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Archives of cardiovascular diseases
Volume 109, n° 8-9
pages 457-464 (août 2016)
Doi : 10.1016/j.acvd.2016.01.016
Received : 19 June 2015 ;  accepted : 27 January 2016
Trends over the past 4 years in population characteristics, 30-day outcomes and 1-year survival in patients treated with transcatheter aortic valve implantation
Évolution des caractéristiques cliniques et des complications à 30jours chez les patients traités par TAVI sur les 4 dernières années

Guillaume Avinée, Eric Durand , Safwane Elhatimi, Fabrice Bauer, Bastien Glinel, Jean-Nicolas Dacher, Guillaume Cellier, Guillaume Viart, Christophe Tron, Matthieu Godin, Pierre-Yves Litzler, Alain Cribier, Hélène Eltchaninoff
 Centre Hospitalier Universitaire Charles-Nicolle, Université de Rouen, Inserm U1096, Rouen, France 

Corresponding author. Department of Cardiology, Charles-Nicolle Hospital, University of Rouen, 1, rue de Germont, 76031 Rouen cedex, France.

Transcatheter aortic valve implantation (TAVI) is recommended in patients with severe aortic stenosis that is either inoperable or at high-risk for surgical valve replacement.


To evaluate trends in the feasibility and safety of transfemoral TAVI over the past 4 years.


Between 2010 and 2013, all consecutive patients undergoing TAVI in our institution were included in a prospective registry. Population characteristics and 30-day and 1-year outcomes were analysed. Outcomes were classified according to the Valve Academic Research Consortium-2.


Overall, 429 patients underwent TAVI; transfemoral access was used in 368 (85.7%). The proportion of patients treated via a transfemoral approach increased (70.1% to 89.9%; P <0.0001) and the use of prior balloon aortic valvuloplasty decreased (44.7% to 11.2%; P <0.0001). The mean logistic EuroSCORE decreased significantly from 19.4±10.9% to 15.8±8.7% (P =0.01). The 30-day mortality rate did not change significantly (6.4% vs. 5.6%; P =0.99). Similarly, rates of major vascular complications (12.8% vs. 15.4%; P =0.87) and stroke (2.1% vs. 1.4%; P =0.75) remained unchanged. Mean length of stay after TAVI decreased significantly from 8.9±11.3 days to 4.8±4.7 days (P =0.002) and 72 (50.3%) patients were discharged early in 2013. One-year survival increased significantly from 81.0% to 94.4% (P =0.03).


Over the past 4 years, TAVI has been increasingly performed using a transfemoral approach. Treated patients are at lower-risk with less co-morbidity. Thirty-day mortality and complications remained unchanged, but length of stay after TAVI and 1-year mortality decreased dramatically.

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L’implantation d’une valve aortique par voie percutanée est actuellement indiquée chez les patients présentant un rétrécissement aortique serré et symptomatique quand ils sont jugés inopérables ou à haut risqué chirurgical.


Évaluation de la faisabilité et de la sécurité d’une implantation d’une valve aortique par voie percutanée (TAVI) sur une période de 4ans.


De 2010 à 2013, les patients bénéficiant d’un TAVI dans notre centre ont été inclus consécutivement dans un registre prospectif. Les caractéristiques de la population, les résultats à 30jours et la survie à un an ont été analysés. Les évènements ont été classés selon les critères établis pas le Valve Academic Research Consortium (VARC)-2.


Quatre cent vingt-neuf patients ont bénéficié d’un TAVI, par accès transfémoral (TF) dans 368 cas (85,7 %). La proportion de voie TF a augmenté de 70,1 % à 89,9 % (p <0,0001) et le recours préalable à une valvuloplastie au ballon a diminué de 44,7 % à 11,2 % (p <0,0001). L’EuroSCORE logistique moyen a diminué de 19,4±10,9 % à 15,8±8,7 % (p =0,01). La mortalité à 30jours ne changeait pas significativement (6,4 % contre 5,6 % ; p =0,99). Les complications vasculaires majeures (12,8 % contre 15,4 % ; p =0,87) et les accidents vasculaires cérébraux (2,1 % contre 1,4 % ; p =0,75) présentaient une incidence stable. La durée moyenne de séjour a diminué de 8,9±11,3 à 4,8±4,7jours (p =0,002) et 72 (50,3 %) patients bénéficiaient d’un retour précoce à domicile. La survie à 1 an s’est améliorée significativement (p =0,03).


