The 2011-12 pilot European Sentinel Registry of Transcatheter Aortic Valve Implantation: in-hospital results in 4,571 patients
Selected in EuroIntervention by S. Brugaletta
Di Mario C, Eltchaninoff H, Moat N, Goicolea J, Ussia G, Kala P, Wenaweser P, Zembala M, Nickenig G, Barrero E, Snow T, Lung B, Zamorano P, Schuler G, Corti R, Alfieri O, Prendergast B, Ludman P, Windecker S, Sabate M,Gilard M, Witkowski A, Danenberg H, Schroeder E, Romeo F, Macaya C, Derumeaux G, Maggioni A, Tavazzi L
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The aim of this prospective multinational registry is to assess and identify predictors of in-hospital outcome and complications of contemporary TAVI practice.
Methods and results: The Transcatheter Valve Treatment Sentinel Pilot Registry is a prospective independent consecutive collection of individual patient data entered into a web-based case record form (CRF) or transferred from compatible national registries. A total of 4,571 patients underwent TAVI between January 2011 and May 2012 in 137 centres of 10 European countries. Average age was 81.4±7.1 years with equal representation of the two sexes. Logistic EuroSCORE (20.2±13.3), access site (femoral approach: 74.2%), type of anaesthesia and duration of hospital stay (9.3±8.1 days) showed wide variations among the participating countries. In-hospital mortality (7.4%), stroke (1.8%), myocardial infarction (0.9%), major vascular complications (3.1%) were similar in the SAPIEN XT and CoreValve (p=0.15). Mortality was lower in transfemoral (5.9%) than in transapical (12.8%) and other access routes (9.7%; p<0.01). Advanced age, high logistic EuroSCORE, pre-procedural ≥grade2 mitral regurgitation and deployment failure predicted higher mortality at multivariate analysis.
Increased operator experience and the refinement of valve types and delivery catheters may explain the lower rate of mortality, stroke and vascular complications than in historical studies and registries.
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What is known
Europe has played a major role in the development of transcatheter valve treatment, with the first balloon valvuloplasty in 1986 and first clinical aortic valve implant in 2002 by Alain Cribier in France. The Placement of Aortic Transcatheter Valves (PARTNER) randomised trial confirmed superiority over medical treatment or equivalency to AVR in patients deemed inoperable or at high surgical risk. The Sentinel Registry of Transcatheter Valve Treatment is part of the ESC EURObservational Study Programme and reports results of 4,571 patients from 10 pilot countries. These are presented focusing on clinical indications, patient characteristics, procedural approach, in-hospital outcome and complications.
- A total of 4571 patients underwent TAVI between January 2011 and May 2012
- Logistic Euroscore, access site, type of anaesthesia and duration of hospital stay showed wide variations amont the participating countries
- In-hospital mortality, stroke, myocardial infarction, major vascular complications were similar in the SAPIEN XT and CoreValve
- Mortality was lower in transfemoral than in transapical and other access routes
- Advanced age, high logistic EuroSCORE, pre-procedural ≥grade 2 mitral regurgitation and deployment failure predicted higher mortality at multivariate analysis
This TAVI database, which currently represents one of the largest published, showed how TAVI is clinically applied in the European countries. Al least two considerations can be drawn. First it is important to see which is the profile of the patient who received TAVI in current practice. It can be noted that 62.4% of them is older than 80 years old, whereas the remaining younger patients have higher incidence of co-morbid conditions, such as COPD or renal impairment. Secondly, it is interesting to see how wide is the variation between different European countries in terms of mean hospital stay, use of transfemoral approach or local anesthesia, etc. This variation in TAVI practice highlights the fact that the technique is in evolution, likely depending on differences in national health policy and experience of each country.