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Archives of cardiovascular diseases
Volume 103, n° 4
pages 236-245 (avril 2010)
Doi : 10.1016/j.acvd.2010.03.006
Received : 25 November 2009 ;  accepted : 18 Mars 2010
Immediate and mid-term results of transfemoral aortic valve implantation using either the Edwards Sapien™ transcatheter heart valve or the Medtronic CoreValve® System in high-risk patients with aortic stenosis
Résultats immédiats et à moyen terme de l’implantation valvulaire aortique transfémorale utilisant la prothèse Edwards Sapien™ transcatheter heart valve ou la prothèse Medtronic CoreValve® System chez des patients ayant une sténose aortique à haut risque chirurgical
 

David Attias a, , Dominique Himbert a, Gregory Ducrocq a, Delphine Détaint a, Nawwar Al-Attar b, Bernard Iung a, Fady Francis c, Jean-Michel Maury c, Eric Brochet a, Daniel Enguerrand d, Patrick Nataf b, Alec Vahanian a
a Departments of Cardiology, Bichat Hospital, Assistance publique–Hôpitaux de Paris, 46, rue Henri-Huchard, 75018 Paris, France 
b Cardiovascular Surgery, Assistance publique–Hôpitaux de Paris, Paris, France 
c Thoracic and Vascular Surgery, Assistance publique–Hôpitaux de Paris, Paris, France 
d Anaesthesiology, Bichat Hospital, Assistance publique–Hôpitaux de Paris, Paris, France 

Corresponding author. Fax: +33 1 40 25 88 65.
Summary
Objective

We sought to describe the results of transfemoral aortic valve implantation using either the Sapien™ prosthesis or the CoreValve® System.

Background

Results of transfemoral aortic valve implantation using both commercially available prostheses have rarely been studied.

Patients

Of 236 patients at high-risk or with contraindications to surgery, consecutively referred for transcatheter aortic valve implantation between October 2006 and June 2009, 83 were treated with transfemoral aortic valve implantation. The Sapien™ was the only prosthesis available until May 2008 and, since then, was used as the first option, while the CoreValve® System was used when contraindications to the Sapien™ prosthesis were present.

Results

Patients were aged 81±9 years, 98% in New York Heart Association classes III/IV, with predicted surgical mortalities of 26±14% using the EuroSCORE and 15±8% using the Society of Thoracic Surgeons Predicted Risk of Mortality score. Seventy-two patients were treated with the Sapien™ prosthesis and 11 with the CoreValve® System. The valve was implanted in 94% of the cases. Thirty-day mortality was 7%. Overall, 1- and 2-year survival rates were 78±5% and 71±7%, respectively. Among patients treated with the Sapien™, the 1-year survival rate was 67±12% in the first 20% of patients versus 86±5% in the last 80% of patients (p =0.02). In univariate analysis, early experience was the only significant predictor of 1-year mortality.

Conclusion

Combining the use of the Sapien™ and the CoreValve® prostheses increases the number of patients who can be treated by transfemoral aortic valve implantation and provides satisfactory results at 2 years in this high-risk population. The results are strongly influenced by experience.

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Résumé
Introduction

Les résultats d’une stratégie d’implantation valvulaire aortique transfémorale utilisant l’une ou l’autre des deux prothèses commercialisées ont été peu décrits.

Objectif

Décrire les résultats de l’implantation valvulaire aortique transfémorale utilisant soit la prothèse Sapien™ soit la prothèse CoreValve® System.

Patients

Sur 236 patients ayant un haut risque ou une contre-indication chirurgicale, consécutivement adressés entre octobre 2006 et juin 2009 pour implantation valvulaire aortique par cathéter, 83 ont été traités par voie transfémorale. La prothèse Sapien™ était la seule disponible jusqu’en mai 2008. Après mai 2008, elle a été utilisée en première intention tandis que la prothèse CoreValve® System a été utilisée en cas de contre-indication à la prothèse Sapien™.

