SOLACE AU Registry: Interim results at 30 days of the Edwards SAPIEN XT ™ Transcatheter Heart Valve in intermediate risk patients with severe aortic stenosis in Australia (original) (raw)
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American Heart Journal, 2010
Transcatheter aortic valve implantation (TAVI) is an alternative treatment option for patients with aortic stenosis deemed high risk or unsuitable for aortic valve replacement. The aim of this study was to assess the feasibility of TAVI in elderly patients, the delivery of this technology with a multidisciplinary approach, and the use of traditional surgical scoring systems. One hundred fifty-one consecutive patients (mean age 82.6 +/- 7.3 years) with severe aortic stenosis underwent TAVI with the Edwards Lifesciences (Irvine, CA) Sapien bioprosthesis using the transapical (n = 84; 56%) or transfemoral (n = 67; 44%) approach from August 2007 to September 2009 at King's Health Partners, London, United Kingdom. We analyzed procedural outcome, complications, functional status, and midterm outcome of patients. The multidisciplinary team comprised interventional cardiologists, cardiothoracic surgeons, imaging specialists, cardiac anesthetists, and specialist nurses. Seventy percent of patients were in New York Heart Association class III/IV, and logistic EuroSCORE was 21.6 +/- 11.9. Procedural success was achieved in 98%. Postoperative complications included stroke (6%), complete atrioventricular block (5.3%), renal failure requiring hemofiltration (9.3%), and vascular injury (8.6%). Overall 30-day mortality was 9.9% (n = 15). The logistic EuroSCORE was a predictor of short-term mortality (logistic regression model, P < .05). Thirty-day mortality post-TAVI for patients with logistic EuroSCORE <20, 20 to 40, and >40 was 5.4%, 13.2%, and 22.2%, respectively. Transcatheter aortic valve implantation is a feasible treatment option in this patient group with promising short/medium-term results. Renal failure is the commonest short-term complication, and the incidence of vascular complications remains high. Risk prediction/case selection remains challenging, and a multidisciplinary team approach appears to be helpful in appropriate patient selection.
The American Journal of Cardiology, 2011
Transcatheter aortic valve implantation (TAVI) with the Cribier-Edwards prosthesis may provide an alternative to conventional aortic valve replacement in high-risk patients with aortic stenosis. Previous studies have indicated that TAVI is feasible in this patient population. Transcatheter implantation of a Cribier-Edwards prosthesis was attempted in 55 patients in a United States Food and Drug Administration-approved prospective observational study. Clinical and echocardiographic outcomes were assessed in hospital and at 30 days, 6 months, and 12 months. Fifty-five patients (55% women, mean age 83 years) with a mean aortic valve area of 0.57 ؎ 0.14 cm 2 and a mean logistic European System for Cardiac Operative Risk Evaluation score of 33.5 ؎ 17.0% were enrolled. Transcatheter heart valves were implanted successfully in 48 patients (87%). Mean echocardiographic aortic valve area improved from 0.56 ؎ 0.14 to 1.6 ؎ 0.48 cm 2 after the procedure (p <0.0001). Thirty-day all-cause mortality and major adverse cardiac and cerebrovascular events were 7.3% and 20%, respectively. There were also 7 major procedural vascular complications (12.7%). Mortality and major adverse cardiac and cerebrovascular events increased to 23.6% and 32.7%, respectively, at 1 year, with most late events related to underlying co-morbidities. Mean New York Heart Association functional class improved from 3.22 ؎ 0.66 at baseline to 1.50 ؎ 0.85 at 1 year follow-up (p <0.001). In conclusion, TAVI in high-risk patients with aortic stenosis was feasible, with sustained clinical benefit at 12 months. Procedural complications and late major adverse cardiac and cerebrovascular events, however, overshadowed the overall clinical benefit of TAVI in this high-risk patient population.
