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 (original) (raw)
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Thirty-day results of the SAPIEN Aortic Bioprosthesis European Outcome (SOURCE) registry
Circulation, 2010
Background-Transcatheter aortic valve implantation was developed to mitigate the mortality and morbidity associated with high-risk traditional aortic valve replacement. The Edwards SAPIEN valve was approved for transcatheter aortic valve implantation transfemoral delivery in the European Union in November 2007 and for transapical delivery in January 2008. Methods and Results-The SAPIEN Aortic Bioprosthesis European Outcome (SOURCE) Registry was designed to assess the initial clinical results of the Edwards SAPIEN valve in consecutive patients in Europe after commercialization. Cohort 1 consists of 1038 patients enrolled at 32 centers. Patients who were treated with the transapical approach (nϭ575) suffered more comorbidities than the transfemoral patients (nϭ463), resulting in a significantly higher logistic EuroSCORE (29.1% versus 25.7%; PϽ0.001). Therefore, these groups are considered different, and outcomes cannot be compared. Overall short-term procedural success was observed in 93.8%. The incidence of valve embolization was 0.3% (nϭ3), and coronary obstruction was reported for 0.6% (nϭ6 cases). Incidence of stroke was 2.5% and similar for both procedural approaches. Thirty-day mortality was 6.3% in transfemoral patients and 10.3% in transapical patients. The occurrence of vascular complications was not a predictor of Ͻ30-day mortality in the transfemoral population. Conclusion-Technical proficiency can be learned and adapted readily as demonstrated by the short-term procedural success rate and low 30-day mortality rates reported in the SOURCE Registry. Specific complication management and refinement of patient selection are needed to further improve outcomes. (Circulation. 2010;122:62-69.) Key Words: aorta Ⅲ catheters Ⅲ stenosis Ⅲ valves Ⅲ balloon valvuloplasty I ncreased life expectancy has resulted in a growing elderly population and consequently an increase in the number of patients with aortic valve disease. Severe aortic stenosis represents the most common indication for aortic valve replacement (AVR). 1 The main cause of acquired aortic stenosis in the United States and Europe is now senile degenerative calcification; a minority of stenoses are a result of rheumatic heart disease. After the onset symptoms (angina, syncope, heart failure), average survival is 2 to 3 years with a high risk of sudden death. 2 Editorial see p 8 Clinical Perspective on p 69 AVR has been the only effective treatment in adults with severe symptomatic aortic stenosis that provides symptomatic relief and long-term survival. 3 The overall operative mortality rate for isolated AVR surgery ranges from 2.5% to 4.0%. 1,4,5 However, the operative risk is higher in octogenarians and nonagenarians (4.9% to 9.6%) 6 and can be up to 25% in patients with comorbid conditions. 6-9 Therefore, minimized-access AVR was developed to mitigate surgical trauma and morbidities associated with AVR through a full median sternotomy. 10 However, it still needs the support of extracorporal circulation. Advancements in transcatheter therapeutics have led to the innovation of transcatheter aortic valve implantation (TAVI). The first patient was treated in 2002 by Cribier and colleagues. 11 Recently, the Edwards SAPIEN valve was approved for commercial use in the European Union; the transfemoral delivery was approved in November 2007 and transapical Continuing medical education (CME) credit is available for this article. Go to http://cme.ahajournals.org to take the quiz.
The Annals of Thoracic Surgery, 2011
Background: Transaortic transcatheter aortic valve implantation (TAo-TAVI) is a recently developed approach that provides an alternative delivery route for valve replacement in patients with vascular abnormalities or existing comorbidities. While initial studies have shown the principal efficacy and safety, the real world effectiveness and safety of this approach remains to be fully assessed. Methods/Design: In this regard, the Registry Of the Utilization of the TAo-TAVI approach using the Edwards SAPIEN Valve (ROUTE) represents the first multicenter, multinational prospective documentation of the course and outcome of patients with severe calcific aortic stenosis (AS) undergoing TAo-TAVI. ROUTE commenced in February 2013 with the goal of consecutively enrolling 300 patients at up to 22 sites across Europe. The primary objective of ROUTE is to determine the 30-day mortality associated with TAo-TAVI using the Edwards SAPIEN THV (Edwards Lifesciences, Irvine, CA). In addition, ROUTE aims to quantify complications, predictors of patient outcome and the value of CT guided valve sizing.