Résultats

L’âge moyen des patients était de 81±9 ans ; 98 % des patients étaient en classe III ou IV de la New York Heart Association (NYHA) avec un score prédit de mortalité chirurgicale de 26±14 % selon l’EuroSCORE et 15±8 % selon le score de la Society of Thoracic Surgeons. Soixante-douze patients ont été traités avec la prothèse Sapien™ et 11 avec la prothèse CoreValve® System. La prothèse a été implantée avec succès dans 94 % des cas. La mortalité à 30 jours a été de 7 %. Au total, les survies à un et à deux ans ont été respectivement de 78±5 % et de 71±7 %. Parmi les patients traités avec la prothèse Sapien™, la survie à un an a été de 67±12 % pour les premiers 20 % contre 86±5 % pour les derniers 80 % (p =0,02). En analyse univariée, l’expérience débutante était le seul facteur prédictif de mortalité à un an.

Conclusion

L’utilisation combinée des prothèses Sapien™ et CoreValve® augmente le nombre de patients pouvant être traités par voie transfémorale et donne des résultats satisfaisants à deux ans dans cette population à haut risque. Les résultats sont fortement influencés par l’expérience des opérateurs.

The full text of this article is available in PDF format.

Keywords : Aortic stenosis, Transfemoral, Transcatheter aortic valve implantation

Mots clés : Implantation valvulaire aortique par cathéter, Voie transfémorale, Rétrécissement aortique

Abbreviations : AVR, NYHA, STS-PROM, TAVI, TEE, THV, TTE, TF


Introduction

Aortic stenosis is the most frequent valvular heart disease in Western countries [1]. According to guidelines, surgical aortic valve replacement (AVR) is the reference treatment for patients with severe symptomatic aortic stenosis [2, 3]. Seven years after the first-in-man report [4], transcatheter aortic valve implantation (TAVI) has emerged as a credible alternative therapy for patients with aortic stenosis who are considered at high-risk or with contraindications for conventional AVR [5]. In most cases, procedures are performed via transfemoral (TF) or transapical approaches [6, 7, 8], but other approaches (e.g., subclavian, transiliac) are being evaluated [9]. Among these possibilities, the TF approach is the most frequently used [10, 11]. However, no study reporting the results of TF TAVI using either of the two commercially available prostheses has been published.

The aim of this study was to describe the outcomes of 83 patients consecutively treated with TF TAVI using either the Edwards Sapien™ transcatheter heart valve (THV) (Edwards Lifesciences Inc., Irvine, CA, USA) or the Medtronic CoreValve® System (Medtronic Int. Trading, Tolochenaz, Switzerland).

Methods
Patients

From October 2006 to June 2009, all high-risk patients with severe symptomatic aortic stenosis evaluated for TAVI underwent multidisciplinary clinical evaluation, transthoracic echocardiography (TTE) and, if necessary, transesophageal echocardiography (TEE), coronary angiography, aortic and femoro-iliac angiography and multislice computed tomography. The decision to perform TAVI was taken in patients with contraindications to, or at high-risk for AVR (EuroSCORE ≥20% or Society of Thoracic Surgeons Predicted Risk of Mortality [STS-PROM] ≥10%); life expectancy >1 year [12, 13]; anatomy suitable for intervention [5]; and no need for coronary artery bypass surgery.

The TF approach was considered as the first option [10], and transapical, subclavian or transiliac in patients with contraindications to the TF approach, including: previous aortofemoral bypass, bulky aortic atherosclerosis, porcelain thoracic aorta, a minimal luminal diameter <6mm for the 18 Fr sheaths, <7mm for the 22 Fr sheaths and <8mm for the 24 Fr sheaths, vessel kinking or severe angulation and severe vascular calcification. From October 2006 to May 2008, the Edwards Sapien™ THV was the only prosthesis used. From May 2008, the Medtronic CoreValve® System was used as an alternative in cases of technical contraindications to the Sapien™ THV:

(1)
femoro-iliac diameters too small, comprised between 6 and 7 or 8mm (according to the size of the prosthesis to be implanted);
(2)
aortic annulus diameters too large, comprised between 25 and 27mm.