Le TAVI a été pratiqué de manière croissante, l’approche transfémorale ayant été possible chez 90 %. Les patients sont à moindre risque. La mortalité à 30jours et les complications restent inchangées alors qu’on note une importante diminution de la durée de séjour et une amélioration de la survie à 1 an.

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Keywords : Aortic stenosis, TAVI, VARC-2

Mots clés : Rétrécissement aortique, TAVI, VARC-2

Abbreviations : CT, STS, TAVI, TTE, VARC-2


Since the first-in-man transcatheter aortic valve implantation (TAVI) in 2002 [1], more than 200,000 patients have been treated worldwide; the technique is currently restricted to inoperable and high-risk patients with severe symptomatic aortic stenosis. Indeed, the PARTNER I randomized studies showed that TAVI is superior to medical therapy in inoperable patients, and is an alternative to surgery in high-risk patients [2, 3]. These data were obtained using first-generation balloon-expandable valves (Edwards SAPIEN; Edwards Lifesciences, Irvine, CA, USA), requiring 22F and 24F sheaths for the 23-mm and 26-mm valves, respectively. The large calibre of the introducers, restricting the femoral route to about 50% of cases, and the lack of a 29-mm valve at that time, were the main limitations of the technique. Since October 2009, subsequent technical and procedural improvements have allowed the development of a new generation of balloon-expandable valves, such as the Edwards SAPIEN XT (Edwards Lifesciences) that has a decreased sheath size, using the NovaFlex™ (Edwards Lifesciences) delivery system. The objective of this study was to evaluate the clinical characteristics, 30-day outcomes and 1-year survival of patients undergoing TAVI at our institution over 4 years, between January 2010 and December 2013.

Patient selection

Between January 2010 and December 2013, 429 consecutive patients underwent TAVI using the balloon-expandable Edwards SAPIEN XT prosthesis (Edwards Lifesciences) or the self-expanding CoreValve (Medtronic, Minneapolis, MN, USA), and were included in a prospective single-centre registry. All patients had severe symptomatic aortic stenosis. The indication for TAVI was based on the decision of the Heart Team. The patients were considered candidates for TAVI when their logistic EuroSCORE was ≥20% in case of frailty or co-morbidities contraindicating surgical aortic valve replacement. All patients provided signed informed consent for subsequent data collection and analysis for research purposes.

The screening process included transthoracic echocardiography (TTE), selective coronary angiography, aortography, iliofemoral angiography and computed tomography (CT) of the aorta/aortic valve and iliofemoral access. Transoesophageal echocardiography was not used. CT was performed to assess the feasibility of a transfemoral approach. A minimum diameter of 6mm was required for a CoreValve and minimum diameters of 6, 6.5 and 7mm were required for the 23-mm, 26-mm and 29-mm Edwards SAPIEN XT valves, respectively. Tortuosities, as well as the degree and extent of calcifications, were assessed to confirm suitability for a femoral approach. CT also assessed the distribution of valvular and annular calcifications, the distances between the annulus and the ostia of both coronary arteries and the measurement of the annulus (diameter, perimeter and area), as previously described.


Briefly, the Edwards SAPIEN XT valve is made of three bovine pericardial leaflets sewn onto a cobalt chromium frame; it is crimped over the shaft of the NovaFlex™ delivery system and mounted on the balloon after introduction into the abdominal aorta. The CoreValve is a self-expanding nitinol-framed valve, with three leaflets made of porcine pericardial tissue, delivered by a catheter after being loaded onto it by a specific compression system.

