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.
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.
Introduction
Aortic stenosis is the most frequent valvular heart disease in Western countries . According to guidelines, surgical aortic valve replacement (AVR) is the reference treatment for patients with severe symptomatic aortic stenosis . Seven years after the first-in-man report , 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 . In most cases, procedures are performed via transfemoral (TF) or transapical approaches , but other approaches (e.g., subclavian, transiliac) are being evaluated . Among these possibilities, the TF approach is the most frequently used . 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 ; anatomy suitable for intervention ; and no need for coronary artery bypass surgery.
The TF approach was considered as the first option , 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 <6 mm for the 18 Fr sheaths, <7 mm for the 22 Fr sheaths and <8 mm 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 8 mm (according to the size of the prosthesis to be implanted);
- (2)
aortic annulus diameters too large, comprised between 25 and 27 mm.
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 75 mg once daily and clopidogrel 75 mg once daily for at least 4 days before the procedure, or a loading dose of clopidogrel 300 mg the day before the procedure. Heparin 70 UI/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 2 cm 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 2 cm 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 48 hours. Physical examination was performed every 6 hours to detect signs of limb ischemia. Antiplatelet therapy consisted of aspirin 75 mg and clopidogrel 75 mg daily. In case of surgical closure, inguinal drainage was withdrawn after 48 hours if blood loss was <50 cc/24 h. Standing was usually authorized after 48 hours. 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 .
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 ≤27 mm) in six cases; femoro-iliac diameters too small (<7 or 8 mm, ≥6 mm) in five cases.
| Overall ( n = 83) | Sapien™ THV ( n = 72) | CoreValve ® System ( n = 11) | P | |
|---|---|---|---|---|
| Age (years, mean ± S.D.) | 81 ± 9 | 81 ± 9 | 79 ± 7 | 0.26 |
| Women | 39 (47) | 36 (50) | 3 (27) | 0.20 |
| New York Heart Association class | ||||
| II | 2 (2) | 2 (3) | 0 (0) | |
| III | 45 (54) | 41 (57) | 4 (36) | 0.32 |
| IV | 36 (43) | 29 (40) | 7 (64) | |
| Coronary artery disease | 42 (51) | 36 (50) | 6 (55) | 1 |
| Previous myocardial infarction | 11 (13) | 9 (13) | 2 (18) | 0.63 |
| Previous PCI | 16 (19) | 13 (18) | 3 (27) | 0.44 |
| Previous CABG | 18 (22) | 17 (24) | 1 (9) | 0.44 |
| Peripheral artery disease | 23 (28) | 20 (28) | 3 (27) | 1 |
| Renal failure | 26 (31) | 21 (29) | 5 (45) | 0.3 |
| Severe COPD | 27 (33) | 21 (29) | 6 (26) | 0.16 |
| Cancer | 27 (32) | 20 (28) | 7 (64) | 0.04 |
| Porcelain aorta | 6 (7) | 4 (6) | 2 (18) | 0.18 |
| Two or more comorbidities | 43 (52) | 36 (50) | 7 (64) | 0.52 |
| Aortic valve area (cm 2 ) | 0.69 ± 0.18 | 0.66 ± 0.16 | 0.89 ± 0.21 | 0.005 |
| Aortic valve area (cm 2 /m 2 BSA) | 0.40 ± 0.10 | 0.38 ± 0.10 | 0.49 ± 0.10 | 0.009 |
| Mean gradient (mmHg) | 52 ± 16 | 53 ± 16 | 46 ± 13 | 0.13 |
| Left ventricular ejection fraction (%) | 52 ± 15 | 51 ± 15 | 58 ± 13 | 0.15 |
| Aortic annulus diameter (mm) | 23 ± 2 | 23 ± 2 | 24 ± 3 | 0.46 |
| Bicuspid aortic valve | 3 (4) | 1 (1) | 2 (18) | 0.04 |
| Minimal arterial diameter (mm) | 7.8 ± 1 | 7.9 ± 1 | 7 ± 1 | 0.12 |
| Logistic EuroSCORE (%), mean ± S.D. (range) | 26 ± 14 (3–90) | 26 ± 15 (3–90) | 23 ± 8 (9–37) | 0.24 |
| STS-PROM (%), mean ± S.D. (range) | 15 ± 8 (3–47) | 15 ± 7 (3–35) | 14 ± 15 (6–47) | 0.93 |
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