In patients with technical contraindications to any TAVI, AVR was reconsidered if the operative risk was not deemed prohibitive. In patients who were too frail to undergo any invasive intervention or with comorbidities that clearly limited short-term life expectancy or precluded future quality of life (mainly malignancies and cognitive disorders), a medical treatment was decided upon.

Transfemoral transcatheter aortic valve implantation (TAVI)

Procedures were performed under general anaesthesia, with fluoroscopic and TEE guidance. Patients received aspirin 75mg once daily and clopidogrel 75mg once daily for at least 4 days before the procedure, or a loading dose of clopidogrel 300mg the day before the procedure. Heparin 70UI/kg was given intravenously before retrograde crossing of the aortic valve.

Edwards Sapien™ transcatheter heart valve (THV)

Vascular access was performed using two different methods over time: a percutaneous X-ray-guided puncture for the first 19 patients; then a surgical, view-guided puncture for the last 53 patients. A femoral arterial 5 Fr sheath was placed in the opposite groin to allow pressure monitoring and aortic angiograms through a Pigtail catheter, and a venous 8 Fr sheath to allow right ventricular rapid pacing.

X-ray-guided puncture

X-ray-guided puncture was performed under fluoroscopic guidance overlying the upper part of the bony femoral head. A 6 Fr sheath (Terumo®, Tokyo, Japan) was placed in the common femoral artery and after stepwise dilatation with 8, 10 and 12 Fr dilatators, a 14 Fr sheath (Cook®, Bloomington, IN, USA) was placed to allow balloon dilatation of the aortic valve. Thereafter, further stepwise dilatation with 16, 18, 20, 22 (±24) Fr dilatators was performed on an Amplatz Extra Stiff wire (Cook®, Bjaeverstov, Denmark) before introducing the 22 or 24 Fr sheath on the same wire. The sheath was pushed through the femoroiliac axis to the aorta, using a gentle twisting motion of the catheter under fluoroscopic control. The artery was closed surgically at the end of the procedure.

View-guided puncture

The common femoral artery was exposed and dissected free just below the inguinal ligament to gain access to a soft area of the artery. Proximal and distal control of the vessel was obtained with vascular loops. After inspection and manual palpation of the artery, a puncture was made through the skin and subcutaneous tissues 2cm below the primary incision, providing a firm anchor for the sheath. The needle was then inserted in the anterior vessel wall of the common femoral artery avoiding important side-branches and bulky plaques. Then, the 22 or 24 Fr sheath was introduced on an Amplatz Extra Stiff wire or on an Extra Back Up Meier wire (Boston Scientific®, Miami, USA), under view control, without predilatation, and pushed to the descending aorta in the same fashion as described above.

Then, after retrograde crossing and predilatation of the native valve, the prosthesis was pushed by a flexible catheter RetroFlex™ (Edwards Lifesciences®, Irvine, CA, USA), positioned within the aortic valve using fluoroscopic and TEE guidance, and then delivered by balloon inflation under rapid ventricular pacing.

After valve implantation, the sheath was withdrawn on the stiff wire to the upper part of the external iliac artery. An angiogram in an anteroposterior view was then performed to study the abdominal aorta, the common iliac, and the first 2cm of the external iliac artery. Before complete withdrawal of the sheath, the access site in the common femoral artery and the visible portion of the external iliac artery were inspected to detect arterial wall disruptions. In the absence of any vascular complications, the common femoral artery was clamped and repaired with polypropylene sutures. After complete surgical vascular repair, a final angiogram was performed using a pigtail introduced in the opposite groin.

Medtronic CoreValve® System

Access and closure of the femoral artery were performed percutaneously in all cases, using the Prostar XL® 10F (Abbott Vascular® Devices Inc., Chicago, USA) with the preclosing technique. An 18 F sheath was inserted and the procedure was similar to that with the Edwards Sapien™ prosthesis until aortic balloon predilatation. Then, the prosthesis was pushed through the aorta to the left ventricle. The outer sheath was slowly retracted, allowing the deployment of the self-expanding prosthesis without rapid pacing. During the progressive deployment of the prosthesis, positioning could be corrected with gentle pull or push, according to the fluoroscopic and TEE guidance. Then, final retraction of the sheath led to complete delivery of the prosthesis.

