Percutaneous Implantation of the CoreValve (R) Self-Expanding Aortic Valve Prosthesis in Patients With Severe Aortic Stenosis: Early Experience in Spain

Area del Corazon, Hospital Universitario Central de Asturias, Oviedo, Spain.
Revista Espa de Cardiologia (Impact Factor: 3.79). 02/2010; 63(2):141-8. DOI: 10.1016/S1885-5857(10)70031-1
Source: PubMed


The aim of the study was to describe early experience and medium-term follow-up with the CoreValve self-expanding aortic prosthesis at three Spanish hospitals.
The study included patients with severe symptomatic aortic stenosis. Other inclusion criteria were: aortic valve area <1 cm(2) (<0.6 cm(2)/m(2)); aortic valve annulus diameter in the range 20-27 mm; diameter of the ascending aorta at the level of the sinotubular junction < or = 40 mm (small prosthesis) or < or = 43 mm (large prosthesis), and femoral artery diameter >6 mm.
The study included 108 patients with a mean age of 78.6 + or - 6.7 years, a mean aortic valve area of 0.63 + or - 0.2 cm(2) and a mean logistic EuroSCORE of 16% + or - 13.9% (range, 2.27%-86.4%). After valve implantation, the maximum echocardiographic transaortic valve gradient decreased from 83.8 + or - 23 to 12.6 + or - 6 mmHg. No patient presented with greater than grade-2 residual aortic regurgitation on angiography. The procedural success rate was 98.1%. No patient died during the procedure. Definitive pacemaker implantation was carried out for atrioventricular block in 38 patients (35.2%). At 30 days, all-cause mortality and the rate of the combined endpoint of death, stroke, myocardial infarction or referral for surgery were 7.4% and 8.3%, respectively. The estimated 1-year survival rate calculated using the Kaplan-Meier method was 82.3% (for a median follow-up period of 7.6 months).
Our early experience indicates that percutaneous aortic valve replacement is a safe and practical therapeutic option for patients with severe aortic stenosis who are at a high surgical risk.

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Available from: Pablo Avanzas,
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    • "Various registries have analysed the results of TAVI in different European countries and Canada [12] [13] [14] [15] [16] [17] [18]. However, except for a cooperative study carried out by three Spanish hospitals [8], no further information has been published on the results of this technique in Spain, Portugal and Ibero-America. The purpose of this paper is to report the early and long-term results, in addition to the factors that are predictive of hospital and late mortality of patients with severe aortic stenosis treated with CoreValve prosthesis in a multi-centre study: the Registro Ibero-Americano [Ibero- American Registry]. "
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    ABSTRACT: Transcatheter aortic valve implantation (TAVI) is the recommended therapy for patients with severe aortic stenosis who are not suitable candidates for surgery. The aim of this study was to describe early experience and long-term follow-up with the CoreValve self-expanding aortic prosthesis at 42 Ibero-American hospitals. Multiple centre observational study including 1220 consecutive patients with symptomatic severe aortic stenosis who are not suitable candidates for surgery and underwent transcatheter aortic valve implantation with the self-expanding Medtronic CoreValve System between December 2007 and May 2012. The registry included 1220 consecutive patients with a mean age of 80.8±6.3years and a mean logistic euroSCORE of 17.8%±13%. The procedural success rate was 96.1%. Hospital mortality was 7.3% and combined end-point was 21.3%. Aortic regurgitation after TAVI was present in 24.5% (Sellers grade≥2). The estimated 1-year and 2-year survival rates were 82.1% and 73.4% respectively. The following issues were significant independent risk factors for hospital mortality: acute kidney failure (odds ratio 3.55); stroke (odds ratio 5.72); major bleeding (odds ratio 2.64) and euroSCORE (odds ratio 1.02). Long-term predictors of mortality were diabetes mellitus (hazard ratio 1.59, 95% confidence interval 1.09-2.31), severe chronic obstructive pulmonary disease (hazard ratio 1.85, 95% confidence interval 1.85-2.88), and functional classes NYHA III-IV (hazard ratio 1.31, 95% confidence interval 1.01-1.70). Transcatheter aortic valve implantation constitutes a safe and viable therapeutic option for high operative risk patients with severe aortic stenosis. Long-term prognosis is conditioned by associate comorbidities.
    International journal of cardiology 10/2013; 169(5). DOI:10.1016/j.ijcard.2013.09.006 · 4.04 Impact Factor
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    • "CoreValve 141 (21%) 320 (48%) 143 (22%) 104 (16%) 189 (29%) Avanzas et al. [17] CoreValve 36 (33%) 9 (8%) 15 (14%) "
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    ABSTRACT: Transcatheter aortic valve implantation (TAVI) has emerged for treating aortic stenosis in patients who are poor candidates for surgical aortic valve replacement. Currently, the balloon-expandable Edwards Sapien valve-which is usually implanted via a transfemoral or transapical approach-and the self-expanding CoreValve ReValving system-which is designed for retrograde application-are the most widely implanted valves worldwide. Although a promising approach for high-risk patients, the indication may be expanded to intermediate- and eventually low-risk patients in the future; however, doing so will require a better understanding of potential complications, risk factors for these complications, and strategies to individualize each patient to a different access route and a specific valve. This paper reviews the most relevant complications that may occur in patients who undergo catheter-based aortic valve implantation.
    05/2013; 2013:956252. DOI:10.1155/2013/956252
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    ABSTRACT: Storia Il primo impianto di protesi aortica per via percutanea della valvola CoreValve ReValving System (CoreValve Inc., Irvine, CA, USA) è stato effettuato da J. La Borde e da E. Grube nel 2004 (1-4) . Il sistema CoreValve ReValving System è una protesi costituita, in quella di prima gene-razione, da lembi di pericardio bovino successivamente sostituiti con pericardio porcino montati su uno stent di nitinolo autoespandibile (Fig. 1). Essa è disponibile in due misure, 26 e 29 mm di inflow, e viene introdotta per via transarteriosa (femorale o succlavia) mediante intro-duttore 18F (protesi di III generazione) (Fig. 1). Dal 2004 il sistema ha avuto continui e costanti progressi tecnologici soprattutto nel sistema di rilascio che da un calibro di 25F è stato ridotto a 18F (prossimamente a 16F) per cui la procedura inizialmente eseguita in aneste-sia generale, con il sistema di assistenza Tandem Heart e con isolamento chirurgico dell'accesso arterioso attual-mente è una procedura eseguibile totalmente per approc-cio percutaneo senza assistenza circolatoria e in anestesia locale con paziente sveglio o in blanda sedazione (5,6) . Selezione del paziente La selezione del paziente è certamente il momento fonda-mentale per l'indicazione corretta e il risultato immediato della procedura (1,4,6-10) . Essa consta di varie fasi come l'analisi della morfologia della valvola aortica, lo studio dell'aorta toracica e soprattutto degli accessi vascolari arteriosi. Un'adeguata valutazione permette di ridurre al minimo il rischio di complicanze peri-e postprocedurali.
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