Transapical aortic valve implantation: mid-term outcome from the SOURCE registry
European Journal of Cardio-Thoracic Surgery, 2013
OBJECTIVES: Transapical (TA) aortic valve implantation using the Edwards SAPIEN™ bioprosthesis was commercially introduced in Europe in January 2008. Limited data on the mid-term results are available. METHODS: Using data from the SOURCE-Registry (largest consecutive cohort treated using Edwards SAPIEN™ bioprosthesis in Europe), we report on the mid-term results (≥30 days-2 years) of TA patients. RESULTS: Between November 2007 and December 2009, a total of 1387 patients from 38 European centres underwent TA aortic valve implantation. The mean follow-up is 14.9 months, with 1004 patients who completed 1 year and 464 patients who completed the 2-year follow-up. The mean age of patients was 80.6 ± 7.1 years with a logistic-EuroSCORE of 27.6%. The main co-morbidities were coronary artery disease (55.8%), previous bypass grafting (25.5%), porcelain aorta (10.2%), previous stroke (6.5%) and peripheral vascular disease (26.4%). A total of 840 patients (60.6%) received a 26 mm and 535 (38.6%) a 23 mm Edwards SAPIEN™ bioprosthesis. Survivals at 30 days, 1 year and 2 years were 88.7, 73.8 and 65.1%, respectively. Causes of the 276 deaths observed between >30 days and 2-year follow-up were cardiac in 86 patients (31.2%), non-cardiac in 142 (51.4%) and unknown in 48 (17.4%). Cardiac causes of death included heart failure (33.7%), sudden cardiac death (33.7%), myocardial infarct (8.1%), endocarditis (5.8%) and others (18.6%). Non-cardiac deaths were related to pulmonary disease (21.1%), cancer (12.7%), renal failure (11.3%), stroke (10.6%), gastrointestinal disease (7.7%) and others (36.6%). Using univariable and multivariable analyses, logistic EuroSCORE, renal insufficiency and liver diseases were identified as independent predictors of 2-year mortality. CONCLUSIONS: These results demonstrate that in elderly patients with severe co-morbidities, TA aortic valve implantation results in excellent mid-term results. Causes of death during the mid-term follow-up are mainly non-cardiac and related to co-morbidities.
European Journal of Cardio-Thoracic Surgery, 2013
OBJECTIVES: The study aimed to evaluate 1-year outcomes of the multicentre PREVAIL transapical (TA) study of TA-aortic valve implantation (AVI) in high-risk patients. METHODS: From September 2009 to August 2010, a total of 150 patients, aged 81.6 ± 5.8 years, 40.7% female, were included at 12 European TA-AVI experienced sites. Patients received 23 (n = 36), 26 (n = 57) and 29 mm (n = 57) second-generation SAPIEN XT™ (Edwards Lifesciences, Irvine, CA, USA) valves. The mean logistic EuroSCORE was 24.3 ± 7.0, and mean Society Thoracic Surgeons score was 7.5 ± 4.4%. RESULTS: Survival was 91.3% at 30 days and 77.9% at 1 year. Subgroup analysis revealed survivals of 91.7/88.9, 86.0/70.2, 96.55/91.2% for patients receiving 23-, 26-and 29-mm valves at 30 days and at 1 year, respectively. Transthoracic echocardiography revealed preserved left ventricular ejection fraction and low gradients. Aortic incompetence was none in 41/48, trace 30/36, mild 22/12 and moderate in 7/4% at discharge and 1 year. Walking distance increased from 221 (postimplant) to 284 m (at 1 year, P = 0.0004). Three patients required reoperation due to increasing aortic incompetence during follow-up. Causes of mortality at 1 year were cardiac (n = 7), stroke (n = 1) and others (n = 5). CONCLUSIONS: The European PREVAIL multicentre trial demonstrates good functionality and good outcomes for TA-AVI using the second-generation SAPIEN XT prosthesis and the ASCENDRA-II delivery system. The 29-mm SAPIEN XT valve was successfully introduced and showed excellent results.
Transcatheter Aortic Valve Replacement With the SAPIEN 3
JACC: Cardiovascular Interventions, 2013
BACKGROUND We compared transcatheter aortic-valve replacement (TAVR), using a self-expanding transcatheter aortic-valve bioprosthesis, with surgical aortic-valve replacement in patients with severe aortic stenosis and an increased risk of death during surgery. METHODS We recruited patients with severe aortic stenosis who were at increased surgical risk as determined by the heart team at each study center. Risk assessment included the Society of Thoracic Surgeons Predictor Risk of Mortality estimate and consideration of other key risk factors. Eligible patients were randomly assigned in a 1:1 ratio to TAVR with the self-expanding transcatheter valve (TAVR group) or to surgical aortic-valve replacement (surgical group). The primary end point was the rate of death from any cause at 1 year, evaluated with the use of both noninferiority and superiority testing. RESULTS A total of 795 patients underwent randomization at 45 centers in the United States. In the as-treated analysis, the rate of death from any cause at 1 year was significantly lower in the TAVR group than in the surgical group (14.2% vs. 19.1%), with an absolute reduction in risk of 4.9 percentage points (upper boundary of the 95% confidence interval, −0.4; P<0.001 for noninferiority; P = 0.04 for superiority). The results were similar in the intention-to-treat analysis. In a hierarchical testing procedure, TAVR was noninferior with respect to echocardiographic indexes of valve stenosis, functional status, and quality of life. Exploratory analyses suggested a reduction in the rate of major adverse cardiovascular and cerebrovascular events and no increase in the risk of stroke. CONCLUSIONS In patients with severe aortic stenosis who are at increased surgical risk, TAVR with a self-expanding transcatheter aortic-valve bioprosthesis was associated with a significantly higher rate of survival at 1 year than surgical aortic-valve replacement.