After valve implantation, confirmation of the vascular integrity was obtained as described above, and the femoral artery was closed using the Prostar XL®.

After the procedure, patients were directed to the intensive care unit for at least 48hours. Physical examination was performed every 6hours to detect signs of limb ischemia. Antiplatelet therapy consisted of aspirin 75mg and clopidogrel 75mg daily. In case of surgical closure, inguinal drainage was withdrawn after 48hours if blood loss was <50cc/24h. Standing was usually authorized after 48hours. At discharge, patients received aspirin plus clopidogrel for 3 to 6 months, and then only one antiplatelet agent was continued. In patients requiring long-term oral anticoagulation, only one antiplatelet agent was used.

Follow-up

Hospital clinical and echocardiographic data were obtained before discharge. All adverse events were prospectively recorded. After the hospital phase, clinical and TTE follow-up were obtained in all survivors at 1 to 3 months, 6 months, 1 year and then annually.

Outcomes

Outcomes were described according to the guidelines for reporting mortality and morbidity after cardiac valve interventions [14].

Implantation success was defined by valve implantation in the correct position. Major vascular complications were defined as lesions requiring immediate or delayed vascular interventions other than a simple arterial suture, or leading to hospital death.

Statistical analysis

Data are expressed as mean±S.D., except for the length of follow-up and length of stay in hospital, which are expressed as median [25th–75th percentiles]. Categorical variables were compared by the chi-square test or Fisher’s exact test.

Late survival was analysed using Kaplan–Meier methods and survival rates are given with their standard errors. To assess experience a binary variable was used to separate the first 20% (n =15) from the last 80% (n =57) of patients treated with the Edwards Sapien™ THV. Analysis of the predictive factors of late survival was performed by a univariate analysis using a log-rank test. The 11 patients treated with the Medtronic CoreValve® System were excluded from this analysis because their implantation began in May 2008. All tests were two-sided. A p value <0.05 was considered to indicate a statistically significant difference. Statistical analysis was performed using statistical software Statistica version 5.0 (Statsoft Inc., Tulsa, Oklahoma).

Results
Patients

Of the 236 patients who were at high-risk or had contraindications to AVR, 83 (35%) were treated by TF TAVI, 72 (30%) using the Sapien™ THV and 11 (5%) the CoreValve® System. Other patients who underwent TAVI were treated by transapical (n =35, 15%) or subclavian/transiliac retroperitoneal (n =1/2, 1%) access. Thirty (13%) patients were reoriented toward conventional AVR, while 85 (36%) were considered too frail, with a life expectancy too short to undergo any invasive intervention, or had technical contraindications to both TAVI and AVR, and were treated medically.

The population studied here consisted of the 83 patients who were treated by TF TAVI. Its characteristics are detailed in Table 1. Overall, the population was at high surgical risk. Mean age was 81±9 years. Nearly all patients (98%) were in New York Heart Association (NYHA) class III or IV. The majority had coronary artery disease and more than two extracardiac comorbidities. The Sapien™ THV was used in 72 patients. Since May 2008, the CoreValve® System was chosen in 11 patients because of contraindications to the Sapien™ THV: aortic annulus diameter too large (>25 and ≤27mm) in six cases; femoro-iliac diameters too small (<7 or 8mm, ≥6mm) in five cases.

The expected operative mortality rates were 26±14% according to the EuroSCORE and 15±8% according to the STS score, with no significant difference between patients treated with the Sapien™ THV and the CoreValve® System. All patients (n =8) with a EuroSCORE <20% and an STS score <10% had contraindications to AVR, which were not taken into account by these scores: severe respiratory failure (n =5), chest radiation sequellae (n =1), intracerebral aneurysm (n =1), morbid obesity (n =1).

