Summary
Background
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.
Aims
To evaluate trends in the feasibility and safety of transfemoral TAVI over the past 4 years.
Methods
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.
Results
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).
Conclusions
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.
Résumé
Contexte
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.
Objectif
Évaluation de la faisabilité et de la sécurité d’une implantation d’une valve aortique par voie percutanée (TAVI) sur une période de 4 ans.
Méthodes
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 30 jours 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.
Résultats
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 30 jours 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 ± 4,7 jours ( 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).
Conclusions
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 30 jours 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.
Background
Since the first-in-man transcatheter aortic valve implantation (TAVI) in 2002 , 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 . 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.
Methods
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 6 mm was required for a CoreValve and minimum diameters of 6, 6.5 and 7 mm 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.
Devices
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 5 mg and midazolam 1 mg) 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 (160 mg) and clopidogrel (300 mg), and continued clopidogrel (75 mg daily) for 1-month and aspirin (75 mg daily) indefinitely. After June 2013, patients no longer received a loading dose of clopidogrel, and clopidogrel was started at 75 mg 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.
Procedure
The techniques of Edwards SAPIEN XT and CoreValve valve implantation have been described in detail elsewhere . 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, 260 cm 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 24 hours 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 30 days 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 30 days according to the Valve Academic Research Consortium-2 (VARC-2) classification . 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 .
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).
Results
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 ( Fig. 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 ( Fig. 1 ).
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.
| Overall population ( n = 368) | 2010 ( n = 47) | 2011 ( n = 83) | 2012 ( n = 95) | 2013 ( n = 143) | P | |
|---|---|---|---|---|---|---|
| Age (years) | 84.1 ± 6.7 | 82.7 ± 7.5 | 85.7 ± 5.8 | 83.0 ± 7.4 | 84.3 ± 6.3 | 0.80 |
| Men | 162 (44.0) | 17 (36.2) | 37 (44.6) | 45 (47.4) | 63 (44.1) | 0.66 |
| Body mass index (kg/m 2 ) | 27.0 ± 5.4 | 27.0 ± 4.8 | 26.9 ± 4.9 | 27.4 ± 6.3 | 26.7 ± 5.2 | 0.71 |
| Hypertension | 266 (72.3) | 38 (80.9) | 55 (66.3) | 61 (64.2) | 112 (78.3) | 0.03 |
| Diabetes | 111 (30.2) | 15 (31.9) | 26 (31.3) | 29 (30.5) | 41 (28.7) | 0.96 |
| Previous myocardial infarction | 41 (11.1) | 7 (14.9) | 8 (9.6) | 8 (8.4) | 18 (12.6) | 0.60 |
| Previous PCI | 84 (22.8) | 13 (27.7) | 16 (19.3) | 21 (22.1) | 34 (23.8) | 0.72 |
| Previous stroke | 23 (6.3) | 2 (4.3) | 5 (6.0) | 6 (6.3) | 10 (7.0) | 0.93 |
| Previous CABG | 35 (9.5) | 6 (12.8) | 8 (9.6) | 13 (13.7) | 8 (5.6) | 0.17 |
| History of atrial fibrillation | 149 (40.5) | 18 (38.3) | 36 (43.4) | 41 (43.2) | 54 (37.8) | 0.78 |
| Right bundle-branch block | 46 (12.7) | 8 (17.0) | 11 (13.3) | 9 (9.7) | 18 (12.9) | 0.66 |
| Pacemaker | 41 (11.1) | 2 (4.3) | 5 (6.0) | 14 (14.7) | 20 (14.0) | 0.08 |
| Previous BAV | 66 (17.9) | 21 (44.7) | 13 (15.7) | 16 (16.8) | 16 (11.2) | < 0.0001 |
| Peripheral artery disease | 40 (10.9) | 9 (19.1) | 6 (7.2) | 12 (12.6) | 13 (9.1) | 0.16 |
| Porcelain aorta | 13 (3.5) | 4 (8.5) | 2 (2.4) | 4 (4.2) | 3 (2.1) | 0.50 |
| Neoplasia | 58 (15.8) | 9 (19.1) | 16 (19.3) | 18 (18.9) | 15 (10.5) | 0.18 |
| Creatinine (μmol/L) | 108.9 ± 52.9 | 120.4 ± 70.0 | 105.0 ± 44.2 | 106.5 ± 62.7 | 109.0 ± 43.3 | 0.48 |
| Creatinine clearance (mL/min) | 48.4 ± 22.2 | 46.9 ± 24.5 | 47.5 ± 43.0 | 52.9 ± 23.8 | 46.4 ± 21.2 | 0.90 |
| Chronic obstructive pulmonary disease | 65 (17.7) | 15 (31.9) | 17 (20.5) | 18 (18.9) | 15 (10.5) | 0.007 |
| Chest irradiation | 19 (5.2) | 3 (6.4) | 4 (4.8) | 3 (3.2) | 9 (6.3) | 0.72 |
| NYHA III or more | 267 (72.8) | 37 (78.7) | 59 (71.9) | 70 (73.7) | 101 (70.6) | 0.59 |
| Logistic EuroSCORE (%) | 17.0 ± 9.4 | 19.4 ± 10.9 | 18.2 ± 11.1 | 16.5 ± 7.5 | 15.8 ± 8.7 | 0.01 |
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