Cardiac catheterization and premedication

Transfemoral procedures were performed in a conventional cardiac catheterization laboratory, with sterile precautions, using local anaesthesia and conscious sedation (nalbuphine 5mg and midazolam 1mg) in all cases. TTE was not used during the procedure and the percutaneous approach was performed using a preclosing system (Prostar; Abbott Inc., Chicago, IL, USA). All of the equipment was present and ready to use in the catheterization laboratory, and the anaesthesiologist, echocardiographer and surgeon were immediately available in the event of any complication. Until June 2013, patients were preloaded with aspirin (160mg) and clopidogrel (300mg), and continued clopidogrel (75mg daily) for 1-month and aspirin (75mg daily) indefinitely. After June 2013, patients no longer received a loading dose of clopidogrel, and clopidogrel was started at 75mg after the procedure. Heparin (70 IU/kg) was administered immediately after insertion of the sheath, and systematically reversed at the end of the procedure by protamine sulphate administration since 2013.


The techniques of Edwards SAPIEN XT and CoreValve valve implantation have been described in detail elsewhere [4, 5]. Briefly, in our centre, supravalvular aortography was performed to select the optimal view, aligning all cusps in a single plane. In many cases, the optimal configuration was preset with the help of three-dimensional CT aorta reconstruction. The selected femoral artery was “preclosed” with a 10F Prostar XL (Abbott Inc.). After crossing the aortic valve, a preshaped, 260cm long, 0.035 inch Amplatz Extra-Stiff Wire (Cook Medical, Bloomington, IN, USA) was placed in the left ventricle. Balloon sizing (i.e. supravalvular aortography performed during balloon aortic valvuloplasty) was performed in all cases under rapid ventricular pacing, as a final annulus assessment to choose the valve size. Valve positioning was based on fluoroscopy, using annular calcification as a landmark. The Edwards SAPIEN XT prosthesis was delivered using rapid ventricular pacing. The femoral arteriotomy was closed using the Prostar device. In the absence of a persistent atrioventricular block, the pacing lead was removed at the end of the procedure. Patients were monitored in the intensive care unit for at least 24hours after valve implantation.

Data collection

Data on clinical and TTE variables were obtained at baseline, discharge and 1-month, and were entered into our institutional database. In patients from remote institutions, outcomes at 30days were obtained by telephone interviews with the referring physician and exchange of TTE reports. One-year survival was obtained by systematic yearly check-up or by telephone interviews for patients lost to follow-up or from remote institutions.

Endpoint definitions

All-cause mortality and complications (stroke, bleeding, acute kidney injury, myocardial infarction and vascular complications) were reported at 30days according to the Valve Academic Research Consortium-2 (VARC-2) classification [6]. Other endpoints included device success and New York Heart Association heart failure functional class. Transvalvular mean aortic gradient, effective aortic valve area and the presence and severity of aortic valvular regurgitation were assessed by TTE according to the VARC-2 guidelines [6].

Statistical analysis

Continuous variables are presented as means±standard deviations or medians (interquartile ranges), according to the distribution. Categorical variables are presented as frequencies and percentages. Comparison between the four periods was done by the Kruskal–Wallis and Bonferroni–Holm–Shaffer tests for continuous and categorical variables, respectively. Survival rates were estimated up to 1 year by Kaplan–Meier analysis, and comparisons were made using the log-rank test. Differences were considered statistically significant at P values<0.05. All statistical analysis was performed using SPSS, version 17.0 (IBM, Armonk, NY, USA).

Baseline characteristics

During the study period, 429 patients underwent TAVI in our centre. The annual number of procedures increased from 67 in 2010 to 159 in 2013 (Figure 1). Among them, 368 (85.7%) were implanted via a transfemoral approach. The proportion of transfemoral approaches increased during this period, from 70.1% in 2010 to 85.1% in 2011, 89.6% in 2012 and 89.9% in 2013 (Figure 1).

Figure 1

Figure 1. 

Bar graph representation of the annual number (and percentage) of procedures over the period of 4 years via transfemoral (TF, blue), transapical (TA, red) and transaortic (TAo, green) approaches.


The baseline clinical characteristics of patients undergoing a transfemoral procedure are shown in Table 1. The mean age was 84.1 years, and this did not vary significantly (P =0.80) over the study period. The proportion of patients previously treated by balloon aortic valvuloplasty decreased significantly from 44.7% in 2010 to 11.2% in 2013 (P <0.0001). The mean logistic EuroSCORE also decreased significantly during this period, from 19.4±10.9% in 2010 to 15.8±8.7% in 2013 (P =0.01). Other baseline characteristics did not vary significantly over the study period. The baseline echocardiographic characteristics are shown in Table 2, and did not vary significantly during the study period.