Thirty-day outcomes

Thirty-day outcomes are detailed in Table 2. Implantation success was achieved in 78 (94%) patients. Technical failures occurred with the Sapien™ THV. Reasons for failure included inability to pass the iliac artery in three patients, to cross the aortic valve with the prosthesis in one patient, and haemopericardium in one patient due to perforation of the left ventricle by the wire, leading to intraprocedural death. There was neither prosthesis embolization nor conversion to on-pump surgical AVR. Immediately after implantation, paravalvular leaks were frequent, but were grade ≥III in only three (4%) patients.

In one patient, emergent implantation of a second prosthesis into the first one (“valve after valve”) was necessary, due to a massive intravalvular regurgitation induced by balloon redilatation performed to treat severe paravalvular leak.

The most frequent complications were vascular, overall 12%; all occurred with the Sapien™ THV. There were four iliac dissections, of which one led to death 4 days after surgical grafting, and six femoral injuries at the entry site. All of these complications were managed during the index procedure by surgical grafting (n =6), stenting (n =2) or combined stenting and surgical grafting (n =2). These vascular complications led to transfusion in seven patients. There were neither aortic dissections nor perforations.

Strokes occurred in 5% of patients, and led to disabling sequellae in one (1%) patient only. Complete atrioventricular block requiring pacemaker implantation occurred in 8% of the cases, and tended to be more frequent after CoreValve® System implantation than after Sapien™ THV (18% vs 7%, p =0.23). One atrioventricular block occurred at 4 days, and one patient had a syncope 2 weeks after the procedure, which was also attributed to delayed complete atrioventricular block.

Causes of deaths are detailed in Table 3. All-cause 30-day mortality rate was 7% (n =6).

Late outcomes

Median follow-up was 9 months (range: 1–36 months) [3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15]. Ten deaths occurred after 30 days: three due to extracardiac causes (infections), four due to heart failure, of which two occurred in inoperable patients with one grade II and one grade III aortic regurgitations, and three were sudden, unexplained (Table 3). One- and 2-year survival rates were 78±5% and 71±7%, respectively (Figure 1). In univariate analysis, early experience was the only significant predictor of 1-year mortality: 1-year survival was 67±12% in the 15 first patients versus 86±5% in the 57 last patients (p =0.02) treated with the Edwards Sapien™ THV (Figure 2).



Figure 1


Figure 1. 

Two-year survival after transfemoral transcatheter aortic valve implantation (TAVI). Kaplan–Meier survival in the 83 patients treated with transfemoral aortic valve implantation (Sapien™ transcatheter heart valve [THV] and CoreValve® System).

Zoom



Figure 2


Figure 2. 

One-year survival after transfemoral transcatheter aortic valve implantation (TAVI) in the first versus the last patients. Kaplan–Meier survival in the first 20% of patients treated with the Sapien™ transcatheter heart valve (THV) compared to the last 80%.

Zoom

Non-lethal valve-related events consisted only in one case of endocarditis due to Streptococcus bovis that occurred 5 months after the procedure and was successfully treated medically, with no valve dysfunction. There was no reintervention, haemolysis or permanent valve-related impairment. No structural valve deterioration or dysfunction was observed. At last follow-up of the 66 survivors, 24 (36%) were in NYHA class I, 30 (46%) in class II, seven (11%) in class III and five (7%) in class IV (Figure 3). In the latter (four men, 83±10 years), reasons for remaining in class IV were not due to a poor haemodynamic result of TAVI (aortic valve area: 1.8±0.1cm2; mean gradient: 8±3mmHg).



Figure 3


Figure 3. 

Functional status before and after transcatheter aortic valve implantation (TAVI). Evolution of the New York Heart Association (NYHA) functional class in patients between the preprocedure condition and the last follow-up, after TAVI.

Zoom

Persistence of disabling symptoms was attributed to severe pulmonary disease in three cases (one of whom had idiopathic pulmonary hypertension), to depressed left ventricular ejection fraction (35%) unchanged after TAVI, and to left ventricular diastolic dysfunction in one case.

Discussion

To the best of our knowledge, this prospective study is the first to report the outcomes of patients with severe symptomatic aortic stenosis and high-risk for or contraindications to AVR, after TF TAVI using either the Sapien™ THV or the CoreValve® System. Owing to the complementarities of the devices, being able to use both of them increased the number of patients who could be treated with the TF approach. Overall, late valve-related events were rare and clinical outcomes satisfactory in terms of survival as well as functional improvement.