Transcatheter Aortic Valve Implantation in High-Risk Patients With Severe Aortic Stenosis
Circulation Journal, 2010
Although surgery is the gold standard for severe aortic stenosis (AS) treatment, it is considered high risk in elderly patients because of high complication rates, which leads to substantial hesitation in submitting such patients to surgery. With the growing need to treat elderly patients with severe AS, percutaneous transcatheter aortic valve implantation (TAVI) was pioneered in 2001, followed by implantation of a self-expanding percutaneous aortic valve in 2005. As of April 2010, these 2 methods of TAVI have been used in more than 15,000 patients throughout the world. The acute success rate of this procedure is now increasing up to 95.4% by the transfemoral approach and 92.7% by the transapical approach with regard to Edwards SAPIEN ® valve implantation. In terms of the Corevalve ReValving ® system, it is reported as 98.2% in an expert's hands. This article reviews the methods of TAVI and the devices, not yet been approved in Japan but are expected to be available in a few years.
Transcatheter aortic valve implantation: the new option for high-risk patients with aortic stenosis
Cardiology journal, 2011
Calcific aortic valve stenosis is the most common valvular heart disease in developed countries. Without surgery, the prognosis is extremely dismal. Therefore there is general agreement that surgical aortic valve replacement should be offered to patients with symptomatic severe aortic valve stenosis. However, surgery is denied to approx. 30-40% of elderly patients with severe, symptomatic aortic stenosis due to high perioperative risk. Transcatheter aortic valve implantation (TAVI) is a novel and effective procedure which provides a promising treatment option for some of these patients. This review focuses on TAVI systems, the patients who would benefit from TAVI, and the advantages and disadvantages of the procedure.
Revista Portuguesa de Cardiologia (English Edition), 2012
Introduction: Transcatheter aortic valve implantation (TAVI) is an alternative to surgical aortic valve replacement in patients with severe aortic stenosis (AS) and unacceptably high surgical risk. Methods: We present our first two years' experience with TAVI. A total of 76 AS patients were evaluated for TAVI and 23 of them underwent a TAVI procedure. These patients had a mean EuroSCORE of 22.4% and a mean age of 81.5 years, and were prospectively followed for a mean of 12.9±11 months. Results: The percutaneous aortic valve was successfully implanted in 100% of the patients. Mortality at 30 days was 4%. The most common complications were access site-related bleeding and transfusion (22%), followed by new permanent pacemaker implantation (9%). After a mean follow-up of 12.9 months, survival was 87%. In a maximum follow-up of 30 months there were no cases of prosthesis dysfunction or cardiovascular death.
Giornale Italiano Di Cardiologia, 2012
Background The aim of this study was to evaluate the outcomes of transcatheter aortic valve implantation (TAVI) in bicuspid aortic valve (BiAV) stenosis using a mechanically expanded Lotus™ device. The prior experience with first-generation devices showed disappointing results mainly due to increased prevalence of aortic regurgitation (AR) that exceeded those observed in tricuspid stenosis. Methods and results We collected baseline, in-hospital, 30-day and 2-year follow-up data from a prospective, multicentre registry of patients with BiAV undergoing TAVI using Lotus™ valve. Safety and efficacy endpoints were assessed according to VARC-2 criteria. The study group comprised 24 patients. The mean age was 73.5 years and the mean EuroSCORE 2 was 4.35 ± 2.56%. MDCT analysis revealed Type 1 BiAV in 75% of patients. The mean gradient decreased from 60.1 ± 18.3 to 15 ± 6.4 mm Hg, the AVA increased from 0.6 ± 0.19 to 1.7 ± 0.21 cm 2. One in-hospital death was observed secondary to aortic perforation. There was no severe AR and the rate of moderate AR equalled 9% at 30 days (n = 2). Device success was achieved in 83% and the 30-day safety endpoint was 17%. In the 2-year follow-up, the overall mortality was 12.5% and the 2-year composite clinical efficacy endpoint was met in 25% of the patients (n = 6) Conclusions The TAVI in selected BiAV patients using the Lotus™ is feasible and characterized by encouraging valve performance and mid-term clinical outcomes.