Procedural outcomes

Procedural outcomes are shown in Table 3. We mostly used the Edwards SAPIEN XT valve (n =359, 97.6%), whereas 7 (1.9%) and 2 (0.5%) patients were treated with the Medtronic CoreValve and SAPIEN 3 prosthesis, respectively. Eight (2.2%) procedures were performed in degenerative surgical aortic prostheses (valve-in-valve).

A percutaneous approach was performed predominantly, and a surgical cut-down was required in only five cases, all performed in 2010. Two patients presented with an annulus rupture leading to death, despite a bailout valve-in-valve procedure (one case in 2011 and the other in 2013). One patient presented with a left ventricular perforation and died at day 1. Two valve migrations occurred, requiring urgent cardiac surgery (in 2012 and 2013). Another patient had fatal perprocedural left main coronary artery occlusion. Vasopressors were used in only 18 patients (4.9%), without significant variation over the study period. X-ray time decreased significantly over the years (from 21.4±1.5minutes in 2010 to 18.1±10.0minutes in 2013; P =0.002), as did the amount of contrast used (208.7±97.0mL vs. 169.9±55.8mL; P <0.0001). Interestingly, the mean length of stay decreased from 8.9±11.3 days in 2010 to 4.8±4.7 days in 2013 (P =0.002). In 2013, 72 patients (50.3%) were discharged home early within 3 days. The proportion of patients requiring a permanent pacemaker was low, and remained stable during the study period.

Post-procedural echocardiographic characteristics

Post-procedural echocardiographic characteristics are shown in Table 4. The mean aortic gradient and the effective aortic valve area were stable over the study period. The incidence of paravalvular aortic regurgitation ≥grade II was also unchanged, and occurred in about 20% of cases.

Thirty-day outcomes

Thirty-day outcomes are shown in Table 5. The overall incidence of 30-day death was 6%, without significant variation over time. The incidences of major stroke and myocardial infarction were low and stable during the study period. Bleeding and vascular complications were the most frequent complications after TAVI, without significant variation over the study period. The use of a covered stent for failure of the percutaneous closure device decreased (13.2% in 2011 vs. 6.2% in 2013), although the difference was not significant (P =0.20).

One-year survival analysis

Kaplan–Meier curves are shown in Figure 2. One-year survival increased during the study period from 81.0% to 94.4% (P =0.03). Interestingly, curves were closely similar during the first 30days, and improved significantly from 1-month to 12-month follow-up during the last 2years.

Figure 2

Figure 2. 

Kaplan–Meier estimates of survival up to 1 year.



We report our experience of TAVI over 4 years in a high-volume centre pioneering the technique. The main findings of this study were the increase in the number of transfemoral procedures; the high success rate; the low and stable rate of complications; the inclusion of lower-risk patients over the years; and the higher 1-year survival.

Since the first-in-man TAVI by Alain Cribier in 2002 [1], the number of procedures performed worldwide has dramatically increased, reaching approximately 200,000 patients around the world. Based on the recommendations of the European Society of Cardiology, TAVI is currently indicated in inoperable patients, and is considered as an alternative to conventional surgery in high-risk patients [7]. While the first generation of valves required a surgical approach for transfemoral procedures, the advent of the Edwards SAPIEN XT valve, with a reduction in the size of the introducer, enabled the development of fully percutaneous procedures and expansion of the femoral approach. The performance of transfemoral procedures using local anaesthesia without transoesophageal echocardiography is constantly increasing, as pointed out in our study, with 90% of patients treated via a transfemoral approach in 2013. Before the advent of the Edwards SAPIEN XT valve, approximately 50% of patients were treated via a transapical approach with the Edwards SAPIEN valve. Furthermore, generalization and simplification of transfemoral procedures in our centre have made early discharge (i.e.<3 days) feasible in over half of cases [8]. The simplification of procedures is a key element in the management of an often elderly population, in whom shorter hospital stay is known as a major determinant for fast recovery and gained autonomy.