Sapien™ transcatheter heart valve (THV) and CoreValve® System

Besides their differences in terms of stent and prosthesis materials, and implantation technique, both devices are not strictly designed for the same anatomical profiles. As compared with the 22/24 Fr sheaths necessary to accommodate the 23/26mm Sapien™ THV, the 18 Fr sheath of the CoreValve® System allows a larger number of patients to be treated with the TF approach. This is of particular importance because vascular access remains the main cause for contraindications, failures and complications of the TF approach. Similarly, patients with large (25–27mm) aortic annulus diameters are eligible for the CoreValve® System only, while, conversely, those with small (18–20mm) diameters are eligible for the 23mm Sapien™ THV only. Despite the differences between the prostheses in terms of implantation technique, both of which required a specific learning period, the experience already acquired with the Sapien™ THV led to a shortening of this period when the CoreValve® program was started in our centre.

Early outcome

Although predictive risk scores have limitations, with a trend towards risk overestimation in the most severe patients [15, 16], the present 7% 30-day mortality clearly compares favourably with the 26% operative mortality predicted by the EuroSCORE and the 15% predicted by the STS score. It is similar to the mortality reported by Piazza et al. in a multicenter registry, using the CoreValve® System in 646 patients who, however, tended to have a lower risk profile (mean EuroSCORE 23%) [7], and it is lower than the 11% mortality reported by Grube et al. in a single-centre registry with the same device [6]. Our mortality is very similar to the one recently reported by Webb et al. in 113 patients treated via the TF approach with the Sapien™ THV [11].

One-third (2/6) of early deaths occurred during the procedure itself, and all but one within the first 24hours after performing the procedure. All deaths were due to cardiovascular causes, and specific analysis of each death suggested that most were linked to potential screening mistakes (e.g., aortic annular rupture, massive paravalvular leak after TAVI in a bicuspid valve), and possibly might have been avoided by experience. We already pointed out the major clinical impact of this learning curve [10], which is also shown by Webb et al. in their last series where 30-day mortality fell from 12.3% in the initial half of experience to 3.6% in the second half of experience [11].

The main cause of severe morbidity when using the Sapien™ THV remained vascular complications, due to the large diameters of the sheaths. However, they were seldom life-threatening or led to secondary intervention, and were mainly associated with a high need for transfusions. As previously observed in a large series [7], this risk was reduced dramatically by the use of the CoreValve® System, compatible with 18 Fr sheaths.

The second most frequent complication was represented by heart blocks necessitating pacemaker implantation. Despite a lack of statistical power, their frequency seemed, as previously observed, higher after CoreValve® System than after Sapien™ THV implantation [6, 7]. Reasons for the difference between both prostheses have been analysed [17]. Particular attention should be paid to the delay in occurrence of conduction defects, up to 4 days in the present series, implying a prolonged cardiac monitoring after the procedure for optimal safety.

Other non-fatal complications were very rare. In particular, it should be noted that there was only one (1%) stroke leading to disabling sequellae, which seems quite unexpected in this aged and high-risk population undergoing retrograde cardiac catheterization with bulky devices. Furthermore, the risk of stroke in our study was comparable with previous surgical AVR series [18], despite our patients were at higher risk than patients selected for conventional surgical AVR. Nevertheless, the risk of stroke remains a major concern. To date, there is no convincing evidence that it can be significantly reduced by the transapical approach, as compared to the TF approach. The current development of lower-profile and smaller catheters may further reduce this risk in the near future.

