The SOURCE Registry: what is the learning curve in trans-apical aortic valve implantation? (original) (raw)
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European Journal of …, 2010
Objective: Trans-catheter aortic valve implantation is an alternative treatment option for patients facing high risk for aortic valve replacement. Currently, the results of trans-apical trans-catheter procedures performed outside controlled trials are unknown. Methods: The Edwards SAPIEN TM Aortic Bioprosthesis European Outcome (SOURCE) Registry collects data of patients treated at European centres during the first year following commercialisation of the Edwards SAPIEN TM bioprosthesis. Only data from centres that could provide 100% of their consecutively treated patients (n = 32) were included in the study population. This article provides the 30-day outcome data involving the trans-apical patients, including univariate and multivariate risk analyses for postoperative 30-day mortality. Results: The interim results are based on a total number of 575 procedures performed between January 2008 and 31 January 2009. Mean age at implant was 80.7 years, and patients had a mean logistic EuroSCORE of 29.1%. Baseline characteristics included coronary artery disease 56%, prior coronary intervention 27.1%, prior coronary bypass grafting 26.9%, concomitant mitral valve disease 32.8%, porcelain aorta 11.5%, peripheral vascular disease 27.5%, prior stroke 6.3% and pulmonary disease 29.4%. Successful valve deployment was observed in 92.7% with a 3.5% conversion rate to open surgery, incidence of coronary obstruction of 0.7% and valve embolisation of 0.5%. The incidence of aortic regurgitation in excess of 2+ was 2.3% immediately following the procedure. The incidence of major postoperative complications included bleeding requiring re-operation 2.1%, dialysis 7.1%, pacemaker implantation 7.3%, stroke 2.6%, major vascular complications 2.4% and myocardial infarction 0.7%. The total 30-day mortality was 10.3%. Logistic EuroSCORE !30% and missing ejection fraction were found to be the only independent predictors for 30-day mortality. Conclusions: These results demonstrate that although trans-apical trans-catheter aortic valve implantation is a complex surgical technique, the learning curve can be minimised by appropriate training programmes. Very high logistic EuroSCOREs predict inferior survival and make it likely that in this subgroup of patients there may be some who, despite having had a successful trans-catheter aortic valve implantation procedure, do not benefit in the midterm.
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 (n=575) suffered more comorbidities than the transfemoral patients (n=463), resulting in a significantly higher logistic EuroSCORE (29.1% versus 25.7%; P <0.001). Therefore, these groups are considered different, and outcomes cannot be compared. Overall short-term procedural success was obser...
Clinical outcomes of transcatheter aortic valve implantation: from learning curve to proficiency
Open heart, 2016
The use of transcatheter aortic valve implantation (TAVI) is growing rapidly in countries with a predominantly elderly population, posing a huge challenge to healthcare systems worldwide. The increment of human and economic resource consumption imposes a careful monitoring of clinical outcomes and cost-benefit balance, and this article is aimed at analysing clinical outcomes related to the TAVI learning curve. Outcomes of 177 consecutive transfemoral TAVI procedures performed in 5 years by a single team were analysed by the Cumulative Sum of failures method (CUSUM) according to the clinical events comprised in the Valve Academic Research Consortium (VARC-2) safety end point and the VARC-2 definition of device success. Margins for events acceptance were extrapolated from landmark trials that tested both balloon or self-expandable percutaneous valves. 30-day and 1-year survival rates were 97.2% and 89.9%, respectively. Achievement of the primary end point (number of cases needed to pr...
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.
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.
Journal of Clinical Medicine, 2022
Background: Data reflecting the benefit of procedural improvements in real-world transcatheter aortic valve implantation (TAVI) practice are sparse. Aims: To compare outcomes and trends of two TAVI eras from real Italian practice. Methods: A total of 1811 and 2939 TAVI patients enrolled in the national, prospective OBSERVANT and OBSERVANT II studies in 2010–2012 and 2016–2018, respectively, were compared in a cohort study. Outcomes were adjusted using inverse propensity of treatment weighting and propensity score matching. Results: The median age (83.0 (79.0–86.0) vs. 83.0 (79.0–86.0)) and EuroSCORE II (5.2 (3.2–7.7) vs. 5.1 (3.1–8.1)) of OBSERVANT and OBSERVANT II patients were similar. At 1 year, patients of the OBSERVANT II study had a significantly lower risk of all-cause death (10.6% vs. 16.3%, Hazard Ratio (HR) 0.63 (95% Confidence Interval (CI) 0.52–0.76)) and rehospitalization for heart failure (HF) (14.3% vs. 19.5%, Sub-distribution HR 0.71 (95%CI 0.60–0.84)), whereas rates...
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.