Although the technique is performed in a high-risk population, the success rate of the procedure is very high, with a low and acceptable rate of major complications. In our centre, the 30-day mortality rate was stable at around 6%. These results are consistent with data from FRANCE, FRANCE 2 and SOURCE registries, which reported 30-day mortality rates of 8.4%, 8.5% and 6.3%, respectively [9, 10, 11]. More recent data released by the Society of Thoracic Surgery and the American College of Cardiology, including patients treated in the USA from November 2010 to May 2013, reported 30-day mortality rates of 5% and 6.7% in high-risk and non-operable patients, respectively [12]. In our study, we did not observe any significant decrease in 30-day mortality and major complications during the study period (2010–2013), using the same device (i.e. the Edwards SAPIEN XT prosthesis) almost exclusively, although we included lower-risk patients in the latest period. We believe that perprocedural complication occurrences, and not the logistic EuroSCORE, have a major effect on 30-day mortality after TAVI. In contrast, 1-year survival improved gradually from 2010 to 2014, and the difference was significant. These results suggest that long-term outcomes are improved in lower-risk patients. On the other hand, the incidence and severity of paravalvular aortic regurgitation was stable during the study period. Using the latest generation of balloon-expandable valves (Edwards SAPIEN 3; 14F–16F introducers), a decrease in vascular complications and the severity of paravalvular aortic regurgitation is anticipated. Because we used the Edwards SAPIEN 3 prosthesis in 2014, the 30-day mortality rate dropped dramatically to 1.5%, and we observed a significant decrease in the occurrence of major vascular complications and paravalvular aortic regurgitation ≥grade II (unpublished data).

Finally, we note that there is a general trend, which goes beyond our institution, towards the inclusion of lower-risk patients. According to data from the FRANCE and FRANCE 2 registries, it appears that patients treated by TAVI are at lower-risk, as the mean logistic EuroSCORE decreased from 25.6±11.4% to 20.5±12.6% during these two periods in France [9, 10]. We included very low-risk patients in the latest period, with a mean logistic EuroSCORE of 15.8±8.7% in 2013, and this was associated with a dramatic increase in 1-year survival. Similar trends are observed in North America, when comparing the population included in the PARTNER IA study, evaluating TAVI in a high-risk population (Society of Thoracic Surgeons [STS] score 11.8±3.3%), with the recent USA post-market registry, including patients with an STS median score of around 7 (interquartile range: 5–11) [3, 12]. Similarly, in the CHOICE study comparing the Edwards SAPIEN XT and CoreValve transcatheter heart valves, the average STS score was 6% [13]. Given the extremely positive data coming from the various recent European and North American registries, it is already routinely accepted that in elderly patients, typically aged>80–85 years, TAVI would be justified whatever their risk score, if a transfemoral approach is feasible. Indeed, most of these patients are eligible for a minimally invasive procedure using local anaesthesia and early discharge (<3 days), and do not show excess mortality compared with surgical treatment [14]. We await the results of randomized studies comparing surgery and TAVI in patients at intermediate risk, especially the SURTAVI and PARTNER 2 studies. A recent preliminary observational study found no difference at 30days and 1 year between two matched groups of patients [15].

Study limitations

This study reports the results of a highly experienced single-centre using the Edwards SAPIEN XT valve predominantly; the results of our study must be weighed against its observational nature. We report the characteristics and outcomes of TAVI over 4 years in a context of rapid technological change. Since the introduction of the third generation Edwards SAPIEN 3 in September 2014, a significant improvement, in terms of residual aortic regurgitation and vascular complications associated with reduced 30-day mortality, has been already described and also observed in our institution [16, 17].


We report our experience of TAVI over a period of 4 years using the Edwards SAPIEN XT valve predominantly. During this period, we observed an increase in the annual number of procedures performed in lower-risk patients. About 90% of procedures are feasible with a transfemoral approach, with a high success rate and stable and low rates of complications. One-year survival has increased yearly since lower-risk patients were included. It is likely that the results will be further improved with the advent of the Edwards SAPIEN 3 valve.

Disclosure of interest

A. C. and H. E.: consultants and proctors for the company Edwards Lifesciences.

P.-Y. L.: proctor for the company Edwards Lifesciences.

The other authors declare that they have no competing interest.


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