Late outcomes

At follow-up with a median time of 9 months and a maximum of 3 years, mortality was due to non-cardiac causes in at least one-third of the patients. As observed by Webb et al. [11], the incidence of late adverse valve-related events was low. However, contrary to the latter, we did not observe severe gastrointestinal bleedings, which occurred in patients with combined dual antiplatelet and warfarin therapy. In those patients requiring long-term anti-thrombotic therapy, our practice was indeed to restrict antiplatelet therapy to either aspirin or clopidogrel. As reported previously [19], aortic regurgitations more than mild were rare but grade ≥II paravalvular leaks contributed, at least in part, to left ventricular failure and late fatal outcomes in two patients. Overall, the 1- and 2-year survival rates were consistent with those reported in the most recent TF series [11], and compared favourably with previous ones [6, 20, 21].

Most importantly, in this aged population, functional class improvement was dramatic and sustained after TAVI. While 98% of patients were in NYHA class III or IV before intervention, 82% of survivors were in class I or II at last follow-up. There was only one stroke leading to definitive sequellae in a patient who died from sepsis 3 months after intervention. In most cases, persistence of NYHA class IV symptoms was associated with concomitant severe pulmonary disease and in others to multifactorial systolic or diastolic left ventricular dysfunction. More accurate determination of clinical predictors of poor functional results of TAVI will be necessary to further improve the effectiveness of the screening process.

Learning curve

The direct impact on patients’ outcomes of a learning curve period has already been observed and discussed in series using the Sapien™ prosthesis via a TF approach alone, or combined TF and transapical approaches [10, 11, 20]. The present study leads to the same conclusions. The comparison of the survival curves of the first and last patients shows that excess mortality in the former group occurs in the periprocedure period, with subsequently parallel curves, thus confirming the close influence of experience on patients’ immediate outcomes, via the screening process, the performance of the procedure and early postoperative care. Indeed, this learning curve involves not only the interventional cardiologists and cardiovascular surgeons in charge of the procedure, but also imaging specialists, anaesthesiologists and all the members of the team participating in the TAVI programme.

Study limitations

This study reflects a single-centre experience, with a learning period, and involving a limited number of patients. It also reflects the current results of the TF approach for TAVI, which may change in the near future due to the expected technological evolutions and greater experience. In the present study, the Sapien™ THV was the only prosthesis available until May 2008, and since then, the CoreValve® System has been used in case of contraindications to the former. This strategy is somewhat arbitrary, but has increased the number of patients who could be treated by TF TAVI. No comparison between prostheses can be drawn from its results. Several other strategies may be interesting to further assess the respective places and results of the different approaches and prostheses available, e.g., using the CoreValve® System in all patients, or the transapical approach with the Sapien™ THV in all patients, or combining the TF approach with the CoreValve® System and the transapical approach with the Sapien™ THV.

Conclusion and future directions

The availability of both Sapien™ THV and CoreValve® System increases the number of patients who can be treated by TF TAVI. Immediate results are strongly related to both the quality of the screening and experience. Late functional and survival results are satisfactory and sustained. In the near future, expected technological improvements, with reduction of sheaths diameters, will allow routine performance of entirely percutaneous procedures under local anaesthesia, and then most probably further extend the place of the TF approach for TAVI, by increasing its feasibility, safety and overall clinical benefit.

Conflicts of interest statement

Dominique Himbert is proctor for Edwards Lifesciences; Bernard Iung received speaker’s fees from Edwards Lifesciences; Alec Vahanian is consultant for Edwards Lifesciences.

