results
A 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 1Bar graph representation of the distribution of length of stay in the overall population.
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.
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.
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 analysis
Variables
Univariate analysis
Odd ratio
95% Confidence Interval
P value
Transfusions
0.07
0.02-0.23
<0.0001
Major vascular complication
0.24
0.10-0.54
0.001
Covered stent
0.28
0.09-0.83
0.02
Left ventricular ejection fraction ≤ 30%
0.30
0.06-1.35
0.19
Life-threatening or major bleeding
0.32
0.13-0.80
0.01
Previous balloon aortic valvuloplasty
0.43
0.23-0.81
0.01
Atrial fibrillation
0.53
0.35-0.98
0.04
NYHA ≥ 3
0.53
0.33-0.88
0.01
Aortic regurgitation ≥ grade 2 post TAVI
0.54
0.31-0.95
0.03
Delta haemoglobin
0.58
0.47-1.72
0.11
Haemoglobin before TAVI
0.90
0.77-1.04
0.15
Creatinine clearance before TAVI
0.99
0.98-1.00
0.02
Delta creatinine
0.99
0.98-1.00
<0.0001
NT-pro brain natriuretic peptide
1.00
1.00-1.00
0.86
Age
1.01
0.98-1.04
0.46
Logistic EuroSCORE
1.02
1.00-1.05
0.07
Diabetes mellitus
1.32
0.81-2.17
0.27
Man
1.37
0.87-2.13
0.17
Sinus rhythm
1.72
1.03-2.86
0.04
Previous pacemaker
2.17
1.10-4.35
0.02
Delta 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.
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.
The 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. Furthermore, length of stay after TAVI is rarely reported in most registries or randomized studies.
Thirty-day results of the SAPIEN Aortic Bioprosthesis European Outcome (SOURCE) registry. A European registry of transcatheter aortic valve implantation using the Edwards SAPIEN valve.
Transcatheter aortic valve implantation for the treatment of severe symptomatic aortic stenosis in patients at very high or prohibitive surgical risk: acute and late outcomes of the multicenter Canadian experience.
German Transcatheter Aortic Valve Interventions-Registry Investigators Transcatheter aortic valve implantation: first results from a multi-centre real-world registry.
CoreValve United States Clinical Investigators Transcatheter aortic valve replacement using a self-expanding bioprosthesis in patients with severe aortic stenosis at extreme risk for surgery.
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.
Comparison of incidence and predictors of left bundle branch block after transcatheter aortic valve implantation using the CoreValve versus the Edwards valve.
Furthermore, delayed (i.e., >24 hours after the procedure) high-grade atrioventricular block has never been reported using the Edwards SAPIEN-XT prosthesis. In contrast, with the Corevalve, the incidence of complete atrioventricular block requiring permanent pacemaker is higher, occurring in up to 25% of cases and can be delayed, thus requiring prolonged electrocardiographic monitoring after TAVI.
Comparison of incidence and predictors of left bundle branch block after transcatheter aortic valve implantation using the CoreValve versus the Edwards valve.
By multivariable analysis, the most powerful predictive factor of early discharge failure was transfusions. Bleeding is a frequent complication after TAVI and is mainly related to femoral access and vascular complications at the puncture site. Life-threatening and major bleedings occurred in 17.2%, and transfusion of at least 1 red blood cell unit was necessary in 18.1%. These results are in accordance with those previously reported by our group and others.
Life-threatening bleeding and postprocedural transfusions are independent predictors of 30-day mortality and are associated with prolonged length of stay after TAVI.
Bleeding after TAVI could be decreased by careful selection of patients, smaller size devices, and avoiding a loading dose of clopidogrel before the procedure.
Finally, early discharge after TAVI should have a significant economic impact. Cost-effectiveness of TAVI has been previously evaluated in the randomized Placement of Aortic Transcatheter Valves (PARTNER) trial.
PARTNER Investigators Cost-effectiveness of transcatheter aortic valve replacement compared with surgical aortic valve replacement in high-risk patients with severe aortic stenosis: results of the PARTNER (Placement of Aortic Transcatheter Valves) trial (Cohort A).
PARTNER Investigators Cost-effectiveness of transcatheter aortic valve replacement compared with standard care among inoperable patients with severe aortic stenosis: results from the placement of aortic transcatheter valves (PARTNER) trial (Cohort B).
Compared with medical management, it has been shown that TAVI increases life expectancy and is a cost-effective treatment in inoperable patients with severe aortic stenosis.
PARTNER Investigators Cost-effectiveness of transcatheter aortic valve replacement compared with surgical aortic valve replacement in high-risk patients with severe aortic stenosis: results of the PARTNER (Placement of Aortic Transcatheter Valves) trial (Cohort A).
PARTNER Investigators Cost-effectiveness of transcatheter aortic valve replacement compared with standard care among inoperable patients with severe aortic stenosis: results from the placement of aortic transcatheter valves (PARTNER) trial (Cohort B).
Comparison of transfemoral transcatheter aortic valve replacement performed in the catheterization laboratory (minimalist approach) versus hybrid operating room (standard approach): outcomes and cost analysis.
recently demonstrated a cost reduction of 10,000 US$ with the minimalist strategy in comparison with the conventional approach in patients hospitalized in the United States. Therefore, TAVI could be an economically attractive strategy compared with surgical aortic valve replacement for patients suitable for transfemoral access and eligible for early discharge.
The results of our study are limited by its design, data being obtained retrospectively from a single large volume center with significant expertise with TAVI. It is, therefore, possible that other confounding unmeasured factors could influence the results. Furthermore, we could not accurately analyze the cause of “nonearly” discharge in patients who did not have major complications. In particular, the autonomy of patient and any refusal by the patient and/or family were not evaluated in this study. A prospective ongoing study is, therefore, mandatory to confirm the feasibility and safety of early discharge after TAVI using the latest generation of balloon-expandable Edwards's prosthesis and to define the ideal candidates for that strategy.
Disclosures
Hélène Eltchaninoff and Alain Cribier are proctors for Edwards Lifesciences and Alain Cribier is consultant for Edwards Lifesciences.
References
Cribier 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.
Treatment of calcific aortic stenosis with the percutaneous heart valve mid-term follow-up from the initial feasibility studies: the French experience.
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.
Thirty-day results of the SAPIEN Aortic Bioprosthesis European Outcome (SOURCE) registry. A European registry of transcatheter aortic valve implantation using the Edwards SAPIEN valve.
Transcatheter aortic valve implantation for the treatment of severe symptomatic aortic stenosis in patients at very high or prohibitive surgical risk: acute and late outcomes of the multicenter Canadian experience.
Comparison of incidence and predictors of left bundle branch block after transcatheter aortic valve implantation using the CoreValve versus the Edwards valve.
Cost-effectiveness of transcatheter aortic valve replacement compared with surgical aortic valve replacement in high-risk patients with severe aortic stenosis: results of the PARTNER (Placement of Aortic Transcatheter Valves) trial (Cohort A).
Cost-effectiveness of transcatheter aortic valve replacement compared with standard care among inoperable patients with severe aortic stenosis: results from the placement of aortic transcatheter valves (PARTNER) trial (Cohort B).
Comparison of transfemoral transcatheter aortic valve replacement performed in the catheterization laboratory (minimalist approach) versus hybrid operating room (standard approach): outcomes and cost analysis.
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