References

Iung B., Baron G., Butchart E.G., and al. A prospective survey of patients with valvular heart disease in Europe: the euro heart survey on valvular heart disease Eur Heart J 2003 ;  24 : 1231-1243 [cross-ref]
Bonow R.O., Carabello B.A., Chatterjee K., and al. Focused update incorporated into the ACC/AHA 2006 guidelines for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (writing committee to revise the 1998 Guidelines for the Management of Patients With Valvular Heart Disease): endorsed by the Society of Cardiovascular Anesthesiologists. Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons Circulation 2008 ;  118 : e523-e661
Vahanian A., Baumgartner H., Bax J., and al. Guidelines on the management of valvular heart disease: the task force on the management of valvular heart disease of the European Society of Cardiology Eur Heart J 2007 ;  28 : 230-268
Cribier A., Eltchaninoff H., Bash A., and al. Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: first human case description Circulation 2002 ;  106 : 3006-3008 [cross-ref]
Vahanian A., Alfieri O.R., Al-Attar N., and al. Transcatheter valve implantation for patients with aortic stenosis: a position statement from the European Association of Cardio-Thoracic Surgery (EACTS) and the European Society of Cardiology (ESC), in collaboration with the European Association of Percutaneous Cardiovascular Interventions (EAPCI) Eur J Cardiothorac Surg 2008 ;  34 : 1-8 [cross-ref]
Grube E., Schuler G., Buellesfeld L., and al. Percutaneous aortic valve replacement for severe aortic stenosis in high-risk patients using the second- and current third-generation self-expanding CoreValve prosthesis: device success and 30-day clinical outcome J Am Coll Cardiol 2007 ;  50 : 69-76 [cross-ref]
Piazza N., Grube E., Gerckens U., and al. Procedural and 30-day outcomes following transcatheter aortic valve implantation using the third generation (18 Fr) corevalve revalving system: results from the multicentre, expanded evaluation registry 1-year following CE mark approval EuroIntervention 2008 ;  4 : 242-249
Eltchaninoff H., Zajarias A., Tron C., and al. Transcatheter aortic valve implantation: technical aspects, results and indications Arch Cardiovasc Dis 2008 ;  101 : 126-132 [inter-ref]
De Robertis F., Asgar A., Davies S., and al. The left axillary artery – a new approach for transcatheter aortic valve implantation Eur J Cardiothorac Surg 2009 ;  36 : 807-812 [cross-ref]
Himbert D., Descoutures F., Al-Attar N., and al. Results of transfemoral or transapical aortic valve implantation following a uniform assessment in high-risk patients with aortic stenosis J Am Coll Cardiol 2009 ;  54 : 303-311 [cross-ref]
Webb J.G., Altwegg L., Boone R.H., and al. Transcatheter aortic valve implantation: impact on clinical and valve-related outcomes Circulation 2009 ;  119 : 3009-3016 [cross-ref]
Lee S.J., Lindquist K., Segal M.R., Covinsky K.E. Development and validation of a prognostic index for 4-year mortality in older adults JAMA 2006 ;  295 : 801-808 [cross-ref]
Rockwood K., Stadnyk K., MacKnight C., McDowell I., Hebért R., Hogan D.B. A brief clinical instrument to classify frailty in elderly people Lancet 1999 ;  353 : 205-206 [cross-ref]
Akins C.W., Miller D.C., Turina M.I., and al. Guidelines for reporting mortality and morbidity after cardiac valve interventions J Thorac Cardiovasc Surg 2008 ;  135 : 732-738 [cross-ref]
Dewey T.M., Brown D., Ryan W.H., Herbert M.A., Prince S.L., Mack M.J. Reliability of risk algorithms in predicting early and late operative outcomes in high-risk patients undergoing aortic valve replacement J Thorac Cardiovasc Surg 2008 ;  135 : 180-187 [cross-ref]
Osswald B.R., Gegouskov V., Badowski-Zyla D., and al. Overestimation of aortic valve replacement risk by EuroSCORE: implications for percutaneous valve replacement Eur Heart J 2009 ;  30 : 74-80
Piazza N., Onuma Y., Jesserun E., and al. Early and persistent intraventricular conduction abnormalities and requirements for pacemaking after percutaneous replacement of the aortic valve J Am Coll Cardiol Intv 2008 ;  1 : 310-316 [cross-ref]
Lung B. Management of the elderly patient with aortic stenosis Heart 2008 ;  94 : 519-524
Détaint D., Lepage L., Himbert D., and al. Determinants of significant paravalvular regurgitation after transcatheter aortic valve: implantation impact of device and annulus discongruence J Am Coll Cardiol Intv 2009 ;  2 : 821-827
Webb J.G., Pasupati S., Humphries K., and al. Percutaneous transarterial aortic valve replacement in selected high-risk patients with aortic stenosis Circulation 2007 ;  116 : 755-763 [cross-ref]
Cribier A., Eltchaninoff H., Tron C., and al. 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 : 1214-1223 [cross-ref]



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